Chlorpheniramine Polistirex (8 brand names, 2 dosage forms, 1 route)
Available dosage forms: SUSPENSION, EXTENDED RELEASE, CAPSULE, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- CODEPREX
- CORSYM
- HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
- HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
- PENNTUSS
- TUSSICAPS
- TUSSIONEX PENNKINETIC
- TUZISTRA XR
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 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
Indications and Usage
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: • Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4 ) ]. • Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]. • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made.
Contraindications
Hydrocodone Polistirex and Chlorpheniramine Polistirex is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions (5.2 , 5.3 ), Use in Specific Populations (8.4) ]. Hydrocodone Polistirex and Chlorpheniramine Polistirex is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment[see Warnings and Precautions (5.4) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9) ]. Hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex [see Adverse Reactions (6) ].
Adverse Reactions
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, abuse, and misuse [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] • Life-threatening respiratory depression [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.8 ), Overdosage (10) ] • Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5) ] • Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.6) ] • Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8) , Drug Interactions (7.1 , 7.5 ) ] • Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9) ] • Increased intracranial pressure [see Warnings and Precautions (5.10 ) ] • Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.10) ] • Seizures [see Warnings and Precautions (5.11) ] • Severe hypotension [see Warnings and Precautions (5.12) ] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.13) ] • Adrenal insufficiency [see Warnings and Precautions (5.14) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or chlorpheniramine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to Hydrocodone Polistirex and Chlorpheniramine Polistirex include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Bod
Drug Interactions
No specific drug interaction studies have been conducted with Hydrocodone Polistirex and Chlorpheniramine Polistirex.
Mechanism of Action
Hydrocodone 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. In excessive doses, hydrocodone will depress respiration. Chlorpheniramine Chlorpheniramine is a propylamine derivative antihistamine (H1-receptor antagonist) of the alkylamine class that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
Overdosage
Clinical Presentation Hydrocodone Acute overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Hydrocodone may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ]. Chlorpheniramine Signs and symptoms of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucinations, gastrointestinal symptoms, convulsions, urinary retention, cardiac arrhythmias and coma) may be observed. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Hydrocodone Polistirex and Chlorpheniramine Polistirex together with institution of a