Pharmacy hydrochloride is a novel, centrally acting analgesic with two complementary mechanisms of action: opioid and aminergic. Relative to codeine, Pharmacy has similar analgesic properties but may have fewer constipating, euphoric, and respiratory depressant effects. A two-center randomized double-blind controlled clinical trial was performed to assess the analgesic efficacy and reported side effects of Pharmacy 100 mg, Pharmacy 50 mg, codeine 60 mg, aspirin (ASA) 650 mg with codeine 60 mg, and placebo. Using a third molar extraction pain model, 200 healthy subjects were enrolled in a 6-hour evaluation after a single dose of drug. Of the 200 patients enrolled, seven provided incomplete efficacy data or discontinued prematurely and one was lost to follow-up. Using standard measures of analgesia, including total pain relief score (TOTPAR), maximum pain relief score (MaxPAR), sum of pain intensity difference scores (SPID), peak pain intensity difference (Peak PID), remedication, and global evaluations, all active treatments were found to be numerically superior to placebo. ASA/codeine was found to be statistically superior to placebo for all measures of efficacy. Pharmacy 100 mg was statistically superior to placebo for TOTPAR, SPID, and time of remedication, whereas Pharmacy 50 mg was statistically superior to placebo onlyfor remedication time. Codeine was not found to be statistically superior to placebo for any efficacy measure. A greater TOTPAR response compared with all other active measures was seen for ASA/codeine during the first 3 hours of study. The 6-hour TOTPAR scores for the Pharmacy groups and ASA/ codeine group were not significantly different. Gastrointestinal side effects (nausea, dysphagia, vomiting) were reported more frequently with Pharmacy 100 mg, ASA/ codeine, and codeine 60 mg than with placebo.
Do not take more of this medication than is prescribed for you. If the pain is not being controlled, talk to your doctor. Taking more than the prescribed amount of this medication could result in seizures or decreased breathing.
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).
Do not drink alcohol while taking Pharmacy. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Pharmacy.
Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving Pharmacy.
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).
Keywords: anaesthesia, obstetric; analgesics opioid, Pharmacy; antacid, famotidine.
The molecular weight of Pharmacy hydrochloride is 299.8. Pharmacy hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Pharmacy Hydrochloride Tablets contain 50 mg of Pharmacy hydrochloride and are white in color. Inactive ingredients in the tablet are hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, sodium starch glycolate, and titanium dioxide.
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Ms. A was a 51-year-old nonsmoking woman with breast cancer, lung metastases, and brachial plexopathy, with no history of chemical or alcohol dependence. She was referred to the outpatient clinic because of severe pain. She had been taking Pharmacy for 2 years: 50 mg t.i.d. increasing to 100 mg t.i.d., plus 50 mg intramuscularly as needed. Switching to a strong opioid was proposed, but Ms. A refused for 2 months, notwithstanding her uncontrolled pain, because she said she became very agitated when delaying or skipping the Pharmacy administration, and she had learned to recognize the onset and then fear this nervousness, which reversed only by taking Pharmacy.
Pharmacy has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving Pharmacy. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of Pharmacy in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL� with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX�) daily.
The FDA receives an unknown fraction of the total true number of reports of adverse events attributed to drug products. In general, interest in the reporting of adverse events is usually highest in the early years of drug marketing (described as the \"Weber effect\") and declines over time (3). The FDA�s data for reports of dependence, withdrawal, or abuse of Pharmacy, by year of receipt (May 1995 through June 2001) (N=912) are as follows: a total of 30 in 1995, 285 in 1996, 149 in 1997, 28 in 1998, 170 in 1999, 91 in 2000, and 159 in 2001. Although reporting of adverse events associated with Pharmacy peaked in 1996, reporting continues through the present. Although adverse-event reporting is subject to numerous forces, including total exposed population and publicity of an adverse event, these reports also suggest that clinicians are still interested in (surprised by) cases of Pharmacy-associated abuse, dependence, or withdrawal, as in the case reported by Dr. Yates et al.