HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HCL- hydrocodone bitartrate, chlorpheniramine maleate, pse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

Available from:

Cypress Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate is indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, 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 bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate 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. Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate is contraindicated for: -

Product summary:

Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution is suppled as a clear, colorless to light yellow, grape-flavored liquid containing 5 mg of hydrocodone bitartrate, 4 mg of chlorpheniramine maleate, and 60 mg of pseudoephedrine hydrochloride. It is available in: Store solution at 20° to 25°C (68° to 77°F). [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 an oral dosing dispenser and correctly measure the oral suspension as prescribed.

Authorization status:

New Drug Application

Patient Information leaflet

HCL- HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE
HYDROCHLORIDE SOLUTION
Cypress Pharmaceutical, Inc.
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
I392 Revised: 06 2018
MEDICATION GUIDE
Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride and
Chlorpheniramine Maleate Oral
Solution, C-II
What is the most important information I should know about hydrocodone
bitartrate, pseudoephedrine
hydrochloride, and chlorpheniramine maleate?
Hydrocodone bitartrate, pseudoephedrine hydrochloride, and
chlorpheniramine maleate is not for
children under 18 years of age.
Hydrocodone bitartrate, pseudoephedrine hydrochloride, and
chlorpheniramine maleate can cause
serious side effects, including:
•
Addiction, abuse and misuse. Taking hydrocodone bitartrate,
pseudoephedrine hydrochloride,
and chlorpheniramine maleate 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 bitartrate, pseudoephedrine hydrochloride, and
chlorpheniramine maleate exactly
as prescribed by your healthcare provider. Your risk 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 bitartrate, pseudoephedrine
hydrochloride, and
chlorpheniramine maleate with other people.
•
Keep hydrocodone bitartrate, pseudoephedrine hydrochloride, and
chlorpheniramine
maleate in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression).
Hydrocodone bitartrate,
pseudoephedrine hydrochloride, and chlorpheniramine maleate can cause
breathing problems
(respiratory depression) that can happen at any time during treatment
and can lead to death.
Your risk of breathing problems is greatest when you first start
taking hydrocodone bitartrate,
pseudoephedrine hydrochloride, and chlorpheniramine maleate, are
taking other medicines
that can c

Summary of Product characteristics

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND
PSEUDOEPHEDRINE HCL- HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE,
PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION
CYPRESS PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE BITRATRATE, PSEUDOEPHEDRINE
HYDROCHLORIDE, AND CHLORPHENIRAMINE MALEATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR
HYDROCODONE BITRATRATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
CHLORPHENIRAMINE MALEATE.
HYDROCODONE BITRATRATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
CHLORPHENIRAMINE MALEATE ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 2011
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 BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
CHLORPHENIRAMINE MALEATE 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 BITARTRATE, PSEUDOEPHEDRINE
HYDROCHLORIDE, AND
CHLORPHENIRAMINE MALEATE, ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF HYDROCODONE. (5.2)
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROCODONE BITARTRATE,
PSEUDOEPHEDRINE HYDROCHLORIDE, AND CHLORPHENIRAMINE MALEATE. 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 BITARTRATE,
PSEUDOEPHEDRINE HYDROCH