Ellzia Pak: Package Insert / Prescribing Information - Drugs.com

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# Ellzia Pak

Package insert / prescribing information
Generic name: triamcinolone acetonide, dimethicone
Dosage form: kit
Drug class: Topical steroids with anti-infectives

Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

## Triamcinolone Acetonide Ointment USP, 0.1%

## Ellzia Pak 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. C 24H 31FO 6. M.W. 434.51; CAS Reg. No. 76-25-5.

Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg triamcinolone acetonide in an ointment base of light mineral oil and white petrolatum.

## Ellzia Pak - 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 for Ellzia Pak

Triamcinolone Acetonide Ointment 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 homeostasis. 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 homeostasis 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:

#### 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 no 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

Itis 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 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).

## Ellzia Pak Dosage and Administration

Apply a thin film to the affected area two to three 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 apply Triamcinolone 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 dressings should be discontinued and appropriate antimicrobial therapy instituted.

## How is Ellzia Pak Supplied

Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes:

15 g tube – NDC 52565-014-15

80 g tube – NDC 52565-014-80

1 lb (454 g) jar – NDC 52565-014-26

### STORAGE

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

Teligent Pharma, Inc.
Buena, New Jersey 08310

Rev. 04/16

## Skin Repair Complex (dimethicone)

## Active ingredient

Dimethicone 5.0%

### Purpose

Skin Protectant

## Uses

■ temporarily protects and helps relieve chapped or cracked skin

## Warnings

For external use only

### Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

### When using this product

■ do not get into eyes

### Stop use and ask a doctor if

■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

### Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

## Directions

■ apply cream liberally as needed

## Other information

■ protect from freezing ■ avoid excessive heat

## Inactive ingredients

Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex ® [consisting of: bisabolol, calcium pantothenate (vitamin B 5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3), pyridoxine HCl (vitamin B 6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

## Ellzia Pak™ - carton:

Packaged in the USA by:
PureTek Corporation
San Fernando, CA 91340
For questions or information
call toll-free: 877-921-7873

Rev. 36773

Ellzia Pak triamcinolone acetonide, dimethicone kit

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:59088-846

Packaging
# | Item Code | Package Description
1 | NDC:59088-846-00 | 1 KIT in 1 CARTON

Quantity of Parts
Part # | Package Quantity | Total Product Quantity
Part 1 | 1 TUBE | 80 g
Part 2 | 1 TUBE | 118 mL

Part 1 of 2
TRIAMCINOLONE ACETONIDE triamcinolone acetonide ointment

Product Information
Item Code (Source) | NDC:52565-014
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

Inactive Ingredients
Ingredient Name | Strength
LIGHT MINERAL OIL |
PETROLATUM |

Packaging
# | Item Code | Package Description
1 | NDC:52565-014-80 | 80 g in 1 TUBE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
ANDA | ANDA205373 |  |

Part 2 of 2
SKIN REPAIR COMPLEX dimethicone cream

Product Information
Item Code (Source) | NDC:59088-333
Route of Administration | TOPICAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
DIMETHICONE (DIMETHICONE) | DIMETHICONE | 50 mg in 1 mL

Inactive Ingredients
Ingredient Name | Strength
CHLORPHENESIN |
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER |
KUKUI NUT OIL |
ALOE VERA LEAF |
BUTYLENE GLYCOL |
CAPRYLYL GLYCOL |
SAFFLOWER OIL |
CETYL ALCOHOL |
EDETATE DISODIUM |
GLYCERIN |
GLYCERYL MONOSTEARATE |
LEVOMENOL |
CALCIUM PANTOTHENATE |
CARTHAMUS TINCTORIUS SEED OLEOSOMES |
MALTODEXTRIN |
NIACINAMIDE |
PYRIDOXINE HYDROCHLORIDE |
SILICON DIOXIDE |
SODIUM ASCORBYL PHOSPHATE |
.ALPHA.-TOCOPHEROL ACETATE, DL- |
GINGER |
PEG-100 STEARATE |
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) |
PHENOXYETHANOL |
WATER |
HYALURONATE SODIUM |
STEARIC ACID |
TROLAMINE |

Packaging
# | Item Code | Package Description
1 | NDC:59088-333-08 | 118 mL in 1 TUBE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
OTC monograph final | part347 |  |

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
unapproved drug other |  | 12/29/2016 |

Labeler - PureTek Corporation (785961046)

PureTek Corporation

## More about Ellzia Pak (dimethicone / triamcinolone topical)

- Check interactions
- Side effects
- Dosage information
- During pregnancy
- Drug class: topical steroids with anti-infectives

### Professional resources

#### Other brands

TriaDime-80, TriHeal-80, Yaliira Pak

### Related treatment guides

- Dermatological Disorders

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