Based on hydrocodone component: Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (morphine, codeine, hydromorphone, levorphanol, oxycodone, oxymorphone); should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, prostatic hyperplasia, or urethral stricture. Also use caution in patients with head injury, increased intracranial pressure, acute abdomen, or impaired thyroid function. Hydrocodone suppresses the cough reflex; caution should be exercised when this agent is used postoperatively and in patients with pulmonary diseases (including asthma, emphysema, COPD); tolerance or drug dependence may result from extended use
Based on homatropine component: Use with caution in patients with hypertension, cardiac disease, or increased intraocular pressure; safety and efficacy not established in infants and young children, therefore, use with extreme caution due to susceptibility of systemic effects; use with caution in obstructive uropathy, paralytic ileus, ulcerative colitis, unstable cardiovascular status in acute hemorrhage; use with caution in children with spastic paralysis, in the elderly, and in patients with prostatic hyperplasia
Cardiovascular: Bradycardia, tachycardia, hyper-/hypotension
Central nervous system: Lightheadedness, dizziness, sedation, drowsiness, fatigue, confusion, hallucinations
Gastrointestinal: Nausea, vomiting, xerostomia, anorexia, impaired GI motility
Genitourinary: Decreased urination, urinary tract spasm
Hepatic: Biliary tract spasm
Neuromuscular & skeletal: Weakness
Ocular: Diplopia, miosis, mydriasis, blurred vision
Respiratory: Dyspnea
Miscellaneous: Histamine release, physical and psychological dependence with prolonged use
Symptoms of overdose include CNS and respiratory depression; gastrointestinal cramping; dilated, unreactive pupils; blurred vision; hot, dry flushed skin; dryness of mucous membranes; difficulty in swallowing, foul breath, diminished or absent bowel sounds, urinary retention, tachycardia, hyperthermia, hypertension, increased respiratory rate
CNS depression is an extension of pharmacologic effect; treatment is supportive; naloxone 0.4 mg I.V. (0.01 mg/kg for children) with repeat administrations as necessary; anticholinergic toxicity is caused by strong binding of the drug to cholinergic receptors. For anticholinergic overdose with severe life-threatening symptoms, physostigmine 1-2 mg (0.5 or 0.02 mg/kg for children) SubQ or I.V., slowly may be given to reverse these effects.
Based on hydrocodone component: Substrate of CYP2D6 (major)
CNS depressants, MAO inhibitors, general anesthetics, and tricyclic antidepressants: May potentiate the effects of opiate agonists; dextroamphetamine may enhance the analgesic effect of opiate agonists
CYP2D6 inhibitors: May decrease the effects of hydrocodone. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.
Based on homatropine component:
Phenothiazine and TCAs may increase anticholinergic effects when used concurrently.
Sympathomimetic amines may cause tachyarrhythmias; avoid concurrent use.
Based on hydrocodone component: Binds to opiate receptors in the CNS, altering the perception of and response to pain; suppresses cough in medullary center; produces generalized CNS depression
Based on homatropine component: Blocks response of iris sphincter muscle and the accommodative muscle of the ciliary body to cholinergic stimulation resulting in dilation and loss of accommodation
Children: 0.6 mg/kg/day in 3-4 divided doses; do not administer more frequently than every 4 hours
A single dose should not exceed 1.25 mg in children <2 years of age, 5 mg in children 2-12 years, and 10 mg in children >12 years
Adults: 10 mg every 4-6 hours, a single dose should not exceed 15 mg; do not administer more frequently than every 4 hours
Syrup (Hycodan®, Hydromet®, Hydropane®): Hydrocodone bitartrate 5 mg and homatropine methylbromide 1.5 mg per 5 mL (480 mL) [cherry flavor]
Tablet (Hycodan®, Tussigon®): Hydrocodone bitartrate 5 mg and homatropine methylbromide 1.5 mg