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/ml

Pharmaceutical form:

solution topical

Prescription type:

OTC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CLOTRIMAZOLE
1% SOLUTION FOR TOPICAL USE
1.1 BRAND NAME – Clotrimazole
1.2 INTERNATIONAL NON-PROPERTY NAME - Clotrimazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
active ingredient: clotrimazole 10.0 mg
_For a full list of excipients, see section 6.1_
3. PHARMACEUTICAL FORM
Clear, colourless solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clotrimazole Solution should be used to treat all fungal skin
infections due to dermatophytes,
yeasts, moulds and other fungi.
It is particularly suitable for use on hairy skin and in fungal
infections of the outer ear (otitis
externa) and middle ear (otomycoses).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Clotrimazole Solution should be thinly and evenly applied to the
affected area 2 or 3 times a day
and gently rubbed in. A few drops are enough to treat an area of about
the size of the hand. To
prevent relapse, treatment should be continued for at least two weeks
after the disappearance of
all signs of infection.
There is no separate dosage schedule for the elderly or the young.
4.3 CONTRAINDICATIONS
Hypersensitivity to clotrimazole or propylene glycol.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None known.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There have been reports of a heat reaction when Clotrimazole Solution
is used concomitantly
with Sofradex drops in the ear.
4.6 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 clotrimazole in
pregnant women. Animal
studies with clotrimazole have shown reproductive toxicity at high
oral doses (see section 5.3).
At the low systemic exposures of clotrimazole following topical
treatment, harmful effects with
respect to reproductive toxicity are not predicted.
Clotrimazole can be used during pregnancy, but only und