HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (homatropine methylbromide)
Hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in adults 18 years of age and older. Use is reserved for patients in whom the benefits of cough suppression outweigh the risks of opioid addiction, abuse, and misuse, and only after a thorough evaluation of the cough's underlying etiology. It is not indicated for pediatric use and is contraindicated in children under 6 years of age.
How HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Works
This combination product consists of hydrocodone, an opioid agonist, and homatropine, a muscarinic antagonist. Hydrocodone exhibits relative selectivity for the mu-opioid receptor and is believed to suppress cough by acting centrally on the cough center in the brain. Homatropine methylbromide is an anticholinergic that inhibits muscarinic acetylcholine receptor activity with less potency than atropine; it is typically included in this formulation to discourage deliberate overdosage.
Details
- Status
- Prescription
- First Approved
- 1983-03-03
- Routes
- ORAL
- Dosage Forms
- SYRUP
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Approval History
What HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Treats
1 indicationsHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is approved for 1 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cough
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Boxed Warning
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) See full prescribing information for complete boxed warning. Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) exposes patients and other users to the risks of opioid ad...
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) See full prescribing information for complete boxed warning. Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions ( 5.1 ) ] Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) therapy or when used in patients at higher risk [ see Warnings and Precautions ( 5.2 ) ] . Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), especially by children, can result in a fatal overdose of hydrocodone [ see Warnings and Precautions ( 5.2
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE FDA Label Details
Indications & Usage
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is indicated for the treatment of Cough.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) See full presc...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.