Rx Product Guide

   
   
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Propoxyphene / Acetaminophen (pro-POX-ee-feen/ass-cet-ah-MEE-noe-fen)
Trade Name(s): Propoxyphene Hydrochloride/Acetaminophen
  Propoxyphene hydrochloride/Acetaminophen
  ·Tablets 65 mg propoxyphene hydrochloride/650 mg acetaminophen
Propoxyphene Napsylate/Acetaminophen
  Darvocet-N 50
  ·Tablets 50 mg propoxyphene napsylate/325 mg acetaminophen
  Darvocet A500
  ·Tablets 100 mg propoxyphene napsylate/500 mg acetaminophen
  Darvocet-N 100
  ·Tablets 100 mg propoxyphene napsylate/650?mg acetaminophen

Indicates Canadian Trade Name.


Class: Opioid analgesic combination

Action: Propoxyphene relieves pain by stimulating opiate receptors in CNS; causes respiratory depression; peripheral vasodilation, inhibition of intestinal peristalsis, sphincter of hepatopancreatic ampulla spasm, stimulation of receptors that cause vomiting, increased bladder tone. Acetaminophen inhibits synthesis of prostaglandins; does not have significant antiinflammatory effects or antiplatelet effects; produces antipyresis by direct action on the hypothalamic heat-regulating center.

Indications: Relief of mild to moderate pain; as analgesic-antipyretic in presence of aspirin allergy, hemostatic disturbances, bleeding diatheses, upper GI disease, and gouty arthritis.

Contraindications: Standard considerations.

Interactions:
Carbamazepine Increased carbamazepine serum levels; increased risk of acetaminophen hepatotoxicity.
Charcoal Decreased propoxyphene absorption.
Cigarette smoking Decreased propoxyphene effect because of liver enzyme induction.
CNS depressants (alcohol, antidepressants, barbiturates, muscle relaxants, sedatives, tranquilizers) Increased CNS and respiratory depression.
Hydantoins Increased risk of acetaminophen hepatotoxicity.
Sulfinpyrazone Increased risk of acetaminophen hepatotoxicity.
Warfarin Acetaminophen may potentiate the hypoprothrombinemic effect.
Lab Test Interferences: Increased amylase and lipase for up to 24 h after administration.

Adverse Reactions:

cardiovascular:
Hypotension.

cns:
Lightheadedness; weakness; fatigue; sedation; dizziness; disorientation; incoordination; paradoxical excitement; euphoria; dysphoria; insomnia; headache; hallucinations.

hepatic:
Abnormal LFTs; reversible jaundice (including cholestatic jaundice).

gi:
Nausea; vomiting; constipation; anorexia; abdominal pain; biliary spasm.

gu:
Urinary retention or hesitancy.

respiratory:
Dyspnea; depression of cough reflex.

specialsenses:
Minor visual disturbances.

miscellaneous:
Tolerance; psychological and physical dependence with long-term use; histamine release; skin rashes.
Precautions:
Warning: Do not prescribe propoxyphene for patients who are suicidal or addiction-prone. Prescribe with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.

Pregnancy: Category C ( Category D if used for prolonged periods).
Lactation: Excreted in breast milk.
Children: Safety and efficacy not established.
Renal function impairment: Use drug with caution; reduce total daily dosage; advise chronic alcoholics to limit acetaminophen intake to less than 2 ? g/day.
Hepatic function impairment: Use drug with caution; reduce total daily dosage; advise chronic alcoholics to limit acetaminophen intake to less than 2 ? g/day.
Special risk patients: Use with caution in patients with myxedema, acute alcoholism, acute abdominal conditions, ulcerative colitis, decreased respiratory reserve, head injury or increased cranial pressure, hypoxia, supraventricular tachycardia, depleted blood volume or circulatory shock.
Drug dependence Has abuse potential.
Fatalities Excessive doses, either alone or in combination with other CNS depressants (including alcohol), are major cause of drug-induced death.
Overdosage: Signs & symptoms CNS depression (stupor to coma), respiratory depression, hypotension, seizures, pulmonary edema, cardiac arrhythmias, respiratory-metabolic acidosis, Cheyne-Stokes respiration, apnea, circulatory collapse, death.

Patient/Family Education:
  • Advise patient to review patient information leaflet before using the first time and with each refill.
  • Advise patient to take prescribed dose without regard to meals but to take with food if GI upset occurs.
  • Advise patient using medication as needed to control pain not to wait until pain level is high to medicate because the medication may not be as effective.
  • Advise patient not to change the dose or stop taking unless advised by health care provider.
  • Caution patient not to exceed prescribed dose and to inform health care provider if prescribed dose does not adequately control pain.
  • Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
  • Advise patient that drug may impair judgment, thinking, or motor skills, or cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Caution patient that taking acetaminophen or other medications containing acetaminophen can be dangerous.


   
Activant AstraZeneca Boehringer Ingelheim Emdeon Endo eRx Network Genzyme Hamacher Health Across America HealthMart Pharmacy Johnson & Johnson Lilly McNeil Pediatrics Merck Novo Nordisk Ortho-McNeil PriCara Roche Scios Takeda Teva