DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Serevent (Salmeterol Xinafoate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Asthma

SEREVENT Inhalation Aerosol is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta2-agonists. It should not be used in patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists.

SEREVENT Inhalation Aerosol may be used alone or in combination with inhaled or systemic corticosteroid therapy.

SEREVENT Inhalation Aerosol is also indicated for prevention of exercise-induced bronchospasm in patients 12 years of age and older.

Chronic Obstructive Pulmonary Disease

SEREVENT Inhalation Aerosol is indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).

DOSAGE AND ADMINISTRATION

SEREVENT Inhalation Aerosol should be administered by the orally inhaled route only (see PATIENT’S INSTRUCTIONS FOR USE). It is recommended to “test spray” SEREVENT Inhalation Aerosol into the air 4 times before using for the first time and in cases where the aerosol has not been used for a prolonged period of time (i.e., more than 4 weeks).

Asthma

For maintenance of bronchodilatation and prevention of symptoms of asthma, including the symptoms of nocturnal asthma, the usual dosage for patients 12 years of age and older is 2 inhalations (42 mcg) twice daily (morning and evening, approximately 12 hours apart). Adverse effects are more likely to occur with higher doses of salmeterol, and more frequent administration or administration of a larger number of inhalations is not recommended.

To gain full therapeutic benefit, SEREVENT Inhalation Aerosol should be administered twice daily (morning and evening) in the treatment of reversible airway obstruction.

If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of asthma. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options, such as inhaled or systemic corticosteroids, should be considered. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Chronic Obstructive Pulmonary Disease

For maintenance treatment of bronchospasm associated with COPD (including chronic bronchitis and emphysema), the usual dosage for adults is 2 inhalations (42 mcg) twice daily (morning and evening, approximately 12 hours apart).

Prevention of Exercise-Induced Bronchospasm

Two inhalations at least 30 to 60 minutes before exercise have been shown to protect against EIB in many patients for up to 12 hours. Additional doses of SEREVENT Inhalation Aerosol should not be used for 12 hours after the administration of this drug. Patients who are receiving SEREVENT Inhalation Aerosol twice daily (morning and evening) should not use additional SEREVENT Inhalation Aerosol for prevention of EIB. If this dose is not effective, other appropriate therapy for EIB should be considered.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with SEREVENT Inhalation Aerosol, efficacy and safety of 42 mcg given twice daily (morning and evening) did not differ from that in younger patients. Consequently, no dosage adjustment is recommended.

HOW SUPPLIED

SEREVENT Inhalation Aerosol is supplied in 13-g canisters containing 120 metered actuations in boxes of 1. Each actuation delivers 25 mcg of salmeterol base (as salmeterol xinafoate) from the valve and 21 mcg of salmeterol base (as salmeterol xinafoate) from the actuator. Each canister is supplied with a green plastic actuator with a teal strapcap and patient's instructions (NDC 0173-0464-00). Also available, SEREVENT Inhalation Aerosol Refill (NDC 0173-0465-00), a 13-g canister only with patient’s instructions.

SEREVENT Inhalation Aerosol is also supplied in institutional packs that consist of a 6.5-g canister containing 60 metered actuations in boxes of 1. Each actuation delivers 25 mcg of salmeterol base (as salmeterol xinafoate) from the valve and 21 mcg of salmeterol base from the actuator (as salmeterol xinafoate). Each canister is supplied with a green plastic actuator with a teal strapcap and patient's instructions (NDC 0173-0467-00).

For use with SEREVENT Inhalation Aerosol actuator only. The green actuator with SEREVENT Inhalation Aerosol should not be used with other aerosol medications, and actuators from other aerosol medications should not be used with a SEREVENT Inhalation Aerosol canister.

The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 13-g canister or 60 actuations from the 6.5-g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations has been used.

Store between 15° and 30°C (59° and 86°F). Store canister with nozzle end down. Protect from freezing temperatures and direct sunlight.

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of reach of children. As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold; for best results, the canister should be at room temperature before use. Shake well before using.

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 trichlorofluoromethane and dichlorodifluoromethane, substances that harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the patient information leaflet of this product pursuant to EPA regulations. The patient’s warning states that the patient should consult his or her physician if there are questions about alternatives.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2004, GlaxoSmithKline. All rights reserved.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012