Instructions Clotrimazole vaginal tablets 100 mg blister No. 10
Composition
active ingredient: clotrimazole;
1 tablet contains clotrimazole (calculated as 100% dry matter) – 100 mg;
excipients: lactose monohydrate, corn starch, microcrystalline cellulose, colloidal anhydrous silicon dioxide, adipic acid, calcium stearate.
Dosage form
Vaginal tablets.
Main physicochemical properties: white or almost white tablets, oval in shape, with a biconvex surface.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATX code G01A F02.
Pharmacological properties
Pharmacodynamics
The mechanism of antifungal action of imidazole 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, and molds.
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 Trichomonas vaginalis, gram-positive microorganisms (streptococci, staphylococci) and gram-negative microorganisms (Bacteroids, Gardnerella vaginalis).
In vitro, clotrimazole inhibits the growth of Corynebacteria and gram-positive cocci (except Enterococci) at a concentration of 0.5-10 μg/ml of substrate and has a trichomonacidal effect at a concentration of 100 μg/ml.
Primary resistant strains of susceptible fungal species are rare. Development of secondary resistance in susceptible fungi during treatment has been observed very rarely to date.
Pharmacokinetics
A small amount of clotrimazole is absorbed (3-10%). Absorbed clotrimazole is rapidly metabolized in the liver to inactive metabolites. Therefore, the peak plasma concentration of clotrimazole after vaginal application at a dose of 500 mg was less than 10 ng/ml. This means that the occurrence of measurable systemic side effects after intravaginal application of clotrimazole is 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
Hypersensitivity to clotrimazole or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Concomitant use of clotrimazole vaginal tablets with oral tacrolimus (FK-506; immunosuppressant) or sirolimus may increase plasma levels of tacrolimus/sirolimus. The patient should be closely monitored for symptoms of tacrolimus or sirolimus overdose, with plasma concentrations monitored as necessary.
When clotrimazole is used simultaneously with nystatin, amphotericin B and other polyene antibiotics, the activity of clotrimazole may decrease.
Dexamethasone, used in high doses, reduces the antifungal effect of clotrimazole.
The antimicrobial effect of clotrimazole is enhanced by high local concentrations of p-oxybenzoic acid propyl ester.
Application features
Do not take the tablets internally. Avoid contact with eyes.
The patient is recommended to consult a doctor if:
symptoms persisting for more than 7 days; symptoms reappearing within 2 months; known hypersensitivity to any antifungal agents or imidazole derivatives; if the patient or her sexual partner has a history of sexually transmitted diseases; more than two episodes of candidal vaginitis in the past 6 months; high body temperature (38 °C or higher), lower abdominal pain, dysuria, back pain, purulent vaginal discharge with an unpleasant odor, vulvar and vaginal ulcers, redness, nausea or vomiting, diarrhea, vaginal bleeding or blood clots accompanied by shoulder pain.
Vaginal intercourse should be avoided while using this medication, as the infection may be transmitted to the sexual partner. The medication may reduce the effectiveness of latex contraceptives (condoms, diaphragms). This effect is temporary and only occurs during treatment. Patients are advised to use alternative methods of contraception for at least 5 days after using the medication.
Upon doctor's prescription, simultaneous treatment of the external genitalia with 1% ointment or 1% Clotrimazole solution is possible; if necessary, the doctor may prescribe additional systemic medications (for example, metronidazole orally).
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 the drug.
In patients with impaired liver function, its functional status should be periodically checked.
In the absence of effect, microbiological examination should be performed to confirm the diagnosis and exclude another cause of the disease. Simultaneous treatment of both sexual partners is recommended.
It is necessary to use the drug for the entire duration of treatment, even if the symptoms of the disease have disappeared earlier. Following these recommendations will help prevent the development of reinfection.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
Clinical studies of the active substance in animals have not revealed any effect of clotrimazole on fertility and no 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 Clotrimazole, vaginal tablets, during the first trimester of pregnancy.
During pregnancy, vaginal tablets should be used without the use of an applicator.
During treatment with Clotrimazole vaginal tablets, breastfeeding should be discontinued.
Method of administration and doses
The drug should be used by adults 1 tablet 2 times a day for 3 days or 1 tablet per day for 6 days.
Vaginal tablets should be inserted into the vagina as deeply as possible, in the evening, most conveniently while lying on your back with your legs slightly bent.
Clotrimazole vaginal tablets must be moistened in the vagina to dissolve completely, otherwise undissolved pieces of the vaginal tablet may fall out of the vagina. To prevent this, it is important to insert the medicine as deeply into the vagina as possible before going to bed. If the vaginal tablets do not dissolve completely overnight, the use of a vaginal cream should be considered.
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 after accidental oral administration. There is no specific antidote.
In the event of accidental oral ingestion, gastric lavage may rarely be necessary if a life-threatening dose has been taken within the previous hour or if there are visible symptoms of overdose (e.g. dizziness, nausea or vomiting). Gastric lavage should only be performed if adequate respiratory protection is available.
Adverse reactions
Immune system: allergic reactions, including erythema, skin rash, edema, syncope, hypotension, shortness of breath, urticaria, itching. If these symptoms appear, treatment with clotrimazole should be discontinued.
Reproductive system and mammary glands: peeling of the skin in the genital area; burning sensation, redness, discomfort, pain and swelling of the mucous membrane in the area of the entrance to the vagina; irritation, pain in the pelvic area, vaginal bleeding.
Digestive tract: abdominal pain, gastrointestinal disorders.
Expiration date
3 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister, 1 blister in a pack.
Vacation category
Without a prescription.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and its business address
Ukraine, 03134, Kyiv, Myru St., 17.
