The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Hydrocodone Bitartrate / Pseudoephedrine Hydrochloride
Pronunciation: HIGH-droe-KOE-dohn by-TAR-trate/SUE-doe-eh-FED-rin HIGH-droe-KLOR-ide
Class: Antitussive combination
- Liquid 5 mg hydrocodone bitartrate and 60 mg pseudoephedrine hydrochloride
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.
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 AdministrationMaximum dose
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).
Store at 59° to 86°F. Keep tightly capped.
Drug InteractionsAlcohol, CNS depressants, narcotic analgesics, phenothiazines or other tranquilizers, sedative-hypnotics
Increased CNS depression (eg, drowsiness) may occur.
Laboratory Test Interactions
None well documented.
Cardiac arrhythmia; increased heart rate; increased BP.
Lightheadedness; dizziness; sedation; drowsiness; weakness; anxiety; fear; fatigue; dysphoria; psychological dependence; confusion.Pseudoephedrine
Convulsions; CNS stimulation; hallucinations; tremors.
Nausea; vomiting; constipation.
Decreased urination; urethral spasm.Pseudoephedrine
Dyspnea; respiratory depression; irregular breathing.Pseudoephedrine
Consult health care provider before use.
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.
Hydrocodone has abuse potential; may be habit forming.
Respiratory and CNS depression, circulatory collapse, cardiopulmonary arrest, deathPseudoephedrine
Cardiac arrhythmias, cerebral hemorrhage, pulmonary edema, palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucination, delirium
- 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.