TRIAMCINOLONE ACETONIDE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 40 mg in 1 mL

Administration route:

INTRA-ARTICULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis and systemic lupus erythematosus. Intra-Articular The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General ). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Product summary:

Triamcinolone Acetonide Injectable Suspension, USP is supplied in vials providing 40 mg triamcinolone acetonide per mL. 40 mg/mL, 1 mL 1 mL single-dose vial:                                                                        NDC 70121-1049-1 1 single-dose vial in 1 carton:                                                           NDC 70121-1049-2 25 single-dose vials in 1 carton:                                                        NDC 70121-1049-5 40 mg/mL, 5 mL 5 mL multiple-dose vial (200 mg per 5 mL) in 1 carton:                      NDC 70121-1168-1 40 mg/mL, 10 mL 10 mL multiple-dose vial (400 mg per 10 mL) in 1 carton:                  NDC 70121-1169-1 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from temperatures below 20°C (68°F). Store vial in carton to protect from light. Store vial upright. Discard unused portions of single-dose vials. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2022-06

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION
AMNEAL PHARMACEUTICALS LLC
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TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR
INTRATHECAL USE
DESCRIPTION
Triamcinolone acetonide injectable suspension, USP is a synthetic
glucocorticoid
corticosteroid with anti-inflammatory action. THIS FORMULATION IS
SUITABLE FOR
INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT
FOR
INTRADERMAL INJECTION.
Each mL of the sterile aqueous suspension provides 40 mg triamcinolone
acetonide,
USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl
alcohol as a
preservative, 0.75% carboxymethylcellulose sodium, and 0.04%
polysorbate 80 in an
aqueous suspension. Sodium hydroxide or hydrochloric acid may be
present to adjust
pH to 5.0 to 7.5. At the time of manufacture, the air in the container
is replaced by
nitrogen.
The chemical name for triamcinolone acetonide is
9-Fluoro-11β,16α,17,21-
tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with
acetone. Its structural
formula is:
MW 434.50
Triamcinolone acetonide, USP occurs as a white to cream-colored,
crystalline powder
having not more than a slight odor and is practically insoluble in
water and very soluble
in alcohol.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Synthetic analogs such as triamcinolone are primarily used for
their anti-
inflammatory effects in disorders of many organ systems.
Triamcinolone acetonide injectable suspension has an extended duration
of effect which
may be sustained over a period of several weeks. Studies indicate that
following a single
intr