Nystatin

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Nystatin Recall

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Side Effects & Adverse Reactions

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

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History

There is currently no drug history available for this drug.

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Other Information

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin cream is for dermatologic use.

Nystatin cream for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminum hydroxide compressed wet gel, cetearyl alcohol (and) ceteareth 20, glyceryl monostearate, polyoxyl 40 stearate, propylene glycol, purified water, simethicone, sorbic acid, sorbitol solution, titanium dioxide, and white petrolatum.

Sources

Nystatin Manufacturers

Lake Erie Medical Dba Quality Care Products Llc

Nystatin | Lake Erie Medical Dba Quality Care Products Llc

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Proficient Rx Lp

Nystatin | Proficient Rx Lp

Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

No Recall
Major Pharmaceuticals

Nystatin | Major Pharmaceuticals

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.

No Recall
Preferred Pharmaceuticals, Inc.

Nystatin | Preferred Pharmaceuticals, Inc.

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected area twice daily or as indicated until healing is complete.

No Recall
Par Pharmaceutical Inc.

Nystatin | Par Pharmaceutical Inc.

Very moist lesions are best treated with the topical dusting powder.

Nystatin Topical Powder

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two (2) or three (3) 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.

No Recall
Midlothian Laboratories, Inc.

Nystatin | Midlothian Laboratories, Inc.

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.

No Recall
Rebel Distributors Corp

Nystatin | Rebel Distributors Corp

Nystatin Cream should be applied liberally to affected areas twice daily or as indicated until healing is complete.

Nystatin Cream is usually preferred to Nystatin Ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with Nystatin Topical Powder.

No Recall
Physicians Total Care, Inc.

Nystatin | Physicians Total Care, Inc.

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.

No Recall
Physicians Total Care, Inc.

Nystatin | Physicians Total Care, Inc.

Nystatin Cream should be applied liberally to affected areas twice daily or as indicated until healing is complete.

Nystatin Cream is usually preferred to Nystatin Ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with Nystatin Topical Powder.

No Recall
Cardinal Health

Nystatin | Cardinal Health

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
Dispensing Solutions, Inc.

Nystatin | Dispensing Solutions, Inc.

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Qualitest Pharmaceuticals

Nystatin | Cvs Pharmacy

adults and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Arbor Pharmaceuticals Inc.

Nystatin | Arbor Pharmaceuticals Inc.

Adults and Pediatric Patients (Neonates and Older)
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
H.j. Harkins Company, Inc.

Nystatin | H.j. Harkins Company, Inc.

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.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Nystatin | Taro Pharmaceuticals U.s.a., Inc.

Adults and Pediatric Patients (Neonates and Older)
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Rebel Distributors Corp

Nystatin | Rebel Distributors Corp

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.

No Recall
A-s Medication Solutions Llc

Nystatin | A-s Medication Solutions Llc

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
A-s Medication Solutions Llc

Nystatin | A-s Medication Solutions Llc

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Actavis Mid Atlantic Llc

Nystatin | Actavis Mid Atlantic Llc

Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

No Recall
Remedyrepack Inc.

Nystatin | Remedyrepack Inc.

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Teva Pharmaceuticals Usa Inc

Nystatin | Teva Pharmaceuticals Usa Inc

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
Perrigo New York Inc

Nystatin | Pd-rx Pharmaceuticals, Inc.

Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir tablets.
Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.
Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of acyclovir tablets should be modified as shown in Table 3.
Table 3. Dosage Modification for Renal Impairment

Normal Dosage Regimen
Creatinine Clearance
(mL/min/1.73 m2)
Adjusted Dosage Regimen
Dose (mg)
Dosing Interval 200 mg every 4 hours

> 10
0-10
200
200
every 4 hours, 5x daily
every 12 hours
400 mg every 12 hours
> 10
0-10
400
200
every 12 hours

every 12 hours 800 mg every 4 hours
> 25
10-25
0-10
800
800
800
every 4 hours, 5x daily
every 8 hours

every 12 hours
Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

No Recall
Heritage Pharmaceuticals Inc

Nystatin | Heritage Pharmaceuticals Inc

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
Heritage Pharmaceuticals Inc

Nystatin |

No Recall
Avkare, Inc.

Nystatin | Avkare, Inc.

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
Preferred Pharmaceuticals, Inc.

Nystatin | Preferred Pharmaceuticals, Inc.

Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.

No Recall
Aidarex Pharmaceuticals Llc

Nystatin | Aidarex Pharmaceuticals Llc

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Nystatin | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected area twice daily or as indicated until healing is complete.

No Recall
Carilion Materials Management

Nystatin | Carilion Materials Management

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

No Recall
Vensun Pharmaceuticals, Inc.

Nystatin | Vensun Pharmaceuticals, Inc.

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.

No Recall
X-gen Pharmaceuticals, Inc.

Nystatin | X-gen Pharmaceuticals, Inc.

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.

No Recall
Gavis Pharmaceuticals, Llc.

Nystatin | Gavis Pharmaceuticals, Llc.

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.

No Recall