Instructions for Clofan 2% cream 20 g
Composition
active ingredient: clotrimazole;
1 g of cream contains clotrimazole 20 mg;
excipients: cetyl palmitate, cetostearyl alcohol, sorbitan monostearate, polysorbate 60, octyldodecanol, benzyl alcohol, purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous viscous white cream.
Pharmacotherapeutic group
Dermatological preparations. Antifungal preparations for use in dermatology. Antifungal preparations for topical use. Imidazole and triazole derivatives. Clotrimazole. ATX code D01A C01.
Pharmacological properties
Pharmacodynamics.
The mechanism of antimycotic action of clotrimazole is associated with inhibition of ergosterol synthesis, which leads to structural and functional damage to the cytoplasmic membrane of fungi.
Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo and is active against dermatophytes, yeasts, molds and other types of fungi.
Under appropriate test conditions, the minimum inhibitory concentrations for these types of fungi are approximately 0.062–8.0 μg/mL substrate.
The mechanism of action of clotrimazole is associated with primary 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 have only minor sensitivity.
In addition to antifungal activity, clotrimazole also acts on gram-positive microorganisms (Streptococci/Staphylococci/Gardnerella vaginalis) and gram-negative microorganisms (Bacteroids).
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 of susceptible fungal species are very rare; the development of secondary resistance of susceptible fungi during treatment has so far been observed only in very rare cases.
Pharmacokinetics.
When applied to intact or inflamed skin, clotrimazole enters the human bloodstream in minimal amounts. Peak serum concentrations of clotrimazole were below the detection limit of 0.001 μg/mL, indicating that systemic effects or adverse reactions are unlikely with topical application of clotrimazole.
Indication
Candidiasis vulvitis.
Candidal vaginitis (as an adjunct).
Treatment of the sexual partner to prevent re-infection.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
When used simultaneously with latex contraceptives, the cream may cause damage to them and reduce their effectiveness. Patients are advised to use alternative methods of contraception for at least five days after using this medication.
Application features
Before using the drug, you should consult a doctor in the following cases:
if this is the first case of candidal vaginitis;
if there are more than two episodes of candidal vaginitis in the last 6 months;
if there is a history of sexually transmitted diseases or a serious history of sexually transmitted diseases in the partner;
during pregnancy or suspected pregnancy;
if the patient is under 16 or over 60 years old;
with known hypersensitivity to imidazole derivatives or to any antifungal agents.
You should not use the drug and consult a doctor if you have any of the following symptoms:
irregular vaginal bleeding;
abnormal vaginal bleeding or vaginal discharge with blood;
ulcers or blisters on the vulva or vagina;
lower abdominal pain or dysuria;
any adverse events, such as redness, irritation, or swelling, related to treatment;
fever or chills;
nausea, vomiting, or diarrhea;
vaginal discharge with an unpleasant odor.
This medicine contains cetostearyl 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.
Use during pregnancy or breastfeeding
Fertility.
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, but animal studies have not shown any effect on fertility.
Pregnancy.
There are limited data on the use of clotrimazole in pregnant women. Animal studies have shown reproductive toxicity of clotrimazole when administered orally at high doses. Given the low systemic exposure to clotrimazole after topical treatment, no harmful effects on reproductive function are expected. Clotrimazole can be used during pregnancy, but only under medical supervision.
There is no data on the excretion of clotrimazole into breast milk. However, systemic absorption is minimal after application and is unlikely to lead to systemic effects. Clofan, cream, can be used during breastfeeding. In the case of topical application to the nipple area, the breast should be washed before feeding the child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Clotrimazole cream has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
The drug is intended for topical use.
Apply a thin layer of the cream to the affected skin of the external genitalia and adjacent areas 2–3 times a day and rub in lightly.
Treatment should be continued until the symptoms of infection disappear.
If symptoms do not improve within seven days of treatment for vaginitis, you should seek medical advice.
Treatment of the sexual partner.
To prevent re-infection, apply a thin layer of the cream to the penis 2–3 times a day and rub in lightly.
Treatment should be continued for 2 weeks.
Children
There is no experience with the use of the drug in children.
Overdose
There is no risk of acute intoxication, as it is unlikely that an overdose would occur after a single application of excessive amounts to the skin (application to a large area of skin under conditions conducive to absorption) or accidental oral ingestion.
There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage may rarely be necessary if a life-threatening dose of clotrimazole has been administered 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 respiratory protection is provided.
Side effects
Since the data on the following undesirable effects 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 system: syncope, hypotension
Respiratory and mediastinal disorders: dyspnea.
Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema, paresthesia, skin peeling, itching, rash, urticaria, skin tingling/burning sensation.
General disorders and administration site conditions: application site irritation, application site reaction, swelling, pain.
Reporting of suspected adverse reactions.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
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 in a cardboard box.
Vacation category
Without a prescription.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and address of its place of business=
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
