Gyno-Pevaryl 1 Vaginal Pessary


Gyno-Pevaryl 1 vaginal pessary

Econazole nitrate

Gyno-Pevaryl is a registered trademark

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet 1. What Gyno-Pevaryl 1 is and what it is used for 2. Before you use Gyno-Pevaryl 1 3. How to use Gyno-Pevaryl 1 4. Possible side effects 5. How to store Gyno-Pevaryl 1 6. Further information What Gyno-Pevaryl 1 is and what it is used for

The name of your medicine is Gyno-Pevaryl 1 vaginal pessary. It is called ‘Gyno-Pevaryl 1’ in this leaflet.

Gyno-Pevaryl 1 is a solid, bullet-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole. This belongs to a group of medicines called ‘antifungals’.

Gyno-Pevaryl 1 is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).

Before you use Gyno-Pevaryl 1 Do not use Gyno-Pevaryl 1 if: You are allergic to anything in Gyno-Pevaryl 1 (listed in section 6 below) You are allergic to any other medicine used to treat thrush or other fungal infections You are under 16 years old

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl 1.

Take special care with Gyno-Pevaryl 1

Check with your doctor or pharmacist before using this medicine if:

You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 1 can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol Pregnancy and breast-feeding

Please tell your doctor before using Gyno-Pevaryl 1 if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Gyno-Pevaryl 1 if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

How to use Gyno-Pevaryl 1

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using the pessary Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary Inserting the pessary with the applicator Remove the pessary from the plastic packet using the easy open tab Pull the plunger of the applicator out until it sticks Gently push the pessary into the cup. Do not force it because it might stick Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first Push the plunger to release the pessary Remove the applicator and dispose of it safely in your household waste If you swallow Gyno-Pevaryl 1

If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Gyno-Pevaryl 1 can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 1 and tell your doctor straight away if you notice the following. You may need urgent medical treatment. Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects less than 1 in 10,000 people) Other side effects: Itchy and red skin around or inside the vagina. This is much milder than an allergic reaction. Tell your doctor or pharmacist if this feeling lasts for more than a few minutes or gets worse (rash, burning or swelling)

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Gyno-Pevaryl 1

Keep out of the reach and sight of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 1: After the expiry date which is stated on the label. The expiry date refers to the last day of that month If the plastic packet is broken or missing If the pessary is not light beige in colour

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further information

The active substance in Gyno-Pevaryl 1 is econazole nitrate. The pessary contains 150mg econazole nitrate.

The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate.

What Gyno-Pevaryl 1 looks like and contents of the pack

Gyno-Pevaryl 1 comes in a plastic strip containing one pessary. It is bullet-shaped and light beige in colour.

The product licence is held by: JANSSEN-CILAG LTD 50-100 Holmers Farm Way High Wycombe Bucks HP12 4EG UK Gyno-Pevaryl 1 is made by: Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse Belgium

OR

McGregor Cory Ltd Middleton Close Banbury Oxfordshire OX16 8RS UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last approved in August 2008.


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Gyno-Daktarin 20mg / g Cream


1. Name Of The Medicinal Product

Gyno-Daktarin 20mg/g cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal cream.

The cream is white and homogeneous.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of mycotic vulvovaginitis and superinfections due to gram-positive bacteria.

4.2 Posology And Method Of Administration

Gyno-Daktarin cream is for vaginal administration.

Recommended dosage

Administer the contents of one applicator (about 5g of cream) once daily deeply into vagina for 10 – 14 days or twice daily for 7 days. For vulvitis the cream should be applied topically twice daily. Continue the course of treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.

4.3 Contraindications

Gyno-Daktarin cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the cream.

4.4 Special Warnings And Precautions For Use

Should local sensitisation or an allergic reaction occur, treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Gyno-Daktarin cream does not stain skin or clothes.

The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gyno-Daktarin cream should not be used concurrently with a latex condom or latex diaphragm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin cream since the constituents of the cream may damage the latex. (see section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

Although intravaginal absorption is limited, Gyno-Daktarin cream should only be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Lactation

It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Daktarin cream during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse Drug Reactions (ADRs) reported by

In the table, the frequencies are provided according to the following convention:

Very common

Common

Uncommon

Rare

Very rare <1/10,000, including isolated reports

Table 1. Adverse Drug Reactions Reported by Gyno-Daktarin-treated Subjects in 2 Single Blind Clinical Trials

 

Body System/Organ Class

Frequency Category

Undesirable effects

 

Skin and subcutaneous tissue disorders

 

 

Common

Rash

Uncommon

Rash pruritic, urticaria

Reproductive System and Breast Disorders

 

 

Very common

Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort

 

Common

Dysmenorrhoea

 

A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.

Table 2.Adverse Drug Reactions Identified During Postmarketing Experience with Gyno-Daktarin by Frequency Category Estimated from Spontaneous Reporting Rates

 

Immune System Disorders

 

Not known

Hypersensitivity including Anaphylactic and Anaphylactoid reactions, Angioedema

Skin and Subcutaneous Tissue Disorders

 

Not known

Pruritis

Reproductive System and Breast Disorders

 

Not known

Vaginal irritation, pelvic cramps

4.9 Overdose

Symptoms

In case of accidental ingestion, no problems are expected.

Treatment

In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification:

(Anti-infectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)

ATC code: G01A F04

Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.

Miconazole inhibits the biosynsthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.

5.2 Pharmacokinetic Properties

Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The mean apparent elimination half-life is 57 hours.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

Tube containing 15 g, 40 g or 78 g of cream.

The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.

The cream is supplied with disposable cardboard vaginal applicators.

*Not all pack sizes are marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 0242/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2008

10. Date Of Revision Of The Text

23rd July 09


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Daktarin Aktiv Cream (McNeil Products Ltd)


1. Name Of The Medicinal Product

Daktarin Aktiv Cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2.0% w/w

(Each gram of cream contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cream

White homogeneous cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of athlete's foot.

4.2 Posology And Method Of Administration

For all ages.

Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Method of administration: Cutaneous application.

4.3 Contraindications

Daktarin Aktiv Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.

4.4 Special Warnings And Precautions For Use

Daktarin Aktiv Cream must not come into contact with the eyes.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

4.6 Pregnancy And Lactation

Pregnancy

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1,000 and < 1/100

Rare > 1/10,000, < 1/1,000

Very rare < 1/10,000, including isolated reports

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema.

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation.

General disorders and administration site conditions

Rare: application site reactions, including application site irritation.

4.9 Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

5.2 Pharmacokinetic Properties

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG 32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.

Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g.

*Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0304

9. Date Of First Authorisation/Renewal Of The Authorisation

01 July 2008

10. Date Of Revision Of The Text

10 July 2008


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Daktarin Cream (Janssen-Cilag Ltd)


1. Name Of The Medicinal Product

Daktarin Cream.

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cream

White homogeneous cream.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.

4.2 Posology And Method Of Administration

Route of administration:

Cutaneous use.

Recommended dosage:

For all ages:

Skin infections: Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

4.3 Contraindications

Daktarin Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.

4.4 Special Warnings And Precautions For Use

Daktarin Cream must not come into contact with the eyes.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

4.6 Pregnancy And Lactation

Pregnancy

In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common

Common

Uncommon

Rare

Very rare <1/10,000, including isolated reports

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation

General disorders and administration site conditions

Rare: application site reactions, including application site irritation

4.9 Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

5.2 Pharmacokinetic Properties

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15 g, 30 g or 70 g* of cream, or aluminium tube inner lined with heat polymerised epoxy-phenol resin with a high density polyethylene cap containing 5 g of cream.

*Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd,

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

13 May 1974 / 08 December 2008

10. Date Of Revision Of The Text

08 December 2008


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Daktacort Ointment


1. Name Of The Medicinal Product

Daktacort™ Ointment.

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.

3. Pharmaceutical Form

White, odourless, fatty ointment.

4. Clinical Particulars 4.1 Therapeutic Indications

For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema.

Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis.

Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

The properties of Daktacort indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with Daktarin™ Cream or Daktarin™ Powder.

4.2 Posology And Method Of Administration

For topical administration.

Daktacort Ointment should be applied topically two or three times daily.

The same dosage applies to both adults and children.

Use in elderly:

Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

In infants, long term continuous topical corticosteroid therapy should be avoided.

If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.

4.3 Contraindications

True hypersensitivity to any of the ingredients. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria.

4.4 Special Warnings And Precautions For Use

When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored.

As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly, application to the face should be avoided.

In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see Section 5.2 Pharmacokinetic properties), clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of Daktacort compared with topical preparations containing hydrocortisone alone.

4.6 Pregnancy And Lactation

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses and administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established. However, combinations of topical steroids with imidazoles should be used in pregnant women only if the practitioner considers it to be necessary.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, local sensitivity may occur requiring discontinuation of treatment.

Additional adverse drug reactions reported in postmarketing reports with DAKTACORT CREAM but not with DAKTACORT OINTMENT are included in Table 1. The frequencies are based on spontaneous reporting rates, according to the following convention:

Very common Common Uncommon Rare Very rare <1/10,000, including isolated reports

Table 1. Adverse Drug Reactions Identified During Postmarketing Experience with Daktacort Cream by Frequency Category Estimated from Spontaneous Reporting Rates

     

Immune system disorders

 

Very rare

Anaphylactic reaction

   

Skin and Subcutaneous Tissue Disorders

 

Very rare

Contact dermatitis, Erythema, Rash

Review of adverse events reported with Daktacort Ointment did not find sufficient evidence to assess any of the events as adverse drug reactions associated with the use of Daktacort Ointment.

4.9 Overdose

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Miconazole nitrate is a potent broad-spectrum antifungal and antibacterial agent with marked activity against dermatophytes, pathogenic yeasts (eg Candida spp) and many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

Hydrocortisone is a widely used topical anti-inflammatory of value in the treatment of inflammatory skin conditions including atrophic and infantile eczema, contact sensitivity reactions and intertrigo.

5.2 Pharmacokinetic Properties

Absorption

Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application. Approximately 3% of the dose of hydrocortisone is absorbed after application on the skin.

Distribution

Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%). More than 90% of hydrocortisone is bound to plasma proteins.

Metabolism and elimination

The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.

The half-life of hydrocortisone is about 100 minutes. Metabolism takes place in the liver and tissues and the metabolites are excreted with the urine, mostly as glucuronides, together with a very small fraction of unchanged hydrocortisone.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polyethylene 5.5% liquid paraffin gel.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store at or below 25°C.

6.5 Nature And Contents Of Container

Aluminium tube with polypropylene cap.

Each tube contains 5 g, 30 g or 75 g ointment.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0130

9. Date Of First Authorisation/Renewal Of The Authorisation Date of First Authorisation: 05/03/87 Renewal of Authorisation: 28/03/03 10. Date Of Revision Of The Text

2nd March 2009

LEGAL CATEGORY

POM.


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antifungal, azole Vaginal


Class Name: antifungal, azole (Vaginal route)

Commonly used brand name(s)

In the U.S.

3 Day Vaginal Cream Femizol-M Gynazole-1 Gyne-Lotrimin Monistat 1 Mycelex-3 Mycelex-7 Terazol 3 Terazol 7 Tioconazole 1 Vagistat-1 Zazole

In Canada

Canesten 2 Canesten 3 Canesten 6 Day Canesten Combi-Pak 1 Day Canesten Combi-Pak 3 Day Canesten External Cream Clotrimaderm Gyne Cure Gyno-Trosyd Miconazole 3 Day Ovule Treatment Miconazole Nitrate Monistat 1 Combination Pack Vaginal Ovule

Available Dosage Forms:

Ointment Kit Cream Suppository Tablet Tampon Uses For This Medicine

Vaginal azoles are used to treat yeast (fungus) infections of the vagina.

For first-time users, make sure your doctor has checked and confirmed that you have a vaginal yeast infection before you use the vaginal azole antifungal medicines that do not require a prescription. Vaginal yeast infections can reoccur over time and, when the same symptoms occur again, self-treating with these medicines is recommended. However, you should see your doctor if the symptoms occur again within 2 months.

Vaginal antifungal azoles are available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of vaginal azoles in children with use in other age groups. It is recommended that these medicines not be used in children up to 12 years of age.

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 vaginal azoles in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies have not been done in humans for use of all azole antifungals during the first trimester of pregnancy. These medicines are safe and effective when used for at least 7 days during the second and third trimesters of pregnancy. However, check with your doctor before using this medicine during the first trimester of pregnancy. Also, use of 1- and 3-day treatments may not be effective during pregnancy.

Breast Feeding

It is not known whether vaginal azoles pass into the breast milk. However, these medicines have not been shown to cause problems in nursing babies.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 This Medicine

Vaginal azoles usually come with patient directions. Read them carefully before using this medicine.

Use this medicine at bedtime, unless otherwise directed by your doctor. The vaginal tampon form of miconazole should be left in the vagina overnight and removed the next morning.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator.

Some of the vaginal suppositories or tablets come packaged with a small tube of cream. This cream can be applied outside of the vagina in the genital area to treat itching. The packages are called combination, dual, or twin packs.

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. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, do not stop using this medicine if your menstrual period starts during the time of treatment.

Dosing

The dose medicines in this class 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 these medicines. 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 butoconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers— Women who are not pregnant: 100 milligrams (mg) (one full applicator) of 2% cream inserted into the vagina at bedtime for three nights in a row. Pregnant women, after the third month: 100 mg (one full applicator) of 2% cream inserted into the vagina at bedtime for six nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers— Women who are not pregnant: 100 mg (one suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For clotrimazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 1% cream: 50 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for six to fourteen nights in a row. 2% cream: 100 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. 10% cream: 500 mg (one full applicator) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—The dose depends on the strength of the vaginal tablet. Women who are not pregnant: 100-mg tablet: Insert one tablet into the vagina at bedtime for six or seven nights in a row. 200-mg tablet: Insert one tablet into the vagina at bedtime for three nights in a row. 500-mg tablet: Insert one tablet into the vagina at bedtime for one night only. Pregnant women: 100 mg (one vaginal tablet) inserted into the vagina at bedtime for seven nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For econazole For yeast infection: For vaginal suppository dosage form: Adults and teenagers—150 milligrams (mg) (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For miconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—20 milligrams (one full applicator) inserted into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—The dose depends on the strength of the suppository. 100-milligram (mg) suppository: Insert one vaginal suppository into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. 200-mg suppository or 400-mg suppository: Insert one vaginal suppository into the vagina at bedtime for three nights in a row. Treatment may be repeated if needed. 1200-mg suppository: Insert one vaginal suppository into the vagina at bedtime for one night. Children up to 12 years of age—Use and dose must be determined by your doctor. For tampon dosage form: Adults and teenagers—100 mg (one tampon) inserted into the vagina at bedtime and then removed the next morning. This is repeated every night for five nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For terconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 0.4% cream: 20 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for seven nights in a row. 0.8% cream: 40 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—80 mg (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For tioconazole For yeast infection: For vaginal ointment dosage form: Adults and teenagers—300 milligrams (mg) (one full applicator) of 6.5% ointment inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—300 mg (one vaginal suppository) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, 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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the vaginal cream, ointment, and suppository forms of this medicine from freezing.

Precautions While Using This Medicine

If your symptoms do not improve within 3 days or have not disappeared in 7 days, or if they become worse, check with your doctor. The 1- or 3-day treatments may take up to 7 days to completely clear up your infection. However, not all vaginal infections are caused by yeast. If symptoms occur again within 2 months, check with your doctor.

Vaginal medicines usually will come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. The use of nonmedicated tampons (like those used for menstrual periods) is not recommended since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties. Wear only clean panties.

If you have any questions about this, check with your health care professional.

Vaginal yeast infections are not usually spread by having sex and your sex partner does not need to be treated. However, if the sex partner has symptoms of local itching or skin irritation of the penis, he may benefit by being treated also.

If you use latex or rubber birth control devices (condoms, diaphragms, or cervical caps), you should wait 3 days after treatment with azole antifungal agents before using them again. Many brands of vaginal azoles contain oils in the product that can weaken these devices. This increases the chances of a condom breaking during sexual intercourse. The rubber in cervical caps or diaphragms may break down faster and wear out sooner. Check with your health care professional to make sure the vaginal azole product you are using can be used with latex rubber birth control devices.

Check with your doctor before douching to obtain advice about whether you may douche and, if allowed, the proper method.

Side Effects of This Medicine

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:

Less common Vaginal burning, itching, discharge, or other irritation not present before use of this medicine Rare Skin rash or hives

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:

Less common or rare Abdominal or stomach cramps or pain burning or irritation of penis of sexual partner headache

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.

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