CLOFAN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CLOFAN (CLOFAN)

Composition:

Active substance: clotrimazole;

1 g of cream contains 10 mg of clotrimazole;

Excipients: cetyl palmitate, cetostearyl alcohol, sorbitan monostearate, polysorbate 60, octyldodecanol, benzyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous, viscous white cream.

Pharmacotherapeutic group.

Dermatological agents. Antifungal agents for dermatological use. Topically applied antifungal agents. Imidazole and triazole derivatives. Clotrimazole. ATC code D01A C01.

Pharmacological properties.

Pharmacodynamics.

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

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

Under appropriate testing conditions, the minimum inhibitory concentration for these fungal types ranges approximately from 0.062 to 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.

In addition to its antifungal activity, clotrimazole also acts against gram-positive microorganisms (Streptococci/Staphylococci/Gardnerella vaginalis) and gram-negative microorganisms (Bacteroides).

In vitro, clotrimazole inhibits the growth of Corynebacteria and gram-positive cocci (except Enterococci) at concentrations of 0.5–10 µg/mL of substrate.

Primary resistant strains among susceptible fungal species are very rare; development of secondary resistance in initially susceptible fungi during treatment has so far been observed only in very isolated cases.

Pharmacokinetics.

When cream is applied to intact skin or skin exhibiting signs of inflammation, clotrimazole enters the human systemic circulation in minimal amounts. Peak serum concentrations of clotrimazole were below the detection limit of 0.001 µg/mL, indicating a low likelihood of systemic effects or adverse reactions with topical use of clotrimazole.

Clinical characteristics.

Indications.

Dermatomycoses caused by mold fungi and other fungi (e.g., Trichophyton).

Dermatomycoses caused by yeast fungi (Candida).

Skin diseases resulting from secondary infection with these fungi.

Candidal vulvitis and candidal balanitis.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Do not use the cream for the treatment of nails or infections of the scalp skin.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with latex contraceptives, the cream may cause their damage and reduce effectiveness. Patients are advised to use alternative contraceptive methods for at least five days after application of this medicinal product.

Special precautions for use.

This medicinal product contains cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis). The cream also contains benzyl alcohol, which may cause allergic reactions and mild irritation at the application site.

Patients should be warned not to smoke or go near naked flames due to the risk of sustaining serious burns. Fabric (clothing, bed linen, dressings, etc.) that has come into contact with this cream is more flammable and constitutes a serious fire hazard. Washing clothing and bed linen may reduce product accumulation but will not completely remove it.

Use during pregnancy or breastfeeding.

Fertility.

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

Pregnancy.

There is limited data on the use of clotrimazole in pregnant women. Animal studies have shown reproductive toxicity of clotrimazole following oral administration at high doses. Due to low systemic exposure to clotrimazole after topical treatment, harmful effects on reproductive function are not expected. Clotrimazole may be used during pregnancy, but only under medical supervision.

Breastfeeding period.

There are no data on the excretion of clotrimazole in human milk. However, systemic absorption is minimal following topical application and is unlikely to result in systemic effects. Klopfan cream can be used during breastfeeding. If applied locally to the nipple area, the breasts should be washed before feeding the infant.

Ability to affect reaction speed when driving or operating machinery.

Clotrimazole cream has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

The product is intended for topical use.

Apply a thin layer of the cream to the affected area of skin 2–3 times daily and gently rub in. A strip of cream (½ cm in length) is sufficient to treat an area the size of a hand. Treatment should continue for at least one month in the case of dermatophytosis and for at least two weeks in the case of candidiasis.

In case of foot infection, the feet should be washed and thoroughly dried before applying the cream, especially between the toes.

Children

There is no experience with the use of this product in children.

Overdose

There is no risk of acute intoxication, as overdose is unlikely following a single topical application of an excessive amount (application over a large skin area under conditions favorable for absorption) or accidental oral ingestion.

There is no specific antidote.

However, in the rare case of accidental oral ingestion, gastric lavage may rarely be necessary if a life-threatening dose of clotrimazole has been ingested within the previous hour or if clinical symptoms of overdose (e.g., dizziness, nausea, or vomiting) are present. Gastric lavage should only be performed if adequate airway protection is ensured.

Adverse Reactions

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

Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.

Vascular disorders: syncope, arterial hypotension.

Respiratory and mediastinal disorders: dyspnea.

Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema, paresthesia, skin peeling, pruritus, rash, urticaria, skin tingling/burning sensation.

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

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after drug authorization is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Do not freeze.

Keep out of reach of children.

Packaging.

20 g in a tube, 1 tube per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and place of business.

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