Generic Name

Benzhydrocodone Hydrochloride with Acetaminophen

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Classification

FDA Approved Indications

• Relief of acute pain severe enough to require opioid analgesic and for which alternative treatments are inadequate

Mechanism of Action

Benzhydrocodone binds to and activates opioid receptors in the central nervous system, altering the perception of and response to pain. Acetaminophen inhibits prostaglandin synthesis in the CNS, providing analgesic and antipyretic effects.

Dosage and Administration

Adult: Typically, 1-2 tablets every 4-6 hours as needed, not to exceed 12 tablets per day.

Pediatric: Not recommended for use in children under 18 years of age.

Geriatric: Adjust dosage carefully, usually starting at the lower end of dosing range due to increased risk of adverse effects.

Renal Impairment: Use with caution; dosage adjustments may be necessary.

Hepatic Impairment: Use with caution; dose adjustments recommended, particularly due to acetaminophen's hepatotoxicity risk.

Pharmacokinetics

Absorption: Rapidly absorbed from the gastrointestinal tract.

Distribution: Widely distributed throughout the body, crosses the blood-brain barrier.

Metabolism: Metabolized in the liver via conjugation pathways.

Excretion: Primarily excreted in urine.

Half Life: Approximately 3.5 hours for benzhydrocodone; 2-3 hours for acetaminophen.

Contraindications

• Known hypersensitivity to benzhydrocodone, acetaminophen, or any component of the formulation.
• Use caution in patients with impaired respiratory function, particularly respiratory depression.
• Use with caution in head trauma or increased intracranial pressure.

Precautions

• Risk of respiratory depression, addiction, and overdose.
• Hepatotoxicity risk from acetaminophen, especially at high doses or with chronic use.
• Potential for interaction with CNS depressants, sedatives, and alcohol.

Adverse Reactions - Common

• Drowsiness (Common)
• Dizziness (Common)
• Nausea (Common)
• Constipation (Common)

Adverse Reactions - Serious

• Respiratory depression (Rare)
• Hepatotoxicity (due to acetaminophen overdose) (Rare)
• Anaphylaxis (Rare)

Drug-Drug Interactions

• Other CNS depressants, sedatives, tranquilizers
• Alcohol
• MAO inhibitors

Drug-Food Interactions

• Alcohol (increase risk of liver toxicity)

Drug-Herb Interactions

• Avoid use with herbs that affect CYP450 enzymes or hepatotoxic herbs

Nursing Implications

Patient/Family Teaching

• Do not exceed prescribed dose of acetaminophen to avoid liver damage.
• Avoid alcohol and other CNS depressants.
• Report symptoms of allergic reactions like rash, difficulty breathing, or swelling.
• Seek immediate medical attention if overdose symptoms occur.

Special Considerations

Black Box Warnings:

• Respiratory depression is a serious hazard, especially in children and in opioid-naive patients.
• Addiction, abuse, and misuse can lead to overdose and death.
• Hepatotoxicity: high doses or chronic use of acetaminophen can cause severe liver injury.
• Accidental ingestion of even one dose of an opioid can be fatal, especially in children.

Genetic Factors: Genetic variations in CYP2D6 enzyme activity may affect drug metabolism.

Lab Test Interference: May interfere with certain liver function tests or urine drug screens.

Overdose Management

Signs/Symptoms: Respiratory depression, extreme drowsiness, cold and clammy skin, pinpoint pupils, coma.

Treatment: Administer naloxone for opioid overdose, provide supportive respiratory and cardiovascular care, and monitor patient closely.

Storage and Handling

Storage: Store at room temperature, away from moisture, light, and children.

Stability: Stable under recommended storage conditions for the duration of the shelf life.