Clotrimazole cream vaginal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clotrimazole

Available from:

Arpimed LLC

ATC code:

G01AF02

INN (International Name):

clotrimazole

Dosage:

20mg/g

Pharmaceutical form:

cream vaginal

Units in package:

50g aluminium tube and (3) applicator

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-07-11

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC) CLOTRIMAZOLE 2% VAGINAL CREAM
1. NAME OF THE MEDICINAL PRODUCT - Clotrimazole NON-PROPRIETARY NAME - Clotrimazole
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each gram of Clotrimazole, vaginal cream 2%, contains:
ACTIVE INGREDIENT: Clotrimazole - 20 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
A homogeneous cream with smooth white colour, odourless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clotrimazole is indicated for the 3-day treatment of vaginal
candidiasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily dose is one full applicator intravaginally for
three consecutive days,
preferably at bedtime. Sufficient cream is provided for 3 intravaginal
applications.
_Dosing Considerations _
Vaginal Candidiasis may be accompanied by irritation in the vaginal
area. Therefore,
concomitant local treatment with Clotrimazole applied to the irritated
vaginal area and as far as
the anal region twice a day is advisable. Clotrimazole applied on the
glans penis may prevent re-
infection by the partner.
N.B.: The cream should be inserted deep intravaginally by means of the
applicator. The plunger
should then be depressed slowly.
4.3 CONTRAINDICATIONS
Patients who are hypersensitive to this drug or to any ingredient in
the formulation or component
of the container.
4.4 PRECAUTIONS FOR USE AND SPECIAL WARNINGS
GENERAL
Clotrimazole is not for ophthalmic use.
Patients should seek medical advice if they have frequent vaginal
infections or if their yeast
infection returns in less than 2 months.
Patients should seek medical advice if they suffer from diabetes
mellitus, or have underlying
immunodeficiency disease (such as HIV-AIDS).
As with all topical agents, skin sensitization may result. Use of
Clotrimazole topical preparations
should be discontinued should such reactions occur, and appropriate
therapy instituted.
Treatment during the menstrual period should not be performed. The
treatment should be
finished before the onset of menstruati