Generic Name

Hydrocodone Polistirex and Chlorpheniramine Polistirex

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Classification

FDA Approved Indications

• Relief of cough and upper respiratory symptoms associated with allergic or non-allergic rhinitis, sinusitis, or common cold

Mechanism of Action

Hydrocodone, an opioid agonist, suppresses cough reflex in the brainstem; Chlorpheniramine, an antihistamine, blocks H1 receptors reducing allergy symptoms and also has anticholinergic effects.

Dosage and Administration

Adult: As prescribed, typically every 12 hours; monitor for dose adjustments based on response and tolerability.

Pediatric: Not recommended for children under 6 years due to risk of respiratory depression.

Geriatric: Start with lower dose; closely monitor due to increased sensitivity and potential for side effects.

Renal Impairment: Use with caution; dose adjustment may be necessary.

Hepatic Impairment: Use with caution; adjust dose based on hepatic function.

Pharmacokinetics

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed, crosses blood-brain barrier.

Metabolism: Hydrocodone primarily metabolized in the liver via CYP450 enzymes; chlorpheniramine undergoes hepatic metabolism.

Excretion: Renal excretion of metabolites; half-life approximately 4-6 hours for hydrocodone, slightly longer in hepatic impairment.

Half Life: Hydrocodone: approximately 3.8 hours, extended with polistirex formulation.

Contraindications

• hypersensitivity to opioid or antihistamine components
• children under 6 years
• respiratory depression or severe respiratory compromise

Precautions

• Use cautiously in patients with history of substance abuse, hepatic or renal impairment, respiratory depression, or head injury. Pregnancy category C; use only if clearly needed.

Adverse Reactions - Common

• Drowsiness, dizziness (Common)
• Dry mouth, nausea (Common)
• Constipation, urinary retention (Common)

Adverse Reactions - Serious

• Respiratory depression (Serious (rare))
• High or low blood pressure, arrhythmias (Serious)
• Dependence, addiction (Serious)

Drug-Drug Interactions

• CNS depressants, other sedatives, alcohol, MAO inhibitors, serotonergic drugs

Drug-Food Interactions

• Alcohol, sedatives

Drug-Herb Interactions

• St. John’s Wort, Kava, Valerian

Nursing Implications

Patient/Family Teaching

• Do not operate heavy machinery or drive until response is known.
• Avoid alcohol and sedatives.
• Report new or worsening symptoms, especially respiratory depression.
• Use as directed; do not exceed prescribed dose.

Special Considerations

Black Box Warnings:

• Potential for addiction, abuse, and misuse; respiratory depression, especially in children and in those not opioid-tolerant.

Genetic Factors: Variability in CYP2D6 metabolism can affect hydrocodone efficacy and safety.

Lab Test Interference: None significant reported.

Overdose Management

Signs/Symptoms: Respiratory depression, somnolence, miosis, coma.

Treatment: Supportive care; administer naloxone if respiratory depression persists or is severe; ensure airway patency, administer oxygen, and provide symptomatic treatment.

Storage and Handling

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

Stability: Stable for the duration of the expiration date on the package.