U.S. Brand Names:
Hycomine® Compound
Synonyms:
Acetaminophen, Caffeine, Hydrocodone, Chlorpheniramine, and Phenylephrine; Caffeine, Hydrocodone, Chlorpheniramine, Phenylephrine, and Acetaminophen; Chlorpheniramine, Hydrocodone, Phenylephrine, Acetaminophen, and Caffeine; Phenylephrine, Hydrocodone, Chlorpheniramine, Acetaminophen, and Caffeine
Generic Available:
No
Use:
Symptomatic relief of cough and symptoms of upper respiratory infection
Restrictions:
C-III
Pregnancy Risk Factor:
C
Lactation:
Excretion in breast milk unknown/contraindicated
Contraindications:
Hypersensitivity to any component of the formulation; patients on MAO inhibitors; patients with heart disease, hypertension, diabetes, hyperthyroidism, presence of intracranial lesion associated with increased intracranial pressure; depressed ventilatory function
Warnings/Precautions:
May be habit-forming. Prescribe and administer with the same degree of caution appropriate to the use of other narcotic drugs or prostatic hyperplasia. Produces dose-related respiratory depression. May produce adverse reactions which may obscure the clinical course of patients with head injuries. May obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Adverse Reactions:
Cardiovascular: Hypertension, postural hypotension, tachycardia, palpitation
Central nervous system: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes
Dermatologic: Rash, pruritus
Gastrointestinal: Nausea, vomiting, constipation with prolonged use
Genitourinary: Ureteral spasms, spasm of vesical sphincters and urinary retention
Ocular: Blurred vision
Respiratory: Respiratory depression
Drug Interactions:
Hydrocodone: Substrate of CYP2D6 (major)
Chlorpheniramine: Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP2D6 (weak)
Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4;
Caffeine: Substrate of CYP1A2 (major), 2C8/9 (minor), 2D6 (minor), 2E1 (minor), 3A4 (minor); Inhibits CYP1A2 (weak), 3A4 (moderate)
Also see individual monographs for Chlorpheniramine, Phenylephrine, and Acetaminophen.
Ethanol/Nutrition/Herb Interactions:
Ethanol: Avoid ethanol (may increase CNS depression). Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity.
Pharmacodynamics/Kinetics:
See Chlorpheniramine, Phenylephrine, and Acetaminophen monographs.
Hydrocodone:
Onset of action: Narcotic analgesic: 10-20 minutes
Duration: 4-8 hours
Distribution: Crosses placenta
Metabolism: Hepatic; O-demethylation; N-demethylation and 6-ketosteroid reduction
Half-life elimination: 3.3-4.4 hours
Excretion: Urine
Dosage:
Adults: Oral: 1 tablet every 4 hours, up to 4 times/day
Patient Education:
Take only as prescribed; do not exceed prescribed dose or frequency. May be habit-forming. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Avoid use of other depressants, alcohol, or sleep-inducing medications, or tranquilizers or pain medications unless approved by prescriber. You may experience orthostatic hypotension (change position slowly when rising from sitting or lying or when climbing stairs); drowsiness, impaired coordination, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help); urinary retention (void before taking medication); or constipation (increased exercise, fluids, fruit, or fiber may help). Report persistent CNS changes (dizziness, sedation, tremor, anxiety, mood changes, or agitation); chest pain, palpitations, rapid heartbeat; respiratory difficulty; visual changes; pain on urination or inability to void; or lack of improvement or worsening or condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
Dental Health: Effects on Dental Treatment:
Key adverse event(s) related to dental treatment:
Acetaminophen: No significant effects or complications reported.
Chlorpheniramine: Prolonged use will cause significant xerostomia (normal salivary flow resumes upon discontinuation).
Phenylephrine: Up to 10% of patients could experience tachycardia, palpitations, and xerostomia; use vasoconstrictor with caution.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions:
Use with caution since phenylephrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response
Mental Health: Effects on Mental Status:
Sedation is common; may cause confusion, dizziness, excitability, nervousness, fatigue, anxiety, restlessness, or depression; may rarely cause hallucinations
Mental Health: Effects on Psychiatric Treatment:
May result in loss of pain control when used in combination with SSRIs (especially paroxetine and fluoxetine); concurrent use with psychotropics may produce additive sedation or dry mouth. Concurrent use with MAO inhibitors may result in hypertensive crisis; avoid combination; barbiturates and carbamazepine may increase the hepatotoxic potential of acetaminophen.
Dosage Forms:
Tablet: Hydrocodone bitartrate 5 mg, chlorpheniramine maleate 2 mg, phenylephrine hydrochloride 10 mg, acetaminophen 250 mg, and caffeine 30 mg [cherry flavor]
References
Barker JD Jr, de Carle DJ, and Anuras S, "Chronic Excessive Acetaminophen Use in Liver Damage,"Ann Intern Med, 1977, 87(3):299-301.
Dionne RA, Campbell RA, Cooper SA, et al, "Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,"J Clin Pharmacol, 1983, 23(1):37-43.
Licht H, Seeff LB, and Zimmerman HJ, "Apparent Potentiation of Acetaminophen Hepatotoxicity by Alcohol,"Ann Intern Med, 1980, 92(4):511.
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