Drug Guide
Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride
Classification
Therapeutic: Narcotic analgesic and decongestant combination
Pharmacological: Hydrocodone: Opioid receptor agonist; Pseudoephedrine: Sympathomimetic decongestant
FDA Approved Indications
- Relief of cough and nasal congestion associated with upper respiratory infections
Mechanism of Action
Hydrocodone binds to mu-opioid receptors in the central nervous system, altering the response to pain and suppressing cough. Pseudoephedrine stimulates alpha-adrenergic receptors causing vasoconstriction in the nasal mucosa, leading to decongestion.
Dosage and Administration
Adult: Dose varies; typically 5-10 mg hydrocodone and 60 mg pseudoephedrine every 4-6 hours as needed, not to exceed recommended daily limits.
Pediatric: Use is not generally recommended; consult specific pediatric guidelines.
Geriatric: Start at lower doses; monitor closely for adverse reactions and accumulation.
Renal Impairment: Use with caution; dose adjustments may be necessary.
Hepatic Impairment: Use with caution; dose adjustments may be necessary.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Hydrocodone: extensive distribution; pseudoephedrine: moderate distribution.
Metabolism: Hydrocodone extensively metabolized in the liver; pseudoephedrine minimally metabolized, primarily excreted unchanged.
Excretion: Renal; elimination half-life approximately 3-4 hours for hydrocodone, 5-8 hours for pseudoephedrine.
Half Life: Hydrocodone: 3-4 hours; pseudoephedrine: 5-8 hours.
Contraindications
- Severe respiratory depression
- Acute or severe bronchial asthma
- Known hypersensitivity to hydrocodone or pseudoephedrine
Precautions
- Use with caution in patients with head injury, increased intracranial pressure, or mood disorders; risk of dependence and abuse; monitor for respiratory depression.
Adverse Reactions - Common
- Drowsiness, dizziness (Common)
- Nausea, constipation (Common)
Adverse Reactions - Serious
- Respiratory depression (Serious (rare))
- Addiction, overdose (Serious (rare))
Drug-Drug Interactions
- CNS depressants, other opioid analgesics, monoamine oxidase inhibitors
Drug-Food Interactions
- Alcohol (enhances sedative effects)
Drug-Herb Interactions
- St. John's Wort (may increase CNS depression)
Nursing Implications
Assessment: Monitor respiratory status, level of consciousness, effectiveness of cough and congestion relief.
Diagnoses:
- Risk for respiratory depression
- Impaired comfort related to cough and congestion
Implementation: Administer with food to decrease gastrointestinal upset; monitor for signs of abuse or misuse.
Evaluation: Assess for effective relief of cough and congestion, and monitor for adverse effects.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Do not operate heavy machinery or drive until effects are known.
- Be aware of potential for dependence.
- Avoid alcohol and other CNS depressants.
- Report any signs of respiratory depression or allergic reactions.
Special Considerations
Black Box Warnings:
- Respiratory depression, addiction, accidental ingestion by children leading to overdose and death.
Genetic Factors: Genetic polymorphisms may affect metabolism of hydrocodone, influencing efficacy and risk of adverse effects.
Lab Test Interference: Pseudoephedrine can cause false positives in urine drug screenings for amphetamines.
Overdose Management
Signs/Symptoms: Drowsiness, respiratory depression, pinpoint pupils, unconsciousness.
Treatment: Supportive care including respiratory support; naloxone for hydrocodone overdose; manage symptoms and provide symptomatic treatment.
Storage and Handling
Storage: Store at room temperature, away from light and moisture.
Stability: Stable under recommended storage conditions for the duration of the shelf life.