AGISTEN CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOTRIMAZOLE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D01AC01

Pharmaceutical form:

CREAM

Composition:

CLOTRIMAZOLE 1 %W/W

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

CLOTRIMAZOLE

Therapeutic area:

CLOTRIMAZOLE

Therapeutic indications:

For the treatment of fungal infections of the skin and mucosa caused be dermatophytes, yeasts, molds and other fungi such as Malassezia furfur as well as skin infections caused by Corynebacterium minutissimum.Indicated also for Candida Vulvitis and Candida balanitis.

Authorization date:

2014-03-31

Summary of Product characteristics

PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Agisten Cream
Agisten Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Agisten Cream:
Clotrimazole 1.0% w/w.
Excipient with known effect: cetostearyl alcohol
Agisten Solution:
Clotrimazole 1.0% w/v.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Agisten Cream: A white cream for topical use.
Agisten Solution: A clear solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Skin infections caused by dermatophytes or candida species.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To ensure complete healing, treatment should be continued for about 2
weeks after the
disappearance of the subjective symptoms. The following are the usual
periods of treatment:
Dermatomycoses
3-4 weeks
Erythrasma
2-4 weeks
Pityriasis versicolor
1-3 weeks
Candida vulvitis and balanitis
1-2 weeks
Agisten Cream
A thin layer should be applied to the affected sites and gently rubbed
in 2-3 times daily. A
strip of cream ½ cm long is sufficient to treat an area about the
size of a hand.
Agisten Solution
A thin layer should be applied to the affected sites and gently rubbed
in 2-3 times daily. A
few drops is sufficient to treat an area about the size of a hand.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1, including cetostearyl alcohol.
Do not use the cream to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Agisten cream contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis). Avoid contact with the eyes.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when Clotrimazole cream is 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.
4.6
PREGNANCY AND LACTATION
Fertility:
No human