Hydrocodone Polistirex And Chlorpheniramine Polistirex
Generic Name: hydrocodone polistirex and chlorpheniramine polistirex
Brand Names:
Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release
11 DESCRIPTION Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension contains hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist. Each 5 mL of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release (ER) Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate.
Overview
11 DESCRIPTION Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension contains hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist. Each 5 mL of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release (ER) Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate.
Uses
1 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) ].
Dosage
2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : 5 mL every 12 hours as needed, not to exceed 2 doses (10 mL) in 24 hours. ( 2.2 ) Measure Hydrocodone Polistirex and Chlorpheniramine Polistirex with an accurate milliliter measuring device. ( 2.1 , 5.5 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. (2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Administer Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension by the oral route only.
Side Effects
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 int...
Interactions
7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with Hydrocodone Polistirex and Chlorpheniramine Polistirex. Phenytoin : Avoid concomitant use; may increase phenytoin levels. ( 7.4 ) Serotonergic drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. ( 7.6 ) Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. ( 7.7 ) Muscle relaxants : Avoid concomitant use. ( 7.8 ) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. ( 7.9 ) Anticholinergic drugs : Concomitant use may cause paralytic ileus.
Warnings
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; INTE... 5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. ( 5.4 ) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.6 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.10 ) Seizures in patients with seizure disorders: Monitor during therapy. ( 5.11 ) Severe hypotension : Monitor during initiation of therapy. 4 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) ].
Pregnancy
8.1 Pregnancy Risk Summary Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions (5.13) , Clinical Considerations ]. There are no available data with Hydrocodone Polistirex and Chlorpheniramine Polistirex use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, is a yellow viscous suspension. NDC 72162-1283-7 3 fl. oz. bottle containing 70 mL suspension. NDC 72162-1283-4 16 fl. oz. bottle containing 473 mL suspension. NDC 72162-1283-2 4 fl. oz.
Frequently Asked Questions
What is Hydrocodone Polistirex And Chlorpheniramine Polistirex used for?▼
1 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) ].
What are the side effects of Hydrocodone Polistirex And Chlorpheniramine Polistirex?▼
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 int...
Can I take Hydrocodone Polistirex And Chlorpheniramine Polistirex during pregnancy?▼
8.1 Pregnancy Risk Summary Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions (5.13) , Clinical Considerations ]. There are no available data with Hydrocodone Polistirex and Chlorpheniramine Polistirex use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
What are the important warnings for Hydrocodone Polistirex And Chlorpheniramine Polistirex?▼
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; INTE... 5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. ( 5.4 ) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.6 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.10 ) Seizures in patients with seizure disorders: Monitor during therapy. ( 5.11 ) Severe hypotension : Monitor during initiation of therapy. 4 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.