Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1151
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Darvocet-N (Tablet, Film Coated)
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Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (��S,1R)-��-[2-(Dimethylamino)-1-methylethyl]-��-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8��mol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9��mol) of propoxyphene hydrochloride. Each tablet of Darvocet-N 50 contains 50 mg (88.4��mol) propoxyphene napsylate and 325 mg (2,150��mol) acetaminophen. Each tablet of Darvocet-N 100 contains 100 mg (176.8��mol) propoxyphene napsylate and 650 mg (4,300��mol) acetaminophen. Each tablet also contains amberlite, cellulose, F D&C Yellow No. 6, magnesium stearate, stearic acid, titanium dioxide, and other inactive ingredients.
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Hypersensitivity to propoxyphene or acetaminophen.
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Darvocet-N Tablets are available in: The 50mg tablets are dark orange, capsule shaped, film-coated and imprinted with the script "DARVOCET-N 50" on one side of the tablet, using edible black ink. They are available as follows: Bottles of 100 NDC 66479-514-10 The 100mg tablets are dark orange, capsule shaped, film-coated, and imprinted with the script "DARVOCET-N 100" on one side of the tablet, using edible black ink. They are available as follows: Bottles of 100 NDC 66479-515-10 Bottles of 500 NDC 66479-515-50 Store at 25��C (77��F); excursions are permitted to 15��- 30��C (59��- 86��F) [see USP Controlled Room Temperature] The following information, including description of dosage forms and the maximum daily dosage of each, is available to patients receiving Darvon products.
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WARNINGS: Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes). Propoxyphene shouldnot be taken in doses higher than those recommended by the physician. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.
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General���Propoxyphene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur. Drug Interactions���The CNS-depressant effect of propoxyphene is additive with that of other CNS depressants, including alcohol. As is the case with many medicinal agents, propoxyphene may slow the metabolism of a concomitantly administered drug. Should this occur, the higher serum concentrations of that drug may result in increased pharmacologic or adverse effects of that drug. Such occurrences have been reported when propoxyphene was administered to patients on antidepressants, anticonvulsants, or warfarin-like drugs. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine. Usage in Pregnancy���Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Instances of withdrawal symptoms in the neonate have been reported following usage during pregnancy. Therefore, propoxyphene should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards. Usage in Nursing Mothers���Low levels of propoxyphene have been detected in human milk. In postpartum studies involving nursing mothers who were given propoxyphene, no adverse effects were noted in infants receiving mother's milk. Usage in Pediatric Patients���Safety and effectiveness in pediatric patients have not been established. Usage in the Elderly���The rate of propoxyphene metabolism may be reduced in some patients. Increased dosing interval should be considered. A Patient Information Sheet is available for this product. See text following "How Supplied" section below.
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propoxyphene napsylate and acetaminophen
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| dailymed-instance:fullName |
Darvocet-N (Tablet, Film Coated)
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| dailymed-instance:warning |
Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes). Propoxyphene shouldnot be taken in doses higher than those recommended by the physician. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.
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| dailymed-instance:name |
Darvocet-N
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