Pharmacy should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from Pharmacy may obscure the existence, extent, or course of intracranial pathology.
This medicine will add to the effects of alcohol and other CNS depressants (medicine that causes drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine .
Australian drug regulatory authorities have received 171 reports of suspected adverse reactions with the pain drugs Pharmacy (ULTRAM) or Pharmacy in combination with acetaminophen (ULTRACET) since Ultram began being marketed in Australia in late 1998. In six of these reports, a very serious adverse reaction known as the serotonin syndrome was listed as the adverse reaction.
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.
Do not take Pharmacy without first talking to your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Pharmacy, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Pharmacy is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant. It is also not known whether Pharmacy appears in breast milk. Do not take Pharmacy without first talking to your doctor if you are breast-feeding. If you are over 75 years of age, you may be more likely to experience side effects from Pharmacy. The maximum daily dose of Pharmacy for people over 75 years of age is 300 mg. Pharmacy is not approved by the FDA for use by children younger than 16 years of age.
Do not take Pharmacy without first talking to your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Pharmacy, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Pharmacy is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant. It is also not known whether Pharmacy appears in breast milk. Do not take Pharmacy without first talking to your doctor if you are breast-feeding. If you are over 75 years of age, you may be more likely to experience side effects from Pharmacy. The maximum daily dose of Pharmacy for people over 75 years of age is 300 mg. Pharmacy is not approved by the FDA for use by children younger than 16 years of age.
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 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.
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Pregnancy�Although studies on birth defects have not been done in pregnant women, Pharmacy has not been reported to cause birth defects. In animal studies, there were drug-related birth defects observed. Studies done in animals given very high (toxic) doses resulted in lower than normal birth weights and some deaths in the fetuses and birth defects in some of the newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
When used for long periods of time or at high doses, Pharmacy may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Pharmacy stops working well. Do not take more than prescribed.
Pharmacy may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
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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).
Opioid and spinal monoaminergic agonists have distinct analgesic properties, which may potentiate eachother. Pharmacy has both opioid and monoaminergic agonist actions. This initial study compared the analgesic and toxic effects of Pharmacy and morphine in patients with strong cancer pain.