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| Product NDC Code | 66689-037 | ||||||
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| Drug Name | Nystatin |
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| Type | Generic | ||||||
| Pharm Class | Polyene Antifungal [EPC], Polyenes [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SUSPENSION | ||||||
| RxCUI drug identifier | 312055 | ||||||
| Application Number | ANDA064142 | ||||||
| Labeler Name | VistaPharm, Inc. | ||||||
| Packages |
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Overdosage of Nystatin
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).
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 Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ). Gastrointestinal : Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic : Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other : Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo . Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo . Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
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 The preparation 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 an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF. 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 Infants: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. Children and Adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .
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 Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.
Spl product data elements
Usually a list of ingredients in a drug product.Nystatin Nystatin NYSTATIN NYSTATIN METHYLPARABEN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE GLYCERIN SACCHARIN SODIUM SUCROSE CARBOXYMETHYLCELLULOSE SODIUM ALCOHOL PROPYLPARABEN Light yellow Nystatin Nystatin NYSTATIN NYSTATIN ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE, DIBASIC GLYCERIN METHYLPARABEN SODIUM PHOSPHATE, MONOBASIC PROPYLPARABEN WATER SACCHARIN SODIUM SUCROSE Light yellow
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 carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
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.PRINCIPAL DISPLAY PANEL - Unit Dose Cup Nystatin Oral Suspension, USP 500,000 units/5 mL Alcohol not more than 1% v/v SHAKE WELL. AVOID FREEZING. Delivers 5 mL Store at 20°–25°C (68°–77°F); see USP CRT conditions. Manufactured by: Largo, FL 33771, USA Xact DOSE™ VistaPharm Rx Only VP2052R2 06/18 NDC 66689-037-01 lidding
PRINCIPAL DISPLAY PANEL - 60 mL NDC 66689-008-02 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) SHAKE WELL BEFORE USING At The Time Of Dispensing Replace Cap with Safety Cap Dropper 2 fl. oz. (60 mL) Rx only VistaPharm® NDC 66689-008-02 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) SHAKE WELL BEFORE USING 2 fl. oz. (60 mL) Rx only VistaPharm® 60 mL bottle 60 mL carton
PRINCIPAL DISPLAY PANEL - 480 mL NDC 66689-008-16 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) SHAKE WELL BEFORE USING 16 fl. oz. (480 mL) Rx only VistaPharm® NDC 66689-008-16 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL (Bubblegum Flavored) Contains: Alcohol 0.5% v/v SHAKE WELL BEFORE USING 16 fl. oz. (480 mL) Rx only VistaPharm® 480 mL bottle 480 mL 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 Manufactured by: Largo, FL 33771 VP2053R2 06/22 Logo
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. AVOID FREEZING.
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. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to 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 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 nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
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 Oral Suspension, USP, 100,000 Nystatin Units per mL, cherry flavored, light creamy yellow, ready-to-use suspension, is available as follows: NDC 66689-037-01: 5 mL unit dose cup. NDC 66689-037-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-037-99: Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each. Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, bubblegum flavored, yellow opaque, ready-to-use suspension is available as follows: NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper. NDC 66689-008-08: 8 fl. oz. bottle (237 mL). NDC 66689-008-16: 16 fl. oz. bottle (480 mL).
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy: Teratogenic Effects Category C Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION .
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