Hydrocodone Bitartrate/homatropine Methylbromide Syrup Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Contact supplier
Manufacturer
Mechanism of Action
Hydrocodone Bitartrate/homatropine Methylbromide Syrup Indications
Indications
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 Syrup Dosage and Administration
Adult
Use accurate measuring device. ≥18yrs: 5mL every 4–6hrs as needed; max 30mL/24hrs.
Children
<18yrs: not recommended.
Hydrocodone Bitartrate/homatropine Methylbromide Syrup 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 Syrup 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 Syrup Warnings/Precautions
Warnings/Precautions
Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation (within 1st 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 Syrup Pharmacokinetics
Absorption
Mean peak concentration: 23.6 ± 5.2 ng/mL.
Elimination
Hydrocodone Bitartrate/homatropine Methylbromide Syrup Interactions
Interactions
Hydrocodone Bitartrate/homatropine Methylbromide Syrup Adverse Reactions
Adverse Reactions
Hydrocodone Bitartrate/homatropine Methylbromide Syrup Clinical Trials
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Hydrocodone Bitartrate/homatropine Methylbromide Syrup Note
Notes
Hydrocodone Bitartrate/homatropine Methylbromide Syrup Patient Counseling
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