A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Otic anesthetics are agents that act locally to relieve pain in the ears. Some of these agents are available with other medicines such as analgesics, decongestants, etc. They are generally available as ear drops.

See also

Medical conditions associated with otic anesthetics:

Acute Otitis Externa Ear Conditions Ear Wax Impaction Otitis Externa Otitis Media Drug List: A-B-Otic Americaine-Otic-Drops Auralgan Aurodex Auroto Re-Benzotic-Otic-Drops Chlorphenylcaine-Ear-Drops Dolotic Neotic-Drops Oticaine Otic-Edge Oticin-Ear-Drops Otilam Otocain-Drops Otogesic Pramotic Pr-Otic Rx-Otic Treagan Tympagesic Uni-Otic-Drops



1. Name Of The Medicinal Product

Ocufen®

2. Qualitative And Quantitative Composition

Flurbiprofen sodium 0.03% w/v

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

Ocufen is indicated for

1) the inhibition of intraoperative miosis. Ocufen does not have intrinsic mydriatic properties and does not replace mydriatic agents.

2) the management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.

4.2 Posology And Method Of Administration

Adult dosage: For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.

To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.

In accordance with standard practice, other topical medication should not be co-administered with Ocufen. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.

Use in children: Safety and effectiveness in children have not been established.

Administration: Topical by instillation into the conjunctival sac.

4.3 Contraindications

Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Ocufen is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.

Use of Ocufen is contra-indicated in patients with known haemostatic defects or who are receiving other medications which may prolong bleeding time. Ocufen is contra- indicated for intraocular use during surgical procedures.

4.4 Special Warnings And Precautions For Use

Wound healing may be delayed with the use of Ocufen.

There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.

Patients with a history of herpes simplex keratitis should be monitored closely.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Ocufen.

4.6 Pregnancy And Lactation

Use in pregnancy: Safety of use in pregnant women has not been established. Ocufen should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The most frequent adverse reactions reported with the use of Ocufen are transient burning and stinging on instillation, and other minor signs of ocular irritation.

4.9 Overdose

No adverse effects are likely to be experienced following overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Flurbiprofen sodium is a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.

Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin- mediated miosis may occur.

Treatment with Ocufen prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.

The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.

Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

5.2 Pharmacokinetic Properties

Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

Liquifilm® (polyvinyl alcohol)

Potassium chloride

Sodium chloride

Sodium citrate dihydrate

Citric acid monohydrate

Sodium hydroxide or

Hydrochloric acid (to adjust pH)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose.

6.4 Special Precautions For Storage

Store at or below 25oC.

6.5 Nature And Contents Of Container

Clear, plastic unit dose vial, each containing 0.4 ml of solution.

6.6 Special Precautions For Disposal And Other Handling

Each vial of Ocufen should be used for a single dose and discarded after use.

7. Marketing Authorisation Holder

Allergan Limited

Marlow International

The Parkway

Marlow

Buckinghamshire SL7 1YL

United Kingdom

8. Marketing Authorisation Number(S)

PL 00426/0069

9. Date Of First Authorisation/Renewal Of The Authorisation

28th June 1991/17th May 2005

10. Date Of Revision Of The Text

24th November 2006



Definition of Otitis Media:

Infection and inflammation of the middle ear space and ear drum.

Symptoms include earache, fever and in some cases, diminished hearing.

Drugs associated with Otitis Media

The following drugs and medications are in some way related to, or used in the treatment of Otitis Media. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Otitis Media Chronic Otitis Media (2 drugs in 2 topics) Otitis Media with Perforation of Ear Drum (0 drugs) Perforated Tympanic Membrane (0 drugs)



A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

See also

Medical conditions associated with other immunosuppressants:

Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia Acute Nonlymphocytic Leukemia Anemia Asthma, Maintenance Atopic Dermatitis Autoimmune Hepatitis Behcet's Disease Biliary Cirrhosis Bladder Cancer Brain Tumor Breast Cancer Bullous Pemphigoid Cervical Cancer Choriocarcinoma Chronic Active Hepatitis Chronic Inflammatory Demyelinating Polyradiculoneuropathy Cogan's Syndrome Colorectal Cancer Crohn's Disease Crohn's Disease, Acute Crohn's Disease, Maintenance Dermatomyositis Ectopic Pregnancy Eczema Esophageal Carcinoma Gastric Cancer Glomerulonephritis Graft-versus-host disease Head and Neck Cancer Hodgkin's Lymphoma Idiopathic Thrombocytopenic Purpura Inflammatory Bowel Disease Leprosy, Erythema Nodosum Leprosum Lymphoma Meningeal Leukemia Multiple Myeloma Multiple Sclerosis Myasthenia Gravis Mycosis Fungoides Myopathy Neoplastic Diseases Nephrotic Syndrome Neurosarcoidosis Non-Hodgkin's Lymphoma Non-Small Cell Lung Cancer Organ Transplant, Rejection Prophylaxis Osteosarcoma Ovarian Cancer Pancreatic Cancer Pemphigoid Pemphigus Pityriasis rubra pilaris Psoriasis Psoriatic Arthritis Renal Transplant Rheumatoid Arthritis Sarcoidosis Small Cell Lung Cancer Soft Tissue Sarcoma Solid Tumors Systemic Lupus Erythematosus Systemic Sclerosis Takayasu's Arteritis Trophoblastic Disease Ulcerative Colitis Uveitis Drug List: Revlimid Xolair Azasan Imuran Rheumatrex Thalomid Trexall



Drugs associated with Organ Transplant, Rejection Reversal

The following drugs and medications are in some way related to, or used in the treatment of Organ Transplant, Rejection Reversal. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Organ Transplant, Rejection Reversal Rejection Reversal (1 drug)



Address Onyx Pharmaceuticals, Inc,



1. Name Of The Medicinal Product

Oruvail IM Injection

2. Qualitative And Quantitative Composition

In terms of the active ingredient

Ketoprofen BP 100mg in 2 ml.

3. Pharmaceutical Form

Solution for IM injection

4. Clinical Particulars 4.1 Therapeutic Indications

Oruvail injection is recommended in the management of acute exacerbations of:

• Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

• Periarticular conditions such as fibrositis, bursitis, capsulitis, tendinitis and tenosynovitis.

• Low back pain of musculoskeletal origin and sciatica.

• Other painful musculoskeletal conditions.

• Acute gout.

• Control of pain and inflammation following orthopaedic surgery.

4.2 Posology And Method Of Administration

Adults: 50 to 100 mg every four hours, repeated up to a maximum of 200 mg in twenty-four hours. Following a satisfactory response, oral therapy should be instituted with ketoprofen capsules. It is recommended that the injection should not normally be continued for longer than three days.

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric dosage: not established.

Oruvail IM Injection is for intramuscular injection only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4

4.3 Contraindications

Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, any other ingredients in this medicine, ASA or other NSAIDs.

Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug.

Ketoprofen is also contraindicated in the third trimester of pregnancy.

Ketoprofen is contraindicated in the following cases:

-severe heart failure

-active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

-haemorrhagic diathesis

-severe hepatic insufficiency

-severe renal insufficiency

-third trimester of pregnancy

Ketoprofen is contraindicated in cases of cerebrovascular bleeding or any other active bleeding.

Ketoprofen is contraindicated in patients with haemostatic disorders or ongoing anticoagulant therapy.

4.4 Special Warnings And Precautions For Use

Oruvail injection is for intramuscular use only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration, and GI and cardiovascular risks below).

The use of ketoprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5 Interactions).

Elderly:

The elderly have an increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see Section 4.2 Posology and method of administration).

Cardiovascular, Renal and Hepatic impairment:

At the start of treatment, renal function must be carefully monitored in patients with heart impairment, heart failure, liver dysfunction, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition (see Section 4.3 Contra-indications).

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen.

Respiratory disorders:

Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3).

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses (see also section 4.2 and 4.3).

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAlD doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

NSAIDs should only be given with care to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Section 4.8 Undesirable effects).

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ketoprofen, the treatment should be withdrawn.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosis (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Impaired female fertility:

The use of ketoprofen, as with other NSAIDs, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ketoprofen should be considered.

Skin reactions:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAlDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Infectious disease:

As with other NSAIDs, in the presence of an infectious disease, it should be noted that the anti-inflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

Risk of gastrointestinal bleeding: the relative risk increases in subjects who have a low body weight. If gastrointestinal bleeding or ulcer occur, treatment must be discontinued immediately.

Blood counts and liver and kidney function tests should be carried out during long-term treatment.

Hyperkalaemia:

Hyperkalaemia promoted by diabetes or concomitant treatment with potassium-sparing agents (see section 4.5 Interactions).

Potassium levels must be monitored regularly under these circumstances.

In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy.

Patients with active or a past history of peptic ulcer.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (i.e. ticlopidine, clopidogrel):

Increased risk of bleeding (see section 4.4).

If co-administration is unavoidable, patient should be closely monitored

Lithium:

Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy.

Other analgesics/NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates:

Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, particularly gastrointestinal ulceration and bleeding (see section 4.4 Special warnings and precautions for use).

Methotrexate:

Serious interactions have been recorded after the use of high dose methotrexate with NSAIDs, including ketoprofen, due to decreased elimination of methotrexate. At doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (> 15mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.

Allow at least 12 hours between the discontinuation or initiation of ketoprofen treatment and the administration of methotrexate.

At doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.

Mifepristone:

NSAlDs should not be used for 8-12 days after mifepristone administration as NSAlDs can reduce the effect of mifepristone.

Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics):

Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).

Diuretics:

Risk of reduced diuretic effect. Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started (see section 4.4 Special warnings and precautions for use).

Cardiac glycosides:

NSAlDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Ciclosporin: Increased risk of nephrotoxicity, particularly in elderly subjects.

Quinolone antibiotics:

Animal data indicate that NSAlDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAlDs and quinolones may have an increased risk of developing convulsions.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus, particularly in elderly subjects.

Thrombolytics:

Increased risk of bleeding.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and precautions for use).

ACE inhibitors and Angiotensin II Antagonists:

In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.

Zidovudine:

Increased risk of haematological toxicity when NSAlDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Risks related to hyperkalaemia:

Certain medicinal products or therapeutic categories can promote hyperkalaemia, i.e. potassium salts, potassium-sparing diuretics, converting enzyme inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular-weight or unfractioned), ciclosporin, tacrolimus and trimethoprim. The occurrence of hyperkalaemia can depend on the presence of co-factors. This risk is enhanced when the drugs mentioned above are administered concomitantly.

Risks related to antiplatelet effect:

Several substances are involved in interactions due to their antiplatelet effects: tirofiban, eptifibarid, abcixiab, and iloprost. The use of several antiplatelet drugs enhances the risk of bleeding.

4.6 Pregnancy And Lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ketoprofen should not be given unless clearly necessary. If ketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of the pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- Inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.

Lactation

No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned about the potential for somnolence, dizziness or convulsions and be advised not to drive or operate machinery if these symptoms occur.

Patients should be warned of possible visual disturbances. If patients experience this, they should not drive or use machines.

4.8 Undesirable Effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been r3eported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Local reactions can occur and may include pain or a burning sensation. In all cases of major adverse effects Oruvail should be withdrawn at once.

Cardiovascular and cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Other adverse reactions reported less commonly include:

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.

Hepatic: abnormal liver function, hepatitis and jaundice.

Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (See section 4.4) , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

4.9 Overdose

Symptoms

In adults, the principal signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. Disorientation, excitation, coma, tinnitus, fainting, occasionally convulsions may also occur. During severe intoxication, hypotension, respiratory depression and gastrointestinal bleeding have been observed.

Adverse effects seen after overdose with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated.

In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures:

The patient must be transferred immediately to a specialised hospital setting where symptomatic treatment can begin.

There is no specific antidote.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient's clinical condition.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ketoprofen is a pharmacopoeial non-steroidal anti-inflammatory drug (NSAID). It is a strong inhibitor of prostaglandin synthetase and potent analgesic agent. Studies in vitro and in vivo show that ketoprofen possesses powerful anti-inflammatory, antipyretic, antibradykinin and lysosomal membrane stabilising properties.

5.2 Pharmacokinetic Properties

Peak concentrations of approximately 10 mg/L are reached at about 0.5-0.75 H after a 100 mg dose. The elimination half life is approximately 1.88 H. Apart from earlier Tmax values, there are no significant differences between the pharmacokinetics of Oruvail IM injection and conventional release capsules (Orudis).

5.3 Preclinical Safety Data

No additional data of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arginine

BP

Benzyl Alcohol

BP

Citric Acid anhydrous (E330)

BP

Water For Injections

BP

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C. Protect from light.

6.5 Nature And Contents Of Container

Cartons containing 10 ampoules each having 2 ml. of injection.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0377

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2005

10. Date Of Revision Of The Text

11 May 2011

LEGAL CATEGORY

POM



There are currently no drugs listed for "Ocular Tuberculosis".

Definition of Ocular Tuberculosis: Tuberculosis infection of the eye(s).

Learn more about Ocular Tuberculosis

Micromedex Care Notes:

Tuberculosis

Medical Encyclopedia:

Disseminated tuberculosis



1. Name Of The Medicinal Product

One-Alpha® Injection

2. Qualitative And Quantitative Composition

Alfacalcidol (1?-hydroxyvitamin D3) 2 micrograms/ml.

3. Pharmaceutical Form

Injection

4. Clinical Particulars 4.1 Therapeutic Indications

One-Alpha® is indicated in all conditions where there is a disturbance of calcium metabolism due to impaired 1 ?-hydroxylation such as when there is reduced renal function.

The main indications are:

a) Renal osteodystrophy

b) Hyperparathyroidism (with bone disease)

c) Hypoparathyroidism

d) Neonatal hypocalcaemia

e) Nutritional and malabsorptive rickets and osteomalacia

f) Pseudo - deficiency (D - dependent) rickets and osteomalacia

g) Hypophosphataemic vitamin D resistant rickets and osteomalacia

4.2 Posology And Method Of Administration

One-Alpha® Injection should be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

The dosage of One-Alpha® Injection is the same as for One-Alpha® in its oral presentations.

Initial dosage for all indications is:

Adults

1 microgram/day

Dosage in the elderly

0.5 microgram/day

Neonates and premature infants

0.05 - 0.1 microgram/kg/day

Children under 20 kg bodyweight

0.05 microgram/kg/day

Children over 20 kg bodyweight

1 microgram/day

The dose of One-Alpha® should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.

Maintenance doses are generally in the range of 0.25 - 1 microgram per day.

When administered as intravenous injection to patients undergoing haemodialysis the initial dosage for adults is 1 microgram per dialysis. The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis.

(a) Renal bone disease:

Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha®. Other therapeutic measures may be indicated.

Before and during treatment with One-Alpha®, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.

(b) Hyperparathyroidism:

In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha® for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, One-Alpha® should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.

(c) Hypoparathyroidism:

In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha®. Severe hypocalcaemia is corrected more rapidly with higher doses of One-Alpha® (eg 3-5 micrograms) together with calcium supplements.

(d) Neonatal hypocalcaemia:

Although the normal starting dose of One-Alpha® is 0.05-0.1 microgram/kg/day (followed by careful titration), in severe cases, doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease.

(e) Nutritional and malabsorptive rickets and osteomalacia:

Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha®. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha®.

(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia:

Although large doses of parent vitamin D would be required, effective doses of One-Alpha® are similar to those required to heal nutritional Vitamin D deficiency rickets and osteomalacia.

(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:

Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha® at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.

4.3 Contraindications

Hypercalcaemia, metastatic calcification.

Hypersensitivity to alfacalcidol or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

One-Alpha® Injection should be avoided in patients with known sensitivity to injections containing propylene glycol.

One-Alpha® should be used with caution for:

• small premature infants

• patients being treated with cardioactive glycosides or digitalis as hypercalcaemia may lead to arrhythmia in such patients

• patients with nephrolithiasis

During treatment with One-Alpha® serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. To maintain serum phosphate at an acceptable level in patients with renal bone disease a phosphate binding agent may be used.

Hypercalcaemia may appear in patients treated with One-Alpha®, the early symptoms are as follows:

• polyurina

• polydipsia

• weakness, headache, nausea, constipation

• dry mouth

• muscle and bone pain

• metallic taste

Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). One-Alpha® treatment may then be restarted at a reduced dose (half the previous dose).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients taking barbiturates or anticonvulsants may require larger doses of One-Alpha® to produce the desired effect due to the induction of hepatic detoxification enzymes.

Use with caution in patients being treated with thiazide diuretics as they may have an increased risk of developing hypercalcaemia.

4.6 Pregnancy And Lactation

There are no adequate data from the use of alfacalcidol in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risks for humans are unknown. Caution should be taken when prescribing to pregnant women as hypercalcaemia during pregnancy may produce congenital disorders in the offspring.

Although it has not been established, it is likely that increased amounts of 1,25 dihydroxyvitamin D will be found in the milk of lactating mothers treated with One-Alpha®. This may influence calcium metabolism in the infant.

4.7 Effects On Ability To Drive And Use Machines

One-Alpha® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

The most frequently reported undesirable effects are hypercalcaemia and various skin reactions. Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). One-Alpha® treatment may then be restarted at half the previous dose.

Based on data from post-market use the total undesirable effect 'reporting rate' is rare or very rare being approximately 1:10,000 patients treated.

Metabolism and Nutrition Disorders

Hypercalcaemia

Hyperphosphataemia

Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

Urticaria

Renal and Urinary Disorders

Nephrocalcinosis

Renal impairment

4.9 Overdose

Hypercalcaemia is treated by suspending the administration of One-Alpha®.

In severe cases of hypercalcaemia general supportive measures should be undertaken. Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Alfacalcidol is converted rapidly in the liver to 1,25 dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of One-Alpha® and 1,25 dihydroxyvitamin D are very similar.

Impaired 1 ?-hydroxylation reduces 1,25 dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of One-Alpha®.

The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of One-Alpha® is the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment.

5.2 Pharmacokinetic Properties

In patients on regular haemodialysis administration of doses between 1 - 4 micrograms of intravenous 1 ?-hydroxyvitamin D3 resulted in increased levels of 1,25 dihydroxyvitamin D. Formation of 1,25 dihydroxyvitamin D3 occurred within 1 hour after intravenous 1 ?-hydroxyvitamin D3 and peak concentrations were reached between 2 and 5 hours. Elimination half life of the formed 1,25 dihydroxyvitamin D was between 14 and 30 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric acid, ethanol, sodium citrate, propylene glycol and water for injection.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store at 2-8°C.

Keep the ampoule in the outer carton in order to protect it from light.

6.5 Nature And Contents Of Container

10 x 0.5ml amber glass ampoules.

10 x 1.0ml amber glass ampoules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0183

9. Date Of First Authorisation/Renewal Of The Authorisation

11/11/2005

10. Date Of Revision Of The Text

May 2009



1. Name Of The Medicinal Product

OreloxTM Paediatric Granules for Oral Suspension.

2. Qualitative And Quantitative Composition

When reconstituted each 5ml volume contains 52mg of cefpodoxime proxetil (equivalent to 40mg cefpodoxime).

3. Pharmaceutical Form

Granules for the preparation of an oral suspension.

4. Clinical Particulars 4.1 Therapeutic Indications

Orelox is a bactericidal cephalosporin antibiotic active against a wide range of Gram-negative and Gram-positive organisms. It is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity.

Indications include:

Upper respiratory tract infections caused by organisms sensitive to cefpodoxime, including acute otitis media, sinusitis, tonsillitis and pharyngitis.

Orelox should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics.

Lower respiratory tract infections caused by organisms sensitive to cefpodoxime. Including pneumonia, acute bronchitis and when bacterial super-infection complicates bronchiolitis.

Upper and lower urinary tract infections caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis.

Skin and soft tissue infections caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers.

4.2 Posology And Method Of Administration

Route of administration: oral.

Adults and Elderly:

Not applicable for this product.

Children:

The recommended mean dosage for children is 8mg/kg/day administered in two divided doses at 12 hour intervals.

The following dosage regimen is proposed as a guide to prescribing:-

Below 6 months: 8mg/kg/day in 2 divided doses

6 months-2 years: 5.0 ml twice daily

3-8 years : 10.0 ml twice daily

Above 9 years : 12.5ml twice daily or 100mg tablet twice daily

Orelox should not be used in infants less than 15 days old, as no experience yet exists in this age group.

A measuring spoon (5ml) is provided with the bottle to aid correct dosing. One measuring spoon (5ml) contains the equivalent of 40 mg cefpodoxime.

The product should be taken during meals for optimal absorption.

Renal Impairment:

The dosage of Orelox does not require modification if creatinine clearance exceeds 40 ml.min-1/1.73m2.

Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately.

CREATININE CLEARANCE

(ML/MIN)

 

39 – 10

Unit dose1 administered as a single dose every 24 hours (i.e half of the usual adult dose).

< 10

Unit dose1 administered as a single dose every 48 hours (i.e quarter of the usual adult dose).

Haemodialysis Patients

Unit dose1 administered after each dialysis session.

NOTE:

1The unit dose is either 100mg or 200mg, depending on the type of infection.

Hepatic Impairment:

The dosage does not require modification in cases of hepatic impairment.

Instructions for Reconstitution:

Before preparing the suspension the silica gel desiccant contained in a capsule inside the cap must be removed and disposed of. The suspension is prepared by adding water to the bottle up to the calibrated mark and shaking thoroughly to obtain an evenly dispersed suspension

4.3 Contraindications

Patients with hypersensitivity to cephalosporin antibiotics.

Patients with phenylketonuria since the product contains aspartame.

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

4.4 Special Warnings And Precautions For Use

Preliminary enquiry about allergy to penicillin is necessary before prescribing cephalosporins since cross allergy to penicillins occurs in 5-10% of cases.

Particular care will be needed in patients sensitive to penicillin: strict medical surveillance is necessary from the very first administration. Where there is doubt, medical assistance should be available at the initial administration, in order to treat any anaphylactic episode.

In patients who are allergic to other cephalosporins, the possibility of cross allergy to Orelox should be borne in mind. Orelox should not be given to those patients with a previous history of immediate type hypersensitivity to cephalosporins.

Hypersensitivity reactions (anaphylaxis) observed with beta-lactam antibiotics can be serious and occasionally fatal.

The onset of any manifestation of hypersensitivity indicates that treatment should be stopped.

Orelox is not the preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia.

In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance.

Antibiotics should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. Orelox may induce diarrhoea, antibiotic associated colitis and pseudomembranous colitis. These side-effects, which may occur more frequently in patients receiving higher doses for prolonged periods, should be considered as potentially serious. The presence of C. difficile should be investigated. In all potential cases of colitis, the treatment should be stopped immediately. The diagnosis should be confirmed by sigmoidoscopy and specific antibiotic therapy (vancomycin) substituted if considered clinically necessary. The administration of products which cause faecal stasis must be avoided. Although any antibiotic may cause pseudomembranous colitis, the risk may be higher with broad-spectrum drugs, such as the cephalosporins.

As with all beta-lactam antibiotics, neutropenia, and more rarely agranulocytosis may develop, particularly during extended treatment. For cases of treatment lasting longer than 10 days, blood count should therefore be monitored, and treatment discontinued if neutropenia is found.

Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibiotics directed against the drug. This can produce a positive Coombs' test and very rarely, haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.

The product should not be used in infants less than 15 days old as no clinical trial data in this age group yet exists.

Changes in renal function have been observed with antibiotics of the same class, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potent diuretics. In such cases, renal function should be monitored.

As with other antibiotics, the prolonged use of cefpodoxime proxetil may result in the overgrowth of non-susceptible organisms. With oral antibiotics the normal colonic flora may be altered, allowing overgrowth by clostridia with consequent pseudomembranous colitis. Repeated evaluation of the patient is essential and if superinfection occurs during therapy, appropriate measures should be taken.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions have been reported during the course of clinical studies.

Histamine H2-antagonists and antacids reduce the bioavailibility of cefpodoxime. Probenecid reduces the excretion of cephalosporins. Cephlasporins potentially enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of oestrogens.

As with other cephalosporins, isolated cases showing development of a positive Coombs' test have been reported (see Precautions).

Studies have shown that bioavailability is decreased by approximately 30% when Orelox is administered with drugs which neutralise gastric pH or inhibit acid secretions. Therefore, such drugs as antacids of the mineral type and H2 blockers such as ranitidine, which cause an increase in gastric pH, should be taken 2 or 3 hours after Orelox administration.

In contrast, drugs which decrease gastric pH such as pentagastrine will increase bioavailability. The clinical consequences remain to be established.

The bioavailability increases if the product is administered during meals.

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Possible side effects include gastrointestinal disorders such as diarrhoea and rarely antibiotic-associated colitis, including pseudomembranous colitis (see Section 4.4: Special Warnings and Precautions for Use), nausea, vomiting and abdominal pain and rash, urticaria and itching. Changes in renal function have been observed with antibiotics from the same group as Cefpodoxime, particularly when co-prescribed with aminoglycosides and/or potent diuretics.

Occasional cases have been reported of headaches, dizziness, tinnitus, parethesia, asthenia and malaise. Rare cases of allergic reactions include hypersensitivity mucocutaneous reactions, skin rashes and pruritus. Occasional cases of bullous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have also been received. Transient moderate elevations of ASAT, ALAT and alkaline phosphatases and/or bilirubin have been reported. These laboratory abnormalities which may be explained by the infection, may rarely exceed twice the upper limit of the named range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic.Slight increases in blood urea and creatinine have also been reported. Exceptionally rare are the occurrence of liver damage and of haematological disorders such as reduction in haemoglobin, thrombocytosis, thrombocytopenia, leucopenia and eosinophilia. Haemolytic anaemia has extremely rarely been reported.

As with other ?-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may develop during treatment with Cefpodoxime, particularly if given over long periods.

As with other cephalosporins, there have been rare reports of anaphylactic reactions, bronchospasm, purpura and angiodema, serum-sickness-like reactions with rashes, fever and arthralgia.

4.9 Overdose

In the event of overdosage with Orelox, supportive and symptomatic therapy is indicated.

In cases of overdosage, particularly in patients with renal insufficiency, encephalopathy may occur. The encephalopathy is usually reversible once cefpodoxime plasma levels have fallen.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Orelox (Cefpodoxime proxetil) is a beta-lactam antibiotic, a 3rd generation oral cephalosporin. It is the prodrug of cefpodoxime.

Following oral administration, Orelox is taken up by the gastro-intestinal wall where it is rapidly hydrolysed to cefpodoxime, a bactericidal antibiotic, which is then absorbed systemically.

BACTERIOLOGY:

The mechanism of action of cefpodoxime is based on inhibition of bacterial cell wall synthesis. It is stable to numerous beta-lactamases.

Cefpodoxime has been shown to possess in vitro bactericidal activity against numerous Gram-positive and Gram-negative bacteria.

ANTIBACTERIAL ACTIVITY:

It is highly active against the Gram-positive organisms:

• Streptococcus pneumoniae

Streptococci of Groups A (S. pyogenes), B (S. agalactiae), C, F and G

Other streptococci (S. mitis, S. sanguis and S. salivarius)

• Propionibacterium acnes

• Corynebacterium diphtheriae

It is highly active against the Gram-negative organisms:

• Haemophilus influenzae (beta-lactamase and non beta-lactamase producing strains)

• Haemophilus para-influenzae (beta-lactamase and non beta-lactamase producing strains)

• Moraxella catarrhalis (beta-lactamase and non beta-lactamase producing strains)

• Escherichia coli

• Klebsiella Spp. (K. pneumoniae)

• Proteus mirabilis

It is moderately active against:

Meticillin-sensitive staphylococci, penicillinase and non-penicillinase producing strains (S. aureus and S. epidermidis)

In addition, as with many cephalosporins, the following are resistant to cefpodoxime.

• Enterococci

Meticillin-resistant staphylococci (S. aureus and S. coagulase (negative))

• Staphylococcus saprophyticus

• Pseudomonas aeruginosa and Pseudomonas Spp.

• Clostridium difficile

• Bacteroides fragilis and related species

As with all antibiotics, whenever possible, sensitivity should be confirmed by in vitro testing.

5.2 Pharmacokinetic Properties

Orelox is taken up in the intestine and is hydrolysed to the active metabolite cefpodoxime. When cefpodoxime proxetil is administered orally to fasting subjects as a tablet corresponding to 100mg of cefpodoxime, 51.5% is absorbed and absorption is increased by food intake. The volume of distribution is 32.3 l and peak levels of cefpodoxime occur 2 to 3 hrs after dosing. The maximum plasma concentration is 1.2mg/l and 2.5mg/l after doses of 100mg and 200mg respectively. Following administration of 100mg and 200mg twice daily over 14.5 days, the plasma pharmacokinetic parameters of cefpodoxime remain unchanged.

Serum protein binding of cefpodoxime, 40% principally to albumin. This binding is non saturable in type.

Concentrations of cefpodoxime in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.

As the majority of cefpodoxime is eliminated in the urine, the concentration is high. (Concentrations in 0-4, 4-8, 8-12 hr fractions after a single dose exceed MIC90 of common urinary pathogens). Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12hrs after an administration of a single 200mg dose (1.6-3.1µG/G). Concentrations of cefpodoxime in the medullary and cortical tissues is similar.

Studies in healthy volunteers show median concentrations of cefpodoxime in the total ejaculate 6-12hrs following administration of a single 200mg dose to be above the MIC90 of N. gonorrhoeae.

The main route of excretion is renal, 80% is excreted unchanged in the urine, with an elimination half life of approx 2.4 hours.

CHILDREN

In children, studies have shown the maximum plasma concentration occurs approximately 2-4 hours after dosing. A single 5mg/kg dose in 4-12 year olds produced a maximum concentration similar to that in adults given a 200mg dose.

In patients below 2 years receiving repeated doses of 5mg/kg 12 hourly, the average plasma concentrations, 2hrs post dose, are between 2.7mg/l (1-6 months) and 2.0mg/l (7 months-2 years).

In patients between 1 month and 12 years receiving repeated doses of 5mg/kg 12 hourly, the residual plasma concentrations at steady state are between 0.2-0.3mg/l (1 month-2 years) and 0.1mg/l (2-12 years).

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The product contains anhydrous colloidal silica, aspartame, banana flavour, carboxymethylcellulose calcium, carboxymethylcellulose sodium, citric acid monohydrate, hydroxypropylcellulose, yellow iron oxide, lactose monohydrate, monosodium glutamate, potassium sorbate, sodium chloride, sorbitan trioleate, sucrose and talc.

6.2 Incompatibilities

None reported during clinical studies.

6.3 Shelf Life

24 months.

Reconstituted suspension: can be stored for up to 10 days refrigerated (2-8°C).

6.4 Special Precautions For Storage

Bottles: unreconstituted product should be stored below 30°C.

6.5 Nature And Contents Of Container

Amber glass bottle with a calibration marking. This is fitted with a polyethylene dehydrating capsule containing silica gel, closed by a cardboard disc make up part of closure. There is a polyethylene pilfer and childproof screw cap fitted with tight triseal joint.

Pack sizes of 100ml of suspension.

A 5ml plastic spoon is supplied with the pack.

6.6 Special Precautions For Disposal And Other Handling

Before preparing the suspension the silica gel desiccant contained in a capsule inside the cap must be removed and disposed of. The suspension is prepared by adding water to the bottle up to the calibrated mark and shaking thoroughly to obtain an evenly dispersed suspension.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

PL 04425/0251

9. Date Of First Authorisation/Renewal Of The Authorisation

23rd July 2004

10. Date Of Revision Of The Text

8 October 2010

LEGAL CATEGORY

POM



Drugs associated with Opioid Overdose

The following drugs and medications are in some way related to, or used in the treatment of Opioid Overdose. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.



Drugs associated with Opiate Dependence

The following drugs and medications are in some way related to, or used in the treatment of Opiate Dependence. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Opiate Dependence Opiate Withdrawal (8 drugs)



OMACOR

1000 mg soft capsules

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may want 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 any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Omacor is and what it is used for



Drugs associated with Osteopenia

The following drugs and medications are in some way related to, or used in the treatment of Osteopenia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.



1. Name Of The Medicinal Product

Oilatum Plus

Oilatum Junior Flare-Up

2. Qualitative And Quantitative Composition

Light liquid paraffin 52.5% w/w, benzalkonium chloride solution 12.0% w/w, triclosan 2% w/w

3. Pharmaceutical Form

Solution

4. Clinical Particulars 4.1 Therapeutic Indications

Topical as a bath additive.

For the prophylactic treatment of eczemas at risk from infection.

4.2 Posology And Method Of Administration

Oilatum Plus must always be used diluted in water. It is an effective cleanser and should not be used with soap.

Use once daily. Do not exceed the recommended dose:

Adults and children: In an eight inch bath add 2 capfuls, in a four inch bath add 1 capful

Infants: Add 1 ml (just sufficient to cover the bottom of the cap) and mix well with water.

Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

Do not use for babies younger than 6 months

4.3 Contraindications

Patients with a known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

Oilatum Plus contains benzalkonium chloride which is irritant and may cause skin reactions.

Avoid contact of the undiluted product with the eyes and skin.

If the undiluted product comes into contact with the eye, reddening may occur. Eye irrigation should be performed for 15 minutes and then the eye examined under fluorescein stain. If there is persistent irritation or any uptake of fluorescein, the patient should be referred for ophthalmological opinion.

If undiluted product is applied directly to the skin, it may cause application site skin irritation and hypersensitivity reactions including skin exfoliation, pain, blister, caustic injury and necrosis.

The patient should be advised to use care to avoid slipping in the bath.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No restrictions on the use of the product in pregnancy and lactation are proposed.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Post-marketing data

Skin and subcutaneous tissues disorders

• Erythema, pruritus, skin reactions, contact dermatitis, atopic dermatitis , skin burning sensation

Immune System disorders

• Application site hypersensitivity

4.9 Overdose

The product is intended for topical use only. Accidental ingestion may cause gastro intestinal irritation with vomiting and diarrhoea. Vomiting may result in foam aspiration. In the case of accidental ingestion, give 1 to 2 glasses of milk or water to drink. If a large quantity of the product is ingested, the patient should be observed in hospital and the use of activated charcoal may be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benzalkonium chloride and triclosan are anti-bacterial agents with proven efficacy against Staphylococcus aureus, the principal causative organism in infected eczemas.

Light liquid paraffin is an emollient widely used in the treatment of eczema.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acetylated lanolin alcohols

Isopropyl palmitate

Oleyl alcohol

Polyoxyethylene lauryl ether

6.2 Incompatibilities

None known.

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

White polyvinyl chloride or high density polyethylene bottles containing 20ml, 25ml, 150ml, 250ml, 350ml, 500ml, 600ml, 1000ml with white urea cap.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Oilatum Plus/Oilatum Junior Flare-Up.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0060

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 16th February 1990

Date of latest renewal: 25th February 2009

10. Date Of Revision Of The Text

14 December 2010



A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Ophthalmic diagnostic agents are given intravenously to perform diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. A few preparations also contain a local anesthetic to reduce pain in the nerves of the eyes.

See also

Medical conditions associated with ophthalmic diagnostic agents:

Diagnosis and Investigation Ophthalmic Surgical Staining Drug List: Ak-Fluor Flucaine-Drops Fluoracaine-Drops Flurox-Ophthalmic-Solution Ic-Green Membraneblue Visionblue



Drugs associated with Osteolytic Bone Lesions of Multiple Myeloma

The following drugs and medications are in some way related to, or used in the treatment of Osteolytic Bone Lesions of Multiple Myeloma. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Osteolytic Bone Lesions of Multiple Myeloma

Micromedex Care Notes:

Multiple Myeloma



Definition of Osteopetrosis: The formation of abnormally dense bone, as opposed to osteoporosis.

Drugs associated with Osteopetrosis

The following drugs and medications are in some way related to, or used in the treatment of Osteopetrosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.



OncoTICE powder for suspension

2-8 X 108 CFU Tice BCG

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, please 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 any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oncotice is and what it is used for 2. Before you are given Oncotice 3. How Oncotice is given 4. Possible side effects 5. How to store Oncotice 6. Further information What Oncotice is and what it is used for

Oncotice contains something called ‘BCG’ (‘Bacillus Calmette-Gu?rin’). This is a bacteria which has been specially altered, so that it can be used as a medicine.

Oncotice is used to: treat bladder cancer prevent bladder cancer from coming back after bladder surgery.

It comes as a powder which is mixed with saline (salt water). It is then run into your bladder through a tube.

BCG is also used as a vaccine for TB (tuberculosis). Oncotice is a much stronger sort of BCG that can’t be used as a vaccine.

Before you are given Oncotice Oncotice should not be given if: You have a urinary tract infection (UTI). This must be treated first. You have blood in your urine. You have or think you have TB (tuberculosis). Before you have Oncotice, your doctor may do a skin reaction test, to see if you have TB. This is called a Tuberculin Test. If you have had Oncotice before, this may give you a positive result in this test. You are HIV-positive. You may need to have a blood test for HIV. Tell your doctor if any of the following apply to you: you have been a drug user and have shared a needle you have had unsafe sex you have had a blood transfusion. You have problems with your immune system. This could be something which runs in the family, or is caused by an illness or other medicines you are taking.

Do not have Oncotice if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before being given Oncotice.

Take special care with Oncotice

Check with your doctor or pharmacist before being given the medicine if:

Your bladder wall or the tube coming into your bladder from your kidneys (called the ‘ureter’) have been damaged during previous treatment.

Treatment with Oncotice will not be given until this has healed.

If you are not sure if any of the above apply to you talk to your doctor or pharmacist before being given Oncotice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicine. This includes medicines obtained without a prescription, including herbal medicines.

Do not have Oncotice and talk to your doctor straight away if:

You are taking medicines for TB.

The following can lower the effect of Oncotice:

antibiotics medicines which affect the immune system (immuno-suppressants) medicines which affect the production of bone marrow cells (bone marrow suppressants) radiation treatment.

If you are having any of these medicines or are having radiation treatment, your doctor will probably delay giving you Oncotice.

Using Oncotice with food and drink Do not drink any liquid for 4 hours before you are given Oncotice. Do not drink any liquid for 2 hours after you have been given Oncotice. Pregnancy and breast-feeding

Do not have Oncotice if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Oncotice will not affect your being able to drive or use any tools or machines.

Important information about some of the ingredients of Oncotice Oncotice contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before being given this medicine. This medicine contains a very small amount of potassium (less than 1mmol or 39mg per dose). This means it is essentially ‘potassium-free’. How Oncotice is given

You will always be given Oncotice by a doctor or nurse.

Before it is given Do not drink any liquid the 4 hours before Oncotice is given to you. You will be asked to pass water immediately before Oncotice is given to you. Being given your medicine First your genital area will be cleaned with a sterile solution. A nurse will then pass a small flexible tube into your bladder. This will remove any urine that is still in your bladder. Oncotice is then run into your bladder through this tube. This will only take a few minutes. The tube will then be removed. After it has been given Oncotice will be left in your bladder for 2 hours. During this time you should move around a little. This makes sure that the Oncotice is spread around all of your bladder. Do not drink any liquid for 2 hours after you have been given Oncotice. After 2 hours you will be asked to pass water, to empty your bladder. You should do this while sitting down to avoid splashing your urine around the toilet. During the next 6 hours If you need to pass water again, also do this while sitting down. Every time you pass water, add two cups of household bleach to the toilet. Leave the bleach and urine to stand in the toilet for 15 minutes before flushing. How often Oncotice is given

Oncotice is usually given once a week for 6 weeks. After this some people have ‘maintenance therapy’, where you may be given more doses. Your doctor will talk to you about this.

Having sex in the week after having Oncotice

If you have sexual intercourse during the week after being given the medicine, you must use a condom. This will lower the chance of the BCG bacteria being passed to your partner.

If you have more Oncotice than you should

Oncotice is made up from a standard bottle by your doctor, pharmacist or nurse. It is unlikely that you will receive too much Oncotice. If you do have too much, your doctor will check carefully to see whether you have BCG infection.

If necessary you will need to have treatment for TB.

OncoTICE Side Effects

Like all medicines, Oncotice can cause side effects, although not everybody gets them.

If you notice the following side effects, see your doctor straight away: a high temperature (fever) above 39 °C that lasts for more than 12 hours, even after taking medicines like paracetamol to lower your temperature. signs of a BCG or TB infection: cough or bronchitis chest pain or tightness sweating sore throat cold in the nose swelling of your lymph glands.

See your doctor straight away if you notice any of these side effects.

Other side effects include:

Very common

(affects more than 1 in 10 people)

bladder infection, pain when passing water, having to pass water often, feeling the need to pass water and bloody urine. Usually this goes away within two days. flu-like symptoms such as fever and feeling off-colour and tired (malaise). This usually happens about 4 hours after treatment and last for 24 to 48 hours.

Common

(affects less than 1 in 10 people)

painful joints or arthritis muscle pain or stiffness feeling sick (nausea) and being sick (vomiting) abdominal pain or diarrhoea chest infection anaemia problems with passing water or having a large amount of blood in your urine shivering with a high temperature (fever).

Uncommon

(affects less than 1 in 100 people)

skin rash jaundice (yellow colour of your skin or eyes) pus in your urine difficulty passing water low blood count (shown in blood tests)

Rare

(affects less than 1 in every 1,000 people)

inflammation of the genitals or prostate.

Very Rare

(affects less than 1 in every 10,000 people)

headache back pain increased muscle tension swollen legs or arms low blood pressure blood problems (shown in blood tests) flatulence or discomfort following meals loss of appetite or weight loss hair loss prickling or itching skin open sores on your skin eye infection feeling confused, sleepy or dizzy kidney problems

Tell your doctor if any side effect is severe or lasts longer than 48 hours.

If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How to store Oncotice

Keep Oncotice out of the reach and sight of children.

Oncotice will be stored in the hospital according to the instructions given by the manufacturer on the packaging.

Store at 2 °C to 8 °C (in a refrigerator).

Do not use Oncotice after the expiry date which is stated on the carton and label.

Further information What Oncotice contains The active substance is Bacillus Calmette-Gu?rin (BCG). It is a specially treated bacteria to be used as a medicine. The other ingredients are: lactose, asparagine, citric acid (E330), potassium phosphate, magnesium sulfate, iron ammonium citrate, glycerol (E422), ammonium hydroxide (E527), zinc formate. What Oncotice looks like and contents of the pack

Oncotice is a freeze-dried powder, packed in 2 ml glass vials (available in packs of 1), each containing 1 dose of 12.5 mg (equivalent to 2 to 8 x 108 CFU) of BCG.

The Marketing authorisation holder is: N.V. Organon PO Box 20 5340 BH Oss The Netherlands The Manufacturer is: Organon Teknika Corporation 100 Rodolphe Street Building 1300 Durham NC27712 USA

This leaflet was last updated in December 2007.

To listen to or request a copy of this leaflet in braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Oncotice

Reference Number: PL 05003/0046

This is a service provided by the Royal National Institute for Blind People

OncoTICE (Tice BCG)

June 2004

REF: USoncviV5.2



1. Name Of The Medicinal Product

Occlusal.

26% w/w cutaneous solution

2. Qualitative And Quantitative Composition

Salicylic Acid 26% w/w.

For excipients, see 6.1

3. Pharmaceutical Form

Cutaneous solution

A colourless to pale yellow solution with a characteristic smell of nail varnish

4. Clinical Particulars 4.1 Therapeutic Indications

Occlusal is indicated for the treatment and removal of common and plantar warts (verrucae).

4.2 Posology And Method Of Administration

For topical application.

Prior to application soak wart in warm water for five minutes. Remove loose tissue with a brush, emery board, pumice or abrasive sponge, being careful to avoid causing pin-point bleeding or abrading the surrounding healthy skin. Dry thoroughly with a towel not used by others to avoid contagion. Carefully apply Occlusal twice to the wart using the brush applicator allowing the first application to dry before applying the second. Thereafter repeat treatment once daily or as directed by physician. Do not apply to surrounding healthy skin. Clinically visible improvement should occur in one to two weeks but maximum effect may be expected after four to six weeks.

There are no differences in dosage for children, adults or the elderly.

4.3 Contraindications

Hypersensitivity to salicylic acid or to any of the excipients.

Occlusal should not be used by diabetics or patients with impaired blood circulation. Do not use if the wart or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.

4.4 Special Warnings And Precautions For Use

Occlusal is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Occlusal and other topical medicines on the treated wart should therefore be avoided.

4.6 Pregnancy And Lactation

Whilst there are no known contra-indications to use of Occlusal during pregnancy and lactation, the safety has not been established. Occlusal should therefore be used with caution or following professional advice.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

A localised irritant reaction may occur if Occlusal is applied to normal skin surrounding the wart. This may normally be controlled by temporarily discontinuing the use of Occlusal and by being careful to apply the solution only to the wart itself when treatment is resumed.

4.9 Overdose

Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Occlusal is used as indicated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Wart and anticorn preparations

ATC code: D11AF

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium. Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.

5.2 Pharmacokinetic Properties

Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Occlusal.

5.3 Preclinical Safety Data

No other information relevant to the prescriber other than that already stated in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polyvinyl butyral

Dibutyl phthalate

Isopropyl alcohol

Butyl acetate

Acrylates copolymer

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

The product is presented in a 10ml amber glass bottle with cap brush assembly. The cap brush assembly comprises of a black cap and a white polythene wand nylon brush with stainless steel staple.

6.6 Special Precautions For Disposal And Other Handling

Occlusal is flammable and should be kept away from flame or fire. Keep the bottle tightly capped when not in use. Do not allow the solution to drip from the brush onto the bottle neck thread, otherwise subsequent opening of the bottle may be difficult.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

2 Bath Road

Chippenham

Wiltshire, SN15 2BB

UK

8. Marketing Authorisation Number(S)

PL 16853/0071

9. Date Of First Authorisation/Renewal Of The Authorisation

7th September 1998/18th May 2005

10. Date Of Revision Of The Text

28th April 2011



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