(See DOSAGE AND ADMINISTRATION.) Geriatric UseĬlinical studies with Mikostat (Nystatin) Cream and Mikostat (Nystatin) Topical Powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Safety and effectiveness have been established in the pediatric population from birth to 16 years. Caution should be exercised when nystatin is prescribed for a nursing woman. It is not known whether nystatin is excreted in human milk. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with any nystatin topical preparation. Pregnancy: Teratogenic EffectsĬategory C. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. Carcinogenesis, Mutagenesis, Impairment of Fertility If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. 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. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. Nystatin, topical preparations should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered. No specific dosage recommendations or precautions. The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater will be its effect.Īdministration should be continued for 48 hours after clinical cure to prevent relapse. 1ml of the suspension should be dropped into the mouth four times daily it should be kept in contact with the affected areas as long as possible.įor the treatment of intestinal candidosis 5ml of the suspension should be dropped into the mouth four times daily.įor prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy.įor prophylaxis in the newborn the suggested dose is 1ml once daily. 1ml should be dropped into the mouth four times a day.įor the treatment of denture sores, and oral infections in children (> 2 years) and adults caused by candidas albicans.
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