Clotrimazole (Vaginal Tablets)

Active material: Clotrimazolum
When ATH: G01AF02
CCF: The drug with the antifungal activity for topical application in gynecology
When CSF: 08.03.01
Manufacturer: MAGISTRA C&C (Romania)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Vaginal Tablets white or nearly white, or almost white with a yellowish tint, parallelepipedic, lenticular, with rounded edges, with a homogeneous surface and a homogeneous structure.

Excipients: lactose monohydrate, corn starch, colloidal silicon dioxide, natriya carbonate, tartaric acid, magnesium stearate.

6 PC. – blisters (1) – cardboard boxes.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Antifungal groups imidazole derivatives for topical use. It has action by disrupting the synthesis of ergosterol, which is part of the cell membrane of fungi. It has a broad spectrum of action.

It is active against dermatophytes, molds, fungi of the genus Candida, Malassezia furfur.

Clotrimazole is also active against Corynebacterium minutissimum, Streptococcus spp., Staphylococcus spp., Trichomonas vaginalis.

Pharmacokinetics

When applied topically clotrimazole well into the different layers of the skin, achieving therapeutic concentrations. When applied topically clotrimazole minor amount absorbed into the blood.

Testimony

Fungal skin and mucous membranes, caused by dermatophytes, molds and yeast-like fungi, pityriasis versicolor, erythrasma, vulvovaginal candidiasis, trichomoniasis, fungal infections, complicated by secondary pyoderma.

Dosage regimen

When applied topically applied to the affected skin 2-3 times / day for 2-4 weeks.

When oral use 1-2 times / day max 7 days.

Intravaginal – by 100-500 mg for 1-6 days.

Side effect

Local reactions: allergic contact dermatitis, redness, burning sensation.

Contraindications

Hypersensitivity to clotrimazole, I trimester of pregnancy.

Pregnancy and lactation

IN experimental studies found, that when used in high doses, clotrimazole has fetotoxic effects.

Unknown, whether clotrimazole allocated with breast milk. Although clotrimazole is not contraindicated during pregnancy and lactation, It should take into account the potential risk in the choice of antifungal therapy.

Cautions

Formulations, intended for intravaginal use, not used during menstruation.

To prevent reinfection should be simultaneous treatment of sexual partners. Clotrimazole is not recommended for use in ophthalmology.

Drug Interactions

While the use of amphotericin B, nystatin clotrimazole reduced activity.