Hydrocodone Bitartrate / Pseudoephedrine Hydrochloride

Pronunciation: HIGH-droe-KOE-dohn by-TAR-trate/SUE-doe-eh-FED-rin HIGH-droe-KLOR-ide
Class: Antitussive combination

Trade Names:
Detussin
- Liquid 5 mg hydrocodone bitartrate and 60 mg pseudoephedrine hydrochloride

Pharmacology

Hydrocodone

Suppresses cough reflex; stimulates opiate receptors in the CNS and peripherally blocks pain impulse generation.

Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, which promotes nasal drainage.

Indications and Usage

Suppression of cough and relief of nasal congestion and other symptoms associated with the common cold, allergies, hay fever, sinusitis, and other respiratory illnesses.

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Contraindications

Hypersensitivity to any component of product, or hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias. Patients known to be hypersensitive to other sympathomimetic amines may exhibit cross sensitivity with pseudoephedrine. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease, and patients on MAOI therapy. P-V-Tussin tablets are contraindicated in breast-feeding mothers because of the higher than usual risk for infants from sympathomimetic amines.

Dosage and Administration

Maximum dose
Adults

Hydrocodone 20 mg/day; pseudoephedrine 240 mg/day.

Adults

For specific dosing by product, refer to the individual manufacturer's prescribing information.

Cough and nasal congestion Liquid Usual dosage

5 mL (3 to 5 mg hydrocodone) to 10 mL (6 mg hydrocodone) 4 times daily as needed.

Maximum dosage

Hydrocodone 20 mg/day; pseudoephedrine 240 mg/day.

Tablets Usual dosage

1 tablet every 4 to 6 h as needed.

Maximum dosage

Hydrocodone 20 mg/day; pseudoephedrine 240 mg/day (4 tablets/day).

Storage/Stability

Store at 59° to 86°F. Keep tightly capped.

Drug Interactions

Alcohol, CNS depressants, narcotic analgesics, phenothiazines or other tranquilizers, sedative-hypnotics

Increased CNS depression (eg, drowsiness) may occur.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hydrocodone

Hypotension; bradycardia.

Pseudoephedrine

Cardiac arrhythmia; increased heart rate; increased BP.

CNS

Hydrocodone

Lightheadedness; dizziness; sedation; drowsiness; weakness; anxiety; fear; fatigue; dysphoria; psychological dependence; confusion.

Pseudoephedrine

Convulsions; CNS stimulation; hallucinations; tremors.

GI

Hydrocodone

Nausea; vomiting; constipation.

Genitourinary

Hydrocodone

Decreased urination; urethral spasm.

Pseudoephedrine

Dysuria.

Respiratory

Hydrocodone

Dyspnea; respiratory depression; irregular breathing.

Pseudoephedrine

Respiratory difficulties.

Miscellaneous

Pseudoephedrine

Pallor.

Precautions

Pregnancy

Consult health care provider before use.

Lactation

Consult health care provider before use.

Hydrocodone

Excreted in breast milk.

Special Risk Patients

As with any narcotic, P-V-Tussin tablets should be given with caution to certain patients such as the elderly or debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addison disease, prostatic hypertrophy or urethral stricture, asthma, and narrow angle glaucoma.

Dependence

Hydrocodone has abuse potential; may be habit forming.

Overdosage

Symptoms

Hydrocodone

Respiratory and CNS depression, circulatory collapse, cardiopulmonary arrest, death

Pseudoephedrine

Cardiac arrhythmias, cerebral hemorrhage, pulmonary edema, palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucination, delirium

Patient Information

  • Advise patient to take prescribed dose up to 4 times daily as needed.
  • Advise caregiver to use dosing spoon or syringe when giving elixir to children.
  • Advise patient to take with food or milk if GI upset occurs.
  • Advise patient to take last dose late in the afternoon or early evening to reduce chance of drug causing sleeplessness.
  • Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient not to double the dose to catch up.
  • Advise patient that if symptoms are not controlled, not to increase the dose of medication but to inform health care provider.
  • Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid alcohol and other CNS depressants because of risk of excessive sedation.
  • Caution patient not to take any OTC decongestants while taking this medication unless advised by health care provider.
  • Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: nervousness, dizziness, sleeplessness.

Copyright © 2009 Wolters Kluwer Health.

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