Label: JUULISSA PHARMAPAK- triamcinolone acetonide kit

  • NDC Code(s): 52565-014-80, 59088-843-00
  • Packager: PureTek Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 26, 2019

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  • Triamcinolone Acetonide Ointment USP, 0.1%

  • 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. C24H31FO6. M.W. 434.51; CAS Reg. No. 76-25-5.

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    Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg 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 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). 

  • 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 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

  • Silazone™ Sheets(silicone gel sheets)

    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 (104°F).
    Storage time above these conditions should not exceed 18 hours. 

  • Juulissa™ Pharmapak - carton:

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

    Rev. 36772

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  • INGREDIENTS AND APPEARANCE
    JUULISSA PHARMAPAK 
    triamcinolone acetonide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-843
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-843-001 in 1 CARTON12/28/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 80 g
    Part 1 of 1
    TRIAMCINOLONE ACETONIDE 
    triamcinolone acetonide ointment
    Product Information
    Item Code (Source)NDC:52565-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    light mineral oil (UNII: N6K5787QVP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52565-014-8080 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA205373
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20537312/28/2016
    Labeler - PureTek Corporation (785961046)