Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3152
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Propoxyphene Hydrochloride&Acetaminophen (Tablet, Film Coated)
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| dailymed-instance:dosage |
This product is given orally. The usual dose is 65 mg propoxyphene hydrochloride and 650 mg acetaminophen every 4 hours as needed for pain. The maximum recommended dose of propoxyphene hydrochloride is 390 mg per day. Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.
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| dailymed-instance:descripti... |
Propoxyphene hydrochloride, USP is an odorless, white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is [S-(R*S*)]-��-[2-(dimethylamino)-1 methylethyl]-��-phenyl-benzene-ethanol, propanoate (ester) hydrochloride, which can be represented by the following structural formula: Acetaminophen, USP is a white, crystalline powder, possessing a slightly bitter taste. It is soluble in boiling water and freely soluble in alcohol. Chemically, it is N-Acetyl-p-aminophenol, which can be represented by the following structural formula: Each tablet for oral administration contains 65 mg of propoxyphene hydrochloride and 650 mg of acetaminophen and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, and FD&C Yellow #6 aluminum lake.
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| dailymed-instance:clinicalP... |
Propoxyphene is a centrally acting narcotic analgesic agent. Equimolar doses of propoxyphene hydrochloride or napsylate provide similar plasma concentrations. Following administration of 65, 130, or 195 mg of propoxyphene hydrochloride, the bioavailability of propoxyphene is equivalent to that of 100, 200, or 300 mg respectively of propoxyphene napsylate. Peak plasma concentrations of propoxyphene are reached in 2 to 2 1/2 hours. After a 65 mg oral dose of propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 mcg/mL are achieved. Repeated doses of propoxyphene at 6-hour intervals lead to increasing plasma concentrations, with a plateau after the ninth dose at 48 hours. Propoxyphene is metabolized in the liver to yield norpropoxyphene. Propoxyphene has a half-life of 6 to 12 hours, whereas that of norpropoxyphene is 30 to 36 hours. Norpropoxyphene has substantially less central nervous system depressant effect than propoxyphene, but a greater local anesthetic effect, which is similar to that of amitriptyline and antiarrhythmic agents, such as lidocaine and quinidine. In animal studies in which propoxyphene and norpropoxyphene were continuously infused in large amounts, intracardiac conduction time (P-R and QRS intervals) was prolonged. Any intracardiac conduction delay attributable to high concentrations of norpropoxyphene may be of relatively long duration.<br/>Actions: Propoxyphene is a mild narcotic analgesic structurally related to methadone. The potency of propoxyphene hydrochloride is from two-thirds to equal that of codeine. Propoxyphene hydrochloride and acetaminophen provide the analgesic activity of propoxyphene and the antipyretic-analgesic activity of acetaminophen. The combination of propoxyphene and acetaminophen produces greater analgesia than that produced by either propoxyphene or acetaminophen administered alone.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Hypersensitivity to propoxyphene or to acetaminophen.
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| dailymed-instance:supply |
Propoxyphene hydrochloride and Acetaminophen Tablets, USP are available containing 65 mg of propoxyphene hydrochloride, USP and 650 mg of acetaminophen, USP. The tablets are film-coated orange, capsule-shaped, and debossed with MYLAN 130. They are available as follows: NDC 0378-0130-01bottles of 100 tablets NDC 0378-0130-05bottles of 500 tablets STORE AT CONTROLLED ROOM TEMPERATURE 15�����30��C (59�����86��F). PROTECT FROM LIGHT. Dispense in a tight, light-resistant container using a child-resistant closure.
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| dailymed-instance:boxedWarn... |
WARNINGS: ���Do not prescribe propoxyphene for patients who are suicidal or addiction prone. ���Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol to excess. ���Tell your patients not to exceed the recommended dose and to limit their intake of alcohol. 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 should not 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 nonnarcotic 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:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:FD&C_Yellow_#6_aluminum_lake,
dailymed-ingredient:hydroxypropyl_cellulose,
dailymed-ingredient:hypromellose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:povidone,
dailymed-ingredient:pregelatinized_starch,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:stearic_acid,
dailymed-ingredient:talc,
dailymed-ingredient:titanium_dioxide
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| dailymed-instance:precautio... |
General: Propoxyphene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur.<br/>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.<br/>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 judgement of the physician, the potential benefits outweigh the possible hazards.<br/>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.<br/>Usage in Children: Propoxyphene is not recommended for use in children, because documented clinical experience has been insufficient to establish safety and a suitable dosage regimen in the pediatric age group.
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| dailymed-instance:genericMe... |
Propoxyphene Hydrochloride and Acetaminophen
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| dailymed-instance:fullName |
Propoxyphene Hydrochloride&Acetaminophen (Tablet, Film Coated)
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| dailymed-instance:adverseRe... |
In a survey conducted in hospitalized patients, less than 1% of patients taking propoxyphene hydrochloride at recommended doses experienced side effects. The most frequently reported have been dizziness, sedation, nausea, and vomiting. Some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, and minor visual disturbances. Liver dysfunction has been reported in association with both active components of propoxyphene hydrochloride and acetaminophen. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice. Hepatic necrosis may result from acute overdoses of acetaminophen . In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen doses of 2.5 to 10 g/day. Fatalities have occurred.
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| dailymed-instance:warning |
���Do not prescribe propoxyphene for patients who are suicidal or addiction prone. ���Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol to excess. ���Tell your patients not to exceed the recommended dose and to limit their intake of alcohol. 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 should not 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 nonnarcotic 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:indicatio... |
This product is indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.
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| dailymed-instance:name |
Propoxyphene Hydrochloride&Acetaminophen
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