Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Pain
Relief of mild to moderate pain. Therapy in combination with acetaminophen or aspirin or with aspirin and caffeine may result in greater analgesia; however, some studies have shown no difference in analgesia.
Dosage and Administration
Administration
Oral Administration
Administer orally.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as propoxyphene hydrochloride and propoxyphene napsylate; dosage expressed in terms of the salt.
Propoxyphene napsylate 100 mg is equivalent to propoxyphene hydrochloride 65 mg.
Adults
Pain
Oral
Propoxyphene hydrochloride: Usual dosage is 65 mg every 4 hours as needed. Doses <65 mg have questionable efficacy.
Propoxyphene napsylate: Usual dosage is 100 mg every 4 hours as needed.
Prescribing Limits
Adults
Pain
Oral
Propoxyphene hydrochloride: Maximum 390 mg daily.
Propoxyphene napsylate: Maximum 600 mg daily.
Special Populations
Hepatic Impairment
Consider dosage reduction.
Renal Impairment
Consider dosage reduction.
Geriatric Patients
Consider increase in dosing interval.
Cautions
Contraindications
Known hypersensitivity to propoxyphene or any ingredient in the formulation.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Opiate Withdrawal
Caution in patients dependent on opiates. Will not support morphine dependence; sudden substitution of usual propoxyphene dosage for opiates may result in acute opiate withdrawal symptoms. Avoid withdrawal symptoms by gradually reducing dosage of prior opiate as propoxyphene is substituted.
Abuse Potential
Possible tolerance, psychologic dependence, and physical dependence. Dependence liability is qualitatively similar to that of codeine, but quantitatively less.
CNS Depression
Performance of activities requiring mental alertness and physical coordination may be impaired.
Concurrent use of other CNS depressants may potentiate CNS depression. (See Specific Drugs under Interactions.)
Acute Toxicity
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Propoxyphene preparations alone or in combination with other CNS depressants (e.g., alcohol) are a major cause of drug-related deaths; usually related to intentional overdose, but may be accidental. (See Contraindications under Cautions.)
General Precautions
Fixed-Combination Products
When used in fixed combination with other drugs, consider the cautions, precautions, and contraindications associated with the other drug(s).
Specific Populations
Pregnancy
Category C (category D, if used for prolonged periods).
Manufacturer states that safe use during pregnancy has not been established. Cases of withdrawal symptoms in neonates reported following use during pregnancy. Use during pregnancy only when potential benefits outweigh possible risks to fetus.
Lactation
Distributed into milk in low concentrations. Use with caution; however, in postpartum studies involving nursing women who received propoxyphene, no adverse effects observed in breast-fed infants.
Pediatric Use
Safety and efficacy not established.
Geriatric Use
Potential for reduced rate of propoxyphene metabolism. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution; serum concentrations of the drug may be increased or elimination may be delayed. (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Use with caution; serum concentrations of the drug may be increased or elimination may be delayed. (See Renal Impairment under Dosage and Administration.)
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