UCB Pharma, Inc. has received approval from the U.S. Food and Drug Administration to market Lortab 10/500 CIII (Hydrocodone* Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg, *Warning: May be habit-forming). The new addition to the Lortab brand line of pain relievers offers American doctors the first 10 mg hydrocodone combination, formulated to maximize therapeutic flexibility and minimize the potential for acetaminophen (APAP) toxicity. The 500 mg APAP content is lower than that of any other 10 mg hydrocodone combination. Suggested dosing of one tablet every four to six hours does not exceed the generally recommended, maximum acetaminophen dose of 4000 mg/day. Like other products in the growing Lortab brand line that it complements, Lortab 10/500 provides analgesic relief in minutes that lasts for hours, with onset of action in 10-30 minutes, and duration from four to six hours. The toleration profile is similar to other narcotic analgesics, with light-headedness and sedation among the most frequently reported adverse effects.
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UCB PHARMA, INC.
