Hydrocodone Bitartrate/Homatropine Methylbromide Tablets Dosage & Rx Info

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Generic Name & Formulations

Legal Class

CII

General Description

Hydrocodone bitartrate 5mg, homatropine methylbromide 1.5mg; tabs.

Pharmacological Class

Antitussive.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

Mechanism of Action

Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Indications

Indications

Cough.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve for use in patients for whom the benefits are expected to outweigh the risks, and in whom an adequate assessment of the etiology has been made.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Dosage and Administration

Adult

≥18yrs: 1 tab every 4–6hrs as needed; max 6 tabs/24hrs.

Children

<18yrs: not recommended.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Contraindications

Contraindications

All pediatric patients <6yrs of age. Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Boxed Warnings

Boxed Warning

Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risk of medication errors; Cytochrome P450 3A4 interaction; Risks from concomitant use with benzodiazepines or other CNS depressants; Interaction with alcohol; Neonatal opioid withdrawal syndrome.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation (within 1^st 24–72hrs) or following a dose increase. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid alternatives. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Acute abdomen. Hypothyroidism. Prostatic hypertrophy. Urethral stricture. Narrow-angle glaucoma. Severe hepatic or renal impairment. Elderly. Cachectic. Debilitated. Labor & delivery. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: not recommended.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Pharmacokinetics

Absorption

Mean peak concentration: 23.6 ± 5.2 ng/mL.

Metabolism

Hepatic (N-demethylation, O-demethylation, and 6keto reduction).

Elimination

Renal. Half-life: ~4 hours (hydrocodone).

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Interactions

Interactions

Increased risk of respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, opioids, antihistamines, antipsychotics, anxiolytics, alcohol); avoid. May affect or be affected by MAOIs, TCAs.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Adverse Reactions

Adverse Reactions

Respiratory depression, drowsiness, hypertension, orthostatic hypotension, palpitations, anticholinergic effects, sedation, anxiety, nausea, rash, pruritus.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Clinical Trials

See Literature

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Note

Notes

Formerly known under the brand name Hycodan.

Hydrocodone Bitartrate/homatropine Methylbromide Tablets Patient Counseling