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| Product NDC Code | 0316-0221 | ||||||
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| Drug Name | Nystatin cream |
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| Type | Generic | ||||||
| Pharm Class | Polyene Antifungal [EPC], Polyenes [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 543546 | ||||||
| Application Number | ANDA207733 | ||||||
| Labeler Name | Crown Laboratories | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General .) To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: C 47 H 75 NO 17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Each gram contains 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. nystatin_structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE 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.
Spl product data elements
Usually a list of ingredients in a drug product.Nystatin Cream Nystatin Cream MINERAL OIL SORBIC ACID PROPYLENE GLYCOL WATER SORBITOL CETYL PALMITATE POTASSIUM SORBATE NYSTATIN NYSTATIN
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
Microbiology
MicrobiologyMicrobiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes . Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.15 gram tube NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9503.01 p950301
15 gram carton NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to close. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9515.00 nystatin_15g_carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only Nystatin Cream, USP For external use only. Not for ophthalmic use. Rx Only
Nystatin Cream: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. 2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION .)
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Nystatin Cream USP is a light yellow to yellow cream that is supplied in: 15 gram tube NDC 0316-0221-15 30 gram tube NDC 0316-0221-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 Printed in USA P9526.00
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API