Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release (Page 2 of 11)

2.2 Recommended Dosage

Adults 18 years of age and older: 5 mL every 12 hours as needed, not to exceed 2 doses (10 mL) in 24 hours

2.3 Monitoring, Maintenance, and Discontinuation of Therapy

Prescribe Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy [see Warnings and Precautions (5.2)].

Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.4)]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)].

Do not abruptly discontinue Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. When a patient who has been taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension regularly and may bephysically dependent no longer requires therapy with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, taper the dose gradually, by25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patientdevelops these signs or symptoms, raise the dose to the previous level and taper more slowly, either byincreasing the interval between decreases, decreasing the amount of change in dose, or both.

3 DOSAGE FORMS AND STRENGTHS

Extended-release suspension: Each 5 mL contains hydrocodone polistirex, which contains 6.66 mg of hydrocodone (equivalent to 10 mg of hydrocodone bitartrate); and chlorpheniramine polistirex, which contains 5.62 mg of chlorpheniramine (equivalent to 8 mg of chlorpheniramine maleate). Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is a yellow-colored suspension [see Description (11)].

4 CONTRAINDICATIONS

Hydrocodone Polistirex and Chlorpheniramine Polistirex is contraindicated for:

Hydrocodone Polistirex and Chlorpheniramine Polistirex is also contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Hydrocodone Polistirex and Chlorpheniramine Polistirex contains hydrocodone, a Schedule II controlled substance. 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. Assess each patient’s risk prior to prescribing Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, prescribe Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Polistirex and Chlorpheniramine Polistirex. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Hydrocodone Polistirex and Chlorpheniramine Polistirex. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2 Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression includes discontinuation of Hydrocodone Polistirex and Chlorpheniramine Polistirex, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex, the risk is greatest during the initiation of therapy, when Hydrocodone Polistirex and Chlorpheniramine Polistirex is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions (5.8)], in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g. elderly, cachectic, or debilitated patients) [see Warnings and Precautions (5.4)].

To reduce the risk of respiratory depression, proper dosing of Hydrocodone Polistirex and Chlorpheniramine Polistirex is essential [see Dosage and Administration (2.1), Warnings and Precautions (5.5)]. Monitor patients closely, especially within the first 24 to 72 hours of initiating therapy or when used in patients at higher risk.

Overdose of hydrocodone in adults has been associated with fatal respiratory depression, and the use of hydrocodone in children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Accidental ingestion of even one dose of Hydrocodone Polistirex and Chlorpheniramine Polistirex, especially by children, can result in respiratory depression and death.

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