Instructions Clotrimazole vaginal tablets 100 mg blister with applicator No. 6
Composition
active ingredient: clotrimazole;
1 tablet contains clotrimazole 100 mg;
excipients: corn starch, lactose, povidone (K-30), magnesium stearate, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A).
Dosage form
Vaginal tablets.
Main physicochemical properties: vaginal tablets are oblong in shape with a biconvex surface, one end is rounded, the other is flat, white in color.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology, except for combined preparations containing corticosteroids. Imidazole derivatives.
ATX code G01A F02.
Pharmacological properties
Pharmacodynamics
The mechanism of antifungal action of imidazole derivatives 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. 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 addition to its antifungal activity, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (streptococci, staphylococci) and gram-negative microorganisms (Bacteroids, Gardnerella vaginalis).
Clotrimazole inhibits the growth of Corynebacteria and Gram-positive cocci (except Enterococci).
Pharmacokinetics
It is known 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 application at a dose of 500 mg is less than 10 ng/ml. This means that measurable systemic effects or side effects after vaginal application 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
Hypersensitivity to clotrimazole or to other components of the drug.
Interaction with other medicinal products and other types of interactions
When used simultaneously with other medicines, the following interactions are possible:
with oral tacrolimus (FK-506; immunosuppressant) – increased plasma levels of the latter; in case of simultaneous use with clotrimazole, the patient’s condition should be carefully monitored to detect symptoms of tacrolimus overdose, if necessary – by checking its plasma levels; with nystatin – decreased activity of clotrimazole; with amphotericin B and other polyene antibiotics – decreased activity of the latter.
When clotrimazole is used simultaneously with latex contraceptives, damage to the latter may occur, so the effectiveness of these contraceptives may be reduced. Patients are advised to use alternative methods of contraception for at least 5 days after using this medicine.
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 more than 7 days; if symptoms reappear within 2 months; if there is a history of venereal diseases or a serious history of venereal diseases in the partner; if there are more than 2 episodes of candidal vaginitis in the last 6 months; in case of pregnancy or suspicion of pregnancy; if the patient is over 60 years old; if hypersensitivity to any antifungal agents or imidazole derivatives is detected.
It is not recommended to use the drug Clotrimazole without consulting a doctor for:
irregular vaginal bleeding, abnormal vaginal bleeding or vaginal bleeding accompanied by shoulder pain, blood clots; vulvar or vaginal ulcers, sores; purulent vaginal discharge with an unpleasant odor; lower abdominal pain, back pain and dysuria; any adverse reactions such as redness, irritation or swelling associated with treatment; fever (38°C or higher); nausea or vomiting; diarrhea.
Treatment should not be carried out during menstruation. Treatment should be completed before the onset of menstruation.
Since both the vagina and the external genitalia (labia and adjacent areas) are usually affected, combined treatment of both areas should be used.
During therapy with the drug Clotrimazole, it is recommended to treat both partners using the appropriate dosage forms.
Sexual contact should be avoided while using this medicine, as the infection may be transmitted to your partner.
The effectiveness and safety of latex products (such as condoms and diaphragms) may be reduced.
Do not use tampons, intravaginal irrigations, spermicides, or other vaginal products during therapy with Clotrimazole.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, however, animal studies have not shown any effect of clotrimazole on fertility.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The number of studies on the use of clotrimazole during pregnancy is limited, therefore it is recommended to avoid the use of the drug Clotrimazole during the first trimester of pregnancy.
During pregnancy, vaginal tablets should be used without the use of an applicator.
If you use the drug Clotrimazole, breastfeeding should be discontinued.
Method of administration and doses
1 vaginal tablet is used in the evening. The course of treatment with 100 mg vaginal tablets is 6 days.
Children over 12 years of age should use the drug Clotrimazole after consulting a doctor.
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, using an applicator. For children over 12 years of age, Clotrimazole should be used without an applicator.
Clotrimazole vaginal tablets must be completely dissolved in the vagina, 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, other dosage forms should be considered.
Children
The drug Clotrimazole is not indicated before the onset of menarche.
Do not use in children under 12 years of age.
Children over 12 years of age should use Clotrimazole after consulting a doctor; do not use an applicator.
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.
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 loss of consciousness, hypotension, shortness of breath, urticaria.
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
4 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 30 °C.
Packaging
6 vaginal tablets in a blister, 1 blister with an applicator in a cardboard pack.
Vacation category
Without a prescription.
Producer
Evertogen Life Sciences Limited.
Location of the manufacturer and its business address
Plot No.: S-8, S-9, S-13/P and S-14/P T S I A C, S I Z Pharma, Green Industrial Park, Polepally (V), Yedcherla (M), Mahabubnagar, Telangana, IH-509 301, India.
