Instructions for Clofan vaginal cream 10% tube 7 g
Composition
active ingredient: clotrimazole;
1 g of cream contains clotrimazole 100 mg;
excipients: tefoz-63 (polyethylene glycol-6 stearate, ethylene glycol stearate, polyethylene glycol-32 stearate); light mineral oil; cetostearyl alcohol; benzyl alcohol; butylhydroxytoluene (E 321); polysorbate 60; sodium dihydrogen phosphate dihydrate; purified water; triethanolamine.
Dosage form
Vaginal cream.
Main physicochemical properties: homogeneous viscous white cream.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Clotrimazole.
ATX code G01A F02.
Pharmacological properties
Pharmacodynamics.
Clotrimazole is a topical antifungal drug from the group of imidazole derivatives. The drug has a broad spectrum of antifungal activity against dermatophytes, yeasts and molds. It is also active against Trichomonas, staphylococci, streptococci and bacteroids. It has no effect on lactobacilli.
The mechanism of antifungal action of clotrimazole occurs by inhibiting the synthesis of ergosterol, which leads to structural and functional damage to the cytoplasmic membrane. Depending on the concentration of clotrimazole at the site of infection, the drug has fungistatic or fungicidal activity. In vitro, clotrimazole exhibits antifungal activity mainly against proliferating fungal elements, since fungal spores have only a slight sensitivity to the action of the drug.
Among fungi naturally sensitive to clotrimazole, primary resistant strains are extremely rare. The development of secondary resistance in fungal strains sensitive to clotrimazole has been observed very rarely so far.
Pharmacokinetics.
Pharmacokinetic studies after 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, the peak plasma concentration of clotrimazole after vaginal administration at a dose of 500 mg was less than 10 ng/ml. This means that the occurrence of systemic effects or side effects after intravaginal administration of clotrimazole is unlikely.
Indication
Infections in the genital area (vulvovaginitis) caused by fungi (usually of the genus Candida) or bacteria sensitive to clotrimazole.
Contraindication
Hypersensitivity to clotrimazole or to other components of the drug.
Special safety measures.
Before starting treatment with clotrimazole, the patient should consult a doctor in the following cases:
• more than two cases of candidal vaginitis in the last 6 months;
• history of sexually transmitted diseases in the patient or her sexual partner;
• pregnancy or suspected pregnancy;
• the patient is over 60 years old;
• known hypersensitivity to imidazole or other vaginal antifungal agents;
• irregular vaginal bleeding;
• abnormal vaginal bleeding or blood clots;
• the presence of ulcers, wounds or blisters in the vaginal or vulva area;
• pain in the lower abdomen;
• back pain;
• dysuria;
• any adverse reactions that have been associated with the use of clotrimazole;
• fever or chills;
• nausea or vomiting;
• diarrhea;
• abnormal vaginal discharge.
During treatment with clotrimazole, the patient should consult a doctor in the following cases:
• occurrence of adverse reactions associated with the use of clotrimazole (redness, irritation or swelling);
• symptoms of the disease persist for more than 7 days from the start of treatment.
After treatment with clotrimazole, the patient should consult a doctor in the following cases:
• symptoms of the disease reappear within 2 months after the end of treatment.
Clotrimazole can be used again if a recurrence of candidal infection occurs 7 days after the end of the disease.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Benzyl alcohol may cause toxic and allergic reactions in children (see section "Children").
Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
In such cases, it is recommended to use dosage forms that do not contain these components instead of cream.
Avoid contact with eyes. Do not swallow.
Interaction with other medicinal products and other types of interactions
Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) may lead to increased plasma levels of tacrolimus. Therefore, the patient should be closely monitored for symptoms of tacrolimus overdose, if necessary by checking its plasma levels.
Simultaneous use of the cream in the genital area with latex contraceptives (such as condoms and diaphragms) may cause damage to the latter, so the effectiveness of these contraceptives may be reduced. This effect is temporary and may only occur during treatment. Patients are advised to use alternative methods of contraception for at least 5 days after using this drug.
Application features
While using this medication, sexual contact should be avoided as the infection may be transmitted to the partner.
During treatment with the drug, it is recommended to treat both sexual partners with Clofan® cream.
Treatment should not be carried out during menstruation. Treatment should be completed before the onset of menstruation.
Do not use tampons, intravaginal irrigations, spermicides, or other vaginal medications while using this medication.
Use during pregnancy or breastfeeding
Based on the results of studies involving pregnant women, there are no epidemiological data indicating an expected harmful effect on the woman and the fetus when using clotrimazole during pregnancy. During pregnancy and breastfeeding, the use of clotrimazole is possible only if, in the opinion of the doctor, the benefit to the woman outweighs the risk to the fetus/child.
During pregnancy, another dosage form of the drug without the use of an applicator should be used.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The cream must be administered intravaginally using the applicator provided.
7 g of Clofan® cream (1 full applicator) is injected as deeply as possible into the vagina in the evening (before bedtime) once. The course of treatment is 1 day. Treatment should not be carried out during menstruation, and therefore the treatment must be completed before it begins. Therapy of these diseases requires simultaneous treatment of both partners.
Children
There is no data on the safe use of the drug in children under 16 years of age, therefore Clofan® should not be used in persons under 16 years of age.
Children over 16 years of age should use after consulting a doctor.
Overdose
Overdose with intravaginal use was practically not observed due to the very low absorption of the drug.
In case of accidental ingestion, preventive measures such as gastric lavage should be used only if clinical symptoms of overdose (such as dizziness, nausea or vomiting) occur.
Adverse reactions
Skin and subcutaneous tissue disorders: skin rash, itching, erythema, edema, urticaria, irritation, peeling, sensation of heat, burning.
From the reproductive system and mammary glands: allergic reactions from the vaginal mucosa, peeling of the skin in the genital area, itching, rash, swelling, discomfort, burning sensation, irritation, pain in the pelvic area.
Gastrointestinal: abdominal pain.
General disorders and administration site conditions: syncope, hypotension, dyspnea.
Expiration date
2 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.
Vacation category
Without a prescription.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and its business address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
