Clotrimazole

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clotrimazole

Available from:

Arpimed LLC

INN (International Name):

clotrimazole

Dosage:

10mg/g

Pharmaceutical form:

cream for topical use

Prescription type:

OTC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CLOTRIMAZOLE
1% CREAM FOR TOPICAL USE
1.1 BRAND NAME – Clotrimazole
1.2 INTERNATIONAL NON-PROPERTY NAME - Clotrimazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10 mg of Clotrimazole
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
A homogeneous cream is a smooth white colour, odorless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of:
(I)
All dermatomycoses due to moulds and other fungi (e.g. _Trichophyton_
species).
(II)
All dermatomycoses due to yeasts (_Candida_ species).
(III) Skin diseases showing secondary infection with these fungi.
(IV) Candidal nappy rash, vulvitis and balanitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in
gently. A strip of cream (½ cm
long) is enough to treat an area of about the size of the hand.
Treatment should be continued for
at least one month for dermatophyte infections and at least two weeks
for candidal infections.
If the feet are infected they should be washed and dried, especially
between the toes, before
applying the cream.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Do not use the cream to treat nail or scalp infections.
4.4 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when used together, this product
may cause damage to
latex contraceptives. Consequently the effectiveness of such
contraceptives may be reduced.
Patients should be advised to use alternative precautions for at least
five days after using this
product.
4.5 FERTILITY, PREGNANCY AND LACTATION
Fertility:
No human studies of the effects of clotrimazole on fertility have been
performed; however,
animal studies have not demonstrated any effects of the drug on
fertility.
Pregnancy:
There is a limited amount of data from the use of clotri