Tuesday, September 13, 2016

Triamcinolone Acetonide topical



Class: Anti-inflammatory Agents
VA Class: DE200
CAS Number: 76-25-5
Brands: Aristocort, Aristocort A, Flutex, Kenalog, Myco II, Mycogen II, Mycolog-II, Myco-Triacet II, Mytrex, NGT, N.T.A., Triacet, Tri-Statin II

Introduction

Synthetic fluorinated corticosteroid.a c


Uses for Triamcinolone Acetonide


Corticosteroid-responsive Dermatoses


Relief of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.a


Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).b


Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.b


Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.b


Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)b


Response may vary from one topical corticosteroid preparation to another.b


Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.b


Triamcinolone acetonide 0.5% cream and 0.1% ointment are considered to have high-range potency.b


Triamcinolone acetonide 0.1% cream and 0.1% lotion are considered to have medium-range potency.b


Oral Lesions


Triamcinolone acetonide paste used as an adjunct for temporary symptomatic relief of oral inflammatory or ulcerative lesions resulting from trauma.c e


Triamcinolone Acetonide Dosage and Administration


General



  • Consider location of the lesion and the condition being treated when choosing a dosage form.b




  • Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.b




  • Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).b Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.b




  • Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.b




  • Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).a (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)



Administration


Topical Administration


For dermatologic use only; avoid contact with eyes.a


The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.b


Apply cream, lotion, or ointment sparingly in a thin film and rub gently into the affected area.c


Use the 0.5% cream and 0.5% ointment only in the treatment of dermatoses that are refractory to treatment with lower concentrations.c


To apply triamcinolone acetonide aerosol, spray an area about the size of the patient’s hand for about 2 seconds from a distance of about 7.5–15 cm.c


For use in the mouth, press a small amount (about 0.6 cm) of the 0.1% paste to the lesion without rubbing until a thin film develops; a larger amount may be required to cover some lesions.c


After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.b


Administration with Occlusive Dressing

Dermatologic preparations of triamcinolone acetonide usually should not be used with occlusive dressings unless directed by a clinician.a However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of triamcinolone preparations when treating severe or resistant dermatoses.c (See Occlusive Dressings under Cautions.)


Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film.b Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.b


If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.b For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.b


Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.b


Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.b


Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.b Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.b


The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.b


In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.b (See Occlusive Dressings under Cautions.)


Dosage


Available as triamcinolone acetonide; dosage expressed in terms of the salt.a c


Pediatric Patients


Administer the least amount of topical preparations that provides effective therapy.a (See Pediatric Use under Cautions.)


Corticosteroid-responsive Dermatoses

Topical

Apply appropriate preparations of triamcinolone acetonide sparingly 2–4 times daily.a c


Apply 0.1 and 0.5% creams 2–3 times daily according to severity of the condition.a


Apply aerosol 3–4 times daily.c


Adults


Corticosteroid-responsive Dermatoses

Topical

Apply appropriate preparations of triamcinolone acetonide sparingly 2–4 times daily.a c


Apply 0.1 and 0.5% creams 2–3 times daily according to severity of the condition.a


Apply aerosol 3–4 times daily.c


Apply paste at bedtime and, if necessary, 2 or 3 times daily, preferably after meals.c If substantial regeneration or repair of oral tissues does not occur after 7 days, further investigate the etiology of the lesions.c


Cautions for Triamcinolone Acetonide


Contraindications



  • Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.a b



Warnings/Precautions


Sensitivity Reactions


Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.b


General Precautions


Hypothalamic-Pituitary-Adrenal Axis Suppression

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.a


Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.a b


If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.a


HPA-axis function recovery generally is prompt and complete following drug discontinuance.a


Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.a b


Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.a b


Risk of adverse systemic effects increases with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.a b


Infants and children may be more susceptible to adverse systemic effects.a (See Pediatric Use under Cautions.)


Local Effects

Possible adverse local reactions (e.g., burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.a b


Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;b these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.b


If irritation occurs, discontinue drug and institute appropriate therapy.a


Skin Infection

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.a If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.a


When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.b g In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.b g


Do not use occlusive dressings in patients with primary skin infection.b


Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin).b However, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.b


Occlusive Dressings

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)


Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.b (See Local Effects under Cautions.)


Do not use occlusive dressings on weeping or exudative lesions.b


Do not use occlusive dressings in patients with primary skin infection.b


Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.b


Use plastic occlusive material with care to avoid the risk of suffocation.b


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category C.a


Lactation

Not known whether topical triamcinolone is distributed into milk.a Caution advised if topical triamcinolone is used.a


Pediatric Use

Safety and efficacy of triamcinolone acetonide paste not established.e


Tight-fitting diapers or plastic pants should not be used on a child being treated with triamcinolone acetonide in the diaper area, since they may constitute occlusive dressings.a


Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing's syndrome than mature individuals because of a greater skin surface area-to-body weight ratio,a especially when topical corticosteroids are applied to >20% of body surface area.b The risk of adrenal suppression appears to increase with decreasing age.b (See Systemic Effects under Cautions.)


Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.a b


Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.b


Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.a b


Striae has been reported in children treated inappropriately with topical corticosteroids.a b


Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.b


Common Adverse Effects


Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis.a b


Interactions for Triamcinolone Acetonide


Specific Drugs and Laboratory Tests









Drug or Test



Interaction



Corticosteroids



Potential pharmacologic interaction with other corticosteroid-containing preparationsb



Nitroblue-tetrazolium test for bacterial infection



Concurrent use of corticosteroids reportedly may result in false-negative resultsb


Triamcinolone Acetonide Pharmacokinetics


Absorption


Bioavailability


Topically applied triamcinolone can be absorbed through normal intact skin.a b


Percutaneous penetration can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).a b


Distribution


Extent


Not known whether topical triamcinolone is distributed into milk.a


Elimination


Metabolism


Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.a


Elimination Route


Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.a


Stability


Storage


Topical


Cream and Ointment

15–30°C.a f


Paste

Tight containers at 15–25°C.e


Lotion and Aerosol

Store according to the manufacturer’s directions.


ActionsActions



  • Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.a b




  • Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.a




  • Anti-inflammatory effects may occur through induction of phospholipase A2 inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids.e Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).e



Advice to Patients



  • Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.a (See Topical Administration under Dosage and Administration.)




  • Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.a




  • Importance of informing parents of children that if triamcinolone acetonide is applied in the diaper area that tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.a




  • Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.a b




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of advising patients of other important precautionary information.a (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name



























































































































Triamcinolone Acetonide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Aerosol



0.2 mg per 2-second spray



Kenalog Spray (with alcohol 10.3% and isobutane propellant)



Sandoz



Cream



0.025%*



Aristocort A (with benzyl alcohol)



Astellas



Aristocort (with propylene glycol)



Astellas



Kenalog (with propylene glycol)



Sandoz



0.1%*



Aristocort A (with benzyl alcohol)



Astellas



Aristocort (with propylene glycol)



Astellas



Kenalog (with propylene glycol)



Sandoz



Triacet



Teva



0.5%*



Aristocort A (with benzyl alcohol)



Astellas



Aristocort (with propylene glycol)



Astellas



Kenalog (with propylene glycol)



Sandoz



Lotion



0.025%*



Kenalog (with propylene glycol)



Sandoz



0.1%*



Kenalog (with propylene glycol)



Sandoz



Ointment



0.025%*



Kenalog



Sandoz



0.1%*



Aristocort A (with propylene glycol)



Astellas



Aristocort



Astellas



Flutex



Syosset



Kenalog



Sandoz



0.5%



Aristocort



Astellas



Kenalog



Sandoz



Triamcinolone Acetonide Ointment



CMC, Rugby



Paste



0.1%



Kenalog in Orabase



Sandoz



Triamcinolone Dental Paste



IVAX, Major, Rugby, Sandoz, Taro


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name



















































































Triamcinolone Acetonide Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Cream



0.1% with Nystatin 100,000 units/g*



Myco II



Bioline



Mycogen II



IVAX



Mycolog-II (with propylene glycol)



Sandoz



Myco-Triacet II



Teva



Mytrex (with benzyl alcohol and propylene glycol)



Savage



NGT



Sandoz



N.T.A. Cream



United Research



Tri-Statin II



Rugby



Ointment



0.1% with Nystatin 100,000 units/g*



Myco II



Bioline



Mycogen II



IVAX



Mycolog-II



Sandoz



Myco-Triacet II



Teva



Mytrex



Savage



N.T.A. Ointment



United Research



Tri-Statin II



Rugby


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Kenalog Aerosol (RANBAXY LABORATORIES): 63/$118.99 or 189/$339.96


Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 15/$12.99 or 45/$20.99


Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 30/$13.99 or 60/$20.98


Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (TARO): 60/$14.99 or 120/$19.98


Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Ointment (TARO): 15/$17.77 or 45/$32.29


Triamcinolone Acetonide 0.025% Cream (PERRIGO PHARMACEUTICALS): 15/$15.99 or 30/$20.98


Triamcinolone Acetonide 0.025% Lotion (MORTON GROVE PHARMACEUTICALS): 60/$40.99 or 180/$115.97


Triamcinolone Acetonide 0.03% Cream (FOUGERA): 80/$17.99 or 240/$39.97


Triamcinolone Acetonide 0.03% Ointment (FOUGERA): 80/$17.99 or 160/$24.99


Triamcinolone Acetonide 0.1% Cream (FOUGERA): 453/$40.99 or 1360/$105.97


Triamcinolone Acetonide 0.1% Cream (PERRIGO PHARMACEUTICALS): 80/$19.99 or 160/$30.98


Triamcinolone Acetonide 0.1% Cream (PERRIGO PHARMACEUTICALS): 15/$14.99 or 30/$22.98


Triamcinolone Acetonide 0.1% Ointment (ACTAVIS MID ATLANTIC): 15/$11.99 or 30/$12.98


Triamcinolone Acetonide 0.1% Ointment (FOUGERA): 454/$31.99 or 908/$55.98


Triamcinolone Acetonide 0.1% Ointment (PERRIGO PHARMACEUTICALS): 80/$29.99 or 160/$49.98


Triamcinolone Acetonide 0.5% Cream (PERRIGO PHARMACEUTICALS): 15/$19.99 or 30/$30.98


Triamcinolone Acetonide 0.5% Ointment (IVAX PHARMACEUTICALS INC.): 15/$14.99 or 30/$18.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. Fougera. Triamcinolone acetonide cream 0.025%, 0.1%, 0.5% prescribing information. Melville, NY; 2001 Mar.



b. AHFS drug information 2005 McEvoy GK, ed. Topical Corticosteroids General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2005:3425-8.



c. AHFS drug information 2005. McEvoy GK, ed. Triamcinolone acetonide. Bethesda, MD: American Society of Health-System Pharmacists; 2005:3437-8.



e. Apothecon. Kenalog in Orabase (triamcinolone acetonide dental paste) 0.1% prescribing information. Princeton, NJ; Undated.



f. Fougera. Triamcinolone acetonide ointment 0.1% prescribing information. Melville, NY; 2003 Apr.



g. AHFS drug information 2006. McEvoy GK, ed. Neomycin Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2006: 2739-40.



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