VoSpire ER® (Albuterol Sulfate) Extended-Release Tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease Patients 6 to 12 years of age: 4 mg every 12 hours Patients over 12 years of age: 8 mg every 12 hours* *In some patients 12 years of age and older, 4 mg every 12 hours may be sufficient.
O One small, extended-release, coated tablet provides up to 12 hours duration of action
O Extended-release formulation allows for twice-daily dosing
O 4 mg and 8 mg tablets allow for individualized dosing
O Option for bronchospasm treatment in conjunction with 1st line reversible obstructive airway
The appropriateness of VoSpire ER® therapy should be determined by the physician based on individual patient needs O Option for patients who simply prefer oral medications
O VoSpire ER® (Albuterol Sulfate) Extended-Release Tablets must be swallowed whole with
the aid of liquids. DO NOT CRUSH OR CHEW THESE TABLETS Important Safety Information
VoSpire ER® Tablets should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, or diabetes. Do not exceed the recommended dose. Albuterol extended-release tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol extended-release tablets should be discontinued immediately and alternative therapy instituted. Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors and tricyclic antidepressants. Adverse reactions are generally transient. The most common adverse reactions reported in clinical trials of adult patients were: tremor, headache, nervousness, and nausea and vomiting. The safety and effectiveness of albuterol extended-release tablets have been established in pediatric patients 6 years of age and older via evidence from adequate and well-controlled studies of albuterol extended-release tablets in adults; the established safety and effectiveness of immediate release albuterol tablets in pediatric patients 6 years of age and older; and clinical trials that support the safety of albuterol extended-release tablets in pediatric patients over 6 years of age. Please see Brief Summary on the back of this page for important considerations regarding albuterol. VoSpire ER® is a registered trademark of DAVA Pharmaceuticals, Inc.
For more information on VoSpire ER® Tablets please visit www.vospireer.com or www.davapharma.com DAVA Headquarters: Parker Plaza, 400 Kelby Street, 10th Floor, Fort Lee, New Jersey 07024. Toll free: (866) 947-DAVA (3282). Telephone: (201) 947-7442. Fax: (201) 947-7964

Source: http://www.vospireer.com/files/file/VOSREP_DetailAid_vf_.pdf?phpMyAdmin=381e318a24be589aa94c3d56d8bb643c

Pii: s0304-3940(02)00027-7

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