Thursday, August 27, 2009

Exoderil

Exoderil®
a topical antimycotic with fungicidal activity


Composition
1 gram cream contains Naftifine hydrochloride 10 mg.
1 ml solution contains Naftifine hydrochloride 10 mg.

Properties
Naftifine is a new topical antimycotic. It acts as primary fungicidal against dermatophytes and fungistatic against Candida species. Exoderil® has a local bactericidal effect on gram-positive and gram-negative bacteria. It is known that 6 % of topical dose is absorbed systematically.

Indications
Exoderil® is indicated for the topical application in the treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum.
Exoderil® is also indicated for onychomycosis.

Administration and dosage
Massage into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Exoderil®, the patient should be re-evaluated.

Tolerance
Exoderil® is well tolerated.

Contraindication
Hypersensitivity against Exoderil® or any adjuvant substance of the compound

Precautions
If irritation or sensitivity develops with the use of Exoderil®, treatment should be discontinued.
For patients:
  • Avoid the use of acclusive dressing on wrapping unless other wise directed by physician.
  • Keep away from the eyes, nose, mouth, and other mucosal membranes.
Pregnancy:
Should be used during pregnancy only if clearly needed,

Nursing mothers:
Caution should be exercised.

Pediatric use:
Safety and effectiveness in children have not been established.

Interactions
Unknown

Side effects
In rare cases mild and fully reversible local irritation such as burning and dryness may be observed. Discontinuation of treatment is only rarely necessary. Erythema and itching.

Storage instruction
Do not store above 30°C, protect from light and humidity.
Keep this and all drugs out of the reach of children.

Presentation
Exoderil® cream, tubes of 15 g and 5 g, Reg.No. DKL9430406929A1.
Exoderil® solution, bottle of 10 ml, Reg.No. DKL8830405341A1.

PRESCRIPTION ONLY

Manufactured by
PT Novartis Indonesia, Citeureup, Bogor, Indonesia
Under license of Sandoz GmbH, Kundl, Austria

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