Boots Clotrimazole 500mg Vaginal Tablet


Boots Clotrimazole 500 mg Vaginal Tablet

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat thrush. However, you still need to use it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice You must contact a pharmacist or doctor if your symptoms worsen or do not go away after 3 days What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called antifungals, which act to treat infections caused by fungi. It can be used to treat thrush (vaginal candidiasis). Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

Itching of the vagina and surrounding area (the vulva) Redness and swelling of the tissues of the vagina and vulva Soreness of the vagina and vulva A white non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but it is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

Soreness and redness of the penis Tightness of the foreskin An abnormal penile discharge Before you use this medicine

This medicine can be used by women between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use: If you are allergic to any of the ingredients If you are pregnant, unless your doctor tells you to – if your doctor tells you to use the pessary do not use the applicator to insert it Talk to your pharmacist or doctor: If this is the first time you have had these symptoms If you are under 16 years, or 61 years or older If you have had thrush more than twice in the last 6 months If you or your partner have been exposed to a sexually transmitted disease If you have lower stomach pain, or pain or a burning sensation on passing urine If you have abnormal or irregular vaginal bleeding, or a blood-stained discharge If you have sores, ulcers or blisters on your vulva or vagina Other important information

The ingredients in the pessary may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the pessary.

You can help the treatment to work if you follow these simple self-help tips:

Although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further Keep the affected areas of skin clean Pay particular attention to drying the skin but avoid excessive rubbing

To help prevent thrush from coming back once you have treated it, follow these simple steps:

Wash daily Wear cotton underwear and loose fitting clothing Try to avoid wearing tights, nylon underwear and tight fitting clothing After going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel Try to avoid washing with perfumed soaps or using vaginal deodorants Do not rub hard with sponges or flannels and avoid hot baths with strong perfumed oils Change your sanitary protection regularly If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time. If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine

The carton contains a single pessary held inside a foil blister pack and an applicator for insertion of the pessary into the vagina. Check the foil is not broken before use. If it is, do not use the pessary.

Women aged 16 to 60 years: Insert the pessary into the vagina at night using the applicator provided.

If you are pregnant do not use the applicator. Wash and dry your hands, and insert the pessary with your fingers.

Directions for inserting the pessary Remove the applicator from the packaging Pull out the plunger until it stops Remove the pessary from the blister pack and place the pessary firmly into the applicator To fit the pessary into the applicator, squeeze the applicator lightly on either side. The pessary fits tightly into the applicator and needs to be pushed into the holder about 1 cm Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when laying on your back with your knees bent up) Holding the applicator in place, slowly press the plunger until it stops so that the pessary is deposited into the vagina. Remove the applicator Dispose of the applicator in a safe place, out of the reach of children The applicator cannot be flushed down the toilet Wash your hands thoroughly after use

For use in the vagina only.

Do not use the pessary at the same time as you are having a period. Wait until your period has finished.

Do not use for children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than one pessary.

After you use the pessary the symptoms of thrush (itching, burning, discharge) should go away within 3 days.

If symptoms worsen or do not go away after 3 days talk to your doctor.

If anyone accidentally swallows the pessary: Talk to a doctor straight away or go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects see a doctor:

Allergic reaction (e.g. skin rash, red or itchy skin)

These other effects are less serious.

If they bother you talk to a pharmacist:

Mild burning or irritation straight after inserting the pessary

The side effects of this medicine can be very similar to the symptoms that you are treating.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

This vaginal tablet contains Clotrimazole 500 mg, which is the active ingredient.

As well as the active ingredient, the vaginal tablet also contains lactose, adipic acid, pregelatinised maize starch, sodium hydrogen carbonate, microcrystalline cellulose, magnesium stearate, maize starch, stearic acid, colloidal silicon dioxide, polysorbate 80.

The pack contains 1 vaginal tablet with an applicator.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE19 3ET

Leaflet prepared February 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3379eMC


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Clotrimazole Betamethasone Lotion



Dosage Form: lotion, cream
Clotrimazole and Betamethasone Dipropionate Cream, USP
Clotrimazole and Betamethasone Dipropionate Lotion

Rx only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.

Clotrimazole Betamethasone Lotion Description

Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.

Chemically, clotrimazole is 1-(o-chloro-?,?-diphenylbenzyl)imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula:

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has the chemical name 9-fluoro-11?,17,21-trihydroxy-16?-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Clotrimazole and Betamethasone Dipropionate Cream, USP contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum; benzyl alcohol as preservative.

Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color.

Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic base of ceteareth-30, cetyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, white petrolatum; benzyl alcohol as preservative.

Clotrimazole and Betamethasone Dipropionate Lotion is opaque and white in color.

Clotrimazole Betamethasone Lotion - Clinical Pharmacology Clotrimazole and Betamethasone Dipropionate

Clotrimazole and Betamethasone Dipropionate Cream, USP has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. No comparative studies have been conducted with Clotrimazole and Betamethasone Dipropionate Lotion and clotrimazole alone. Use of corticosteroids in the treatment of a fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate.

Clotrimazole

Skin penetration and systemic absorption of clotrimazole following topical application of Clotrimazole and Betamethasone Dipropionate Cream or Lotion have not been studied. The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm3 in the stratum corneum, to 0.5 to 1 mcg/cm3 in the reticular dermis, and 0.1 mcg/cm3 in the subcutis. No measurable amount of radioactivity (<0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.

Microbiology Mechanism of Action

Clotrimazole is an imidazole antifungal agent. Imidazoles inhibit 14-?-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-?-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.

Activity In Vivo

Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum.

Activity In Vitro

In vitro, clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown.

Drug Resistance

Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles including clotrimazole has been reported in some Candida species. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes.

Betamethasone Dipropionate

Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. (See DOSAGE AND ADMINISTRATION section.) Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. (See DOSAGE AND ADMINISTRATION section.)

Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Studies performed with Clotrimazole and Betamethasone Dipropionate Cream and Lotion indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore, use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.

CLINICAL STUDIES (Clotrimazole and Betamethasone Dipropionate Cream, USP)

In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP showed a better clinical response at the first return visit than patients treated with clotrimazole cream. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP were as good as or better than in those patients treated with clotrimazole cream. In these same clinical studies, patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP showed better clinical responses and mycological cure rates when compared with patients treated with betamethasone dipropionate cream.

CLINICAL STUDIES (Clotrimazole and Betamethasone Dipropionate Lotion)

In the treatment of tinea pedis twice daily for 4 weeks, Clotrimazole and Betamethasone Dipropionate Lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2. Clotrimazole and Betamethasone Dipropionate Lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with Clotrimazole and Betamethasone Dipropionate Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

In the treatment of tinea cruris twice daily for 2 weeks, Clotrimazole and Betamethasone Dipropionate Lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, and pruritus after 3 days. It is unclear if the relief of symptoms after 3 days in this clinical study with Clotrimazole and Betamethasone Dipropionate Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

The comparative efficacy and safety of Clotrimazole and Betamethasone Dipropionate Lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of Clotrimazole and Betamethasone Dipropionate Lotion and Clotrimazole and Betamethasone Dipropionate Cream have also not been studied.

Indications and Usage for Clotrimazole Betamethasone Lotion

Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.

Contraindications

Clotrimazole and Betamethasone Dipropionate Cream or Lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

Precautions General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. Patients applying Clotrimazole and Betamethasone Dipropionate Cream or Lotion to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary-free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

In a small study, Clotrimazole and Betamethasone Dipropionate Cream, USP was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the eight normal subjects on whom Clotrimazole and Betamethasone Dipropionate Cream, USP was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing (see PRECAUTIONS – Pediatric Use section).

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (See PRECAUTIONS – Pediatric Use section).

If irritation develops, Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be discontinued and appropriate therapy instituted.

THE SAFETY OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM OR LOTION HAS NOT BEEN DEMONSTRATED IN THE TREATMENT OF DIAPER DERMATITIS. ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP FOR DIAPER DERMATITIS. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM OR LOTION IN THE TREATMENT OF DIAPER DERMATITIS IS NOT RECOMMENDED.

Information for Patients

Patients using Clotrimazole and Betamethasone Dipropionate Cream or Lotion should receive the following information and instructions:

The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis. This medication should only be used for the disorder for which it was prescribed. Other corticosteroid-containing products should not be used with Clotrimazole and Betamethasone Dipropionate Cream or Lotion without first talking with your physician. The treated skin area should not be bandaged, covered, or wrapped so as to be occluded (See DOSAGE AND ADMINISTRATION section). Any signs of local adverse reactions should be reported to your physician. Patients should avoid sources of infection or reinfection. When using Clotrimazole and Betamethasone Dipropionate Cream or Lotion in the groin area, patients should use the medication for 2 weeks only, and apply the cream or lotion sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. The safety of Clotrimazole and Betamethasone Dipropionate Cream or Lotion has not been demonstrated in the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP for diaper dermatitis. The use of Clotrimazole and Betamethasone Dipropionate Cream or Lotion in the treatment of diaper dermatitis is not recommended. Laboratory Tests

If there is a lack of response to Clotrimazole and Betamethasone Dipropionate Cream or Lotion, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy.

The following tests may be helpful in evaluating HPA-axis suppression due to the corticosteroid components:

  Urinary-free cortisol test   Morning plasma cortisol test   ACTH (cosyntropin) stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.

Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the maximum human dose based on body surface areas, respectively.

In a combined study of the effects of clotrimazole on fertility, teratogenicity, and postnatal development, male and female rats were dosed orally (diet admixture) with levels of 5, 10, 25, or 50 mg/kg/day (approximately 1-8 times the maximum dose in a 60 kg adult based on body surface area) from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.

Pregnancy Teratogenic Effects Pregnancy Category C

There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.

Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) revealed no evidence of fetotoxicity due to clotrimazole exposure.

No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/ kg/day during gestation days 6-15. However, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights) and maternally toxic (reduced body weight gain) to rats. Clotrimazole dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal and therefore fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg clotrimazole, was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks.

Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day (2-15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18-55 times the maximum human dose).

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/ kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.

Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids. Therefore, Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clotrimazole and Betamethasone Dipropionate Cream or Lotion is administered to a nursing woman.

Pediatric Use

Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with Clotrimazole and Betamethasone Dipropionate Cream, USP. In openlabel studies, 17 of 43 (39.5%) evaluable pediatric patients (aged 12 to 16 years old) using Clotrimazole and Betamethasone Dipropionate Cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label study, 8 of 17 (47.1%) evaluable pediatric patients (aged 12 to 16 years old) using Clotrimazole and Betamethasone Dipropionate Cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM OR LOTION IN THE TREATMENT OF PATIENTS UNDER 17 YEARS OF AGE OR PATIENTS WITH DIAPER DERMATITIS IS NOT RECOMMENDED.

Because of higher ratio of skin surface area to body mass, pediatric patients under the age of 12 years are at a higher risk with Clotrimazole and Betamethasone Dipropionate Cream or Lotion. The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment. Adverse effects, including striae and growth retardation, have been reported with inappropriate use of Clotrimazole and Betamethasone Dipropionate Cream, USP in infants and children (see PRECAUTIONS and ADVERSE REACTIONS sections).

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Clotrimazole and Betamethasone Dipropionate Cream or Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Postmarket adverse event reporting for Clotrimazole and Betamethasone Dipropionate Cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM OR LOTION UNDER OCCLUSION, SUCH AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED.

Adverse Reactions

Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients.

Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients.

The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). In the pediatric population, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include growth retardation, benign intracranial hypertension, Cushing's syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

Overdosage

Amounts greater than 45 g/week of Clotrimazole and Betamethasone Dipropionate Cream, USP or 45 mL /week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. Acute overdosage with topical application of Clotrimazole and Betamethasone Dipropionate Cream or Lotion is unlikely and would not be expected to lead to a life-threatening situation. Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used for longer than the prescribed time period.

Topically applied corticosteroids, such as the one contained in Clotrimazole and Betamethasone Dipropionate Cream or Lotion, can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS section).

Clotrimazole Betamethasone Lotion Dosage and Administration

Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.

Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.

Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used with occlusive dressings.

How is Clotrimazole Betamethasone Lotion Supplied

Clotrimazole and Betamethasone Dipropionate Cream, USP is supplied in 15-gram (NDC 51672-4048-1) and 45-gram (NDC 51672-4048-6) tubes; boxes of one. Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature].

Clotrimazole and Betamethasone Dipropionate Lotion is supplied in 30-mL bottles (NDC 51672-1308-3); box of one.

Store at 20° – 25°C (68° – 77°F) in the upright position only; [see USP Controlled Room Temperature].

SHAKE WELL BEFORE EACH USE.

Clotrimazole and Betamethasone Dipropionate Cream, USP is manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110

Clotrimazole and Betamethasone Dipropionate Lotion is manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada
L6T 1C1

Dist. by:
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: May, 2011

Patient Information Leaflet

Patient's Instructions for Use

Clotrimazole and Betamethasone Dipropionate Cream, USP
Clotrimazole and Betamethasone Dipropionate Lotion

SHAKE LOTION WELL BEFORE EACH USE

Rx only

What is Clotrimazole and Betamethasone Dipropionate Cream or Lotion?

Clotrimazole and Betamethasone Dipropionate Cream and Lotion are medications used on the skin to treat fungal infections of the feet, groin, and body, as diagnosed by your doctor. Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be used for fungal infections that are inflamed and have symptoms of redness and/or itching. Talk to your doctor if your fungal infection does not have these symptoms. Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain a corticosteroid. Notify your doctor if you notice side effects with the use of Clotrimazole and Betamethasone Dipropionate Cream or Lotion (see "What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion?" below). Clotrimazole and Betamethasone Dipropionate Cream or Lotion is not to be used in the eyes, in the mouth, or in the vagina.

How do Clotrimazole and Betamethasone Dipropionate Cream and Lotion work?

Clotrimazole and Betamethasone Dipropionate Cream and Lotion are combinations of an antifungal agent (clotrimazole) and a corticosteroid (betamethasone dipropionate). Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of fungal infections.

Who should NOT use Clotrimazole and Betamethasone Dipropionate Cream or Lotion?

Clotrimazole and Betamethasone Dipropionate Cream and Lotion are not recommended for use in patients under the age of 17 years. Clotrimazole and Betamethasone Dipropionate Cream or Lotion is not recommended for use in diaper rash.

Patients who are sensitive to clotrimazole and betamethasone dipropionate, other corticosteroids or imidazoles or any ingredients in the preparation should not use Clotrimazole and Betamethasone Dipropionate Cream and Lotion.

How should I use Clotrimazole and Betamethasone Dipropionate Cream or Lotion?

Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected and surrounding skin areas twice a day, in the morning and evening. Treatment for 2 weeks on the groin or on the body, and for 4 weeks on the feet is recommended. The use of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for longer than 4 weeks is not recommended for any condition. Prolonged use of Clotrimazole and Betamethasone Dipropionate Cream or Lotion may lead to unwanted side effects.

What other important information should I know about Clotrimazole and Betamethasone Dipropionate Cream and Lotion?

1) This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify your doctor if there is no improvement after 1 week of treatment on the groin or body or after 2 weeks on the feet. 2) This medication should only be used for the disorder for which it was prescribed. 3) The treated skin area should not be bandaged or otherwise covered or wrapped. 4) Other corticosteroid-containing products should not be used with Clotrimazole and Betamethasone Dipropionate Cream or Lotion without first talking with your physician. 5) Any signs of side effects where Clotrimazole and Betamethasone Dipropionate Cream or Lotion is applied should be reported to your doctor. 6) When using Clotrimazole and Betamethasone Dipropionate Cream or Lotion in the groin area, it is especially important to use the medication for 2 weeks only, and to apply the cream or lotion sparingly. You should tell your doctor if your problem persists after 2 weeks. You should also wear loose-fitting clothing so as to avoid tightly covering the area where Clotrimazole and Betamethasone Dipropionate Cream or Lotion is applied. 7) This medication is not recommended for use in diaper rash.

What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion?

The following side effects have been reported with topical corticosteroid medications: itching, irritation, dryness, infection of the hair follicles, increased hair, acne, fragile blood vessels, spider veins, sensitization (local reactions upon repeated application of product), change in skin color, allergic skin reaction, skin thinning, and stretch marks. In children, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include slower growth, Cushing's syndrome (a type of hormone imbalance that can be very serious), and local skin reactions, including thinning skin and stretch marks. Hormone imbalance (adrenal suppression) was demonstrated in clinical studies in children.

Can Clotrimazole and Betamethasone Dipropionate Cream or Lotion be used if I am pregnant or plan to become pregnant or if I am nursing?

Before using Clotrimazole and Betamethasone Dipropionate Cream or Lotion, tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are nursing.

How should Clotrimazole and Betamethasone Dipropionate Cream or Lotion be stored?

Clotrimazole and Betamethasone Dipropionate Cream, USP should be stored at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature].

Clotrimazole and Betamethasone Dipropionate Lotion should be stored at 20° – 25°C (68° – 77°F) in the upright position only; [see USP Controlled Room Temperature]. Shake well before using Clotrimazole and Betamethasone Dipropionate Lotion.

General advice about prescription medicines

This medicine was prescribed for your particular condition. Only use Clotrimazole and Betamethasone Dipropionate Cream or Lotion to treat the condition for which your doctor has prescribed. Do not give Clotrimazole and Betamethasone Dipropionate Cream or Lotion to other people. It may harm them.

This leaflet summarizes the most important information about Clotrimazole and Betamethasone Dipropionate Cream and Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clotrimazole and Betamethasone Dipropionate Cream and Lotion that is written for health professionals.

Clotrimazole and Betamethasone Dipropionate Cream, USP is manufactured by Taro Pharmaceuticals Industries Ltd., Haifa Bay, Israel 26110

Clotrimazole and Betamethasone Dipropionate Lotion is manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: May, 2011

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

NDC 51672-4048-6

45 g

Clotrimazole and Betamethasone
Dipropionate Cream USP, 1%/0.05%

ATTENTION PHARMACIST: Dispense with enclosed Patient Information Leaflet.

ATTENTION PATIENT: See Patient Information Leaflet before using this product.

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. NOT RECOMMENDED
FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

30 mL

NDC 51672-1308-3

Clotrimazole
and
Betamethasone
Dipropionate
Lotion

DO NOT USE IN EYES

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC,
ORAL OR INTRAVAGINAL USE.

NOT RECOMMENDED FOR PATIENTS
UNDER THE AGE OF 17 YEARS AND
NOT RECOMMENDED FOR
DIAPER DERMATITIS.

Keep this and all
medications out of the
reach of children.

Rx only

TARO


CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE 
clotrimazole and betamethasone dipropionate  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-4048 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clotrimazole (Clotrimazole) Clotrimazole 10 mg  in 1 g Betamethasone Dipropionate (Betamethasone) Betamethasone Dipropionate 0.64 mg  in 1 g Inactive Ingredients Ingredient Name Strength ceteareth-30   cetostearyl alcohol   mineral oil   phosphoric acid   propylene glycol   water   sodium phosphate, monobasic   petrolatum   benzyl alcohol   Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51672-4048-1 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (51672-4048-1) 2 51672-4048-6 1 TUBE In 1 CARTON contains a TUBE 2 45 g In 1 TUBE This package is contained within the CARTON (51672-4048-6)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075673 05/29/2001
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE 
clotrimazole and betamethasone dipropionate  lotion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-1308 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clotrimazole (Clotrimazole) Clotrimazole 10 mg  in 1 mL Betamethasone Dipropionate (Betamethasone) Betamethasone Dipropionate 0.64 mg  in 1 mL Inactive Ingredients Ingredient Name Strength ceteareth-30   cetyl alcohol   mineral oil   phosphoric acid   propylene glycol   water   sodium phosphate, monobasic   stearyl alcohol   petrolatum   benzyl alcohol   Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51672-1308-3 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 mL In 1 BOTTLE This package is contained within the CARTON (51672-1308-3)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076493 07/28/2004
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE Establishment Name Address ID/FEI Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE Revised: 02/2012Taro Pharmaceuticals U.S.A., Inc.
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methimazole


meth-IM-a-zole

Commonly used brand name(s)

In the U.S.

Tapazole

Available Dosage Forms:

Tablet

Therapeutic Class: Antithyroid Agent

Chemical Class: Thionamide

Uses For methimazole

Methimazole is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment.

Methimazole is an antithyroid medicine. It works by making it harder for the body to use iodine to make thyroid hormone. It does not block the effects of a thyroid hormone that was made by the body before its use was begun.

methimazole is available only with your doctor's prescription.

Before Using methimazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methimazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methimazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methimazole in children.

Geriatric

No information is available on the relationship of age to the effects of methimazole in geriatric patients.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking methimazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using methimazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol Anisindione Dicumarol Phenindione Phenprocoumon Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of methimazole. Make sure you tell your doctor if you have any other medical problems, especially:

Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia)—Use with caution. May make these conditions worse. Liver disease—Effects may be increased because of slower removal of the medicine from the body. Proper Use of methimazole

Take methimazole only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

methimazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Food in your stomach may change the amount of methimazole that is able to enter the bloodstream. To make sure that you always get the same effects, try to take methimazole at the same time in relation to meals every day. That is, always take it with meals or always take it on an empty stomach.

Dosing

The dose of methimazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methimazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For treatment of hyperthyroidism (overactive thyroid): Adults—At first, 15 to 60 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is 5 to 15 mg daily. Children—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.4 mg per kilogram (kg) of body weight per day, divided into 3 equal doses and given every 8 hours. The maintenance dose is 0.2 mg/kg of body weight per day. Missed Dose

If you miss a dose of methimazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using methimazole

It is very important that your doctor check your progress at regular visits to make sure that methimazole is working properly. Blood tests may be needed to check for unwanted effects.

Using methimazole while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking methimazole. If you think you have become pregnant while using the medicine, tell your doctor right away.

Methimazole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Liver problems may occur while you are using methimazole. Stop using methimazole and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

While you are being treated with methimazole, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methimazole may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before having any kind of surgery, tell the medical doctor in charge that you are using methimazole. Taking methimazole together with medicines used during surgery may increase the risk of side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

methimazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Black, tarry stools chest pain chills cough fever painful or difficult urination shortness of breath sore throat sores, ulcers, or white spots on the lips or in the mouth swollen glands unusual bleeding or bruising unusual tiredness or weakness Rare Backache increase or decrease in urination swelling of the feet or lower legs Incidence not known Abdominal or stomach pain bleeding gums bleeding under the skin blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cough or hoarseness dark urine difficulty with moving fever with or without chills general feeling of discomfort, illness, or weakness general feeling of tiredness or weakness headache joint pain light-colored stools loss of appetite and weight lower back or side pain muscle aching or cramping muscle pain or stiffness nausea and vomiting numbness or tingling of the hands, feet, or face pinpoint red spots on the skin soreness of the muscles sores, ulcers, or white spots on the lips or in the mouth swollen joints swollen salivary glands swollen, painful, or tender lymph glands in the neck, armpit, or groin tightness in the chest upper right abdominal pain wheezing yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Cloudy or bloody urine cracks in the skin high blood pressure loss of heat from the body red, swollen skin scaly skin sensation of pins and needles stabbing pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known Abnormal loss of hair dizziness or lightheadedness feeling of constant movement of self or surroundings heartburn hives or welts itching loss of taste pain or discomfort in the chest, upper stomach, or throat redness of the skin sensation of spinning skin rash sleepiness vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: methimazole side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More methimazole resources Methimazole Side Effects (in more detail) Methimazole Dosage Methimazole Use in Pregnancy & Breastfeeding Drug Images Methimazole Drug Interactions Methimazole Support Group 0 Reviews for Methimazole - Add your own review/rating methimazole Concise Consumer Information (Cerner Multum) Methimazole Prescribing Information (FDA) Methimazole Monograph (AHFS DI) Methimazole Professional Patient Advice (Wolters Kluwer) Methimazole MedFacts Consumer Leaflet (Wolters Kluwer) Tapazole Prescribing Information (FDA) Compare methimazole with other medications Hyperthyroidism
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Carbimazole 20mg (Archimedes Pharma UK Ltd)


1. Name Of The Medicinal Product

Carbimazole 20mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 20mg of carbimazole

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Tablet

Pale pink, uncoated, round, biconvex tablets marked with LINK C20 on one side and a scoreline on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

Carbimazole is an anti-thyroid agent. It is indicated in all conditions where reduction of thyroid function is required.

Such conditions are:

1. Hyperthyroidism.

2. Preparation for thyroidectomy in hyperthyroidism.

3. Therapy prior to and post radio-iodine treatment.

4.2 Posology And Method Of Administration

Carbimazole should only be administered if hyperthyroidism has been confirmed by laboratory tests.

Adult:

The initial dose is in the range 20mg to 60mg, taken as two to three divided doses. The dose should be titrated against thyroid function until the patient is euthyroid in order to reduce the risk of over-treatment and resultant hypothyroidism.

Subsequent therapy may then be administered in one of two ways.

Maintenance regimen: Final dosage is usually in the range 5mg to 15mg per day, which may be taken as a single daily dose. Therapy should be continued for at least six months and up to eighteen months. Serial thyroid function monitoring is recommended, together with appropriate dosage modification in order to maintain a euthyroid state.

Blocking-replacement regimen: dosage is maintained at the initial level, i.e. 20mg to 60mg per day, and supplemental L-thyroxine, 50mcg to 150mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should be continued for at least six months and up to eighteen months. Where a single dosage of less than 20mg is recommended, it is intended that carbimazole 5mg tablets should be taken.

Elderly:

No special dosage regimen is required, but care should be taken to observe the contraindications and warnings as it has been reported that the risk of a fatal outcome to neutrophil dyscrasia may be greater in the elderly (aged 65 or over).

Children:

The usual initial daily dose is 15mg per day adjusted according to response.

4.3 Contraindications

Carbimazole 20mg tablets are contraindicated in patients with a previous history of adverse reactions to carbimazole or to any of the excipients listed in section 6.1 List of Excipients.

Serious, pre-existing haematological conditions, severe hepatic insufficiency.

4.4 Special Warnings And Precautions For Use

As fatal cases of agranulocytosis with carbimazole have been reported and early treatment of agranulocytosis is essential, it is important that patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever, malaise and should be instructed to stop the drug and to seek medical advice immediately.

In such patients white blood cell counts should be performed, particularly where there is any clinical evidence of infection. Following the onset of any signs and symptoms of hepatic disorder (pain in the upper abdomen, anorexia, general pruritus) in patients, the drug should be stopped and liver function tests performed immediately. Early withdrawal of the drug will increase the chance of complete recovery.

Carbimazole tablets should be used with caution in patients with mild-moderate hepatic insufficiency. If abnormal liver function is discovered, the treatment should be stopped. The half-life may be prolonged due to the liver disorder.

Carbimazole should be stopped temporarily at the time of administration of radio-iodine (to avoid thyroid crisis).

Patients unable to comply with the instructions for use or who cannot be monitored regularly should not be treated with Carbimazole.

Regular full blood count checks should be carried out in patients who may be confused or have a poor memory.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Precaution should be taken in patients with intrathoracic goitre, which may worsen during initial treatment with Carbimazole. Tracheal obstruction may occur due to intrathoracic goitre.

The use of carbimazole in non-pregnant women of childbearing potential should be based on individual risk/benefit assessment (see section 4.6).

There is a risk of cross-allergy between carbimazole, the active metabolite thiamazole (methimazole) and propylthiouracil.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Little is known about interactions. Particular care is required in case of concurrent administration of medication capable of inducing agranulocytosis. Since carbimazole is a vitamin K antagonist, the effect of anticoagulants could be intensified. The serum levels of theophylline can increase and toxicity may develop if hyperthyroidic patients are treated with antithyroid medications without reducing the theophylline dosage.

4.6 Pregnancy And Lactation

Carbimazole crosses the placenta but, provided the mother's dose is within the standard range and her thyroid status is monitored; there is no evidence of neonatal thyroid abnormalities. Studies have shown that the incidence of congenital malformations is greater in the children of mothers whose hyperthyroidism has remained untreated than in those who have been treated with carbimazole.

However, very rare cases of congenital malformations have been observed following the use of carbimazole or its active metabolite methimazole during pregnancy.

A causal relationship of these malformations, especially choanal atresia and aplasia cutis congenital (congential scalp defects), to transplacental exposure to carbimazole and methimazole cannot be excluded.

Therefore the use of carbimazole in non-pregnant women of childbearing potential should be based on individual risk/benefit assessment (see section 4.4 Special warnings and precautions for use).

Cases of renal, skull, cardiovascular congenital defects, exomphalos, gastrointestinal malformation, umbilical malformation and duodenal atresia have also been reported. Therefore, carbimazole should be used in pregnancy only when propylthiouracil is not suitable.

If carbamazole is used in pregnancy, the dose of carbimazole tablets must be regulated by the patient's clinical condition. The lowest dose possible should be used, and this can often be discontinued three or four weeks before term, in order to reduce the risk of neonatal complications.

The blocking-replacement regimen should not be used during pregnancy since very little thyroxine crosses the placenta in the last trimester.

Carbimazole is excreted in milk and if treatment is continued during lactation the patient should not continue to breast-feed her baby.

4.7 Effects On Ability To Drive And Use Machines

The effect on the ability to drive and use machines is not known.

4.8 Undesirable Effects

Adverse reactions usually occur in the first eight weeks of treatment. The most common minor reactions are nausea, headache, arthralgia, mild gastrointestinal disturbance, skin rashes and pruritus. These reactions are usually self-limiting and may not require withdrawal of the drug.

Blood and lymphatic system disorders

Bone marrow depression including neutropenia, eosinophilia, leucopenia, agranulocytosis has been reported. Fatalities with carbimazole-induced agranulocytosis have been reported.

Rare cases of pancytopenia/aplastic anaemia and isolated thrombocytopenia have also been reported. Additionally, very rare cases of haemolytic anaemia have been reported.

Patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever, malaise and should be instructed to stop the drug and to seek medical advice immediately. In such patients, white blood cell counts should be performed immediately particularly where there is any clinical evidence of infection.

Nervous system disorders

Headache

Gastrointestinal system disorders

Nausea, mild gastrointestinal disturbance.

Loss of sense of taste has been observed.

General disorders and administration site conditions

Fever, Malaise

Hepato-biliary system disorders

Hepatic disorders, including abnormal liver function tests, hepatitis, cholestatic hepatitis, cholestatic jaundice and most commonly jaundice, have been reported; in these cases carbimazole tablets should be withdrawn.

Injury, poisoning and procedural complications

Bruising

Skin and subcutaneous tissue disorders

Skin rashes, pruritus, urticaria. Hair loss has been occasionally reported.

Musculoskeletal system disorders

Isolated cases of myopathy have been reported. Patients experiencing myalgia after the intake of Carbimazole should have their creatine phosphokinase levels monitored.

Hypersensitivity and allergic reaction

Angioedema and multi-system hypersensitivity reactions such as cutaneous vasculitis, liver, lung and renal effects occur.

Vascular Disorders

Bleeding

4.9 Overdose

No symptoms are likely from a single large dose and so no specific treatment is indicated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: H03B B01 - a thyroid reducing agent.

Carbimazole, a thionamide, is a pro-drug which undergoes rapid and virtually complete metabolism to the active metabolite, thiamazole, also known as Methimazole. The method of action is believed to be inhibition of the organification of iodide and the coupling of iodothyronine residues which in turn suppress the synthesis of thyroid hormones.

5.2 Pharmacokinetic Properties

Carbimazole is rapidly metabolised to thiamazole. The mean peak plasma concentration of thiamazole is reported to occur one hour after a single dose of thiamazole.

After oral ingestion, peak plasma concentrations of thiamazole, the active moiety, occur at 1 to 2 hours. The total volume of distribution of thiamazole is 0.5l/kg. Thiamazole is concentrated in the thyroid gland. This intrathyroidal concentration of thiamazole has the effect of prolonging the activity of carbimazole. However, thiamazole has a shorter half-life in hyperthyroid patients than in normal controls and so more frequent initial doses are required while the hyperthyroidism is active.

Thiamazole is moderately bound to plasma proteins.

Carbimazole has a half-life of 5.3 to 5.4 hours. It is possible that the plasma half-life may also be prolonged by renal or hepatic disease. See Section 4.2. Posology and method of administration.

Thiamazole crosses the placenta and appears in breast milk. The plasma:milk ratio approaches unity.

Over 90% of orally administered carbimazole is excreted in the urine as thiamazole or its metabolites. The remainder appears in faeces. There is 10% enterohepatic circulation.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Anhydrous lactose,

Croscarmellose sodium

Iron oxide (red) (E172)

Magnesium stearate

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Store the blisters in the original package.

6.5 Nature And Contents Of Container

The tablets are supplied in white, opaque 250 micron thermoformed PVC blister packs sealed with 20 micron lacquered aluminium foil containing 28, 56, 100 or 112 tablets (not all pack sizes may be marketed).

The heatseal coating lacquer of the aluminium foil consists of a PVC/PVAC co-polymer and polymethacrylate, with the outer side being a heat resistant lacquer based on polyester.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Archimedes Pharma UK Ltd

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

08/05/2008

10. Date Of Revision Of The Text

08/05/2008


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Clotrimazole Lotion


Pronunciation: kloe-TRIM-uh-zole
Generic Name: Clotrimazole
Brand Name: Lotrimin AF
Clotrimazole Lotion is used for:

Treating athlete's foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.

Clotrimazole Lotion is an antifungal agent. It kills sensitive fungi by binding to the fungal cell membrane and weakening it. This allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Clotrimazole Lotion if: you are allergic to any ingredient in Clotrimazole Lotion

Contact your doctor or health care provider right away if any of these apply to you.

Before using Clotrimazole Lotion:

Some medical conditions may interact with Clotrimazole Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Clotrimazole Lotion. Because little, if any, of Clotrimazole Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Clotrimazole Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clotrimazole Lotion:

Use Clotrimazole Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clotrimazole Lotion is for topical use on the skin only. Clean the affected area with soap and water and dry thoroughly. Shake well before each use. Apply a thin layer of medicine to the affected area. Rub it in gently. Do not cover unless directed to by your doctor. Wash your hands immediately after using Clotrimazole Lotion, unless your hands are part of the treated area. To clear up your infection completely, use Clotrimazole Lotion for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses. If you miss a dose of Clotrimazole Lotion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clotrimazole Lotion.

Important safety information: Clotrimazole Lotion is for external use only. If you get Clotrimazole Lotion in your eyes, immediately flush them with cool tap water. Be sure to use Clotrimazole Lotion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clotrimazole Lotion while you are pregnant. It is not known if Clotrimazole Lotion is found in breast milk. If you are or will be breast-feeding while you use Clotrimazole Lotion, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Clotrimazole Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); reddening, blistering, peeling, itching, or burning of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Clotrimazole Lotion may be harmful if swallowed.

Proper storage of Clotrimazole Lotion:

Store Clotrimazole Lotion at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clotrimazole Lotion out of the reach of children and away from pets.

General information: If you have any questions about Clotrimazole Lotion, please talk with your doctor, pharmacist, or other health care provider. Clotrimazole Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clotrimazole Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Clotrimazole resources Clotrimazole Use in Pregnancy & Breastfeeding Clotrimazole Support Group 2 Reviews for Clotrimazole - Add your own review/rating Compare Clotrimazole with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Canesten Topical


Generic Name: clotrimazole (Topical route)

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.

Clotrim Antifungal Cruex Prescription Strength Lotrimin Lotrimin AF Mycelex

In Canada

Canesten Clotrimaderm Desenex Myclo-Derm Neo-Zol

Available Dosage Forms:

Lotion Solution Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Canesten

Clotrimazole topical preparations are used to treat fungus infections on the skin.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Canesten

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fentanyl Tacrolimus Trimetrexate Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of clotrimazole

This section provides information on the proper use of a number of products that contain clotrimazole. It may not be specific to Canesten. Please read with care.

Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.

Keep this medicine away from the eyes.

When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage forms (cream, lotion, and solution): Fungal infections (treatment): Adults and children—Use two times a day, morning and evening. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Canesten

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.

Canesten Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Canesten Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Canesten Topical resources Canesten Topical Side Effects (in more detail) Canesten Topical Use in Pregnancy & Breastfeeding Canesten Topical Support Group 1 Review for Canesten Topical - Add your own review/rating Compare Canesten Topical with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor
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armodafinil


Generic Name: armodafinil (ar moe DAF i nil)
Brand Names: Nuvigil

What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

Armodafinil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about armodafinil? You should not use this medication if you are allergic to armodafinil or modafinil (Provigil).

Before using armodafinil, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, a heart valve disorder, a history of mental illness, a history of drug or alcohol addiction, or if you have recently had a heart attack.

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to armodafinil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.

There may be other drugs that can interact with armodafinil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my health care provider before taking armodafinil? You should not use this medication if you are allergic to armodafinil or modafinil (Provigil).

To make sure you can safely take armodafinil, tell your doctor if you have any of these other conditions:

cirrhosis or other liver problem;

kidney disease;

a heart muscle or valve disorder such as mitral valve prolapse;

a history of mental illness;

a history of drug or alcohol addiction;

heart disease or high blood pressure;

if you have recently had a heart attack.

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be. FDA pregnancy category C. It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Armodafinil can make certain types of birth control less effective for as long as a month after you stop taking armodafinil. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking armodafinil. It is not known whether armodafinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give armodafinil to anyone younger than 17 years old. How should I take armodafinil?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually given for up to 12 weeks. Follow your doctor's instructions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil.

Store at room temperature away from moisture and heat.

See also: Armodafinil dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include confusion, feeling excited or agitated, fast or slow heart rate, and chest pain.

What should I avoid while taking armodafinil? Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil. Armodafinil side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using armodafinil and call your doctor at once if you have a serious side effect such as:

fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;

the first sign of any type of skin rash, no matter how mild;

bruising, severe tingling, numbness, pain, muscle weakness;

easy bruising or bleeding;

mouth sores, trouble swallowing;

upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

depression, confusion, hallucinations, aggression, unusual thoughts or behavior;

chest pain, uneven heart beats.

Less serious side effects may include:

headache, dizziness;

feeling nervous or anxious;

nausea, diarrhea, upset stomach;

trouble sleeping (insomnia); or

dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Armodafinil Dosing Information

Usual Adult Dose for Narcolepsy:

150 mg or 250 mg orally once daily in the morning
It is not clear if doses beyond 150 mg daily confer additional benefit.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 mg or 250 mg orally once daily in the morning
It is not clear if doses beyond 150 mg daily confer additional benefit.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once daily one hour prior to the start of the work shift

What other drugs will affect armodafinil?

Tell your doctor about all other medicines you use, especially:

cyclosporine (Neoral, Sandimmune, Gengraf);

propranolol (Inderal);

omeprazole (Prilosec);

St. John's wort;

rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

an antidepressant such as nefazodone or clomipramine (Anafranil);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

HIV medication such as efavirenz (Atripla, Sustiva), etravirine (Intelence), nevirapine (Viramune), or ritonavir (Norvir);

a sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with armodafinil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More armodafinil resources Armodafinil Side Effects (in more detail) Armodafinil Dosage Armodafinil Use in Pregnancy & Breastfeeding Armodafinil Drug Interactions Armodafinil Support Group 138 Reviews for Armodafinil - Add your own review/rating armodafinil Advanced Consumer (Micromedex) - Includes Dosage Information Armodafinil Professional Patient Advice (Wolters Kluwer) Armodafinil MedFacts Consumer Leaflet (Wolters Kluwer) Armodafinil Monograph (AHFS DI) Nuvigil Prescribing Information (FDA) Nuvigil Consumer Overview Compare armodafinil with other medications ADHD Bipolar Disorder Chronic Fatigue Syndrome Depression Fibromyalgia Hypersomnia Jet Lag Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Shift Work Sleep Disorder Where can I get more information? Your pharmacist can provide more information about armodafinil.

See also: armodafinil side effects (in more detail)


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paclitaxel protein-bound


Generic Name: paclitaxel protein-bound (PAK li TAX el PRO teen-bound)
Brand Names: Abraxane

What is paclitaxel protein-bound?

Paclitaxel protein-bound is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Paclitaxel protein-bound is used in the treatment of breast cancer.

Paclitaxel protein-bound is usually given after other cancer medicines have been tried without successful treatment.

Paclitaxel protein-bound may also be used for purposes not listed in this medication guide.

What is the most important information I should know about paclitaxel protein-bound? Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving paclitaxel protein-bound, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. You should not use paclitaxel protein-bound if you are allergic to it, or if you have a low white blood cell count.

Before you receive this medication, tell your doctor if you have kidney disease, liver disease, heart disease, or bone marrow suppression.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, mouth sores, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, swelling or rapid weight gain, chest pain, sudden cough, rapid heart rate, or trouble breathing. What should I discuss with my healthcare provider before receiving paclitaxel protein-bound? You should not use paclitaxel protein-bound if you are allergic to it, or if you have a low white blood cell count.

To make sure you can safely receive paclitaxel protein-bound, tell your doctor if you have any of these other conditions:

kidney disease;

liver disease;

heart disease; or

bone marrow suppression.

FDA pregnancy category D. Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving paclitaxel protein-bound, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. It is not known whether paclitaxel protein-bound passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving paclitaxel protein-bound. How is paclitaxel protein-bound given?

Paclitaxel protein-bound is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Paclitaxel protein-bound must be given slowly, and the IV infusion can take at least 30 minutes to complete.

Paclitaxel protein-bound is usually given once every 3 weeks. Follow your doctor's dosing instructions very carefully.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when paclitaxel protein-bound is injected.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your paclitaxel protein-bound injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while using paclitaxel protein-bound? Paclitaxel protein-bound can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. Paclitaxel protein-bound side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

feeling like you might pass out;

swelling, rapid weight gain; or

chest pain, sudden cough, wheezing, trouble breathing, fast heart rate.

Less serious side effects may include:

numbness or tingly feeling;

muscle or joint pain;

nausea, vomiting;

diarrhea; or

hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Paclitaxel protein-bound Dosing Information

Usual Adult Dose for Breast Cancer:

260 mg/m2 administered intravenously over 30 minutes every 3 weeks

What other drugs will affect paclitaxel protein-bound?

Tell your doctor about all other medicines you use, especially:

bosentan (Tracleer);

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

montelukast (Singulair) or zafirlukast (Accolate);

rifampin (Rifater, Rifadin, Rifamate);

selegiline (Eldepryl, Emsam, Zelapar);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

an antidepressant such as nefazodone or fluoxetine (Prozac);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

a blood thinner such as warfarin (Coumadin);

cancer medication such as paclitaxel (Taxol) or tamoxifen (Soltamox);

heart or blood pressure medications such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), losartan (Hyzaar, Cozaar), nifedipine (Nifedical, Procardia), torsemide (Demadex), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);

seizure medications such as fosphenytoin (Cerebyx), or phenytoin (Dilantin);

oral diabetes medication such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase); or

sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

This list is not complete and other drugs may interact with paclitaxel protein-bound. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More paclitaxel protein-bound resources Paclitaxel protein-bound Side Effects (in more detail) Paclitaxel protein-bound Dosage Paclitaxel protein-bound Use in Pregnancy & Breastfeeding Paclitaxel protein-bound Drug Interactions Paclitaxel protein-bound Support Group 1 Review for Paclitaxel protein-bound - Add your own review/rating paclitaxel protein-bound Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Abraxane Prescribing Information (FDA) Abraxane MedFacts Consumer Leaflet (Wolters Kluwer) Abraxane Consumer Overview Compare paclitaxel protein-bound with other medications Breast Cancer Breast Cancer, Metastatic Where can I get more information? Your doctor or pharmacist can provide more information about paclitaxel protein-bound.

See also: paclitaxel protein-bound side effects (in more detail)


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terconazole vaginal


Generic Name: terconazole vaginal (ter KON a zole VAJ in al)
Brand Names: Terazol 3, Terazol 7, Zazole

What is terconazole vaginal?

Terconazole is an antifungal antibiotic that fights infections caused by fungus.

Terconazole vaginal is used to treat candida (yeast) infections of the vagina.

Terconazole vaginal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about terconazole vaginal?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. What should I discuss with my healthcare provider before using terconazole vaginal? You should not use terconazole vaginal if you are allergic to it, or if you have:

a fever;

stomach pain; or

foul-smelling vaginal discharge.

To make sure you can safely use terconazole vaginal, tell your doctor if you have any of these other conditions:

diabetes;

HIV or AIDS.; or

if you have ever had an allergic reaction to similar medications such as butoconazole (Femstat, Mycelex), clotrimazole (Lotrimin, Femcare), econazole (Spectazole), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), miconazole (Monistat), and others.

FDA pregnancy category C. It is not known whether terconazole vaginal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether terconazole passes into breast milk. Do not use terconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use terconazole vaginal?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Terconazole vaginal is usually applied once daily at bedtime for 3 days in a row. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Call your doctor if your symptoms do not improve, or if they get worse while using terconazole vaginal. Do not use terconazole vaginal to treat any vaginal condition that has not been checked by your doctor. Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using terconazole vaginal? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Avoid using other vaginal medications or douches during your treatment with terconazole vaginal, unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to a sexual partner.

Avoid exposure to sunlight or tanning beds. Terconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Terconazole vaginal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

severe vaginal burning or irritation; or

fever, chills, flu symptoms.

Less serious side effects may include:

headache; or

menstrual cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Terconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

Vaginal suppositories: 1 suppository intravaginally once a day at bedtime for 3 consecutive days
0.8% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 3 consecutive days
0.4% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 7 consecutive days

What other drugs will affect terconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More terconazole vaginal resources Terconazole vaginal Side Effects (in more detail) Terconazole vaginal Dosage Terconazole vaginal Use in Pregnancy & Breastfeeding Terconazole vaginal Support Group 6 Reviews for Terconazole - Add your own review/rating Compare terconazole vaginal with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about terconazole vaginal.

See also: terconazole side effects (in more detail)


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FungiCURE Pump Spray


Generic Name: clotrimazole topical (kloe TRIM a zole)
Brand Names: Anti-Fungal Liquid, Desenex AF Prescription Strength, FungiCURE Pump Spray, Lotrimin AF Cream, Lotrimin AF For Her, Lotrimin AF Jock Itch, Lotrimin AF Solution, Lotrimin Jock Itch Powder, MPM Anti-Fungal, Prescription Strength Cruex

What is FungiCURE Pump Spray (clotrimazole topical)?

Clotrimazole topical is an antifungal antibiotic that fights infections caused by fungus.

Clotrimazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Clotrimazole topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about FungiCURE Pump Spray (clotrimazole topical)? You should not use clotrimazole topical if you are allergic to it.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth. What should I discuss with my healthcare provider before using FungiCURE Pump Spray (clotrimazole topical)? You should not use clotrimazole topical if you are allergic to it. FDA pregnancy category B. Clotrimazole topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether clotrimazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use FungiCURE Pump Spray (clotrimazole topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Wash your hands before and after using this medication, unless you are using it to treat a hand infection.

Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks.

Do not take this medication by mouth.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using FungiCURE Pump Spray (clotrimazole topical)? Avoid getting this medication in your eyes, nose, or mouth.

Avoid using other medications on the areas you treat with clotrimazole topical unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until the infection is healed.

FungiCURE Pump Spray (clotrimazole topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using clotrimazole topical and call your doctor at once if you have unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect FungiCURE Pump Spray (clotrimazole topical)?

There may be other drugs that can interact with clotrimazole topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More FungiCURE Pump Spray resources FungiCURE Pump Spray Side Effects (in more detail) FungiCURE Pump Spray Use in Pregnancy & Breastfeeding FungiCURE Pump Spray Support Group 0 Reviews for FungiCURE Pump - Add your own review/rating Canesten Topical Advanced Consumer (Micromedex) - Includes Dosage Information Gyne-Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Mycelex Prescribing Information (FDA) Compare FungiCURE Pump Spray with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about clotrimazole topical.

See also: FungiCURE Pump side effects (in more detail)


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