ACTION AND MECHANISM

Clotrimazole is an antifungal agent with fungistatic action, belonging to the imidazole group. It works by altering the permeability of the fungal cell 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).

PATIENT ADVICE

- It is preferable to administer it at bedtime.

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

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

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

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

CONTRAINDICATIONS

- [ALLERGY TO AZOLE ANTIFUNGALS].

PREGNANCY

No harmful effects have been observed in the mother and child during pregnancy. However, the risk/benefit ratio should be assessed during the first trimester. In pregnant patients, an increased risk of vaginal candidiasis and a decreased response to treatment have been observed. Short courses of treatment lasting 1-3 days have proven less effective in pregnant women than in non-pregnant women. Therefore, the duration of therapy in pregnant women should be 6 days.

PHARMACOKINETICS

Following vaginal application, a small amount of clotrimazole (3-10% of the dose) is absorbed. 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 for up to 3 days after a 500 mg dose.

INDICATIONS

- Treatment of uncomplicated [VAGINAL CANDIDIASIS].

GUIDELINES FOR PROPER ADMINISTRATION

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

POSOLOGY

- Adults and children over 12 years: - Vaginal cream (2%): 5 g (1 applicator)/24 hours, for 3 consecutive days. If necessary, additional treatment may be administered. - Vaginal tablets: 500 mg, single dose. If necessary, an additional dose or 100 mg/24 hours may be administered for 6 consecutive days. If necessary, the dose may be increased to 200 mg/24 hours for 6-12 days.

ADVERSE REACTIONS

The adverse effects of this medication are generally mild and transient. The most common side effects are:
- Occasionally [URETHRAL BURNING]; rarely [VAGINAL ITCHING], [VAGINITIS], [URINARY INCONTINENCE], [CYSTITIS].
- Rarely: [EXANTHEMATOUS ERUPTIONS], [PRURITUS], and digestive and sexual disturbances ([DYSPAREUNIA]).
Treatment should be discontinued immediately if the patient experiences any episode of vulvar burning sensation, irritation, or skin rashes.

COMPOSITION

CLOTRIMAZOLE (GYNECOLOGICAL): 100 MILLIGRAMS