Cotren

Clotrimazole.

COTREN VAGINAL TABLETS 100 mg: Each tablet contains: Clotrimazole 100 mg.
COTREN VAGINAL TABLETS 500 mg: Each tablet contains: Clotrimazole 500 mg.

Pharmacology: The drug acts by binding with phospholipids in cell membrane of susceptible fungi with a resultant change in membrane permeability.
Pharmacokinetics: Small amounts of clotrimazole are absorbed systemically when the drug is administered intravaginally. About 3 - 10% of an intravaginal dose of the drug reaches systemic circulation, principally as metabolites. The finding of low clotrimazole concentrations in serum and high concentration in vaginal secretions suggest that it remains in the vagina for 48 hours, and in some cases 72 hours, in fungicidal concentration.
Microbiology: Cotren inhibits or kills many fungi, including yeasts and dermatophytes; it is also effective against trichomonas vaginalis.

Vaginal infections caused by fungi-mainly candida and/or trichomonas.

Cotren vaginal tablet 500 mg: 1 tablet of Cotren vaginal tablet 500 mg should be used as a single dose inserted deep in vagina.
Cotren vaginal tablet 100 mg: 1 tablet of Cotren vaginal tablet 100 mg to be introduced each evening on 6 successive days. Alternatively, 2 vaginal tablets may be inserted into the vagina at bedtime for 3 consecutive nights.
The vaginal tablet should be inserted as deeply as possible into the vagina in the evening before going to bed. Insertion is best achieved when lying back with the legs slightly drawn up.
Clotrimazole vaginal tablets need moisture in the vagina to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this it is important to insert the medication as deeply as possible into the vagina at bedtime. Should the vaginal tablet not dissolve completely within one night the use of a vaginal cream should be considered.
If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause. Patient should seek medical advice if symptoms return within 2 months.
If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in addition to the intravaginal treatment (combination treatment).
The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.
Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product the partner could become infected.
During pregnancy, the vaginal tablets should be used and should be inserted without using an applicator. Not for use in children under 16.

No symptom of overdosage has been reported. Should they occur, symptomatic treatment should be provided.

Hypersensitivity to Clotrimazole or any components of the preparation.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Cotren vaginal tablets, medical advice must be sought if any of the following are applicable: more than two infections of candidal vaginitis in the last six months; previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease; pregnancy or suspected pregnancy; aged under 16 or over 60 years; known hypersensitivity to imidazoles or other vaginal antifungal products.
Cotren vaginal tablets should not be used if the patient has any of the following symptoms whereupon medical advice should be sought: irregular vaginal bleeding; abnormal vaginal bleeding or a blood-stained discharge; vulval or vaginal ulcers, blisters or sores; lower abdominal pain or dysuria; any adverse events such as redness, irritation or swelling associated with the treatment; fever or chills; nausea or vomiting; diarrhoea; foul smelling vaginal discharge.
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Cotren vaginal tablets. The pessaries can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.
Effects on Ability to Drive and Use Machine: The medication has no or negligible influence on the ability to drive or use machinery.

Pregnancy: Experimental and clinical investigations give no indication that Cotren vaginal tablets has any harmful effects on the mother and child when administered during pregnancy. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
During pregnancy the Cotren vaginal tablets should be inserted without using an applicator.
Administration during the first trimester of pregnancy should be used with clear indication.
Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk. Breast-feeding should be discontinued during treatment with clotrimazole.

Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticarial, pruritus).
Reproductive system and breast disorders: genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.
Gastrointestinal disorders: abdominal pain.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Store at temperature not exceeding 30°C.

Preparations for Vaginal Conditions

G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.

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