Zalain 2%, 1 tube x 5 g
Generic Name: Sertaconazol
Once in a day twice in a day 3 times in a day 4 times in a day
What is Sertaconazole?
Sertaconazole topical is an antifungal medication. Sertaconazole topical prevents fungus from growing on the skin.
Sertaconazole topical is used to treat fungal infections of the skin such as athlete’s foot.
Sertaconazole topical may also be used for purposes other than those listed in this medication guide.
Sertaconazole® (Sertaconazole nitrate) cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
How should I use Sertaconazole?
Use Sertaconazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Sertaconazole. Talk to your pharmacist if you have questions about this information.
- Clean and dry the affected area before applying for the medicine.
- Gently rub the medicine until it is evenly distributed to the affected area and to a small section of healthy skin that surrounds the area.
- Do not bandage or wrap the affected area unless directed otherwise by your doctor.
- Wash your hands immediately after using Sertaconazole.
- To clear up your infection completely, continue using Sertaconazole for the full course of treatment, even if your symptoms get better in a few days. Do not miss any doses.
- If you miss a dose of Sertaconazole, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Sertaconazole.
Uses of Sertaconazole in details
Sertaconazole is used to treat a fungal infection called tenia pedis or athlete’s foot (a fungal infection of the skin on the feet and between the toes) and other fungal and yeast infections.
Sertaconazole nitrate is an antifungal medication of the imidazole class. It is available as a cream to treat skin infections such as athlete’s foot. [Wikipedia]
In the treatment of interdigital tinea pedis, Sertaconazole cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Sertaconazole cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.
Not for ophthalmic, oral, or intravaginal use.
Dosage Forms And StrengthsCream, 2%. Each gram of Sertaconazole cream, 2%, contains 17.5 mg of Sertaconazole (as Sertaconazole nitrate, 20 mg) in a white cream base.
Storage And HandlingSertaconazole cream, 2%, is white in color and supplied in tubes in the following size:
60-gram tube NDC 0187-5115-60
Store at 20°C -25°C (68°F -77°F); excursions permitted to 15°-30°C (59°-86°F).
Distributed by: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 Product of Spain. For more information call 1-800-321-4567. Revised: January 2014
Drug/Laboratory Test Interactions: Potential interactions between SertaconazoleTM Cream, 2%, and other drugs or laboratory tests have not been systematically evaluated.
Sertaconazole side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Sertaconazole® cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.
In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Sertaconazole® cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.
The following adverse reactions have been identified during post-approval use of Sertaconazole cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In post-marketing surveillance for Sertaconazole cream, 2%, the following were reported:
Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
SertaconazoleTM Cream, 2%, is contraindicated in patients who have a known or suspected sensitivity to Sertaconazole nitrate or any of its components or to other imidazoles.
Active ingredient matches for Sertaconazole: