AGISTEN SOLUTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOTRIMAZOLE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D01AC01

Pharmaceutical form:

SOLUTION

Composition:

CLOTRIMAZOLE 1 %

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

CLOTRIMAZOLE

Therapeutic area:

CLOTRIMAZOLE

Therapeutic indications:

Skin infection caused by dermatophytes or candida species.

Authorization date:

2014-05-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Agisten
®
Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/v.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Colourless to slightly yellowish liquid 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
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 clotrimazole or to any of the
excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not known
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not known
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
under the
supervision of a physician.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown
excretion
of clotrimazole/metabolites in milk after intravenous administration
(see section
5.3). A risk to the suckling child cannot be excluded. A decision must
be