Chartwell RX, LLC

Nystatin Nystatin STARCH, CORN SUCROSE HYDROXYPROPYL CELLULOSE (90000 WAMW) ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE TALC MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE FD&C YELLOW NO. 6 FD&C RED NO. 40 FD&C BLUE NO. 2 POLYSORBATE 80 NYSTATIN NYSTATIN HP51

Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula: C 47H 75NO 17                                                   M.W. 926.13 Nystatin tablets, USP are for oral administration and contain 500,000 units of nystatin, USP per tablet.
Nystatin tablets, USP contain the inactive ingredients: corn starch, confectioner sugar, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue #2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide. Chemical Structure

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.

Nystatin is both fungistatic and fungicidal in vitroagainst a wide variety of yeasts and yeast-like fungi. Candida albicansdemonstrates no significant resistance to nystatin in vitroon repeated subculture in increasing levels of nystatin; other Candidaspecies become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candidaspecies with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

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.

Teratogenic Effects Category C Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

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.

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General. )

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 ).

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.

Nystatin Tablets, USP 500,000 Units are round brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in:
             Bottles of 90: NDC 62135-741-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Manufactured by:
Vivimed Life Sciences Private Limited
Alathur, Kanchipuram – 603 110, Tamilnadu, India.
M.L. No.: TN00002327 Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920 Revised: 08/2023 L71669

Nystatin Tablets, USP (Oral), 500,000 units - NDC 62135-741-90 - 90's Bottle Label bottle-label