ZUTRIPRO- hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride solution

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:

Hawthorn Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZUTRIPRO 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 ZUTRIPRO 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. ZUTRIPRO is contraindicated for: - All children younger than 6 years of age [see Warnings and Precautions (5.2), Use in Specific Populations (8.4) ]. ZUTRIPRO is also contraindicated in patients with: - Significant respiratory depression [see Warnings and Pre

Product summary:

ZUTRIPRO (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) 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

HYDROCHLORIDE SOLUTION
Hawthorn Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
HI247 Revised: June 2018
MEDICATION GUIDE
ZUTRIPRO® (Zoo-truh-proh)
(hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine
hydrochloride)
oral solution, C-II
What is the most important information I should know about ZUTRIPRO?
ZUTRIPRO is not for children under 18 years of age.
ZUTRIPRO can cause serious side effects, including:
•
Addiction, abuse and misuse. Taking ZUTRIPRO 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 ZUTRIPRO 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 ZUTRIPRO with other people.
•
Keep ZUTRIPRO in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression). ZUTRIPRO
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 ZUTRIPRO, are
taking other medicines that can cause breathing problems, have certain
lung problems, are elderly,
or have certain other health problems. Children are at higher risk for
respiratory depression.
Breathing problems can happen even if you take ZUTRIPRO exactly as
prescribed by your
healthcare provider.
Call your healthcare provider or get emergency medical help right away
if anyone taking
ZUTRIPRO has any of the symptoms below:
•
increased sleepiness
•
confusion
•
difficulty breathing
•
shallow breathing
•
limpness
Keep ZUTRIPRO in a safe place away from children. Accidental use of
even 1 dose of ZUTRIPRO,
especially by a child, is a medical emergency and can cause breathing
problems (respiratory
depression) which can lead to d

Summary of Product characteristics

ZUTRIPRO- HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND
PSEUDOEPHEDRINE
HYDROCHLORIDE SOLUTION
HAWTHORN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZUTRIPRO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZUTRIPRO.
ZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND
PSEUDOEPHEDRINE HYDROCHLORIDE) 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._
ZUTRIPRO 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 ZUTRIPRO, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF
HYDROCODONE. (5.2)
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
ZUTRIPRO. 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 ZUTRIPRO IN PATIENTS TAKING
CYP3A4 INHIBITORS OR
INDUCERS. (5.7, 7.2, 7.3)
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 ZUTRIPRO IN PATIENTS TAKING BENZODIAZEPINES, OTHER CNS
DEPRESSANTS, OR ALCOHOL. (5.8, 7.5)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE TAKING ZUTRIP