Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release 8 mg/5mL
Hydrocodone Polistirex and Chlorpheniramine Polistirex · SUSPENSION, EXTENDED RELEASE · Cranbury Pharmaceuticals, LLC
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release is a suspension, extended release containing hydrocodone polistirex and chlorpheniramine polistirex at 8 mg/5mL, taken oral. Manufactured by Cranbury Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release
- Generic Name
- Hydrocodone Polistirex and Chlorpheniramine Polistirex
- NDC Code (Product)
27808-086- Manufacturer
- Cranbury Pharmaceuticals, LLC
- Strength
- 8 mg/5mL
- Dosage Form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA091632
- Marketing Start
- 03/06/2015
Recall History
Tris Pharma Inc.
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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) ]. • 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. Hydrocodone Polistirex and Chlorpheniramine Polistirex is a combination of hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H1) receptor antagonist, 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 ol…
Dosage & Administration
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. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension can be taken with or without food. Shake well before using. Do not mix Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with other liquids or medicines. Mixing may change how Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension works. Always use an accurate milliliter measuring device when administering Hydrocodone Polistirex an…
Contraindications
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) ]. 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) ]. Children younger than 6 years of age. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus.( 4 ) Hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in Hydrocodon…
Drug 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. ( 5.9 , 7.10 ) 7.1 Alcohol Concomitant use of alcohol with Hydrocodone Polistirex and Chlorpheniramine Polistirex can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on Hydrocodone Polistirex and Chlorpheniramine Polistirex therapy [ see Warnings and Precautions (5.8) , Clinical Pharmacology…
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 Precautio…
Frequently Asked Questions
What is Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release used for?
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release contains Hydrocodone Polistirex and Chlorpheniramine Polistirex. It is a suspension, extended release taken oral. Consult your doctor for specific uses.
Is Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release a controlled substance?
Yes, Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release?
The generic name for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release is Hydrocodone Polistirex and Chlorpheniramine Polistirex. There are no other listed brand versions of Hydrocodone Polistirex and Chlorpheniramine Polistirex.
What is the NDC code for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release 8 mg/5mL?
The NDC (National Drug Code) for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release 8 mg/5mL is 27808-086, listed by Cranbury Pharmaceuticals, LLC.
Other Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)