Nystatin label

Nystatin

Nystatin Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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.

History

There is currently no drug history available for this drug.

Other Information

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

This is an image of the structural formula for nystatin.

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.

Nystatin Manufacturers

  • Lake Erie Medical Dba Quality Care Products Llc
    Nystatin | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Nystatin | 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.

  • Proficient Rx Lp
    Nystatin | Proficient Rx Lp
    No Recall

    Nystatin | 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.

  • Major Pharmaceuticals
    Nystatin | Major Pharmaceuticals
    No Recall

    Nystatin | 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.

  • Preferred Pharmaceuticals, Inc.
    Nystatin | Preferred Pharmaceuticals, Inc.
    No Recall

    Nystatin | 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.

  • Par Pharmaceutical Inc.
    Nystatin | Par Pharmaceutical Inc.
    No Recall

    Nystatin | 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.

  • Midlothian Laboratories, Inc.
    Nystatin | Midlothian Laboratories, Inc.
    No Recall

    Nystatin | 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.

  • Nystatin | Rebel Distributors Corp
    No Recall

    Nystatin | 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.

  • Physicians Total Care, Inc.
    Nystatin | Physicians Total Care, Inc.
    No Recall

    Nystatin | 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.

  • Physicians Total Care, Inc.
    Nystatin | Physicians Total Care, Inc.
    No Recall

    Nystatin | 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.

  • Nystatin | Cardinal Health
    No Recall

    Nystatin | 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.

  • Dispensing Solutions, Inc.
    Nystatin | Dispensing Solutions, Inc.
    No Recall

    Nystatin | 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.

  • Qualitest Pharmaceuticals
    Nystatin | Cvs Pharmacy
    No Recall

    Nystatin | Cvs Pharmacy

    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

  • Arbor Pharmaceuticals Inc.
    Nystatin | Arbor Pharmaceuticals Inc.
    No Recall

    Nystatin | 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.

  • Nystatin | H.j. Harkins Company, Inc.
    No Recall

    Nystatin | 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.

  • Taro Pharmaceuticals U.s.a., Inc.
    Nystatin | Taro Pharmaceuticals U.s.a., Inc.
    No Recall

    Nystatin | 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.

  • Nystatin | Rebel Distributors Corp
    No Recall

    Nystatin | 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.

  • Nystatin | A-s Medication Solutions Llc
    No Recall

    Nystatin | 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.

  • Nystatin | A-s Medication Solutions Llc
    No Recall

    Nystatin | 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.

  • Nystatin | Actavis Mid Atlantic Llc
    No Recall

    Nystatin | 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.

  • Remedyrepack Inc.
    Nystatin | Remedyrepack Inc.
    No Recall

    Nystatin | 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.

     

  • Nystatin | Teva Pharmaceuticals Usa Inc
    No Recall

    Nystatin | 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.

  • Perrigo New York Inc
    Nystatin | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Nystatin | Pd-rx Pharmaceuticals, 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.

  • Heritage Pharmaceuticals Inc
    Nystatin | Heritage Pharmaceuticals Inc
    No Recall

    Nystatin | 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.

  • Heritage Pharmaceuticals Inc
    Nystatin |
    No Recall

    Nystatin |

    Nystatin |
  • Avkare, Inc.
    Nystatin | Avkare, Inc.
    No Recall

    Nystatin | 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.

  • Preferred Pharmaceuticals, Inc.
    Nystatin | Preferred Pharmaceuticals, Inc.
    No Recall

    Nystatin | 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.

  • Aidarex Pharmaceuticals Llc
    Nystatin | Aidarex Pharmaceuticals Llc
    No Recall

    Nystatin | 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.

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

    Nystatin | 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.

  • Nystatin | Carilion Materials Management
    No Recall

    Nystatin | 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.

  • Vensun Pharmaceuticals, Inc.
    Nystatin | Vensun Pharmaceuticals, Inc.
    No Recall

    Nystatin | 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.

  • X-gen Pharmaceuticals, Inc.
    Nystatin | X-gen Pharmaceuticals, Inc.
    No Recall

    Nystatin | 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.

  • Gavis Pharmaceuticals, Llc.
    Nystatin | Gavis Pharmaceuticals, Llc.
    No Recall

    Nystatin | 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.