Gine Canesten 20 Mg/G Vaginal Cream 1 Tube 20 Grams

Gine Canesten 20 Mg/G Vaginal Cream 1 Tube of 20 Grams

Action and mechanism

Clotrimazole is an antifungal with fungistatic action, from the imidazole group. It acts by altering the permeability of the fungal membrane by inhibiting ergosterol synthesis. It has a broad antifungal spectrum, including dermatophytes and yeasts (Candida, etc.). It is also active against Trichomonas vaginalis, gram-positive microorganisms (Streptococci / Staphylococci), and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis).

Pharmacokinetics

- After vaginal application a small amount of clotrimazole is absorbed (3-10% of the dose). The resulting serum concentrations are always below the limit of detection (< 10 ng/ml) and do not cause appreciable systemic effects or adverse reactions. In some studies antifungal concentrations of clotrimazole were detected in vaginal fluid up to 3 days after a 500 mg dose.

Indications

[GENITAL CANDIDIASIS: vulvovaginal simple or mixed aetiology.

- Vaginal cream may also be used in Candida [BALANITIS] and as an adjunctive treatment in infected women.

Posology

- Adults and children over 12 years of age:

- Vaginal cream (2%): 5 g (1 applicator)/24 hours, for 3 consecutive days. Additional treatment may be given if necessary.

- Vaginal tablets: 500 mg, single dose. If necessary, an additional dose or 100 mg/24 hours can be administered for 6 consecutive days. If necessary, the dose can be increased to 200 mg/24 hours for 6-12 days.

Guidelines for correct administration

* Vaginal tablets: The tablet should be inserted deeply into the vagina directly with the middle finger, after careful washing of the hands, with the patient lying on her back and with her legs slightly bent.

* Vaginal cream: Attach the applicator to the tube, fill the applicator until the plunger has moved as far as it will go. Detach the applicator from the tube and insert it as deeply as possible into the vagina (preferably with the patient lying on her back and with her legs slightly bent), emptying it by pressing on the plunger. Remove the applicator and discard it.

Contraindications

- ALLERGY TO AZOLE ANTIFUNGALS].

Advice to the patient

Advice to patients:

- Administration at bedtime is preferable.

- It is preferable not to have sexual intercourse during treatment.

- Complete the prescribed treatment continuously. Do not interrupt treatment during menstruation.

- Vaginal tablets and vaginal cream may damage condoms and diaphragms (latex-containing products). It is advisable to use an alternative method of contraception during treatment.

- It is recommended to protect intimate apparel, due to the possibility of vaginal drainage.

Pregnancy

- No harmful effects on mother and child have been observed during pregnancy. However, during the first trimester the risk/benefit should be assessed.

An increased risk of vaginal candidiasis and decreased response to treatment has been observed in pregnant patients. Short courses of 1-3 days duration have been found to be less effective in pregnant than in non-pregnant women. Therefore, the duration of therapy in pregnant women should be 6 days.

Adverse reactions

The side effects of this drug are generally mild and transient. The most characteristic side effects are:

- Occasionally [URETHRAL BURNING]; rarely [VAGINAL PRURITUDE], [VAGINITIS], [URINARY INCONTINENCE], [CYSTITIS].

- Rarely: [EXEMPTEMATIC ERUPTIONS], [PRURITUS], digestive and sexual disturbances ([DYSPAREUNIA]).

Treatment should be discontinued immediately if the patient experiences any episode of vulvar burning sensation, irritation or rash.

Storage

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- Store at room temperature (<30°C).