HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

Opioid Analgesic

Brand names: Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release

Oral

Mechanism of Action

12.1 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 (H 1 -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.

Indications

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

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 )
• including paralytic ileus [ see Warnings and Precautions (5.9) ]. Hypersensitivity to hydrocodone
• chlorpheniramine
• including paralytic ileus.( 4 ) Hypersensitivity to hydrocodone

FDA Warnings

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
6 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use
As an opioid, Hydrocodone Polistirex and Chlorpheniramine Polistirex exposes users to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence (9 ) ], which can lead to overdose and death [ see Overdosage (10) ]
Reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension 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

Known Side Effects

4 documented side effects by frequency

Anxiety

0.1-1%

Depression

0.1-1%

Nausea

0.1-1%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral