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Azmacort Inhalation (Triamcinolone Acetonide Inhalation) - Indications and Dosage

 
 



INDICATIONS

Azmacort Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. Azmacort Inhalation Aerosol is also indicated for asthma patients who require systemic corticosteroid administration, where adding Azmacort may reduce or eliminate the need for the systemic corticosteroids.

Azmacort Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

Adults:    The usual recommended dosage is two inhalations (200 mcg) given three to four times a day or four inhalations (400 mcg) given twice daily. The maximal daily intake should not exceed 16 inhalations (1600 mcg) in adults. Higher initial doses (12 to 16 inhalations per day) may be considered in patients with more severe asthma.

Children 6 to 12 Years of Age:    The usual recommended dosage is one or two inhalations (100 to 200 mcg) given three to four times a day or two to four inhalations (200 to 400 mcg) given twice daily. The maximal daily intake should not exceed 12 inhalations (1200 mcg) in children 6 to 12 years of age. Insufficient clinical data exist with respect to the safety and efficacy of the administration of Azmacort Inhalation Aerosol to children below the age of 6. The long-term effects of inhaled steroids, including Azmacort Inhalation Aerosol, on growth are still not fully known.

Rinsing the mouth after inhalation is advised.

Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit of Azmacort Inhalation Aerosol:

Note: In all patients, it is desirable to titrate to the lowest effective dose once asthma stability has been achieved.

Patients Not Receiving Systemic Corticosteroids:    Patients who require maintenance therapy of their asthma may benefit from treatment with Azmacort Inhalation Aerosol at the doses recommended above. In patients who respond to Azmacort Inhalation Aerosol, improvement in pulmonary function is usually apparent within one to two weeks after the initiation of therapy.

Patients Maintained on Systemic Corticosteroids:    Clinical studies have shown that Azmacort Inhalation Aerosol may be effective in the management of asthmatics dependent or maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient's asthma should be reasonably stable before treatment with Azmacort Inhalation Aerosol is started. Initially, Azmacort Inhalation Aerosol should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. Inhaled corticosteroids should be used with caution when used chronically in patients receiving prednisone regimens, either daily or alternate day. (See WARNINGS.)

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

Directions for Use:    An illustrated leaflet of patient instructions for proper use accompanies each package of Azmacort Inhalation Aerosol.

HOW SUPPLIED

Azmacort Inhalation Aerosol contains 60 mg triamcinolone acetonide in a 20 gram package which delivers at least 240 actuations. It is supplied with a white plastic actuator, a white plastic spacer-mouthpiece and patient's leaflet of instructions: box of one. NDC 60598-061-60. Each actuation delivers 200 mcg triamcinolone acetonide from the valve and 100 mcg from the spacer-mouthpiece under defined in vitro test conditions.

Avoid spraying in eyes.

For best results, the canister should be at room temperature before use.

Shake well before using.

CONTENTS UNDER PRESSURE. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Keep out of reach of children unless otherwise prescribed. Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

WARNING: Contains CFC-12, a substance which harms public health and the environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the "Information For The Patient" portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.

Azmacort is a registered trademark

©2004 Kos Pharmaceuticals, Inc.

Manufactured for: Kos Pharmaceuticals, Inc.

Cranbury, NJ 08512

400201/0604

Rev. June 2004

50072141

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