HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX suspension, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE (UNII: 6YKS4Y3WQ7) (HYDROCODONE - UNII:6YKS4Y3WQ7), CHLORPHENIRAMINE (UNII: 3U6IO1965U) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

Available from:

Neos Therapeutics LP

INN (International Name):

HYDROCODONE

Composition:

HYDROCODONE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension 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 Extended-Release Oral 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

Product summary:

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension, equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, is a gold- colored suspension, available as: Each bottle is supplied with a plastic dosing spoon calibrated for measuring 2.5 mL and 5 mL doses. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child resistant closure. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CHLORPHENIRAMINE POLISTIREX SUSPENSION, EXTENDED RELEASE
Neos Therapeutics LP
----------
MEDICATION GUIDE
HYDROCODONE POLISTIREX AND
CHLORPHENIRAMINE POLISTIREX
EXTENDED-RELEASE ORAL SUSPENSION, CII
This Medication Guide
has been approved by
the U.S. Food and
Drug Administration.
U.S. Patent 8,470,375;
8,512,759; 8,318, 210;
7,871,645; 8,329,224;
8,343,546 PIN030117
07/20
Revised: July 2020
What is the most important information I
should know about Hydrocodone Polistirex
and Chlorpheniramine Polistirex Extended-
Release Oral Suspension?
Hydrocodone Polistirex and
Chlorpheniramine Polistirex Extended-
Release Oral Suspension is not for children
under 18 years of age.
Hydrocodone Polistirex and
Chlorpheniramine Polistirex Extended-
Release Oral Suspension can cause serious
side effects, including:
•
Addiction, abuse and misuse. Taking
Hydrocodone Polistirex and
Chlorpheniramine Polistirex
Extended-Release Oral Suspension
or other medicines that contain an
opioid can cause addiction, abuse
and misuse, which can lead to
overdose and death. This can happen
even if you take Hydrocodone
Polistirex and Chlorpheniramine
Polistirex Extended-Release Oral
Suspension exactly as prescribed by
your healthcare provider. Your risk
MEDICATION GUIDE
HYDROCODONE POLISTIREX AND
CHLORPHENIRAMINE POLISTIREX
EXTENDED-RELEASE ORAL SUSPENSION, CII
of addiction, abuse, and misuse is
increased if you or a family member
has a history of drug or alcohol
abuse or addiction, or mental health
problems.
•
Do not share your
Hydrocodone Polistirex and
Chlorpheniramine Polistirex
Extended-Release Oral
Suspension with other
people.
•
Keep Hydrocodone Polistirex
and Chlorpheniramine
Polistirex Extended-Release
Oral Suspension in a safe
place away from children.
•
Life-threatening breathing problems
(respiratory depression).
Hydrocodone Polistirex and
Chlorpheniramine Polistirex
Extended-Release Oral Suspension
can cause breathing problems
(respiratory depression) that can
happen at any time during treatment
and can lead to death. Your risk of

Summary of Product characteristics

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX-
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX SUSPENSION,
EXTENDED
RELEASE
NEOS THERAPEUTICS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE POLISTIREX
AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR HYDROCODONE POLISTIREX AND
CHLORPHENIRAMINE POLISTIREX
EXTENDED-RELEASE ORAL SUSPENSION.
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
EXTENDED-RELEASE SUSPENSION, FOR
ORAL ADMINISTRATION, CII
INITIAL U.S. APPROVAL: 1987
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
EXTENDED-RELEASE ORAL
SUSPENSION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD
TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND
MONITOR CLOSELY
FOR THESE BEHAVIORS AND CONDITIONS. ( 5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (
5.2)
ACCIDENTAL INGESTION OF HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE
POLISTIREX
EXTENDED-RELEASE ORAL SUSPENSION, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL
OVERDOSE OF HYDROCODONE. ( 5.2)
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROCODONE
POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE ORAL
SUSPENSION.
DOSING ERRORS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH. ( 2,1, 5.5)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF HYDROCODONE. AVOID THE USE OF
HYDROCODONE POLISTIREX
AND CHLORPHENIRAMINE P