HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE- hydrocodone bitartrate, chlorpheniramine mal

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Paddock Laboratories, LLC

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution 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 Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is contraindicated for: Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is also contraindicated in patients with: Risk Summary Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.13), Clinical Considerations ]. There are no available data with hydrocodone bitartrate, chlorpheniramine maleate and pseudo

Product summary:

Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution is supplied 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: NDC 0574-1103-16 One pint (480 mL) 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:

Abbreviated New Drug Application

Patient Information leaflet

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND
PSEUDOEPHEDRINE HYDROCHLORIDE- HYDROCODONE BITARTRATE,
CHLORPHENIRAMINE MALEATE
AND PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION
Paddock Laboratories, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Hydrocodone Bitartrate (hye'' droe koe' done bye tar' trate),
Chlorpheniramine Maleate (klor'' fen ir' a meen mal' ee ate), and
Pseudoephedrine Hydrochloride (soo'' doe e fed' rin hye'' droe klor'
ide)
Oral Solution, CII
What is the most important information I should know about hydrocodone
bitartrate, chlorpheniramine
maleate, and pseudoephedrine hydrochloride oral solution?
Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine
hydrochloride oral solution is
not for children under 18 years of age.
Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine
hydrochloride oral solution can
cause serious side effects, including:
•
Addiction, abuse and misuse. Taking hydrocodone bitartrate,
chlorpheniramine maleate, and
pseudoephedrine hydrochloride oral solution 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, chlorpheniramine maleate, and
pseudoephedrine hydrochloride oral
solution 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.
o
Do not share your hydrocodone bitartrate, chlorpheniramine maleate,
and pseudoephedrine
hydrochloride oral solution with other people.
o
Keep hydrocodone bitartrate, chlorpheniramine maleate, and
pseudoephedrine hydrochloride
oral solution in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression).
Hydrocodone bitartrate,
chlorpheniramine maleate, and pseudoephedrine hydrochloride oral
solution can cause breathing
problems (respiratory depression) that can happen at any time during
treatment

Summary of Product characteristics

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND
PSEUDOEPHEDRINE HYDROCHLORIDE- HYDROCODONE BITARTRATE,
CHLORPHENIRAMINE MALEATE
AND PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION
PADDOCK LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE BITARTRATE,
CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ORAL
SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCODONE
BITARTRATE, CHLORPHENIRAMINE
MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SOLUTION.
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._
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RECENT MAJOR CHANGES
7/2018
7/2018
Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine
hydrochloride oral solution 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, chlorpheniramine
maleate and pseudoephedrine hydrochloride
oral solution, especially by children, can result in a fatal overdose
of hydrocodone. (5.2)
Ensure accuracy when prescribing, dispensing, and administering
hydrocodone bitartrate, chlorpheniramine
maleate and pseudoephedrine hydrochloride oral solution. Dosing errors
can result in accidental overdose and
death. (2,1, 5.5)
Concomitant use with CYP3A4 inhibitors (or disco