Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release (Page 9 of 11)

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, available as:

NDC 27808-086-01 4 fl. oz. bottle containing 115 mL suspension.
NDC 27808-086-03 3 fl. oz. bottle containing 70 mL suspension.
Each bottle is supplied with a dosing cup calibrated for measuring 2.5 mL and 5 mL doses.
Shake well. Dispense entire bottle as one unit.

NDC 27808-086-02 16 fl. oz. bottle containing 473 mL suspension.
Shake well. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Light Sensitive: Protect from light. Store away from direct sunlight.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature.]

Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize the oral dosing dispenser and correctly measure the oral suspension as prescribed.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse, and Misuse

Inform patients that the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with others and to take steps to protect Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension from theft or misuse.

Important Dosing and Administration Instructions

Instruct patients how to measure and take the correct dose of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension. Advise patients to measure Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage. Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see Dosage and Administration (2.1) and Warnings and Precautions (5.5)]. 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)].

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Polistirex and Chlorpheniramine Polistirex and that it can occur even at recommended dosages [see Warnings and Precautions (5.2)]. Advise patients how to recognize respiratory depression and to seek medicalattention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension securely and to properly dispose of unused Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension in accordance with the local state guidelines and/or regulations.

Activities Requiring Mental Alertness

Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension may produce marked drowsiness [see Warnings and Precautions (5.6)].

Interactions with Benzodiazepines and Other Central Nervous System Depressants, Including Alcohol

Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is used with benzodiazepines or other CNS depressants, including alcohol. Advise patients to avoid concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with benzodiazepines or other CNS depressants and instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.5)].

Constipation

Advise patients of the potential for severe constipation [see Warnings and Precautions (5.9), Adverse Reactions (6)].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6)].

MAOI Interaction

Inform patients not to take Hydrocodone Polistirex and Chlorpheniramine Polistirex while using or within 14 days of stopping any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Hydrocodone Polistirex and Chlorpheniramine Polistirex [see Drug Interactions (7.7)].

Hypotension

Inform patients that Hydrocodone Polistirex and Chlorpheniramine Polistirex may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.12)].

Pregnancy

Advise patients that use of Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended during pregnancy [see Use in Specific Populations (8.1)].

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that 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 [see Warnings and Precautions (5.13), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that Hydrocodone Polistirex and Chlorpheniramine Polistirex can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise women that breastfeeding is not recommended during treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex [see Use in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids, such as hydrocodone, a component of Hydrocodone Polistirex and Chlorpheniramine Polistirex, may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].

Adrenal Insufficiency

Inform patients that Hydrocodone Polistirex and Chlorpheniramine Polistirex could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.14)].

Serotonin Syndrome

Inform patients that Hydrocodone Polistirex and Chlorpheniramine Polistirex could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications. [see Adverse Reactions (6), Drug Interactions (7.6)].

Disposal of Unused Hydrocodone Polistirex and Chlorpheniramine Polistirex

Advise patients to properly dispose of unused Hydrocodone Polistirex and Chlorpheniramine Polistirex. Advise patients to throw the drug in the household trash following these steps. 1) Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs). 2) Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag, or to dispose of in accordance with local state guidelines and/or regulations.

Manufactured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852
LB8535 Rev. 03 05/2021

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.