The instruction for medical use
the Trade name
the International unlicensed
name Clotrimazolum Dosage Form
of the Tablet vaginal, 100 mg
One tablet contains
active agent – Clotrimazolum of 100 mg,
excipients: lactoses monohydrate, potato starch, adipic acid, Natrii hydrocarbonas, magnesium stearate, silicon dioxide colloidal anhydrous, sodium lauryl sulfate.
the White biconvex tablets with the cut edges, oblong shape which are rounded off since one end and cut off at right angle from another.
Anti-infectious and antiseptic drugs for use in gynecology. Imidazole derivatives. Clotrimazolum.
The ATX G01AF02 code
Pharmacokinetics Absorption Later properties of intravaginalny administration of Clotrimazolum in a dose of 100 mg its maximum serumal concentration in blood plasma reached an indicator of 0.03 mkg/ml for 1-2 day after introduction that speaks about absorption size in number of 3 – 10% of the entered dose.
of 50% of Clotrimazolum contacts blood plasma albumine, distribution in bodies insignificant.
Metabolism and removal
Clotrimazolum is metabolized in a liver to an inactive metabolite 2-chlorophenyl-4-hydroxyphenyl-fenilmetana. At intake of Clotrimazolum inside, 10% of the accepted dose 25% are removed in the first day with urine, – by sixth day, and only 1% of drug is removed in an invariable look.
the action Mechanism
Clotrimazolum suppresses growth and cell fission. In small concentration works fungistaticly, and in big – it is fungicidal. The anti-mycotic effect of Clotrimazolum is connected with disturbance of synthesis of the ergosterol which is a part of a cellular membrane of mushrooms and linking with phospholipids of a cell wall of a mushroom.
Clinical trials showed that the effect at use of Clotrimazolum is similar to effect of use of derivatives of an imidazole – to an econazol and a ketokonazol.
In a fungal cell Clotrimazolum also inhibits biosynthesis of protein, fats, DNA and polysaccharides, destroys cellular nucleic acids and increases potassium loss. Can suppress activity of enzymes and biosynthesis of triglycerides and phospholipids in a cell wall. In high concentrations Clotrimazolum leads to damage of a cellular membrane by means of the mechanisms independent of synthesis of sterols.
Clotrimazolum used for treatment of the infections caused by Candida albicans suppresses transformation blastofor in its invasive form. Changes in structure of a cellular membrane lead of cells to death. Extent of influence of drug depends on degree of susceptibility of a microorganism to Clotrimazolum.
The activity range
Clotrimazolum is characterized by a wide range of antifungal and antimicrobial action, suppresses growth and carries out to death of dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeast-like mushrooms (Candida sp., Cryptococcus neoformans), dimorphous mushrooms (Coccidioides immitis, Histoplasma capsulatum, Paracoccidicides brasiliensis) and a protozo (Trichomonas vaginalis).
Clotrimazolum has antimicrobic effect concerning gram-positive microorganisms.
In vitro Clotrimazolum possesses broad fungistatic and fungicide action. Its effect on dermatophytes is similar to the effect rendered by griseofulvin, and on sort Candida organisms – polyenes (amfotetsin In and nystatin).
In concentration lower than 1 mkg/ml Clotrimazolum suppresses the majority of strains of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis.
In concentration from 3 mkg/ml Clotrimazolum suppresses growth of the majority of bacteria: Pitorosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains of Staphylococcus aureus, Streptococcus pyogenis, and also some strains of Proteus vulgaris and Salmonella. Clotrimazolum is active against Sporotrix, Cryptococcus, Cefalosporium and Fusarium. Concentration higher than 100 mkg/ml are effective against Trichomonas vaginalis.
Clotrimazolum-resistant strains meet extremely seldom, the only described strain characteristic resistance – Candida guilliermondi.
There are no reports on resistance among the strains sensitive to Clotrimazolum, after crops of Candida albicans and Trichophyton mentagrophytes. The resistance to Clotrimazolum at strains of C. albicans with resistance to half-yen antibiotics was not observed.
– candidiasis of a vagina and vulva
– the genital infections caused by the bacteria resistant to nystatin
– sanitation of patrimonial ways before
the sorts Route of administration and doses
Adults and teenagers are more senior than 16 years
Daily on 1 tablet (100 mg) 2 times a day within 3 days or
on 1 tablet (100 mg) once in day within 6-7 days.
The dryness of a vagina can lead to incomplete dissolution of a tablet, and the women having this pathology can find not dissolved tablet remains. In this regard it is strongly recommended to enter vaginal tablets as it is possible more deeply in a vagina in a dorsal decubitus at slightly bent legs (preferably before going to bed). If the infection extended to vulvar lips and adjacent areas, topical treatment of the involved sites by cream Clotrimazolum is recommended.
Before periods the treatment should be stopped.
During the Clotrimazolum drug treatment it is not necessary to apply tampons, syringing, spermitsida or other drugs administered intravaginalno.
If symptoms of a disease do not disappear after 7 days of use of drug, it is necessary to consult with the doctor.
The tablets Clotrimazolum can be reused if symptoms renewed after 7 days. If the infection recurrence more often than twice within six months, it is necessary to consult with the doctor is revealed.
the Frequency of manifestation of side effects of drug is defined as follows: very often (≥1/10), it is frequent (≥1/100 and & lt, 1/10), infrequently (≥1/1000 and & lt, 1/100), is rare (≥1/10000 and & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (not enough data for assessment).
It is unknown
– vulvovaginal discomfort, hypostasis, burning, irritation, an itching, rash, pains in the field of a basin, local hyperaemia, vaginal bleedings
– allergic reactions (urticaria, short wind, hypotension, a loss of consciousness)
– pains in
the Contraindication stomach
– hypersensitivity to Clotrimazolum or any other component of drug
– the periods period
– children’s age up to 16 years
Preaparat can have negative impact on latex contraceptives, damaging them and reducing their contraceptive ability. Patients have to use alternative methods of contraception at least for five days after the termination of a course of therapy by the drug Clotrimazolum.
Intravaginalny use of the drug Clotrimazolum and drug takrolimus for intake (FK-506, immunosuppressant) can lead to increase in level of a takrolimus in blood plasma in this connection patients have to be under careful observation of the doctor regarding emergence of symptoms of overdose takrolimusy and, as necessary, definitions of its concentration in plasma.
Avoid contact with eyes. Not to accept inside. All infected areas have to be processed at the same time.
the Drug Clotrimazolum are not used during periods, treatment has to be stopped before approach of the next periods.
in case of existence of the symptoms described below before use of the drug Clotrimazolum it is necessary to consult with the doctor:
– more than two cases of development of candidiasis for the last six months
– the previous cases of diseases, sexually transmitted, or presence of the sexual partner with this type of diseases
– existence of pregnancy or expected pregnancy
– age are younger than 16 years or 60 years are more senior
– the known hypersensitivity to an imidazole or other vaginal antifungal
drugs Drug Clotrimazolum it should not be applied if at the patient are revealed any of the listed symptoms:
– irregular vaginal bleedings
– abnormal vaginal bleedings or bloody discharges
– vaginal discharges with an unpleasant smell
– ulcers, blisters or wounds on mucous vulvas or vaginas
– pains in the bottom of a stomach or urination disturbance
– reddening, irritation, hypostasis mucous, associated with therapy
– fever (38 ºС above) either a fever
– nausea or vomiting
– a dorsodynia and a shoulder girdle
Exist limited data on use of Clotrimazolum at pregnant women. Researches on animals do not indicate the direct or indirect negative impact connected with reproductive toxicity. As a precautionary measure it is preferred to avoid use of Clotrimazolum during the first trimester of pregnancy.
In case of prescribing of drug to the pregnant woman, it is necessary to warn her that at introduction of vaginal tablets it is not necessary to use the applicator.
the Available pharmakodinamicheskiye / toxicological data at animals showed discharge of Clotrimazolums/metabolites in breast milk. Feeding by a breast during treatment with Clotrimazolum is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect or has insignificant impact on ability to run the vehicle or potentially dangerous mechanisms.
Overdose by drug is improbable in connection with a dosage form, a form of introduction and low absorption of Clotrimazolum.
Symptoms: in case of unforeseen use of drug the dizziness, nausea, vomiting are inside possible.
Treatment: there is no specific antidote. If necessary – symptomatic treatment.
Form of release and packing
of the Tablet vaginal, 100 mg.
On 6 tablets place in blister strip packaging from aluminum foil and a film polyvinylchloride.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach!
A period of storage
not to take the drug after an expiration date.
the Producer/packer S.A. GlaksoSmitKlyayn Pharmasyyutikalz, Poland
(189 Grunwaldzka Street, 60-322 Poznan, Poland)
the Owner of the registration certificate
S.A. GlaksoSmitKlyayn Pharmasyyutikalz, Poland
(189 Grunwaldzka Street, 60-322 Poznan, Poland)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo kompanii GlaksoSmitKlyayn Export Ltd in
Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 701 9908566, +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
To Develop firstname.lastname@example.org