FORADIL CERTIHALER is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children 5 years of age and older with reversible obstructive airway disease.

Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, FORADIL CERTIHALER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g. low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including FORADIL CERTIHALER. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta₂-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled, short-acting beta₂-agonists.

FORADIL CERTIHALER should be administered only by the oral inhalation route (see the accompanying Medication Guide).

For Maintenance Treatment of Asthma

Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, FORADIL CERTIHALER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g. low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including FORADIL CERTIHALER. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta₂-agonists.

For adults and children 5 years of age and older, the usual dosage is one 10 mcg inhalation from the FORADIL CERTIHALER every 12 hours. The patient must not exhale into the device. The total daily dose of FORADIL CERTIHALER should not exceed one inhalation twice daily (20 mcg total daily dose). More frequent administration or administration of a larger number of inhalations is not recommended. If symptoms arise between doses, an inhaled short-acting beta₂-agonist should be taken for immediate relief.

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.

FORADIL CERTIHALER consists of a number of assembled plastic components, the main parts being the mouthpiece, dosing mechanism, reservoir, body, valve socket, and counter. The body of the inhaler is light blue; the mouthpiece is white, and the protective cap is dark blue. The target net content (fill weight) is approximately 560 mg of formoterol powder blend. FORADIL CERTIHALER delivers 8.5 mcg of formoterol fumarate per dose, with 60 doses contained within the inhaler. The inhaler device will lock closed after the final dose is administered.

FORADIL CERTIHALER contains: one CERTIHALER Inhaler and Instructions for Using FORADIL CERTIHALER (NDC XXXX_XXXX_XX).

Unit Dose

Box of 1 CERTIHALER Inhaler (60 doses) NDC xxxx-xxxx-xx

Store at 25°C (77°F). Excursions permitted to 15–30°C (59–86 °F) [see USP Controlled Room Temperature]. Protect from heat and moisture.

Keep out of the reach of children.

Printed in U.S.A.
Manufactured by: SkyePharma Production SAS, Saint Quentin-Fallavier, France
Distributed by: Novartis Pharmaceuticals Corp., East Hanover, NJ 07936
©2006 Novartis Pharmaceuticals Corporation. All rights reserved.
FDA rev date: 12/6/2006

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