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CODEPREX
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Drug Name CODEPREX
Active Ingredient(s) • CODEINE POLISTIREX; CHLORPHENIRAMINE POLISTIREX
Form(s) and
Strength(s) Available
• SUSPENSION, EXTENDED RELEASE; ORAL:0

Product Information / Press Release

CELLTECH ANNOUNCES U.S. FDA APPROVAL FOR 12-HOUR CODEPREX(TM)

- First codeine cough suppressant to be dosed every 12 hours -

Celltech Group plc (LSE: CCH; NYSE: CLL) announces that the U.S. Food and Drug
Administration ('FDA') has approved Codeprex(TM) (codeine polistirex/ chlorpheniramine polistirex) Extended-Release Suspension CIII for cough relief. Codeprex(TM) uses Celltech's proprietary Pennkinetic(R) extended-release drug delivery technology to provide 12-hour dosing.  Codeprex(TM) is the first codeine-based cough suppressant to provide 12-hour dosing and offers patients the convenience of less frequent dosing compared to other codeine cough suppressants, in particular by avoiding the need for middle of the night dosing.

Codeprex(TM) is indicated for the temporary relief of cough - as may occur with the common cold or inhaled irritants - and for the temporary relief of: runny nose, sneezing, itching of the nose or throat; and itchy watery eyes due to hay fever, other upper respiratory allergies, or allergic rhinitis. Codeprex(TM) is expected to be available in retail pharmacies by the fourth quarter.

'Celltech is introducing Codeprex(TM) in order to offer a 12-hour dosing option for patients requiring a prescription codeine cough suppressant, ' said Dan Greenleaf, president, US operations, Celltech Pharmaceuticals. 'The approval of Codeprex(TM) extends our leadership in the cough/cold market, which can be in part attributed to Celltech's proprietary Pennkinetic(R) technology. It is the foundation for a full range of antitussives developed by Celltech to meet individual patient needs.'

Celltech also manufactures Tussionex(R) (hydrocodone polistirex/chlorpheniramine polistirex) Extended-Release Suspension CIII, the number one prescribed hydrocodone antitussive, and Delsym(R) Extended-Release Suspension, an over-the-counter (OTC) dextromethorphan antitussive that provides 12-hour cough relief.  Delsym(R)'s efficacy has helped position it as the number two brand in the cough suppressant category, and the number one brand in pediatric dollar sales.

Codeprex(TM) is contraindicated in persons with sensitivity to codeine or chlorpheniramine. Codeprex(TM) should be used with caution in patients with persistent or chronic cough, as occurs with smoking, asthma or emphysema, or with cough accompanied by excessive phlegm. Caution is also advised when prescribing to patients with narrow-angle glaucoma or prostatic hypertrophy. The possibility of tolerance and/or dependence, particularly in patients with a history of drug abuse, should be considered. Common side effects may include drowsiness, confusion, dizziness, nausea, constipation, dry mouth, headache, and allergic reactions.

Tussionex(R) is contraindicated in the presence of known allergy to hydrocodone or chlorpheniramine. The most common adverse reactions associated with Tussionex (R) are sedation, drowsiness, and mental clouding, which may impair the mental and/or physical abilities required for potentially hazardous tasks. The possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered.


Manufacturers URL : www.celltechgroup.com








 
 
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