Each 1 mL contains triamcinolone acetonide 0.2 mg.
Inactive Ingredients/Excipients: Propylene glycol, Citric acid anhydrous, Sodium citrate dihydrate, Disodium EDTA, Ethanol and Purified water.
Pharmacology: Pharmacodynamics: Mechanism of Actions: Triamcinolone acetonide is a topical corticosteroid which is ranked in the medium potency based on vasoconstrictor assay. It is an adrenocorticosteroid derivative incorporated into a vehicle suitable for application to skin or external mucous membranes. The primary therapeutic effects of topical triamcinolone are due to its anti-inflammatory activity which is non-specific. Topical triamcinolone diffuses across cell membranes to interact with cytoplasmic receptors located in both the dermal and intradermal cells. Triamcinolone appears to induce phospholipase A2 inhibitory proteins (lipocortins) at the cellular level, thus depressing formation, release and activity of the endogenous mediators of inflammation such as prostaglandins, kinins, histamine, liposomal enzymes and the complement system. When triamcinolone is applied to inflamed skin, it inhibits the migration of macrophages and leukocytes into the area by reversing vascular dilation and permeability. The clinical result is a decrease in edema, erythema and pruritus. Topical triamcinolone has an antimitotic effect on epidermal cells by suppressing DNA synthesis.
Dose/concentration/time-pharmacodynamic response relationship: Data is not available.
Mechanism of toxicity: Data is not available.
Pharmacokinetics: Absorption: The amount of triamcinolone absorbed from the skin depends on the intrinsic properties of the vehicle used, the duration of exposure and the surface area and condition of the skin to which it is applied. In general, absorption will be enhanced by increased skin temperature, hydration, application to inflamed or denuded skin, intertriginous areas (e.g., eyelids, groin, axilla) or skin surfaces with a thin stratum corneum layer (e.g., face, scrotum). Palms, soles and crusted surfaces are less permeable. Occlusive dressings greatly enhance skin penetration and, therefore, increase drug absorption.
Infants and children have a higher total body surface to body weight ratio that decreases with age. Therefore, proportionately more topically applied triamcinolone will be absorbed systemically in this population, putting them at a greater risk for systemic effects.
Metabolism: Following topical absorption, triamcinolone enters the systemic circulation and is metabolized in the most tissues but primarily in the liver, to biologically inactive compounds.
Elimination: Inactive metabolites are excreted by the kidneys, primarily as glucuronides and sulfates, but also as unconjugated products. Small amounts of unmetabolized drugs are also excreted in urine.
Occlusive dressings: Occlusive dressings such as a plastic wrap increase skin penetration approximately tenfold by increasing the moisture content of the stratum corneum. Occlusion can be beneficial in resistant cases but it may also lead to sweat retention and increased bacterial and fungal infections. Additionally, increased absorption of triamcinolone may produce systemic side effects. Therefore, do not use occlusive dressings for more than 12 hours per day.
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Apply lotion sparingly to the affected skin areas 2 to 4 times daily.
General consideration: Topical triamcinolone has a repository effect; with continuous use, one or two applications per day may be as effective as three or more. Many clinicians advise applying twice daily until clinical response is achieved, and then only as frequently as needed to control the condition.
Do not discontinue treatment abruptly. After long-term use, in order to prevent a rebound effect, switch to a less potent agent or alternate use of topical corticosteroids and emollient products.
Mode of administration: Apply Tri-am GPO (0.02%) sparingly to the affected skin area and rub in gently. To use the lotion on the scalp, apply a small amount of the lotion on the affected area and rub it in gently. Protect the area from washing, clothing, rubbing, etc until the lotion dries. Washing or soaking the area before application may increase drug penetration.
Incompatibilities: Data is not available.
Topical triamcinolone can be absorbed in sufficient amounts to produce systemic effects. Systemic absorption of topical triamcinolone has produced reversible HPA axis suppression, Cushing's syndrome, hyperglycemia and glycosuria. Periodically evaluate patients for evidence of HPA axis suppression by using morning plasma cortisol, urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, attempt to withdraw the drug, reduce the frequency of applications, substitute a less potent steroid or use a sequential approach with the occlusive technique. Also test for impairment of thermal homeostasis. 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.
Hypersensitivity to triamcinolone or any component of the formulation.
Monotherapy in primary bacterial infections such as impetigo, paronychia, erysipelas, cellulitis, angular cheilitis.
Treatment of rosacea, perioral dermatitis or acne.
When applied to the eyelids or skin near the eyes, the drug may enter the eyes (prolonged ocular exposure may cause steroid-induced glaucoma and cataracts).
Do not ingest.
Do not use topical triamcinolone as sole therapy in widespread plaque psoriasis.
Systemic effects: Systemic absorption of topical triamcinolone has produced reversible the hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and glycosuria.
Local irritation: If local irritation develops, discontinue use and institute appropriate therapy.
Skin atrophy: This is common and may be clinically significant in 3 to 4 weeks with potent preparations. Atrophy occurs most readily at sites where percutaneous absorption is high. However, Tri-am GPO (0.02%) is classified as medium potency topical corticosteroid product.
Psoriasis: Do not use topical triamcinolone as sole therapy in widespread plaque psoriasis.
Atrophic changes: Certain areas of the body, such as the face, groin and axillae, are more prone to atrophic changes than other areas of the body following treatment with triamcinolone. Frequent observation of the patient is important if these areas are to be treated.
Infections: In the presence of an infection, institute therapy with an antifungal or antibacterial agent. If a favorable response does not occur promptly, discontinue triamcinolone until the infection has been controlled. Treating skin infections with topical triamcinolone can extensively worsen the infection.
For external use only: Avoid ingestion or contact with eyes.
Occlusive therapy: Discontinue the use of occlusive dressings if infection develops and institute appropriate antimicrobial therapy.
Effect on ability to drive and use machine: Data is not available.
Use in Children: Children may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than adults because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome and intracranial hypertension have occurred in children receiving topical corticosteroids. Manifestations of adrenal suppression include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to adrenocorticotropic hormone (ACTH) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.
Limit administration to the least amount compatible with effective therapy. Chronic corticosteroid therapy may interfere with the growth and development of children.
Pregnancy: US Pregnancy Category: C.
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) when administered systemically at relatively low dosages and there are no controlled studies in women or studies in women and animals are not available. Drug should be given only if the potential benefit justifies the potential risk to the fetus. In pregnant patients, do not use extensively; do not use in large amounts or for prolonged periods of time.
Labor and delivery: Data is not available.
Lactation: It is not known whether topical triamcinolone could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, exercise caution when administering topical triamcinolone to a nursing mother.
Burning; itching; irritation; erythema; dryness; folliculitis; hypertrichosis; pruritus; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; numbness of fingers; stinging and cracking/tightening of skin; maceration of the skin; secondary infection; skin atrophy; striae; miliaria; telangiectasia. These may occur more frequently with occlusive dressings.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glycosuria. This is more likely to occur with occlusive dressings and with the more potent steroids. Patients with liver failure or children may be at a higher risk. Lightheadedness and hives have been reported rarely.
Following prolonged application around the eyes, cataracts and glaucoma may develop. In diffusely atrophied skin, blood vessels may become visible on the skin surface; telangiectasia and purpura may occur at the site of trauma.
Do not store above 30°C. Store in the original container.
D07AB09 - triamcinolone ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.
Lotion 0.02% (clear, colorless solution) x 60 mL x 1's.