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PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN
Overview
What is PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
Propoxyphene Napsylate, USP is an odorless, white crystalline solid with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS, 1 )-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72.
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 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride.
Each tablet of propoxyphene napsylate and acetaminophen contains 100 mg (176.8 μmol) propopoxyphene napsylate and 650 mg (4,300 μmol) acetaminophen.
Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose 2910 6cP, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, and stearic acid. Each white tablet also contains hypromellose 2910 3cP, hypromellose 2910 6cP, hypromellose 2910 50cP, polydextrose, polyethylene glycol 8000, titanium dioxide and triacetin. Each pink tablet also contains FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, polyethylene glycol 8000, titanium dioxide and triacetin.
What does PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN look like?
What are the available doses of PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
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What should I talk to my health care provider before I take PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
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How should I use PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
Propoxyphene napsylate and acetaminophen tablets, 100 mg/650 mg are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.
These products are given orally. The usual dosage is 100 mg propoxyphene napsylate and 650 mg acetaminophen every 4 hours as needed for pain. The maximum recommended dose of propoxyphene napsylate is 600 mg per day.
Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.
What interacts with PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
Hypersensitivity to propoxyphene or acetaminophen
What are the warnings of PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
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What are the precautions of PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
General:
Propoxyphene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur.
Patient Information
A Patient Information Sheet is available for this product. A separate Patient Information Sheet is available for this drug product.
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.
Pediatric Use
Propoxyphene is not recommended to use in pediatric patients, because documented clinical experience has been insufficient to establish safety and suitable dosage regimen in the pediatric age group.
Geriatric Use
The rate of propoxyphene metabolism may be reduced in some patients. Increased dosing interval should be considered.
What are the side effects of PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
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 were 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, hallucinations, and minor visual disturbances.
Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophen tablets, USP. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see ). In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred.
Renal papillary necrosis may result from chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin.
Subacute painful myopathy has occurred following chronic propoxyphene overdosage.
What should I look out for while using PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
Hypersensitivity to propoxyphene or acetaminophen
What might happen if I take too much PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdose. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts.
Initial consideration should be given to the management of the CNS effects of propoxyphene overdosage. Resuscitative measures should be initiated promptly.
How should I store and handle PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in:The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows:Bottles of 100 NDC 62037-930-01Bottles of 500 NDC 62037-930-05The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows:Bottles of 100 NDC 62037-931-01Bottles of 500 NDC 62037-931-05Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Manufactured by:Andrx Pharmaceuticals, Inc.Ft. Lauderdale, FL 33314Rev date: 01/047360
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 2.5 hours. After a 100 mg oral dose of propoxyphene napsylate, peak plasma levels of 0.05 to 0.1 mcg/mL are achieved. As shown in , the napsylate salt tends to be absorbed more slowly than the hydrochloride. At or near therapeutic doses, this absorption difference is small when compared with that among subjects and among doses.
Because of this several hundredfold difference in solubility, the absorption rate of very large doses of the napsylate salt is significantly lower than that of equimolar doses of the hydrochloride.
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 (PR and QRS intervals) was prolonged. Any intracardiac conduction delay attributable to high concentrations of norpropoxyphene may be of relatively long duration.
Non-Clinical Toxicology
Hypersensitivity to propoxyphene or acetaminophenThe 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.
Propoxyphene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur.
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 were 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, hallucinations, and minor visual disturbances.
Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophen tablets, USP. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see ). In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred.
Renal papillary necrosis may result from chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin.
Subacute painful myopathy has occurred following chronic propoxyphene overdosage.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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