Dermazone: Package Insert / Prescribing Information - Drugs.com

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# Dermazone

Package insert / prescribing information
Generic name: triamcinolone acetonide
Dosage form: cream, kit
Drug class: Topical steroids

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

## Triamcinolone Acetonide Cream USP (0.1%)

### DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is:

Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

### 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. Corticosteriods 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 cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

### CONTRAINDICATIONS

Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

### 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 a 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. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. 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.

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

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

- Urinary free cortisol test
- ACTH stimulation test

Carcinogenesis, Mutagenesis, and 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 have revealed negative results.

Pregnancy 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 not adequate and well-controlled studies in pregnant women on 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.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings'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
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin Atrophy
- Striae
- Miliaria

### 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 two to three times daily depending on the severity of the condition.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

### HOW SUPPLIED

Triamcinolone acetonide cream USP 0.1% is supplied in
80 g tube NDC 67877-251-80

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

## Related/similar drugs

Taltz, prednisone, methotrexate, Humira, dexamethasone, triamcinolone topical, sucralfate

## Silazone™ Sheet (Silicone Gel Sheet)

### IMPORTANT:

Apply Silazone Sheet to the skin for 4-8 hours to ensure no adverse reactions occur. Once a trial application is completed without adverse reaction, the Silazone Sheet may be applied to clean skin nightly before bed and removed each morning. Most treatment periods will last for two months. In case of serious skin conditions, continue using for 3-6 months or as directed by your physician.

### How to use:

1) Open the aluminized bag and remove Silazone Sheet.

2) Cut the sheet to the size and shape of the affected skin area. If the skin area is larger, several sheets may be applied with edges aligned.

3) Remove the plastic film from the back of the sheet carefully and place the adhesive side onto clean skin. With good extensibility, it won’t tend to fall off. However, during sleeping or doing a lot of exercise, you can use a thin flex yarn tape or an adhesive tape to keep it in place.

4) Replace the sheet weekly or when it is no longer secure on the skin.

### Cautions:

1) Stop use, in case of itching, blisters, or skin irritation.

2) Do not apply to the surgical wound until at least 1 week after suture removal.

3) Skin surface must be cleaned before use. Using this product on uncleaned skin surface or applying it with excessive tightness may result in roseola.

4) Product can be reused. If adhesive side is dirty, rinse with warm water and allow to be dried before reapplying.

5) The Silazone Sheet should not be shared with other individuals.

6) Do not use on unhealed or open wounds.

Keep out of direct sunlight and Under 40ºC (104ºF).
Storage time above these conditions should not exceed 18 hours.

## PRINCIPAL DISPLAY PANEL

Dermazone™ (triamcinolone acetonide cream, silicone gel sheet)

Rx Only

Packaged in the USA by:
PureTek Corporation
San Fernando, CA 91340

For questions or information
call toll free: 877-921-7873

Established Pharmacological Class

Substance | Pharmacological Class
Silazone Sheet | Tape And Bandage, Adhesive

Dermazone triamcinolone acetonide kit

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:69621-393

Packaging
# | Item Code | Package Description
1 | NDC:69621-393-00 | 1 KIT in 1 KIT

Quantity of Parts
Part # | Package Quantity | Total Product Quantity
Part 1 | 1 TUBE | 80 g
Part 2 | 3 CARTON | 3

Part 1 of 2
TRIAMCINOLONE ACETONIDE triamcinolone acetonide cream

Product Information
Item Code (Source) | NDC:67877-251
Route of Administration | TOPICAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) | TRIAMCINOLONE ACETONIDE | 1 mg in 1 g

Packaging
# | Item Code | Package Description
1 | NDC:67877-251-80 | 1 TUBE in 1 CARTON
1 |  | 80 g in 1 TUBE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
ANDA | ANDA088042 |  |

Part 2 of 2
SILAZONE SHEET

Product Information
Item Code (Source) | GS1:731477861930

Packaging
# | Item Code | Package Description
1 | GS1:731477861930 | 1 in 1 CARTON

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
exempt device | KGX |  |

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
ANDA | ANDA088042 | 04/20/2016 |

Labeler - Shoreline Pharmaceuticals, Inc. (078542781)

Shoreline Pharmaceuticals, Inc.

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