Prescription Required
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Manufacturer
PERRIGO CO.
SKU
45802005911

nystatin 100,000 unit/gm cream

Generic
$8.76 / tube
$26.25 / tube
$17.49 / tube
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1,000 tubes Available
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Uses

Cutaneous and Mucocutaneous Candidiasis

Nystatin is used topically as a cream, ointment, or powder for the treatment of cutaneous infections caused by Candida albicans, such as perleche, intertriginous candidiasis, paronychia, and diaper rash.

Topical nystatin also is used in conjunction with a topical corticosteroid (i.e., triamcinolone acetonide) for the treatment of cutaneous candidiasis as a commercially available fixed-combination cream or ointment that contains both drugs. Combined therapy with the drugs is more effective than nystatin alone for improving the clinical severity of cutaneous candidiasis, especially during the first few days of treatment; combined therapy generally provides earlier relief of signs and symptoms of this infection than does nystatin alone. Combinations of nystatin and corticosteroids may be of value in reducing local inflammation and pain that may accompany candidal infection. Nystatin creams and ointments were previously commercially available in combination with corticosteroids and antibacterial agents (e.g., gramicidin, neomycin) for the treatment of cutaneous candidiasis, other superficial infections, and various other dermatologic conditions complicated by candidal and/or bacterial infection, but these preparations have been reformulated and the indications for use narrowed because there was a lack of substantial evidence of efficacy for these combinations in the treatment of these conditions.

Candidal Diaper Dermatitis

Nystatin has been administered orally as a suspension in conjunction with local 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 antifungal agent therapy (e.g., topical nystatin, miconazole, clotrimazole). In addition, some clinicians recommend that an oral antifungal agent (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection. Although 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.

Oropharyngeal Candidiasis

Nystatin is used orally in the form of an oral suspension for the topical treatment of oropharyngeal candidiasis (thrush).

Topical therapy with oral nystatin oral suspension has been used in the treatment of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Some clinicians consider oral topical therapy with clotrimazole lozenge or nystatin oral suspension the treatment of choice for uncomplicated oropharyngeal candidiasis in HIV-infected patients and recommend that systemic antifungals (e.g., oral fluconazole, oral itraconazole, oral ketoconazole) be reserved for the treatment of oropharyngeal candidiasis unresponsive to oral topical agents or for the treatment of severe oropharyngeal candidiasis with esophageal involvement. However, other clinicians prefer to use an oral azole antifungal agent for initial therapy of oropharyngeal candidiasis in HIV-infected individuals. Topical oral therapy with nystatin oral suspension is ineffective for the treatment of esophageal candidiasis in HIV-infected individuals.

Although oral nystatin has been used for prophylaxis against oropharyngeal candidiasis in HIV-infected individuals, the drug is no longer included in the prophylaxis guidelines of the Prevention of Opportunistic Infections Working Group of the US Public Health Service and Infectious Diseases Society of America (USPHS/IDSA). If prophylaxis of oropharyngeal candidiasis is indicated in HIV-infected individuals, the USPHS/IDSA recommends oral fluconazole or oral itraconazole solution.

Intestinal Candidiasis

Nystatin is used orally for the treatment of mucous membrane (nonesophageal) GI candidiasis. Oral nystatin also has been used in conjunction with an intravaginal antifungal agent to treat coexisting intestinal candidiasis and vulvovaginal candidiasis.(See Uses: Vulvovaginal Candidiasis.)

Vulvovaginal Candidiasis

Nystatin vaginal tablets are used for the treatment of uncomplicated vulvovaginal candidiasis. Prior to administration of intravaginal nystatin therapy, the diagnosis should be confirmed either by demonstrating yeast or pseudohyphae with direct microscopic examination of vaginal discharge (saline or 10% potassium hydroxide [KOH] wet mount or Gram stain) or by culture; identifying Candida by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10-20% of women harbor Candida or other yeasts in the vagina.

Up to 75% of women reportedly have at least one episode of vulvovaginal candidiasis and 40-45% have 2 or more episodes during their lifetime, but a small percentage of women (up to 5%) have recurrent vulvovaginal candidiasis (i.e., 4 or more episodes of symptomatic vulvovaginal candidiasis each year). While certain factors may precipitate a sporadic attack of vulvovaginal candidiasis and have been associated with an increased risk for recurrent vulvovaginal candidiasis (e.g., uncontrolled diabetes mellitus, pregnancy, oral contraceptive use, corticosteroid or other immunosuppressive therapy, immunodeficiency, use of intravaginal sponges or devices, repeated courses of topical or systemic antibacterial agents), these factors are not present in most women who have recurrent episodes.

Azole antifungals (imidazole and triazole derivatives) are considered the drugs of choice for the treatment of vulvovaginal candidiasis. The US Centers for Disease Control and Prevention (CDC) and other clinicians generally recommend that uncomplicated vulvovaginal candidiasis (defined as vulvovaginal candidiasis that is mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, or occurring in immunocompetent women) should be treated with an intravaginal azole antifungal (e.g., butoconazole, clotrimazole, miconazole, terconazole, tioconazole) given in appropriate single-dose or short-course regimens or, alternatively, oral fluconazole given in a single-dose regimen. These regimens generally have been associated with clinical and mycologic cure rates of 80-90% in otherwise healthy, nonpregnant women with uncomplicated infections, and there is no clear evidence that any one intravaginal azole antifungal regimen is superior to other intravaginal azole regimens available for the treatment of these infections. While a 14-day regimen of intravaginal nystatin tablets also can be used for the treatment of uncomplicated vulvovaginal candidiasis, intravaginal nystatin generally is less effective than intravaginal azole antifungals.

Vulvovaginal candidiasis usually is not acquired through sexual activity, and treatment of sexual partner(s) is not recommended but may be considered in women who have recurrent infections. However, male sexual partners who have symptomatic balanitis or penile dermatitis may benefit from treatment with a topical antifungal agent to relieve symptoms.

In patients with coexisting intestinal candidiasis and vulvovaginal candidiasis, nystatin has been administered orally in conjunction with intravaginal application of an antifungal agent. While early studies provide 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.

For additional information on treatment of uncomplicated vulvovaginal candidiasis and information on treatment of complicated and recurrent vulvovaginal candidiasis, see Uses: Vulvovaginal Candidiasis in Clotrimazole 84:04.08.08.

Other Uses

External ophthalmic candidal infections have been treated with local ophthalmic application of nystatin or with subconjunctival injection of the drug. However, nystatin preparations for ophthalmic application are not commercially available.

Nystatin is ineffective in and should not be used for the treatment of infections caused by dermatophytes such as species of Trichophyton, Microsporum, or Epidermophyton.

For information on use of oral nystatin for prophylaxis of candidal infections,

Dosage and Administration

Administration

Nystatin is applied topically to the skin as a cream, ointment, or powder and applied topically to the oral cavity as an oral suspension. The drug is administered intravaginally as a vaginal tablet. Nystatin is administered orally as film-coated tablets.

Topical Administration

Nystatin topical cream, ointment, or powder should not be ingested, applied to the eye, or administered intravaginally.

The cream may be preferred instead of the ointment in intertriginous areas; the powder may be preferred if lesions are very moist.

Nystatin cream or ointment should be applied to affected areas and gently and thoroughly massaged into the skin. Alternatively, the powder may be applied to affected areas. For the treatment of candidal foot infections, the powder should be dusted onto the feet and into shoes and stockings.

Occlusive dressings should be avoided. In addition, the affected areas should be kept dry and exposed to air if possible.

Oral Topical Administration

Commercially available nystatin oral suspension may be administered undiluted as provided by the manufacturer. The oral suspension should be shaken well prior to administration. One-half of the dose should be placed in one side of the mouth (use a dropper in infants and young children) and retained in the mouth for as long as possible (e.g., several minutes) before swallowing; this procedure should be repeated on the other side of the mouth using the second half of the dose. Infants should not be fed for 5-10 minutes after the dose.

Alternatively, the commercially available powder for oral suspension may be used by the patient to extemporaneously prepare each individual dose at the time of administration. The extemporaneous oral suspension is prepared by adding the appropriate dose of powder (units of nystatin) to the volume of water recommended by the manufacturer (e.g., 118-177 mL); the preparation should be stirred well until homogeneous. One-half of the dose of extemporaneously prepared oral suspension should be placed in one side of the mouth and retained in the mouth for as long as possible before swallowing; this procedure should be repeated on the other side of the mouth using the second half of the dose.

Intravaginal Administration

The nystatin vaginal tablet should be inserted high in the vagina using the applicator provided by the manufacturer. Intravaginal nystatin therapy may be continued during menstruation.

Dosage

Cutaneous Candidiasis

For the topical treatment of cutaneous candidiasis, nystatin cream, ointment, or powder containing 100,000 units/g may be applied to affected areas 2 or 3 times daily. Alternatively, a fixed-combination cream or ointment containing nystatin and triamcinolone acetonide may be applied topically to affected areas in the morning and evening.

Treatment of cutaneous candidal infections should be continued for at least 2 weeks and discontinued only after 2 successive negative tests for Candida. Symptomatic improvement generally occurs within 1-3 days after topical nystatin therapy is initiated. The manufacturers state that topical therapy for cutaneous candidiasis using nystatin in fixed combination with triamcinolone acetonide should be discontinued if signs and symptoms persist after 25 days of therapy. Clinical and mycologic cure may require several months of therapy for chronic paronychia. A single course of nystatin therapy may be effective, but additional courses may be necessary; relapse may be caused by reinfection from the intestinal tract.

Candidal Diaper Dermatitis

For the topical treatment of candidal diaper dermatitis, nystatin cream, ointment, or powder containing 100,000 units/g has been applied to affected areas several times daily for 7-10 days. Alternatively, a fixed-combination cream or ointment containing nystatin and triamcinolone acetonide may be applied to the affected area in the morning and evening.

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

Oropharyngeal Candidiasis

For the topical treatment of oropharyngeal candidiasis, adults and children may receive 400,000 to 600,000 units of nystatin as a topical oral suspension 4 times daily. Infants may receive nystatin as an oral suspension in a dosage of 200,000 units 4 times daily; results of limited studies indicate that premature and low birthweight infants may receive 100,000 units 4 times daily. If nystatin is used for the topical treatment of oropharyngeal candidiasis in individuals with human immunodeficiency virus (HIV) infection, a dosage of 500,000 to 1,000,000 units 3-5 times daily given as an oral suspension is recommended by some clinicians.

Treatment should be continued for 14 days and for at least 48 hours after perioral symptoms have subsided and cultures have returned to normal.

Intestinal Candidiasis

For the topical treatment of intestinal candidiasis, nystatin oral suspension has been given in a dosage of 500,000 to 1 million units 3 times daily for at least 48 hours after clinical cure. Alternatively, 2 film-coated tablets (500,000 to 1 million units) have been given 3 times daily for at least 48 hours after clinical cure.

Vulvovaginal Candidiasis

For the treatment of vulvovaginal candidiasis, the usual dosage is 1 vaginal tablet containing 100,000 units of nystatin once daily at bedtime for 14 days.

For the treatment of coexisting intestinal candidiasis in women with vulvovaginal candidiasis, nystatin may be administered as oral tablets in a dosage of 500,000 to 1 million units 3 times daily; oral therapy should be continued for at least 48 hours after clinical cure to prevent relapse.

Cautions

Adverse Effects

Nystatin administered topically, intravaginally, or orally generally is well tolerated, even during prolonged use. Irritation and sensitization have occurred rarely. Rash, urticaria, and Stevens-Johnson syndrome have been reported rarely.

Diarrhea (including a case of bloody diarrhea), nausea, vomiting, and GI upset or disturbances have been reported with oral nystatin, especially when large doses were used.

Hypersensitivity reactions to topical nystatin have been reported only rarely; however, preservatives (e.g., ethylenediamine, parabens, thimerosal) in some of the formulations are associated with a high incidence of contact dermatitis. An acneiform eruption has occurred rarely following topical application of nystatin and triamcinolone acetonide. For cautions associated with oral use of nystatin, see Nystatin 8:14.28.

Precautions and Contraindications

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

If irritation or sensitization occurs during topical, intravaginal, or oral nystatin therapy, the drug should be discontinued. Patients should be instructed to contact their physician if symptoms of irritation or sensitization occur.

When nystatin vaginal tablets are used, patients should be warned against interrupting or discontinuing the drug during a prescribed regimen, even during menstruation or if symptomatic relief occurs after only a few days of therapy, unless otherwise instructed by their physician. Patients should be advised that adjunctive measures such as therapeutic douches are not necessary and may be inadvisable during vaginal nystatin therapy; however, cleansing douches may be used in nonpregnant women, if desired, for aesthetic effect.

Microbiologic studies should be conducted when apparent therapeutic failure occurs; appropriate anti-infective therapy should be instituted if necessary.

Nystatin topical cream, ointment, or powder should not be used for the treatment of systemic, oral, ophthalmic, or intravaginal infections.

Nystatin oral suspensions or film-coated oral tablets should not be used for the treatment of systemic fungal infections.

The commercially available sterile powder for laboratory use has been sterilized with ethylene oxide, leaving a residue of ethylene chlorohydrin which is highly irritating. Therefore, this powder should not be used for extemporaneous compounding, especially of ophthalmic preparations.

When a fixed-combination topical preparation containing nystatin and triamcinolone acetonide is used, the usual cautions, precautions, and contraindications associated with topical corticosteroid therapy also should be considered. (See Cautions in the Topical Corticosteroids General Statement 84:06.)

Pediatric Precautions

Topical nystatin in fixed combination with triamcinolone acetonide has been used effectively in the management of cutaneous candidiasis in a limited number of children 2 months to 12 years of age in clinical studies. However, it should be remembered that pediatric patients may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature individuals because of the greater skin surface area-to-body weight ratio. (See Cautions: Pediatric Precautions, in the Topical Corticosteroids General Statement 84:06.)

Safety and efficacy of nystatin vaginal tablets have not been established in pediatric patients.

Pregnancy

Pregnancy

Animal reproduction studies have not been performed with nystatin. It is not known whether nystatin can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. Oral nystatin should be used in a pregnant woman only if clearly needed.

The manufacturer states that no adverse fetal effects or delayed complications (i.e., effects on growth, development, and functional maturation during childhood) have been attributed to nystatin in infants born to women treated with nystatin vaginal tablets during pregnancy. However, because the possibility of harm to the fetus cannot be ruled out, nystatin vaginal tablets should be used during pregnancy only when considered essential to the welfare of the patient.

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membranes. Only very limited amounts of nystatin are absorbed from the GI tract. Plasma concentrations of nystatin usually are undetectable following oral administration of usual dosages of the drug; however, oral administration in patients with renal impairment may result in detectable plasma concentrations of the drug.

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