Drug Guide
Hydrocodone Bitartrate and Acetaminophen
Classification
Therapeutic: Analgesic and Antipyretic
Pharmacological: Opioid Agonist and NSAID combination (acetaminophen as NSAID)
FDA Approved Indications
- Moderate to severe pain
Mechanism of Action
Hydrocodone binds to opioid receptors in the central nervous system to provide analgesia and sedation. Acetaminophen acts centrally to inhibit prostaglandin synthesis, reducing pain and fever.
Dosage and Administration
Adult: As prescribed, typically every 4-6 hours as needed. Do not exceed 4 grams of acetaminophen per day to avoid toxicity.
Pediatric: Use only under medical supervision; dosage based on weight and age.
Geriatric: Start with lower dose due to increased sensitivity and monitor closely.
Renal Impairment: Adjust dose cautiously; regular monitoring recommended.
Hepatic Impairment: Use with caution; dose adjustment may be necessary due to increased risk of toxicity.
Pharmacokinetics
Absorption: Rapidly absorbed from gastrointestinal tract.
Distribution: Widely distributed; crosses the blood-brain barrier.
Metabolism: Hydrocodone metabolized in the liver via CYP3A4 and CYP2D6 pathways; acetaminophen metabolized in the liver.
Excretion: Renal excretion of metabolites.
Half Life: Hydrocodone approximately 3.3 hours; acetaminophen approximately 2-3 hours.
Contraindications
- Severe respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting
- Use of monoamine oxidase inhibitors within 14 days
Precautions
- History of hypersensitivity to opioids, hepatic impairment, addiction history, respiratory depression, head injury, increased intracranial pressure
Adverse Reactions - Common
- Drowsiness (Common)
- Nausea (Common)
- Dizziness (Common)
- Constipation (Common)
Adverse Reactions - Serious
- Respiratory depression (Serious)
- Hepatotoxicity (from acetaminophen overdose) (Serious)
- Allergic reactions, including rash and pruritus (Less common)
Drug-Drug Interactions
- CNS depressants, alcohol, other acetaminophen-containing products, CYP3A4 inhibitors and inducers
Drug-Food Interactions
- Alcohol can increase hepatotoxicity risk
Drug-Herb Interactions
- St. John’s Wort may affect metabolism
Nursing Implications
Assessment: Monitor pain relief, respiratory status, hepatic function, signs of opioid misuse.
Diagnoses:
- Pain, Acute
- Risk for Respiratory Depression
- Impaired Liver Function
Implementation: Administer with food if GI upset occurs; monitor for signs of overdose or toxicity; check LFTs periodically.
Evaluation: Effective pain relief without adverse effects; hepatic function remains stable.
Patient/Family Teaching
- Take as prescribed; do not exceed recommended dose.
- Avoid alcohol and other CNS depressants.
- Report signs of allergic reactions or difficulty breathing.
- Be aware of potential for addiction and misuse.
Special Considerations
Black Box Warnings:
- Addiction, abuse, and misuse; respiratory depression leading to death
Genetic Factors: Metabolism varies with CYP2D6 polymorphisms, affecting opioid efficacy.
Lab Test Interference: May cause elevated liver enzymes or interfere with tests of liver function.
Overdose Management
Signs/Symptoms: Respiratory depression, somnolence, cyanosis, pin-point pupils, hypothermia, coma.
Treatment: Administer naloxone promptly; support airway and breathing; provide supportive care and monitoring for hepatic toxicity.
Storage and Handling
Storage: Store at room temperature, away from moisture, heat, and light.
Stability: Stable under recommended conditions; check manufacturer instructions.