Hydrocodone Bitartrate / Homatropine Methylbromide

Pronunciation: (HIGH-droe-KOE-dohn by-TAR-trate/hoe-MAT-troe-peen METH-ill-BROE-mide)Class: Antitussive combination

Trade Names:Hydrocodone/Homatropine- Syrup 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide

Trade Names:Tussigon- Tablets 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide

Pharmacology

Hydrocodone

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

Atropine

Inhibits action of acetylcholine or other cholinergic stimuli at postganglionic cholinergic receptors.

Indications and Usage

Symptomatic relief of cough.

Contraindications

Hypersensitivity to any component of product.

Dosage and Administration

Adults and Children (12 yr of age and older)

PO 1 tablet or 1 tsp (5 mL) of syrup every 4 to 6 h (max, 6 tablets or 6 tsp in 24 h).

Children 6 to 12 yr of age

PO ½ tablet or ½ tsp (2.5 mL) every 4 to 6 h (max, 3 tablets or 3 tsp in 24 h).

General Advice

Measure and administer prescribed dose of syrup using dosing syringe, dosing spoon, or dosing cup.

Storage/Stability

Store tablets and syrup at controlled room temperature (59° to 86°F). Keep syrup tightly capped and protect from freezing.

Drug Interactions

Alcohol, antianxiety agents, antihistamines, antipsychotic agents, CNS depressants, narcotics

CNS depressant effects may be increased.

MAOIs, tricyclic antidepressants

Effects of these agents or hydrocodone may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Sedation; drowsiness; mental clouding; lethargy; impairment of mental and physical performance; anxiety; fear; dysphoria; dizziness; psychic dependence; mood change.

Dermatologic

Skin rash; pruritus.

GI

Nausea; vomiting; constipation.

Genitourinary

Ureteral spasm; spasm of vesicle sphincters; urinary retention.

Respiratory

Dose-related respiratory depression.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

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

Special Risk Patients

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

Acute abdominal conditions

Diagnosis may be obscured.

Dependence

Hydrocodone has abuse potential; may be habit forming.

Head injury or increased intracranial pressure

Diagnosis of adverse reactions may be obscured; respiratory depression properties and capacity to elevate cerebrospinal fluid pressure of hydrocodone may be markedly exaggerated.

Overdosage

Symptoms

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

Patient Information

• Review dosing schedule for prescribed dose form (ie, syrup or tablet).
• 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 cough is not controlled not to increase the dose of medication but to inform health care provider.
• Advise patient to inform health care provider if any of the following occur: cough associated with fever, rash, persistent headache, or bothersome adverse reactions.
• 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.

Copyright © 2009 Wolters Kluwer Health.