OXYCODONE HYDROCHLORIDE solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Akorn

INN (الاسم الدولي):

OXYCODONE HYDROCHLORIDE

تركيب:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Oxycodone hydrochloride oral solution is indicated in adults 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]: Oxycodone hydrochloride oral solution is contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ]. Available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses

ملخص المنتج:

Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: 500 mL bottle packaged with calibrated measuring cup 5 mL unit dose in trays of ten cups, case of 40. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Store oxycodone hydrochloride oral solution securely and dispose of properly [see Patient Counseling Information (17)] .

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Akorn
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MEDICATION GUIDE
MEDICATION GUIDE
Oxycodone Hydrochloride Oral Solution
(ox-ee-CO-dohn)
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 history of:
•
head injury, seizures ● liver, kidney, thyroid problems
•
problems ur

خصائص المنتج

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
AKORN
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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 CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); 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._
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•
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RECENT MAJOR CHANGES
Dosage and Administration (2.2) 03/2021
INDICATIONS AND USAGE
Oxycodone hydrochloride oral solution is indicated in adults 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
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 SOLUTION OF DIFFERENT
CONCENTRATIONS CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1, 5.1)
OXYCODONE HYDROCHLORIDE ORAL SOLUTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE,
2.1 IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONSAND MISUSE, WHICH
CAN LEAD
TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND
MONITOR
REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AN