OXYCODONE HYDROCHLORIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

RedPharm Drug, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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): Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. 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

Prehľad produktov:

Oxycodone Hydrochloride Tablet USP are available as follows: Each Oxycodone Hydrochloride Tablet USP 5 mg is available as a white round convex tablet with a  on one side and “0552” with a vertical bisect between the fives on the other. Bottles of 100............................. NDC 0406-0552-01 Unit Dose (10 x 10)................... NDC 0406-0552-62 Each Oxycodone Hydrochloride Tablet USP 15 mg is available as a light green round convex tablet with a  on one side and “15” above a bisect on the other. Bottles of 100............................. NDC 0406-8515-01 Unit Dose (10 x 10)................... NDC 0406-8515-62 Each Oxycodone Hydrochloride Tablet USP 30 mg is available as a light blue round convex tablet with a  on one side and “30” above a bisect on the other. Bottles of 100............................. NDC 0406-8530-01 Unit Dose (10 x 10)................... NDC 0406-8530-62 Dispense in a tight, light-resistant container with child-resistant closure. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
RedPharm Drug, Inc.
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Medication Guide
Oxycodone Hydrochloride Tablets USP, CII
(ox" i koe' done hye" droe klor' ide)
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 many 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
•
ab

Súhrn charakteristických

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
OXYCODONE 5MG
OXYCODONE 5MG
WARNING: 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.
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)
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 and Mitigation
Strategy (REMS) for these products. ( 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 tablets, especially by
children, can result in a
fatal overdose of oxycodone. ( 5.3)
Prolonged use of oxycodone hydrochloride tablets 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)
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4
inducers) can result in a
fatal overdose of oxycodone from oxycodone hydrochloride tablets. (
5.5, 7, 12.3)
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression, coma, and
death. Reserve concomitant prescribing for use in patients for whom
alternative treatment options