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Trivaris

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Trivaris

Trivaris

INDICATIONS

Ophthalmic Use

TRIVARIS™ (triamcinolone acetonide injectable suspension) 80 mg/mL is indicated for:

Intramuscular Use

Where oral therapy is not feasible, TRIVARIS™ (triamcinolone acetonide injectable suspension) 80 mg/mL 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, craniotomy, or head injury.

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 Use

The intra-articular or soft tissue administration of TRIVARIS™ (triamcinolone acetonide injectable suspension) (triamcinolone acetonide injectable suspension) 80 mg/mL 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.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The initial dose of TRIVARIS™ (triamcinolone acetonide injectable suspension) 80 mg/mL may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see DOSAGE AND ADMINISTRATION). However, in certain overwhelming, acute, life threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drugdosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

General Administration

Strict Aseptic Technique Is Mandatory.

Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

TRIVARIS™ (triamcinolone acetonide injectable suspension) should be inspected visually for particulate matter and discoloration prior to administration.

Always allow the pre-filled glass syringe to sit at room temperature for at least 30 minutes before the procedure.

Intravitreal Dosing

The recommended intravitreal dose is a single injection of 4 mg per 0.05 mL (i.e., 50 microliters of 80 mg/mL suspension).

Preparation for Intravitreal Injection

TRIVARIS™ (triamcinolone acetonide injectable suspension) is available without an attached needle. Therefore, it is necessary to firmly attach a desired needle to the syringe. A 27 gauge ½ inch needle is suggested. Prepare the proper volume of TRIVARIS™ (triamcinolone acetonide injectable suspension) to be injected by advancing the plunger to the single line marked on the pre-filled glass syringe shaft. Hold the syringe and the needle at an angle and express excess gel suspension over a sterile surface. The plunger is correctly positioned when white compound is no longer visible between the plunger and the fill line on the syringe. This will provide the recommended dose of 4 mg per 0.05 mL. Always check the needle to ensure it is firmly attached to the syringe before injecting the patient.

The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for reperfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Each syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new syringe should be used and the sterile field, syringe, gloves, drapes, and eyelid speculum and injection needles should be changed before TRIVARIS™ (triamcinolone acetonide injectable suspension) is administered to the other eye.

Systemic Dosing

The suggested initial dose is 60 mg, injected deeply into the gluteal muscle. Atrophy of subcutaneous fat may occur if the injection is not properly given. Dosage is usually adjusted within the range of 40 to 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on doses as low as 20 mg or less.

For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections. Each syringe should only be used for a single treatment. Multiple injections are required to reach the recommended dose. In pediatric patients, the initial dose of triamcinolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m² bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

Cortisone, 25 Triamcinolone, 4
Hydrocortisone, 20 Paramethasone, 2
Prednisolone, 5 Betamethasone, 0.75
Prednisone, 5 Dexamethasone, 0.75
Methylprednisolone, 4  

These dose relationships generally apply to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

Hay fever or pollen asthma: Patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single injection of 40 to 100 mg.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of triamcinolone for a week followed by 64 mg every other day for one month, are recommended (see WARNINGS AND PRECAUTIONS).

Intra-articular Dosing

A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms.

Initial dose: 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints, depending on the specific disease entity being treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient. Single injections into several joints, up to a total of 80 mg, have been given.

For treatment of joints, the usual intraarticular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid. Each syringe should only be used for a single treatment. Multiple injections may be required to reach the recommended dose.

With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the gel suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath, rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

HOW SUPPLIED

Dosage Forms And Strengths

Single-use 0.1 mL syringe containing 8 mg (80 mg/mL) of triamcinolone acetonide suspension.

Storage And Handling

TRIVARIS™ (triamcinolone acetonide injectable suspension) 80 mg/mL is supplied in blister packs with 1 single-use glass syringe containing 8 mg in 0.1 mL as follows:

Syringe without needle: NDC 0023XXXX-XX

Storage: Keep refrigerated 36°- 46°F (2°8°C) until use. Avoid freezing and protect from light.

Allergan, Inc., Irvine, CA 92612, U.S.A. FDA revision date: 6/16/2008

Last reviewed on RxList: 7/8/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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