February 27, 2017
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Nystatin Cream

"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...

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Nystatin Cream




Warnings
Precautions

WARNINGS

Please refer to the PRECAUTIONS section.

PRECAUTIONS

General

Nystatin cream 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.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.

Pregnancy

Teratogenic Effects

Category C

Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION.)

Geriatric Use

Clinical studies with nystatin cream 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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/14/2016

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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