HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), HOMATROPINE METHYLBROMIDE (UNII: 68JRS2HC1C) (METHYLHOMATROPINE - UNII:P97OGJ7L1L)

Beszerezhető a:

Akorn

INN (nemzetközi neve):

HYDROCODONE BITARTRATE

Összetétel:

HYDROCODONE BITARTRATE 5 mg in 5 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in patients 18 years of age and older. Important Limitations of Use: Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: Hydrocodone bitartrate and homatropine methylbromide is also contraindicated in patients with: Risk Summary Hydrocodone bitartrate and homatropine methylbromide 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 and homatropine methylbromide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (see Data). Reproductive toxicity studies have not been cond

Termék összefoglaló:

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is available as a clear red colored, cherry flavored oral solution supplied as: Bottles of 16 fl. oz. (one pint) - NDC 50383-043-16 Store oral solution at controlled room temperature 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. 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

and homatropine methylbromide solution
Akorn
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Medication Guide
MEDICATION GUIDE
Hydrocodone Bitartrate and
Homatropine Methylbromide Oral Solution
(High-droe-KOE-dohn by-TAR-trate/hoe-MAT-troe-peen
Meth-ill-BROE-mide)
What is the most important information I should know about Hydrocodone
Bitartrate and Homatropine Methylbromide Oral Solution?
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is
not for
children under 18 years of age.
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution can
cause
serious side effects, including:
•
Addiction, abuse and misuse. Taking Hydrocodone Bitartrate and
Homatropine Methylbromide 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 and
Homatropine Methylbromide 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 and Homatropine Methylbromide
Oral Solution with other people.
o
Keep Hydrocodone Bitartrate and Homatropine Methylbromide Oral
Solution in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression).
Hydrocodone
Bitartrate and Homatropine Methylbromide Oral Solution 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 and
Homatropine
Methylbromide Oral Solution, 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 Hydrocodone Bitartrate
and
Homatropine Methylbromide Oral Solution exactly as p

Termékjellemzők

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE-
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE
BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR HYDROCODONE BITARTRATE AND
HOMATROPINE
METHYLBROMIDE ORAL SOLUTION.
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION,
CII
INITIAL U.S. APPROVAL: 1943
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._
•
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 05/2018
Indications and Usage (1) 05/2018
Dosage and Administration (2.1, 2.3) 05/2018
Dosage and Administration, Children under 18 years (2.2) Removed
05/2018
Contraindications (4) 05/2018
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 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 AND HOMATROPINE
METHYLBROMIDE
ORAL SOLUTION, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE
OF HYDROCODONE.
(5.2)
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROCODONE
BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION. 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 HYDRO