Clonafan®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KLOFAN® (CLOFAN®)

Composition:

Active substance: clotrimazole;

1 g of cream contains 100 mg of clotrimazole;

Excipients: Tefoz-63 (polyethylene glycol-6 stearate, ethylene glycol stearate, polyethylene glycol-32 stearate); light mineral oil; cetylstearyl alcohol; benzyl alcohol; butylhydroxytoluene (E 321); polysorbate 60; sodium dihydrogen phosphate dihydrate; purified water; triethanolamine.

Pharmaceutical form. Vaginal cream.

Main physicochemical characteristics: homogeneous white viscous cream.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Clotrimazole.

ATC code G01AF02.

Pharmacological properties.

Pharmacodynamics.

Azoles (particularly clotrimazole) are generally recommended for topical treatment of vulvovaginal candidiasis, which is characterized by vulvovaginal symptoms such as itching, burning, discharge, redness, swelling, and pain.

Clotrimazole is a locally acting antifungal agent from the group of imidazole derivatives.

The antifungal mechanism of action of clotrimazole is associated with inhibition of ergosterol synthesis, leading to structural and functional damage of the cytoplasmic membrane.

Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo, acting against dermatophytes, yeasts, and molds.

Under appropriate testing conditions, minimal inhibitory concentrations for these fungal types are approximately less than 0.062–8.0 µg/ml of substrate.

The mechanism of action of clotrimazole involves primarily fungistatic or fungicidal activity, depending on the concentration of clotrimazole at the site of infection.

In vitro, activity is limited to proliferating fungal elements; fungal spores exhibit only minimal sensitivity.

Primary resistant fungal strains are very rare. Development of secondary resistance in previously sensitive fungal strains has been observed very rarely to date.

Pharmacokinetics.

Pharmacokinetic studies following vaginal administration have shown that only a small amount of clotrimazole (3–10%) is absorbed. Absorbed clotrimazole is rapidly metabolized in the liver to inactive metabolites. Therefore, peak plasma concentrations of clotrimazole after vaginal administration of a 500 mg dose were less than 10 ng/ml. This indicates that the occurrence of measurable systemic effects or adverse reactions following intravaginal administration of clotrimazole is unlikely.

Clinical characteristics.

Indications.

Vaginal cream with clotrimazole is recommended for the treatment of candidal vaginitis.

Contraindications.

Hypersensitivity to clotrimazole or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Latex contraceptives.

Concomitant use of the cream in the genital area with latex contraceptives (such as condoms and diaphragms) may cause damage to the latter; therefore, the effectiveness of these contraceptives may be reduced. Patients are advised to use alternative methods of contraception for at least 5 days after application of this medicinal product.

Tacrolimus/sirolimus.

Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) or sirolimus may lead to increased plasma levels of tacrolimus/sirolimus. Therefore, the patient's condition should be carefully monitored for symptoms of tacrolimus or sirolimus overdose, and plasma levels should be checked when necessary.

Special precautions for use.

Before starting treatment with clotrimazole vaginal cream, it is necessary to consult a physician.

Consult a doctor if symptoms persist for longer than 7 days during the use of clotrimazole vaginal cream.

Clotrimazole vaginal cream may be used again if symptoms of candidal infection recur 7 days after completion of therapy. However, consult a doctor if there have been more than two episodes of candidal vaginitis within the past 6 months.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of eyes and mucous membranes.

Use during pregnancy or breastfeeding.

Pregnancy.

The amount of clinical data on the use of clotrimazole in pregnant women is limited. Animal studies have shown reproductive toxicity of clotrimazole when administered orally at high doses. Due to the low systemic exposure following vaginal administration, harmful effects in terms of reproductive toxicity are not expected.

Clotrimazole may be used during pregnancy only under medical supervision.

During pregnancy, an alternative dosage form of clotrimazole that does not require the use of an applicator should be used.

Breastfeeding period.

There are no data on the excretion of clotrimazole in breast milk. However, systemic absorption after topical application is minimal and is unlikely to result in systemic effects. Clotrimazole, vaginal cream (Klofan®), may be used during breastfeeding.

Fertility.

Clinical studies on the effect of clotrimazole on female fertility have not been conducted; however, animal studies have not shown any effect of clotrimazole on fertility.

Ability to influence reaction speed when driving or operating machinery.

Klofan®, vaginal cream, has no effect or only a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

The cream should be administered intravaginally using the provided applicator.

7 g of Clotrimazole® cream (1 full applicator) should be inserted as deeply as possible into the vagina in the evening (before bedtime) as a single dose. Treatment course – 1 day. A second course of therapy may be prescribed if necessary.

Treatment should not be carried out during menstruation. Therapy should be completed before the onset of menstruation. Do not use tampons, intravaginal douches, spermicides, or other vaginal products during the use of this medication.

Sexual intercourse should be avoided during treatment, as the infection may be transmitted to the partner.

Children

There is no experience with the use of Clotrimazole® in children under 16 years of age; therefore, it should not be used in this patient group.

Overdose

There is no risk of acute intoxication, as overdose is unlikely following a single vaginal dose or topical application to the skin (application over large skin areas under conditions favoring increased absorption), as well as after accidental oral ingestion. There is no specific antidote.

In case of accidental oral ingestion, only if clinical symptoms of overdose occur (such as dizziness, nausea, or vomiting), preventive measures such as gastric lavage should be applied. Gastric lavage should only be performed if adequate airway protection is ensured.

Side effects

Since data on the adverse reactions listed below are based on spontaneous reports, it is not possible to determine the exact frequency of their occurrence.

Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.

Vascular disorders: syncope, arterial hypotension.

Respiratory, thoracic and mediastinal disorders: dyspnea.

Gastrointestinal disorders: abdominal pain, nausea.

Skin and subcutaneous tissue disorders: rash, urticaria, pruritus.

Reproductive system and breast disorders: skin desquamation in the genital area, vaginal discharge, vaginal bleeding, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning, vulvovaginal pruritus, vulvovaginal pain.

General disorders and administration site conditions: irritation at the application site, reaction at the application site, swelling, pain.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization of the medicinal product is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, patients, or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

7 g in a tube, 1 tube with an applicator in a cardboard box.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and location of operations.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.