Hydrocodone Bitartrate / Chlorpheniramine Maleate

Pronunciation: hye-droe-KOE-done bye-TAR-trate/KLOR-fen-IR-a-meen MAL-ee-ate
Class: Antitussive combination

Trade Names

TussiCaps Half Strength
- Capsules, ER hydrocodone bitartrate 5 mg and chlorpheniramine maleate 4 mg

TussiCaps Full Strength
- Capsules, ER hydrocodone bitartrate 10 mg and chlorpheniramine maleate 8 mg

Tussionex Pinnkinetic
- Suspension, ER hydrocodone bitartrate 10 mg and chlorpheniramine maleate 8 mg per 5 mL

Pharmacology

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

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Competitively antagonizes histamine at H ₁ receptor sites.

Indications and Usage

Relief of cough and upper respiratory tract symptoms associated with allergy or a cold.

Contraindications

Hypersensitivity to any component of the product; children younger than 6 yr of age ( Tussionex ).

Dosage and Administration

Hydrocodone 20 mg/day; chlorpheniramine 16 mg/day

Hydrocodone 10 mg/day; chlorpheniramine 8 mg/day

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

Hydrocodone 10 mg/chlorpheniramine 8 mg every 12 h.

Hydrocodone 20 mg/day; chlorpheniramine 16 mg/day.

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

Hydrocodone 5 mg/chlorpheniramine 4 mg every 12 h.

Hydrocodone 10 mg/day; chlorpheniramine 8 mg/day.

General Advice

• Shake suspensions well before using.
• Measure suspension with an accurate measuring device.
• Do not dilute or mix with other drugs or fluids.

Storage/Stability

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

Drug Interactions

Increased CNS depression (eg, drowsiness) may occur.

Risk of paralytic ileus may be increased.

The effects of these agents or hydrocodone may be increased.

Laboratory Test Interactions

May interfere with diagnostic test results for skin tests using allergen extracts.

Adverse Reactions

CNS

Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, impaired mental and physical performance, lethargy, mental clouding, mood change, psychic dependence, sedation.

Dermatologic

Pruritus, rash.

GI

Constipation, nausea, vomiting.

Genitourinary

Spasm of vesical sphincter, ureteral spasm, urinary retention.

Respiratory

Respiratory depression.

Miscellaneous

Chest tightness, dryness of the pharynx.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 yr of age.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Special Risk Patients

Use with caution in postoperative, elderly, or debilitated patients, and in patients with narrow-angle glaucoma, asthma, prostatic hypertrophy, severe hepatic or renal function impairment, hypothyroidism, Addison disease, pulmonary disease, or urethral stricture.

Acute abdominal conditions

Diagnosis or clinical course of patients with acute abdominal conditions may be obscured.

Dependence

Has abuse potential and may be habit-forming.

Head injury or increased intracranial pressure

Opioids may elevate cerebrospinal fluid pressure, which may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure.

Obstructive bowel disease

Opioids may result in obstructive bowel disease, especially in patients with underlying intestinal motility disorder.

Respiratory depression

Dose-related respiratory depression can occur.

Overdosage

Symptoms

Apnea, bradycardia, cardiac arrest, circulatory collapse, cold and clammy skin, death, extreme somnolence progressing to stupor or coma, hypotension, respiratory depression, skeletal muscle flaccidity.

Patient Information

• Advise patient to take prescribed dose every 12 h as needed.
• Advise caregiver to use dosing spoon or syringe when giving syrup to children.
• Advise patient to take with food or milk if GI upset occurs.
• 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 allergy 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 the risk of excessive sedation.
• Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by health care provider.
• Advise patient having allergy skin testing not to take the medication for at least 6 days before the skin testing.
• Instruct patient to stop taking drug and immediately report persistent nausea or excessive drowsiness to health care provider.

Copyright © 2009 Wolters Kluwer Health.