Triamcinolone acetonide lotion

Spl unclassified section

Description

Triamcinolone Acetonide Lotion, USP is supplied in the following strengths: 0.025%, 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, dimethicone, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol. It may contain10% citric acid solution or 10% sodium citrate solution for pH adjustment.

Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11, 16, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

The molecular formula is C 24H 31FO 6. It has the following structure:

Triamcinolone Acetonide

M.W. 434.51

Clinical pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increases percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

Laboratory tests

The following tests may be helpful in evaluating the HPA axis suppression:

  • Urinary-free cortisol test
  • ACTH stimulation test

Nursing mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing women.

Pediatric use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced 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

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning
Perioral dermatitis
Itching
Allergic contact dermatitis
Irritation
Maceration of the skin
Dryness
Secondary infection
Folliculitis
Skin Atrophy
Hypertrichosis
Striae
Acneiform eruptions
Miliaria
Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).

Dosage and administration

Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How supplied

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL.

Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].

AVOID FREEZING

SHAKE WELL BEFORE USING

Rx Only

Product No.: 8561

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8561-60

REV. 05-10

Ingredients and appearance - Product information

Triamcinolone acetonide lotion- Triamcinolone acetonide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60432-561
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Triamcinolone acetonide ( UNII: F446C597KA)( Triamcinolone acetonide - UNII: F446C597KA ) 1 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Anhydrous citric acid ( UNII: XF417D3PSL)
Polysorbate 20 ( UNII: 7T1F30V5YH)
Propylene glycol ( UNII: 6DC9Q167V3)
Dimethicone ( UNII: 92RU3N3Y1O)
Cetyl alcohol ( UNII: 936JST6JCN)
Stearyl alcohol ( UNII: 2KR89I4H1Y)
Sorbitan monopalmitate ( UNII: 77K6Z421KU)
Trisodium citrate dihydrate ( UNII: B22547B95K)

Product Characteristics

Color WHITE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA088451 USA

Labeler - Morton Grove Pharmaceuticals, Inc.( 801897505)

Establishment

Name ID/FEI Business Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS( 60432-561), MANUFACTURE( 60432-561), PACK( 60432-561)

Principal display panel ml bottle label

MGP

NDC 60432-561-60

TRIAMCINOLONE

ACETONIDE

LOTION, USP 0.1%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx Only

NET: 60 mL

MGP

NDC 60432-561-61

TRIAMCINOLONE

ACETONIDE

LOTION, USP 0.1%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx Only

NET: 60 mL

Carton