Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE- hydrocodone bitartrate and chlorpheniramine maleate suspension, extended release
Tris Pharma Inc

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; 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 use an accurate milliliter measuring device when measuring and administering Hydrocodone Polistirex and Chlorpheniramine Polistirex [see Dosage and Administration (2.1), Warnings and Precautions (5.5)].

Cytochrome P450 3A4 Interaction

The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking a CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.7), Drug Interactions (7.2, 7.3)].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol [see Warning and Precautions (5.8), Drug Interactions (7.5)].

Interaction with Alcohol

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Hydrocodone Polistirex and Chlorpheniramine Polistirex. The co-ingestion of alcohol with Hydrocodone Polistirex and Chlorpheniramine Polistirex may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Warnings and Precautions (5.8) and Drug Interactions (7.1)].

Neonatal Opioid Withdrawal Syndrome

Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women [see Use in Specific Populations (8.1)]. Prolonged use of Hydrocodone Polistirex and Chlorpheniramine Polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If Hydrocodone Polistirex and Chlorpheniramine Polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.13)].

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.

2 DOSAGE AND ADMINISTRATION

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 and Chlorpheniramine Polistirex Extended-Release Suspension to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [see Warnings and Precautions (5.5)]. The dosing cup is provided with the 3 oz (70 mL) and 4 oz (115 mL) packaged product. The dosing cup fills for 2.5 mL dose and for 5 mL dose. Instruct the patient to fill to the line that the dose has been prescribed. Do not fill over the dose prescribed. Rinse the measuring cup with water after each use. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.

Advise patients not to increase the dose or dosing frequency of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2) and Overdosage (10)]. The dosage of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage andAdministration (2.3) and Warnings and Precautions (5.4)].

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