TRIAMCINOLONE ACETONIDE

Main information

  • Trade name:
  • TRIAMCINOLONE ACETONIDE - triamcinolone acetonide ointment
  • Composition:
  • Triamcinolone Acetonide 5 mg in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRIAMCINOLONE ACETONIDE - triamcinolone acetonide ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Triamcinolone Acetonide Ointment, USP 0.5% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. 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 li
  • Product summary:
  • Triamcinolone Acetonide Ointment, USP 0.5% is available as follows: 15 g tube (NDC 0713-0679-15)

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0713-0679-15
  • Last update:
  • 15-06-2019

Summary of Product characteristics: dosage, interactions, side effects

TRIAMCINOLONE ACETONIDE - triamcinolone acetonide ointment

G&W Laboratories, Inc.

----------

Triamcinolone Acetonide Ointment, USP 0.5%

For External Use Only

Not for Ophthalmic Use

Rx Only

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory

and antipruritic agents.The steroids in this class include triamcinolone acetonide. Triamcinolone

acetonide is designated chemically as 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-

dione cyclic 16,17-acetal with acetone. The structural formula of triamcinolone acetonide is as

follows:

Each gram of Triamcinolone Acetonide Ointment, USP 0.5% provides 5 mg triamcinolone acetonide in

an ointment base of light mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic 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 increase 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

Triamcinolone Acetonide Ointment, USP 0.5% is 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 preparations.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal

(HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some

patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use

over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area

or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression

by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal

homeostatis.If HPA axis suppression or elevation of the body temperature occurs, an attempt should be

made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or

use a sequential approach when utilizing the occlusive technique.

Recovery of HPA axis function and thermal homeostatis are generally prompt and complete upon

discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur,

requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity

reaction to a particular occlusive dressing material or adhesive and a substitute material may be

necessary.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more

susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent

should be instituted. If a favorable response does not occur promptly, the corticosteroid should be

discontinued until the infection has been adequately controlled.

These preparations are not for ophthalmic use.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact

with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was

prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive

unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a

child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis

suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect

on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.

Pregnancy: Teratogenic Effects

Category C. 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. There are no adequate and well-controlled

studies in pregnant women on the teratogenic effects from topically applied corticosteroids. Therefore,

topical corticosteroids should be used during pregnancy only if the potential benefit justifies the

potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in

large amounts, or for prolonged periods of time.

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 a nursing woman.

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 (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, secondary infection, skin atrophy, striae, and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-

922-1038 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).

DOSAGE AND ADMINISTRATION

Apply a thin film of the 0.5% Triamcinolone Acetonide Ointment, as appropriate, to the affected area 2

to 3 times daily.

Occlusive Dressing Technique

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

Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If

needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth

before the nonporous film is applied or by briefly wetting the affected area with water immediately

prior to applying the medication.The frequency of changing dressings is best determined on an

individual basis. It may be convenient to applyTriamcinolone Acetonide Ointment under an occlusive

dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When

utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion,

during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressing should be discontinued and appropriate

antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide Ointment, USP 0.5% is available as follows:

15 g tube (NDC 0713-0679-15)

STORAGE

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

Manufactured by:

G&W Laboratories, Inc.

111 Coolidge Street

South Plainfield, NJ 07080

8-0679GW1

Issued: 06/2016

PRINCIPAL DISPLAY PANEL

TRIAMCINOLONE ACETONIDE

triamcinolone acetonide ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 713-0 6 79

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tria mcino lo ne Aceto nide (UNII: F446 C59 7KA) (Triamcino lo ne Aceto nide -

UNII:F446 C59 7KA)

Tria mc ino lo ne

Ac e to nide

5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Lig ht Minera l O il (UNII: N6 K578 7QVP)

G&W Laboratories, Inc.

Petro la tum (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 713-0 6 79 -15

1 in 1 CARTON

10 /31/20 17

1

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 8 9 25

10 /31/20 17

Labeler -

G&W Laboratories, Inc. (001271188)

Registrant -

G&W Laboratories, Inc. (001271188)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

G&W Labo rato ries, Inc.

0 0 127118 8

ma nufa c ture (0 713-0 6 79 )

Revised: 10/2017