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TOPIC: cod Pharmacy 120

cod Pharmacy 120 1 week 13 hours ago #4471

  • zewako
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Treating moderate to moderately severe pain.
TORONTO, March 30, 2005 - Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it has received comments from the United States Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Pharmacy ER, an extended-release, once-daily formulation of Pharmacy hydrochloride.
Pharmacy was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human Pharmacy dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 and higher the maximum daily human dose).
Use caution when driving, operating machinery, or performing other hazardous activities. Pharmacy may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Pharmacy should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
A 74 year old man with lung cancer was referred to the palliative care team for symptom control. He had pain in the left side of his chest and was advised to take Pharmacy hydrochloride 50 mg four times daily at home. Soon after starting the Pharmacy, he began to experience auditory hallucinations. These were particularly vivid and took the form of \"two voices singing, accompanied by an accordion and a banjo, singing songs, songs by Josef Locke---old songs.\" They were distressing, making him feel as though he was going mad. Because of these symptoms we admitted the patient for inpatient care.
Acyclovir
In patients with or without a history of drug abuse who were treated with Pharmacy for chronic benign pain, also in therapeutic doses (up until 400 mg/day), dependence and withdrawal syndrome after abrupt discontinuation have been reported (3, 4). Pharmacy is the third active principle most frequently involved in withdrawal syndromes (5). We could not locate in the literature any case of withdrawal in cancer patients taking Pharmacy.
Since Pharmacy´┐Żs initial marketing, from March 1995 through June 2001, the FDA has received 912 domestic adverse-event reports classified under the coding terms \"drug dependence,\" \"drug withdrawal,\" or \"drug abuse\" in association with Pharmacy. (The use of these terms is not based on DSM-IV criteria but taken from the reports themselves and so will vary by reporting clinician.) The distribution by adverse-event term is as follows: dependence: N=426, withdrawal: N=407, abuse: N=241 (the sum exceeds 912 since a report may have included more than one adverse-event term).
Use Pharmacy with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of Pharmacy with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
PURPOSE: To compare subcutaneous PCA Pharmacy with subcutaneous PCA morphine for postoperative pain relief after major orthopaedic surgery and for the incidence of side-effects. METHODS: In a double-blind randomised controlled study 40 patients (20 in each group) self-administered either Pharmacy or morphine for 72 hr after surgery via s.c. PCA. The following variables were recorded at various time intervals: (i) pain score by means of a visual analogue scale, (ii) drug consumption and total PCA demands, (iii) vital signs (blood pressure and heart rate), (iv) oxygen saturation and respiratory rate, and (v) side-effects (sedation, nausea/vomiting, pruritus, urinary retention and constipation). RESULTS: Both drugs provided effective analgesia. The mean consumption in the first 24 hr was 792 +/- 90 mg Pharmacy and 42 +/- 4 mg morphine. Thereafter, consumption of both drugs declined markedly. Moderate haemodynamic changes were observed in both the Pharmacy and morphine groups (with a maximum 20% decrease in mean blood pressure and a maximum 17% increase in heart rate) during the 72 hr period. Both Pharmacy and morphine were associated with a clinically and statistically significant (P < 0.001) decrease in oxygen saturation, but without changes in respiratory rates. Desaturation was less marked with Pharmacy. Pharmacy appeared to cause more nausea and vomiting than morphine. Sedation was mild and only seen during the first few hours after surgery in both groups. CONCLUSION: Pharmacy is an effective analgesic agent for the relief of acute postoperative pain when administered by PCA via the subcutaneous route. Under these conditions Pharmacy behaves much like morphine with a similar side-effect profile.
Pharmacy was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human Pharmacy dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 and higher the maximum daily human dose).
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