HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE solution

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)

Available from:

Acella Pharmaceuticals, 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 and chlorpheniramine maleate oral solution is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 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)] . Hydrocodone bitartrate and chlorpheniramine maleate oral solution is contraindicated in: - Patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine maleate or any of the inactive ingredients of hydrocodone bitartrate and chlorpheniramine maleate oral solution. - Patients receiving MAOI therapy or within 14 days of stopping such therapy. - Patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies of hydrocodone bitartrate and chlorpheniramine maleate oral solut

Product summary:

Hydrocodone bitartrate and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in: White HDPE bottles of one pint (480 mL): NDC 42192-612-16 Store solution at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CHLORPHENIRAMINE MALEATE SOLUTION
Acella Pharmaceuticals, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration Issued: March
2017
MEDICATION GUIDE
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Chlorpheniramine Maleate (klor-fen-AIR-uh-meen MAL-ee-ate) Oral
Solution, CII
What is the most important information I should know about hydrocodone
bitartrate and
chlorpheniramine maleate?
•
Taking hydrocodone bitartrate and chlorpheniramine maleate with
benzodiazepines, or other
central nervous system depressants, including alcohol can cause severe
drowsiness, breathing
problems (respiratory depression), coma, and death.
•
Hydrocodone bitartrate and chlorpheniramine maleate can cause you to
be drowsy. Avoid driving
a car or operating machinery during treatment with hydrocodone
bitartrate and chlorpheniramine
maleate.
•
Women who breastfeed should talk to their healthcare provider before
taking hydrocodone
bitartrate and chlorpheniramine maleate.
•
Call your healthcare provider or get emergency medical help right away
if anyone taking
hydrocodone bitartrate and chlorpheniramine maleate has any of the
symptoms below:
•
increased sleepiness
•
confusion
•
difficulty breathing
•
shallow breathing
•
limpness
•
your baby has difficulty breastfeeding
•
Keep hydrocodone bitartrate and chlorpheniramine maleate in a safe
place away from children.
Accidental use by a child is a medical emergency and can cause death.
If a child accidentally
takes hydrocodone bitartrate and chlorpheniramine maleate, get
emergency medical help right
away.
•
Hydrocodone bitartrate and chlorpheniramine maleate can cause serious
side effects, including
death.
•
Take hydrocodone bitartrate and chlorpheniramine maleate exactly as
prescribed by your
healthcare provider. If you take the wrong dose of hydrocodone
bitartrate and chlorpheniramine
maleate, you could overdose and die.
•
Hydrocodone bitartrate and chlorpheniramine maleate is not for
children under 18 years

Summary of Product characteristics

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE- HYDROCODONE
BITARTRATE AND CHLORPHENIRAMINE MALEATE SOLUTION
ACELLA PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE BITARTRATE AND
CHLORPHENIRMINE MALEATE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
HYDROCODONE BITARTRATE AND CHLORPHENIRMINE MALEATE ORAL SOLUTION.
HYDROCODONE BITARTRATE AND CHLORPHENIRMINE MALEATE ORAL SOLUTION FOR
ORAL ADMINISTRATION
CII.
INITIAL U.S. APPROVAL: 1987
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 _[SEE WARNINGS_
_AND PRECAUTIONS ( 5.1), DRUG INTERACTIONS ( 7.1)] _. AVOID USE OF
OPIOID COUGH MEDICATIONS IN PATIENTS TAKING
BENZODIAZEPINES, OTHER CNS DEPRESSANTS, OR ALCOHOL.
RECENT MAJOR CHANGES
Boxed Warning
1/2017
Warnings and Precautions ( 5)
1/2017
INDICATIONS AND USAGE
Hydrocodone bitartrate and chlorpheniramine maleate oral solution is a
combination of hydrocodone bitartrate, an
antitussive, and chlorpheniramine maleate, a histamine-1 (H
) receptor antagonist, indicated for relief of cough and
symptoms associated with upper respiratory allergies or a common cold
( 1.1)
Limitations of Use:
Not indicated for pediatric patients under 18 years of age ( 1.1)
DOSAGE AND ADMINISTRATION
For Oral Use Only ( 2)
Adults 18 years of age and older: 5 mL every 4 to 6 hours as needed,
not to exceed 4 doses (20 mL) in 24 hours ( 2)
DOSAGE FORMS AND STRENGTHS
Each 5 mL of hydrocodone bitartrate and chlorpheniramine maleate oral
solution contains: hydrocodone bitartrate, USP, 5
mg and chlorpheniramine maleate, USP, 4 mg ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to hydrocodone bitartrate,
chlorpheniramine, or any of the inactive ingredients of
hydrocodone bitartrate and chlorp