Nystatin and Triamcinolone Acetonide (Page 2 of 2)

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Pregnancy Category C

There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

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

In clinical studies of a limited number of pediatric patients ranging from two months through 12 years, nystatin and triamcinolone acetonide cream formulation cleared or significantly ameliorated the disease state in most patients.

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.

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

Nystatin and Triamcinolone Acetonide Cream 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).

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 Cream and Ointment should not be used with occlusive dressings.

HOW SUPPLIED

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

STORAGE

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

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Revised: September, 2004

PK-1111-2
141

PRINCIPAL DISPLAY PANEL — 15 g Tube Carton

NDC 51672-1272-1

15 g

Nystatin and Triamcinolone Acetonide Ointment USP

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 15 g Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 g Tube Carton

NDC 51672-1263-1

15 g

Nystatin and Triamcinolone Acetonide Cream USP

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 15 g Tube Carton
(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:51672-1272
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:51672-1272-1 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (51672-1272-1)
2 NDC:51672-1272-2 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (51672-1272-2)
3 NDC:51672-1272-3 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (51672-1272-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063305 03/29/1993
NYSTATIN AND TRIAMCINOLONE ACETONIDE
nystatin and triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-1263
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
polysorbate 60
aluminum hydroxide
titanium dioxide
glyceryl monostearate
sorbic acid
propylene glycol
petrolatum
methylparaben
propylparaben
Sorbitol
Product Characteristics
Color YELLOW (light yellow to buff color) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-1263-1 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (51672-1263-1)
2 NDC:51672-1263-2 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (51672-1263-2)
3 NDC:51672-1263-3 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (51672-1263-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062364 12/22/1987
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (51672-1263), MANUFACTURE (51672-1272)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (51672-1263)

Revised: 11/2012 Taro Pharmaceuticals U.S.A., Inc.

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