HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release)
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release.
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (brand names: Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release) is classified as High risk (7 risk points) by AllMeds. It is a S8 medication under the TGA in Australia. FDA approved in the United States. Extended-release opioid combination with enhanced CNS depression risk from antihistamine.
Key Takeaways
- TGA Schedule: S8 in Australia
- Risk level: High (7 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
- Respiratory depression risk: Requires monitoring, especially with other CNS depressants
- Recommended maximum duration: 7 days
- SIRA reportable: Flagged for NSW workers compensation reporting
- OME factor: 1 (oral morphine equivalent conversion)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S8 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Extended-release opioid combination with enhanced CNS depression risk from antihistamine.
Regulatory and Compliance Guidance
When HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Work capacity impact: As a CNS depressant, HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S8 under the Therapeutic Goods Administration (TGA).
Flagged as reportable under SIRA guidelines in NSW. Claims involving this medication may require additional reporting and clinical justification.
SIRA best practice guidelines recommend a maximum opioid duration of 7 days for acute pain. Prescribing beyond this requires documented clinical justification and may trigger a Reasonable and Necessary determination.
WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for all S8 opioids. WorkCover QLD Pain Intervention Guidelines recommend multimodal pain management with opioids as a last resort.
United Kingdom NICE / MHRA / FPM
NICE NG193 (Chronic Pain) recommends against initiating opioids for chronic primary pain. The Faculty of Pain Medicine (FPM) Opioids Aware resource recommends structured opioid prescribing with regular review, dose limits, and documented tapering plans.
For personal injury claims in the UK, opioid prescribing duration and dose should be reviewed against NICE and FPM guidelines. Costs may be recoverable as a disbursement in high-value PI claims.
UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: 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 fatal overdose of hydrocodone [ see Warnings and Precautions (5.2 ) ]. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Polistirex and Chlorpheniramine Polistirex. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering Hydrocodone Polistirex and Chlorpheniramine Polistirex [ see Dosage and Administration (2.1) , Warnings and Precautions (5.5 ) ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking a CYP3A4 inhibitor or inducer [ see Warnings and Precautions (5.7) , Drug Interactions (7.2 , 7.3) ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol [ see Warning and Precautions (5.8) , Drug Interactions (7.5) ]. Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Hydrocodone Polistirex and Chlorpheniramine Polistirex. The co-ingestion of alcohol with Hydrocodone Polistirex and Chlorpheniramine Polistirex may result in increased plasma levels and a potentially fatal overdose of hydrocodone [ see Warnings and Precautions (5.8 ) and Drug Interactions (7.1) ]. Neonatal Opioid Withdrawal Syndrome Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women [ see Use in Specific Populations (8.1) ]. Prolonged use of Hydrocodone Polistirex and Chlorpheniramine Polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If Hydrocodone Polistirex and Chlorpheniramine Polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ see Warnings and Precautions (5.13 ) ]. 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 See full prescribing information for complete boxed warning. Hydrocodone Polistirex and Chlorpheniramine Polistirex exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. ( 5.2 ) Accidental ingestion of Hydrocodone Polistirex and Chlorpheniramine Polistirex, especially by children, can result in a fatal overdose of hydrocodone. ( 5.2 ) Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Polistirex and Chlorpheniramine Polistirex. Dosing errors can result in accidental overdose and death. ( 2.1 , 5.5 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking CYP3A4 inhibitors or inducers. ( 5.7 , 7.2 , 7.3 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol. ( 5.8 , 7.5 ) Instruct patients not to consume alcohol or any products containing alcohol while taking Hydrocodone Polistirex and Chlorpheniramine Polistirex because co-ingestion can result in fatal plasma hydrocodone levels. ( 5.8 , 7.1) Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women. Prolonged use of Hydrocodone Polistirex and Chlorpheniramine Polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If Hydrocodone Polistirex and Chlorpheniramine Polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ( 5.13 , 8.1 )
The CDC Clinical Practice Guideline for Prescribing Opioids (2022) recommends non-opioid therapies as first-line treatment for pain. When opioids are prescribed, the lowest effective dose should be used for the shortest duration needed.
For workers compensation claims, many states require prior authorization for opioids beyond initial acute prescribing. State drug formularies (e.g. California MTUS, Texas, New York) may restrict or require step therapy before opioid approval.
New Zealand ACC / BPAC NZ / Medsafe
BPAC NZ recommends reassessing opioid therapy at regular intervals and limiting duration. The NZ Opioid Prescribing B-QuiCK Guide provides structured prescribing and tapering protocols.
ACC (Accident Compensation Corporation) covers treatment-related medications for accepted claims. Opioid prescribing beyond guidelines may require ACC clinical review and approval.
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.