Emzor Nystatin Oral Suspension

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

• Very moist lesions are best treated with the topical dusting powder
• Adults and
• Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete
• For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear

Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ].

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

• INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: The patient should be instructed to use this medication as directed (including the replacement of missed doses)
• This medication is not for any disorder other than that for which it is prescribed
• Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed
• If symptoms of irritation develop, the patient should be advised to notify the physician promptly

Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS General Nyamyc® (Nystatin Topical Powder, USP) should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens. …

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ].

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

STORAGE Nyamyc® (Nystatin Topical Powder, USP) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.