Hycomine

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Hycomine&

Hycomine (Hydrocodone bitartrate (Hycomine) and Phenylpropanolamine hydrochloride (Hycomine)) is indicated for the symptomatic relief of cough and nasal congestion.

Adults: The usual dose for adults is one teaspoonful HYCOMINE Syrup (Hydrocodone bitartrate (Hycomine) 5 mg and Phenylpropanolamine hydrochloride (Hycomine) 25 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period.

Children 6 to 12 years of age: The usual dose for children 6 to 12 years of age is one teaspoonful HYCOMINE Pediatric Syrup (Hydrocodone bitartrate (Hycomine) 2.5 mg and Phenylpropanolamine hydrochloride (Hycomine) 12.5 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period.

Hycomine is contraindicated in patients hypersensitive to hydrocodone or phenylpropanolamine, and in patients on concurrent MAO inhibitor therapy. Patients known to be hypersensitive to other opioids or sympathomimetic amines may exhibit cross sensitivity to Hycomine. Phenylpropanolamine is contraindicated in patients with heart disease, hypertension, diabetes or hyperthyroidism. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure; and whenever ventilatory function is depressed.

Cytochrome P450 1A₂ (CYP1A₂) is known to be the major enzyme involved in the metabolism of Hycomine. Therefore, Hycomine has the potential to interact with drugs that are substrates for CYP1A₂, inhibit CYP1A₂, or induce CYP1A₂.

Few data exist on drug interactions with Hycomine in preterm neonates. Based on adult data, lower doses of Hycomine may be needed following coadministration of drugs which are reported to decrease Hycomine elimination (e.g., cimetidine and ketoconazole) and higher Hycomine doses may be needed following coadministration of drugs that increase Hycomine elimination (e.g., phenobarbital and phenytoin).

Hycomine administered concurrently with ketoprofen reduced the urine volume in 4 healthy volunteers. The clinical significance of this interaction in preterm neonates is not known.

Interconversion between Hycomine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.

Respiratory System

Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centers.

Cardiovascular System

Hypertension, postural hypotension, tachycardia and palpitations.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision.

Gastrointestinal System

Nausea and vomiting occur more frequently in ambulatory than in recumbent patients. Prolonged administration of Hycomine may produce constipation.

Dermatological

Skin rash, pruritus.