OXYCODONE HYDROCHLORIDE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Akorn

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. (1) Oxycodone hydrochloride oral solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use ( 1) 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 r

Rezumat produs:

Oxycodone hydrochloride oral solution 100 mg per 5 mL (20 mg per mL) is a yellow solution, supplied as: NDC 50383-964-30: Bottle of 30 mL supplied with a calibrated oral syringe Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). PROTECT from MOISTURE and LIGHT. Store oxycodone hydrochloride oral solution securely and dispose of properly [see Patient Counseling Information (17)].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Akorn
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MEDICATION GUIDE
Medication Guide
Oxycodone Hydrochloride
(ox-ee-CO-dohn) Oral Solution,
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 or call 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. Talk to your healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
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. Selling or giving away oxycodone
hydrochloride
oral solution is against the law.
•
Store oxycodone hydrochloride oral solution securely, out of sight and
reach
of children, and in a location not accessible by others, including
visitors to
the home.
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 ta

Caracteristicilor produsului

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
Warnings and Precautions (5.2, 5.4, 5.7) 03/2021
Indications and Usage (1) 07/2021
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. (1)
Oxycodone hydrochloride oral solution 100 mg per 5 mL (20 mg/mL) is
indicated for the relief of pain in
opioid-tolerant adults.
Limitations of Use (1)
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]:
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 PATIEN