Instructions for use Clofan vaginal suppositories 500 mg strip No. 1
Composition
active ingredient: clotrimazole;
1 suppository contains clotrimazole 500 mg;
excipient: solid fat.
Dosage form
Vaginal suppositories.
Main physicochemical properties: suppositories from white to light yellow in color, torpedo-shaped.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology, except for combinations with corticosteroids. Clotrimazole.
ATX code G01A F02.
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.
Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo, acting on dermatophytes, yeasts, molds, and dimorphic fungi.
Under appropriate test conditions, the minimum inhibitory concentrations for these types of fungi are approximately less than 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 its 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 rare. Development of secondary resistance during treatment in susceptible fungi has been observed very rarely to date.
Preclinical studies conducted in volunteers using single and repeated toxic doses did not reveal any harmful toxic, genotoxic or reproductive effects.
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 measurable systemic effects or side effects after intravaginal administration of clotrimazole are unlikely.
Indication
Infections in the genital area (vaginitis) caused by fungi (usually of the genus Candida) and superinfections caused by bacteria sensitive to clotrimazole.
Contraindication
Increased individual sensitivity to clotrimazole or other components of the drug.
Interaction with other medicinal products and other types of interactions
Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) or sirolimus may result in increased plasma levels of tacrolimus/sirolimus. Therefore, the patient should be closely monitored for symptoms of tacrolimus or sirolimus overdose, if necessary by monitoring their plasma levels.
The simultaneous use of vaginal suppositories with latex contraceptives (such as condoms and diaphragms) may cause damage to the latter, so the effectiveness of these contraceptives may decrease. This effect is temporary and may occur only during treatment. Patients are advised to use alternative methods of contraception for at least 5 days after using this drug.
Application features
Avoid contact with eyes. Do not swallow.
The patient is advised to consult a doctor:
at the first manifestations of the disease;
if symptoms persist for longer than 7 days;
if symptoms recur within 2 months or more than 4 times in the last 12 months;
with known hypersensitivity to any antifungal agents or imidazole derivatives;
if there is a history of sexually transmitted diseases or a serious history of sexually transmitted diseases in the partner;
if there are more than two episodes of candidal vaginitis in the last 6 months;
if the patient has a high body temperature (over 38 °C), lower abdominal pain, dysuria, back pain, purulent vaginal discharge with an unpleasant odor, vulvar and vaginal ulcers, redness, diarrhea, nausea, vomiting, vaginal bleeding accompanied by shoulder pain.
Sexual intercourse should be avoided while using the drug, as the infection may be transmitted to the partner. The effectiveness and safety of latex products (such as condoms and diaphragms) may be reduced (see section "Interaction with other medicinal products and other types of interactions").
During treatment with Clofan, vaginal suppositories, it is recommended to treat both partners with the 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 products while using this medication.
Use during pregnancy or breastfeeding
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, but animal studies have not shown an effect of clotrimazole on fertility.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The number of studies with the use of clotrimazole during pregnancy is limited, therefore it is recommended to avoid the use of Clofan, vaginal suppositories during the first trimester of pregnancy.
During treatment with Clofan, vaginal suppositories, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug has no or negligible influence on the ability to drive a vehicle or use other mechanisms.
Method of administration and doses
One vaginal suppository should be used at night.
The vaginal suppository should be inserted into the vagina as deeply as possible before going to bed. It is most convenient to insert the suppository while lying on your back with your legs slightly bent.
A second course of therapy may be prescribed if necessary.
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 products while using this medication.
While using this medication, sexual contact should be avoided as the infection may be transmitted to the partner.
Children.
Do not use in children under 12 years of age. Use in children over 12 years of age after consulting a doctor.
Overdose
There is no risk of acute intoxication, as overdose is unlikely to occur after a single vaginal dose or cutaneous application (application to large areas of skin under conditions conducive to increased absorption), or after accidental oral administration. There is no specific antidote.
However, in the event of accidental oral ingestion and only if clinical symptoms of overdose (such as dizziness, nausea or vomiting) occur, preventive measures such as gastric lavage should be used. Gastric lavage should only be performed in cases where adequate respiratory protection is available.
Adverse reactions
On the part of the immune system: allergic reactions, including fainting, hypotension, shortness of breath, urticaria, itching.
Reproductive system and breast disorders: peeling of the skin in the genital area, itching, rash, swelling, erythema, discomfort, burning sensation, irritation, pelvic pain, vaginal bleeding.
Gastrointestinal: abdominal pain.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
1 suppository in a strip. 1 strip in a cardboard box.
Vacation category
Without a prescription.
Producer
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.
