Nystatin and Triamcinolone Acetonide (Page 2 of 2)

Nursing Mothers

It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during the use of this preparation by a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions to Nystatin and Triamcinolone Acetonide

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.

To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General); however, acute overdosage and serious adverse effects with dermatologic use are unlikely.

DOSAGE AND ADMINISTRATION

A thin film of Nystatin and Triamcinolone Acetonide Ointment is usually applied to the affected areas twice daily in the morning and evening. The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests).

Nystatin and Triamcinolone Acetonide Ointment should not be used with occlusive dressings.

HOW SUPPLIED

Nystatin and Triamcinolone Acetonide Ointment is supplied in 15 g, 30 g, and 60 g tubes.

15 g tube – NDC 52565-042-15

30 g tube – NDC 52565-042-30

60 g tube – NDC 52565-042-60

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Manufactured by:
Teligent Phama, Inc.
Buena, NJ 08310

Rev 08/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

52565-042-15
Nystatin and Triamcinolone Acetonide
Ointment, USP
15 grams
For Dermatological Use Only
Not for Ophthalmic Use
Keep this and all medication out of the reach of children.
Rx only

15 g carton PDP
(click image for full-size original)
NYSTATIN AND TRIAMCINOLONE ACETONIDE
nystatin and triamcinolone acetonide ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52565-042
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nystatin (Nystatin) Nystatin 100000 [USP'U] in 1 g
Triamcinolone Acetonide (Triamcinolone Acetonide) Triamcinolone Acetonide 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
mineral oil
petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52565-042-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (52565-042-15)
2 NDC:52565-042-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (52565-042-30)
3 NDC:52565-042-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (52565-042-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208287 12/30/2016
Labeler — Teligent Pharma, Inc. (011036910)
Establishment
Name Address ID/FEI Operations
Teligent Pharma, Inc. 011036910 manufacture (52565-042)

Revised: 12/2016 Teligent Pharma, Inc.

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