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nystatin 500,000 unit oral tab

In stock Manufacturer HERITAGE PHARMA 23155005101
$1.26 / Tablet

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Uses

Candida Infections

Oral nystatin is used for the treatment of certain infections of the GI tract caused by Candida, including oropharyngeal candidiasis and nonesophageal mucous membrane GI candidiasis. Nystatin should not be used for the treatment of systemic fungal infections.

Oropharyngeal Candidiasis

Nystatin oral suspension is used for the treatment of candidiasis of the oral cavity (oropharyngeal candidiasis).

For the treatment of oropharyngeal candidiasis, the Infectious Diseases Society of America (IDSA) recommends topical treatment with clotrimazole lozenges or nystatin oral suspension for mild disease and systemic treatment with oral fluconazole for moderate to severe disease.

For the treatment of oropharyngeal candidiasis in adults and adolescents with human immunodeficiency virus (HIV) infection, the US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and IDSA recommend oral fluconazole as the preferred drug of choice for initial episodes and topical treatment with clotrimazole lozenges or nystatin oral suspension as alternative drugs of choice. Topical treatment with clotrimazole lozenges or nystatin oral suspension also is recommended for early, uncomplicated oropharyngeal candidiasis in HIV-infected infants and children; however, oral fluconazole may be more effective for initial treatment in infants and is recommended if a systemic antifungal is considered necessary.

Nonesophageal Mucous Membrane GI Candidiasis

Nystatin tablets are used for the treatment of nonesophageal mucous membrane GI candidiasis. Systemic anti-infective therapy (e.g., oral or IV fluconazole, IV amphotericin B, IV echinocandin) is necessary for the treatment of esophageal candidiasis.

In patients with coexisting intestinal candidiasis and vulvovaginal candidiasis, nystatin has been administered orally in conjunction with intravaginal application of an antifungal. While early studies provided some limited evidence that, by reducing intestinal candidal colonization, combined oral and intravaginal antifungal therapy possibly could improve the mycologic response and reduce the recurrence rate of vulvovaginal candidiasis, most evidence suggests that combined therapy does not substantially reduce the risk of recurrence compared with intravaginal therapy alone.

Candidal Diaper Dermatitis

Nystatin oral suspension has been used in conjunction with topical application of the drug for the treatment of candidal diaper dermatitis. The majority of infants with candidal diaper dermatitis harbor C. albicans in their intestines, and infected feces appear to be an important source of the cutaneous infection. Candidal diaper dermatitis usually is treated with topical antifungaltherapy (e.g., topical nystatin, amphotericin B, miconazole, clotrimazole). In addition, some clinicians recommend that an oral antifungal(e.g., nystatin, fluconazole) be administered concomitantly to treat the intestinal infection. Despite the fact that results of 2 small studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone, some clinicians suggest that such a strategy may be warranted.

Prevention of Fungal Infections in Transplant Recipients, Cancer Patients, or Other Patients at High Risk

Transplant Recipients and Patients with Cancer

Nystatin tablets or oral suspension have been used in various regimens for prophylaxis against Candida infections during periods of iatrogenic neutropenia in patients receiving immunosuppressive therapy (e.g., patients with malignancies, transplant recipients) with variable results. Use of primary antifungal prophylaxis against Candida infections in nonneutropenic patients or neutropenic cancer or transplant patients has been controversial, particularly since such prophylaxis may predispose the patient to colonization with resistant fungi and/or result in the emergence of highly resistant organisms.

While there is some limited evidence that oral nystatin prophylaxis may reduce the incidence of mucocutaneous candidiasis in some neutropenic patients, it is unlikely that the drug would decrease the frequency of invasive candidiasis. In addition, there is some evidence that oral fluconazole is more effective than oral nystatin for prophylaxis against Candida infections in immunocompromised patients. In one study in adult and pediatric liver transplant patients randomized to receive antifungal prophylaxis with nystatin oral suspension or oral fluconazole, Candida infections developed in 27% of those receiving nystatin and 12% of those receiving fluconazole (intent-to-treat analysis). Superficial Candida infections or documented systemic invasive Candida infections developed in 25.3 or 6%, respectively, of those receiving nystatin and in 10.5 or 1.3%, respectively, of those receiving fluconazole.

If primary prophylaxis against candidiasis is indicated in individuals with chemotherapy-induced neutropenia, the IDSA recommends fluconazole, posaconazole, or caspofungin during induction chemotherapy and continued for the duration of neutropenia. If postoperative antifungal prophylaxis is indicated in solid organ transplant recipients at high risk for invasive candidiasis (i.e., liver, pancreas, or small bowel transplant recipients), the IDSA recommends fluconazole or IV amphotericin B.

Low Birthweight Neonates

Oral nystatin has been used for prophylaxis to reduce the incidence of invasive candidiasis in low birthweight neonates at high risk. There is some evidence that nystatin prophylaxis can decrease the risk of colonization and reduce the incidence of invasive candidiasis in low birthweight neonates if initiated within 48 hours of birth; however, some studies indicate it is less effective than fluconazole for such prophylaxis and additional study is needed. Although antifungal prophylaxis in low birthweight neonates has been controversial, the American Academy of Pediatrics (AAP) and IDSA recommend oral fluconazole when such prophylaxis is used (e.g., in very low birthweight neonates weighing less than 1 kg in nurseries that have very high rates of neonatal invasive candidiasis).

For use of nystatin in the topical treatment of cutaneous candidiasis and vulvovaginal candidiasis and additional information on treatment of oropharyngeal candidiasis, see Nystatin 84:04.08.

Dosage and Administration

Administration

Nystatin is administered orally as an oral suspension or film-coated tablets.

When nystatin is administered as the commercially available oral suspension containing 100,000 units/mL for the treatment of oropharyngeal candidiasis, one-half of the dose should be placed in each side of the mouth and retained in the mouth for as long as possible before swallowing. Infants should not be fed for 5-10 minutes after the dose. The oral suspension should be shaken well prior to administration.

Dosage

Oropharyngeal Candidiasis

For the treatment of candidiasis of the oral cavitary (oropharyngeal candidiasis), the manufacturers state that the usual dosage of nystatin oral suspension is 400,000-600,000 units 4 times daily in adults and children and 200,000 units 4 times daily in infants. The manufacturers recommend that treatment be continued for at least 48 hours after perioral symptoms have subsided and cultures are negative for Candida albicans.

For the treatment of oropharyngeal candidiasis in adults, adolescents, or children with human immunodeficiency virus (HIV) infection, the US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Infectious Diseases Society of America (IDSA) recommend that nystatin oral suspension be given in a dosage of 400,000-600,000 units 4 times daily for 7-14 days.

Nonesophageal Mucous Membrane GI Candidiasis

For the treatment of nonesophageal mucous membrane GI candidiasis, the manufacturers recommend that nystatin tablets be given in a dosage of 500,000 to 1 million units 3 times daily (1 or 2 tablets 3 times daily). To prevent relapse, the drug generally should be continued for at least 48 hours after clinical cure.

Candidal Diaper Dermatitis

As an adjunct to topical nystatin therapy for the treatment of candidal diaper rash, nystatin oral suspension has been given in a dosage of 100,000 units 4 times daily.

Cautions

Adverse Effects

Adverse effects occur infrequently with oral nystatin therapy. Diarrhea (including bloody diarrhea), nausea, vomiting, and GI upset/disturbances have been reported. High oral dosages (e.g., exceeding 5 million units daily) are most likely to produce adverse GI effects.

Oral irritation and sensitization have been reported in patients receiving nystatin. Rash, urticaria, and Stevens-Johnson syndrome also have been reported rarely.

Other adverse effects that have been reported rarely with nystatin include tachycardia, bronchospasm, facial swelling, and nonspecific myalgia.

Precautions and Contraindications

Nystatin is contraindicated in individuals hypersensitive to the drug or any ingredient in the formulation.

If irritation or sensitization occurs, nystatin should be discontinued.

Mutagenicity and Carcinogenicity

Studies have not been conducted to date to assess the mutagenic or carcinogenic potential of nystatin in humans or animals.

Pregnancy, Fertility, and Lactation

Pregnancy

Animal reproduction studies have not been performed with nystatin, and it is not known whether the drug can cause fetal harm when administered to pregnant women. Nystatin should be used during pregnancy only when clearly needed.

Fertility

Studies have not been conducted to date to determine whether nystatin affects fertility in males or females.

Lactation

Since it is not known whether nystatin is distributed into human milk, the drug should be used with caution in nursing women.

Pharmacokinetics

Nystatin is poorly absorbed from the GI tract, and detectable blood concentrations are not obtained after usual doses. Following oral administration, nystatin is excreted almost entirely in feces as unchanged drug. The drug is not absorbed from intact skin or mucous membranes.

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