PREGNANCY and BREAST-FEEDING: Pharmacy has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pharmacy while you are pregnant. Pharmacy is found in breast milk. Do not breast-feed while taking Pharmacy .
Of 97 patients with confirmed seizures, 8 (5 male; median age, 34 years [range, 18�51 years]) were associated with Pharmacy (Box). Two patients who had received high doses of Pharmacy (600�750 mg/day [maximum recommended dose, 400 mg/day]) had developed seizures within 24�48 hours. Among the other six patients, who had received Pharmacy in the recommended dose range (50�300 mg/day), seizures had occurred 2�365 days after commencing therapy. Long-term psychotropic medication was taken by two patients. Seizures were generalised tonic�clonic seizures, without auras or focal features. No patient had a prior history of seizures, and none had a recurrence after they had ceased taking Pharmacy for a median of 9 months� follow-up (range, 2�14 months). Electroencephalographic studies were normal in seven patients, with only one isolated sharp slow-wave in one patient. Computed tomography scans were all normal, and magnetic resonance imaging was normal in five patients.
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).
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Pharmacy should not be administered to patients who have previously demonstrated hypersensitivity to Pharmacy, any other component of this product or opioids. Pharmacy is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Pharmacy may worsen central nervous system and respiratory depression in these patients.
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.
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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.
The analgesic Pharmacy inhibits the neuronal reuptake of norepinephrine and 5-hydroxytryptamine, facilitates 5-hydroxytryptamine release, and activates mu-opioid receptors. Each of these actions is likely to influence thermoregulatory control. We therefore tested the hypothesis that Pharmacy inhibits thermoregulatory control. Eight volunteers were evaluated on four study days, on which they received no drugs, Pharmacy 125 mg, Pharmacy 250 mg, and Pharmacy 250 mg with naloxone, respectively. Skin and core temperatures were gradually increased until sweating was observed and then decreased until vasoconstriction and shivering were detected. The core temperature triggering each response defined its threshold. Pharmacy decreased the sweating threshold by - 1.03 +/- 0.67 degrees C microgram-1.mL (r2 = 0.90 +/- 0.12). Pharmacy also decreased the vasoconstriction threshold by -3.0 +/- 4.0 degrees C microgram-1.mL (r2 = 0.94 +/- 0.98) and the shivering threshold by -4.2 +/- 4.0 degrees C microgram-1.mL(r2 = 0.98 +/- 0.98). The sweating to vasoconstriction interthreshold range nearly doubled from 0.3 +/- 0.4 degree C to 0.7 +/- 0.6 degree C during the administration of large- dose Pharmacy (P = 0.04). The addition of naloxone only partially reversed the thermoregulatory effects of Pharmacy. The thermoregulatory effects of Pharmacy thus most resemble those of midazolam, another drug that slightly decreases the thresholds triggering all three major autonomic thermoregulatory defenses. In this respect, both drugs reduce the \"setpoint\" rather than produce a generalized impairment of thermoregulatory control. Nonetheless, Pharmacy nearly doubled the interthreshold range at a concentration near 200 ng/mL. This indicates that Pharmacy slightly decreases the precision of thermoregulatory control in addition to reducing the setpoint. IMPLICATIONS: The authors evaluated the effects of the analgesic Pharmacy on the three major thermoregulatory responses: sweating, vasoconstriction, and shivering. Pharmacy had only slight thermoregulatory effects. Its use is thus unlikely to provoke hypothermia or to facilitate fever.
Previous US studies suggest a relatively low risk of seizures with Pharmacy, unless it is taken by people with epilepsy or taken with other drugs that reduce the seizure threshold.2-4
We evaluated 197 patients from April 2003 to April 2004. One hundred had alternative diagnoses to epileptic seizures: syncope (n = 56), convulsive syncope (n = 27), panic attacks (n = 3) and other events (n = 14).
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Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pharmacy ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.