Drug Guide
Propoxyphene Hydrochloride with Aspirin and Caffeine
Classification
Therapeutic: Analgesic, Non-opioid combination
Pharmacological: NSAID analgesic combination
FDA Approved Indications
- Relief of mild to moderate pain
Mechanism of Action
Propoxyphene is a narcotic analgesic that acts on the CNS to produce analgesia and sedation. Aspirin provides anti-inflammatory, analgesic, and antipyretic effects via inhibition of cyclooxygenase enzymes. Caffeine acts as a central nervous system stimulant, enhancing the analgesic effect and reducing fatigue.
Dosage and Administration
Adult: As prescribed, usually 65-130 mg every 4 hours as needed, not exceeding 6 grams per day.
Pediatric: Not recommended for children due to safety concerns.
Geriatric: Use caution; start at lower doses and monitor closely for adverse effects.
Renal Impairment: Adjust dose as necessary, monitor renal function.
Hepatic Impairment: Use with caution; dose adjustments may be necessary.
Pharmacokinetics
Absorption: Rapid after oral administration.
Distribution: Widely distributed; crosses the blood-brain barrier.
Metabolism: Metabolized in the liver.
Excretion: Excreted mainly via the kidneys.
Half Life: Propoxyphene approximately 6-8 hours; caffeine approximately 3-7 hours.
Contraindications
- Hypersensitivity to propoxyphene, aspirin, caffeine.
- Use in respiratory depression, acute asthma, or nasal polyps.
Precautions
- History of opioid addiction, history of hepatic disease, bleeding disorders, or gastrointestinal bleeding. Use with caution in the elderly and patients with compromised renal or hepatic function.
Adverse Reactions - Common
- Nausea (Common)
- Drowsiness (Common)
- Dizziness (Common)
Adverse Reactions - Serious
- Respiratory depression (Rare)
- Hepatotoxicity (Rare)
- Allergic reactions including skin rash (Rare)
Drug-Drug Interactions
- MAO inhibitors, other CNS depressants, anticoagulants
- Caffeine (with other stimulants)
Drug-Food Interactions
- Avoid alcohol, which can increase sedation and risk of gastrointestinal bleeding
Drug-Herb Interactions
- Potential interactions with St. John's Wort, valerian, or other CNS-active herbs
Nursing Implications
Assessment: Monitor pain relief, respiratory status, hepatic and renal functions.
Diagnoses:
- Impaired breathing, risk of drug dependence, risk for gastrointestinal bleeding.
Implementation: Administer with food if gastrointestinal upset occurs. Monitor for signs of opioid toxicity. Educate patient on avoiding other CNS depressants.
Evaluation: Assess pain relief, respiratory status, and adverse effects periodically.
Patient/Family Teaching
- Inform about potential for drowsiness, dizziness, and sedation.
- Advise against alcohol and other CNS depressants.
- Warn about signs of overdose and when to seek medical help.
Special Considerations
Black Box Warnings:
- Addiction, abuse, and misuse leading to overdose and death.
- Risk of respiratory depression.
- Potential for accidental overdose in children.
Genetic Factors: Genetic variations affecting CYP2D6 enzyme may influence metabolism of propoxyphene.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Respiratory depression, somnolence, pinpoint pupils, coma, hypotension.
Treatment: Supportive care; possibly naloxone for opioid overdose, activated charcoal to prevent absorption, ventilatory support.
Storage and Handling
Storage: Store at room temperature away from moisture and light.
Stability: Stable under recommended storage conditions.