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NDC 00121-0810-02 Nystatin 100000 [USP'U]/mL Details
Nystatin 100000 [USP'U]/mL
Nystatin is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is NYSTATIN.
MedlinePlus Drug Summary
Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.
Related Packages: 00121-0810-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nystatin
Product Information
| NDC | 00121-0810 |
|---|---|
| Product ID | 0121-0810_d57cde69-0eb9-180d-e053-2995a90a33aa |
| Associated GPIs | 88100010001805 |
| GCN Sequence Number | 009537 |
| GCN Sequence Number Description | nystatin ORAL SUSP 100000/ML ORAL |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 42440 |
| HICL Sequence Number | 004129 |
| HICL Sequence Number Description | NYSTATIN |
| Brand/Generic | Generic |
| Proprietary Name | Nystatin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | NYSTATIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 100000 |
| Active Ingredient Units | [USP'U]/mL |
| Substance Name | NYSTATIN |
| Labeler Name | Pharmaceutical Associates, Inc. |
| Pharmaceutical Class | Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203621 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00121-0810-02 (00121081002)
| NDC Package Code | 0121-0810-02 |
|---|---|
| Billing NDC | 00121081002 |
| Package | 60 mL in 1 BOTTLE, DROPPER (0121-0810-02) |
| Marketing Start Date | 2016-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a Details
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
C 47H 75NO 17 MW 926.13
Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.
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.
INDICATIONS AND USAGE
CONTRAINDICATIONS
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.
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 non-specific myalgia have also been rarely reported.
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).
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.
HOW SUPPLIED
Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:
NDC 0121-0810-02: 2 fl oz (60mL) bottle with calibrated dropper
NDC 0121-0810-16: 16 fl oz (473mL) bottle
NDC 0121-4810-05: 5mL unit dose cup
NDC 0121-4810-40: Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in
4 trays of 10 unit dose cups each.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
60 mL
NDC 0121-0810-02
Nystatin Oral Suspension, USP
100,000 units per mL
SHAKE WELL BEFORE USING
Packaged with Calibrated Dropper
DO NOT USE IF TAMPER EVIDENT
SEAL IS BROKEN OR MISSING.
Rx ONLY
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Each mL of cherry, peppermint flavored
oral suspension contains 100,000 units
Nystatin, USP and alcohol (≤ 1% v/v).
USUAL DOSAGE: For Infants: 2 mL(200,000 units) four times daily (in infants andyoung children, use dropper to place one half of dose in each side of the mouth and avoid feeding feeding for 5 to 10 minutes). See insert.
WARNINGS: Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance orcontact a Poison Control Center immediately.
Keep tightly closed. Protect from light.
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature}. AVOID FREEZING
R04/17
X01810020417
PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label
INGREDIENTS AND APPEARANCE
| NYSTATIN
nystatin suspension |
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nystatin suspension |
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 097630693 | manufacture(0121-0810, 0121-4810) | |