For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of Pharmacy can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, Pharmacy 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
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For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, Pharmacy 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.
Although Pharmacy is known to exhibit a local anaesthetic effect, how Pharmacy exerts this effect is not understood fully.
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No effects on fertility were observed for Pharmacy at oral dose levels up to 50 mg/kg (300 mg/m2) in male rats and 75 mg/kg (450 mg/m2) in female rats. These dosages are 1.2 and 1.8 times the maximum daily human dosage of 246 mg/m2, respectively.
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Allergies�Tell your doctor if you have ever had any unusual or allergic reaction to Pharmacy or narcotic analgesics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that it has received confirmation, with an effective date of February 29, 2004, for the filing of its December 31, 2003 submission for a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Ralivia ER (Pharmacy hydrochloride) Extended Release tablets. Ralivia ER is a once-daily oral controlled-release medication intended for the treatment of moderate to moderately severe pain.
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Pharmacy should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Pharmacy increases the risk of CNS and respiratory depression in these patients.
