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Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g

Nystatin and Triamcinolone Acetonide · CREAM · Lupin Pharmaceuticals, Inc.

4 Recalls on Record
Plain English

This cream combines an antifungal medication with a corticosteroid to treat fungal skin infections while reducing inflammation and itching. It is applied directly to the affected skin area as prescribed by your doctor.

Key Facts

Brand Name
Nystatin and Triamcinolone Acetonide
Generic Name
Nystatin and Triamcinolone Acetonide
NDC Code (Product)
68180-545
Manufacturer
Lupin Pharmaceuticals, Inc.
Strength
100000 [USP'U]/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA208205
Drug Class
Polyene Antifungal [EPC]; Corticosteroid [EPC]
Marketing Start
11/29/2018

Recall History

4 Recalls on Record
Class II09/21/2018

Dr. Reddy's Laboratories, Inc.

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

TerminatedVoluntary: Firm initiated
Class II03/28/2017

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class III07/17/2019

Lupin Pharmaceuticals Inc.

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective23 reports
product use in unapproved indication11 reports
application site pain8 reports
pruritus8 reports
drug ineffective for unapproved indication6 reports
off label use5 reports
pain5 reports
rash5 reports
accidental exposure to product4 reports
application site pruritus4 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

Dosage & Administration

DOSAGE AND ADMINISTRATION Nystatin and Triamcinolone Acetonide Cream USP is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS , Laboratory Tests). Nystatin and Triamcinolone Acetonide Cream USP should not be used with occlusive dressings.

Contraindications

CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

Adverse Reactions

ADVERSE REACTIONS A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur. The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.

Frequently Asked Questions

What is Nystatin and Triamcinolone Acetonide used for?

This cream combines an antifungal medication with a corticosteroid to treat fungal skin infections while reducing inflammation and itching. It is applied directly to the affected skin area as prescribed by your doctor.

Is Nystatin and Triamcinolone Acetonide a controlled substance?

Nystatin and Triamcinolone Acetonide is not classified as a controlled substance by the DEA.

What is the generic name for Nystatin and Triamcinolone Acetonide?

The generic name for Nystatin and Triamcinolone Acetonide is Nystatin and Triamcinolone Acetonide. There are 2 other brand versions of Nystatin and Triamcinolone Acetonide.

What is the NDC code for Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g?

The NDC (National Drug Code) for Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g is 68180-545, listed by Lupin Pharmaceuticals, Inc..

Product NDC

68180-545

Package NDC

68180-545-02

Other Nystatin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)