OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Oxycodone hydrochloride tablets are 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 (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride tablets are contraindicated in patients with: Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)] Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)] . Available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Product samenvatting:

Product: 71335-0855 NDC: 71335-0855-1 120 TABLET in a BOTTLE NDC: 71335-0855-2 30 TABLET in a BOTTLE NDC: 71335-0855-3 60 TABLET in a BOTTLE NDC: 71335-0855-4 90 TABLET in a BOTTLE NDC: 71335-0855-5 40 TABLET in a BOTTLE NDC: 71335-0855-6 28 TABLET in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Bryant Ranch Prepack
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Medication Guide
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) Tablets
USP, CII
Oxycodone hydrochloride tablets are:
•
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 tablets:
•
Get emergency help right away if you take too much oxycodone
hydrochloride tablets (overdose).
When you first start taking oxycodone hydrochloride tablets, 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 tablets 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 tablets. They
could die from taking it. Store
oxycodone hydrochloride tablets away from children and in a safe place
to prevent stealing or
abuse. Selling or giving away oxycodone hydrochloride tablets is
against the law.
Do not take oxycodone hydrochloride tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
allergy to oxycodone.
Before taking oxycodone hydrochloride tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures • liver, kidney, thyroid problems
•
problems urinating • pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction,

Productkenmerken

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE
HYDROCHLORIDE TABLETS.
OXYCODONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1950
WARNING: 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._
•
•
•
•
•
•
RECENT MAJOR CHANGES
BOXED WARNING
12/2016
INDICATIONS AND USAGE
12/2016
DOSAGE AND ADMINISTRATION
12/2016
WARNINGS AND PRECAUTIONS
12/2016
INDICATIONS AND USAGE
Oxycodone hydrochloride tablets are an opioid agonist indicated for
the management of pain severe enough to require an
opioid analgesic and for which alternative treatments are inadequate.
(1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve oxycodone
hydrochloride tablets for use in patients for whom alternative
treatment options (e.g., non-opioid analgesics or non-opioid
combination products):
•
•
DOSAGE AND ADMINISTRATION
•
•
OXYCODONE HYDROCHLORIDE TABLETS EXPOSE 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. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.2)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE TABLETS DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH