HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE tablet HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Genus Lifesciences Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. 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 and homatropine methylbromide 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 and homatropine methylbromide is contraindicated for: - All pediatric patients younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)]. - Significant respiratory depression [see Warnings and Precautions (5.2)]

Огляд продуктів:

Hydrocodone bitartrate and homatropine methylbromide is supplied as a white-colored, biconvex tablet, one face bisected and debossed with "205", and the other face plain, available in: Store tablets at controlled room temperature 20°C to 25°C (68°F 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. Hydrocodone bitartrate and homatropine methylbromide is available as a clear red-colored, cherry-flavored oral solution in: Store oral solution at controlled room temperature 20°C to 25°C (68°F 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.

Статус Авторизація:

New Drug Application Authorized Generic

інформаційний буклет

AND HOMATROPINE METHYLBROMIDE TABLET
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE
BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION
Genus Lifesciences Inc.
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MEDICATION GUIDE
Hydrocodone bitartrate and homatropine methylbromide tablets and oral
solution, for oral use
(HIGH-droe-KOE-dohn by-TAR-trate and hoe-MAT-troe-peen
METH-ill-BROE-mide)
CII
What is the most important information I should know about Hydrocodone
Bitartrate and Homatropine
Methylbromide?
Hydrocodone bitartrate and homatropine methylbromide is not for
children under 18 years of age.
Hydrocodone bitartrate and homatropine methylbromide can cause serious
side effects, including:
•
Addiction, abuse and misuse. Taking hydrocodone bitartrate and
homatropine methylbromide 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
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 and homatropine methylbromide
with other people.
•
Keep hydrocodone bitartrate and homatropine methylbromide in a safe
place away from
children.
•
Life-threatening breathing problems (respiratory depression).
Hydrocodone bitartrate and
homatropine methylbromide 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, 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

Характеристики продукта

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE-
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE-
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION
GENUS LIFESCIENCES INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE BITARTRATE
AND HOMATROPINE METHYLBROMIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE.
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS, FOR ORAL
USE, CII
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._
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 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,
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. 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
AND HOMATROPINE METHYLBROMIDE IN PATIENTS TAKING CYP3A4 INHIBITORS OR