HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (chlorpheniramine polistirex)
This combination medication helps adults manage coughs and upper respiratory symptoms caused by allergies or the common cold. It is used for patients 18 years of age and older when a healthcare provider determines that the benefits of suppressing a cough outweigh the potential risks associated with opioid use. Before use, clinicians should evaluate the underlying cause of the cough to ensure this treatment is appropriate
How HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX Works
Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor; it is believed to suppress the cough reflex through a central mechanism of action in the cough center of the brain. Chlorpheniramine is an H1-receptor antagonist (antihistamine) that prevents released histamine from causing capillary dilation and edema of the respiratory mucosa. It also possesses anticholinergic and sedative activity.
Details
- Status
- Prescription
- First Approved
- 2010-10-01
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
Companies
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX Approval History
What HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX Treats
3 indicationsHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cough
- Allergy
- Common Cold
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX 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 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 W...
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 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 Addiction, Abuse, and Misuse Hydrocodone Polistirex and Chlorpheniramine Polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex 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 Polistirex and Chlorpheniramine Polistirex, prescribe Hydrocodone Polistirex and Chlorpheniramine Polistirex for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition 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 Polistirex and Chlorpheniramine Polistirex. Monitor for respiratory depression, especially during initiation of Hydrocodone Polistirex and Chlorpheniramine Polistirex 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 Polistirex and Chlorpheniramine Polistirex, especially by children, can result in a f
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX 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.
Drugs Similar to HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 POLISTIREX AND CHLORPHENIRAMINE POLISTIREX FDA Label Details
Indications & Usage
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX is indicated for the treatment of Cough; Allergy; Common Cold.
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 WARNING: ADDICTION, A...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.