As stated in the current product label, Pharmacy is not recommended for patients with a history of drug abuse or dependence, as these patients are at high risk for abuse or dependence with Pharmacy. In addition, and of particular relevance to the issue raised by Dr. Yates et al., the recently revised (August 2001) approved product label for Pharmacy states that dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain Pharmacy, are not limited to patients with a prior history of opioid dependence.
What should I discuss with my healthcare provider before taking Pharmacy?
Pharmacy is used for shot-term use only. I�m talking about not recommended for everyday use pass the 5 day mark, because the risk of getting addicted to Pharmacy is greater after 5 days. Unless appointed by a physician, you should only use Pharmacy for acute pain that will not go away.
A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m2 or 0.36 times the maximum daily human dosage of 246 mg/m2) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m2, or 0.73 times the maximum daily human dosage).
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.
Healthy elderly subjects aged 65 to 75 years have plasma Pharmacy concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. In subjects over 75 years, maximum serum concentrations are elevated (208 vs. 162 ng/mL) and the elimination half-life is prolonged (7 vs. 6 hours) compared to subjects 65 to 75 years of age. Adjustment of the daily dose is recommended for patients older than 75 years (see DOSAGE AND ADMINISTRATION).
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Conclusion. A single i.m. dose of Pharmacy is useful pre-treatment to minimize the risk of acid aspiration during operation, and in improving pain relief during 24 h after surgery.
Since Pharmacy�s 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).
A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m2 or 0.36 times the maximum daily human dosage of 246 mg/m2) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m2, or 0.73 times the maximum daily human dosage).
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In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg Pharmacy tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg.
