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Serevent Aerosol

[salmeterol xinafoate]

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.

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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 consists 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).

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