OXYCODONE HYDROCHLORIDE solution OXYCODONE HYDROCHLORIDE solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Доступна с:

KVK-Tech, Inc.

ИНН (Международная Имя):

OXYCODONE HYDROCHLORIDE

состав:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see  Warnings and Precautions ( 5.2)] , reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4)] . Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects an

Обзор продуктов:

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), is a red solution, supplied as: NDC 10702-183-50: Bottle of 500 mL supplied with a calibrated measuring cup Oxycodone Hydrochloride Oral Solution, USP 100 mg per 5 mL (20 mg per mL), is a yellow solution, supplied as: NDC 10702-171-03: Bottle of 30 mL supplied with a calibrated oral syringe Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
KVK-Tech, Inc.
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MEDICATION GUIDE
Oxycodone Hydrochloride (ox'' i koe' done hye'' droe klor' ide) Oral
Solution, USP
CII
Oxycodone Hydrochloride Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid pain medicine, when other pain
treatments such as non-opioid
pain medicines do not treat your pain well enough or you cannot
tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead
to death.
Important information about Oxycodone Hydrochloride Oral Solution:
•
Get emergency help right away if you take too much Oxycodone
Hydrochloride Oral Solution
(overdose). When you first start taking Oxycodone Hydrochloride Oral
Solution, when your dose
is changed, or if you take too much (overdose), serious or
life-threatening breathing problems that
can lead to death may occur.
•
Taking Oxycodone Hydrochloride Oral Solution with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your Oxycodone Hydrochloride Oral Solution.
They could die from
taking it. Store Oxycodone Hydrochloride Oral Solution away from
children and in a safe place to
prevent stealing or abuse. Selling or giving away Oxycodone
Hydrochloride Oral Solution is
against the law.
Do not take Oxycodone Hydrochloride Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
an allergy to oxycodone or any of the ingredients in Oxycodone
Hydrochloride Oral Solution.
Before taking Oxycodone Hydrochloride Oral Solution, tell your
healthcare provider if you have a
histor

Характеристики продукта

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
KVK-TECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OXYCODONE HYDROCHLORIDE
ORAL SOLUTION.
OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL
SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT
USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE HYDROCHLORIDE ORAL
SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER
OXYCODONE HYDROCHLORIDE
ORAL SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN RESULTS IN ACCIDENTAL
OVERDOSE AND DEATH. ( 2.1, 5.1_)_
OXYCODONE 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 REGULARLY FOR
THESE BEHAVIORS AND CONDITIONS. ( 5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. ( 5.3)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYCODONE. ( 5.3)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION DURING
PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED. IF
PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. ( 5.4)
THE CONCOMITANT USE WITH CYP3A4 INHIBITORS