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
Trade Names:
TussiCaps Full Strength
- Capsules, ER hydrocodone bitartrate 10 mg and chlorpheniramine maleate 8 mg
Trade Names:
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.
ChlorpheniramineCompetitively 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
Adults and Children 12 yr of age and olderPO
TussiCapsOne 10/8 mg capsule every 12 h; max, two 10/8 mg capsules per 24 h.
Tussionex5 mL every 12 h; max, 10 mL per 24 h.
Children 6 to 11 yr of agePO
TussiCapsOne 5/4 mg capsule every 12 h; max, two 5/4 mg capsules per 24 h.
Tussionex2.5 mL every 12 h; max, 5 mL per 24 h.
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
Alcohol, antihistamines, antipsychotics, anxiolytics, CNS depressants, narcotic analgesics, phenothiazines or other tranquilizers, sedative-hypnoticsIncreased CNS depression (eg, drowsiness) may occur.
AnticholinergicsRisk of paralytic ileus may be increased.
MAOIs, tricyclic antidepressantsThe 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.
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