Nystatin Cream (Nystatin Cream)

Trade Name : Nystatin Cream

Crown Laboratories

CREAM

Strength 100000 [USP'U]/g

NYSTATIN Polyene Antifungal [EPC],Polyenes [CS]

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nystatin Cream (Nystatin Cream) which is also known as Nystatin Cream and Manufactured by Crown Laboratories. It is available in strength of 100000 [USP'U]/g per ml. Read more

Nystatin Cream (Nystatin Cream) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Nystatin Cream, USP
For external use only.
Not for ophthalmic use. Rx Only

Nystatin is a polyene antifungal antibiotic obtained from n n
Structural formula:
Cn Hn NOn Molecular Weight: 926.13n
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.

Pharmacokinetics
Nystatin is not absorbed from intact skin or mucous membrane.

Nystatin is an antibiotic which is both fungistatic and fungicidaln against a wide variety of yeasts and yeast-like fungi, including n . 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, n does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of n 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.n

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by n and other susceptible n species. n n

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

Generaln nNystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.n
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.

Patients using this medication should receive the following information and instructions:n n1. 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.n n2. 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.n n3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.n

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

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.

Teratogenic Effectsn n n nAnimal 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.n

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See n .)n

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.

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 n .)n
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/

Adults and Pediatric Patients (Neonates and Older)

Nystatin Cream USP is a light yellow to yellow cream that is supplied in:n n15 gram tube NDC 0316-0221-15n n30 gram tube NDC 0316-0221-30n
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Avoid freezing.
Crown Laboratories, Inc., Johnson City, TN 37604
Printed in USA
P9526.00

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:
TO OPEN:
IMPORTANT:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Avoid freezing.
Usual Dosage:
See crimp of tube for Lot Number and Expiration Date.
Manufactured and Distributed by:
Crown Laboratories, Inc., Johnson City, TN 37604
P9503.01

NDC 0316-0221-15
Rx Only
Nystatin Cream, USP
100,000 units per gram
WARNING:n- Keep out of reach of children.
For external use only.
Not for ophthalmic use.
15 grams
Each gram contains:
Directions for puncturing tube seal:
IMPORTANT:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Avoid freezing.
Usual Dosage:
See end of carton for Lot Number and Expiration Date.
Manufactured and Distributed by:
Crown Laboratories, Inc., Johnson City, TN 37604
P9515.00

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Nystatin Cream (Nystatin Cream)

Trade Name : Nystatin Cream

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Nystatin Cream (Nystatin Cream)

Trade Name : Nystatin Cream

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?