OXYCODONE HYDROCHLORIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

SpecGx LLC

Designación común internacional (DCI):

OXYCODONE HYDROCHLORIDE

Composición:

OXYCODONE HYDROCHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 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 contraindicated in patients with: - Significant respiratory depression [ see Warnings and Precautions (5.3) ] . - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [ see Warnings and Precautions (5.7) ] . - Known or suspected gastrointestinal obstruction, including paralytic ileu

Resumen del producto:

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 10 mg is available as a mottled pink round convex tablet with a  on one side and “10” above a bisect on the other. Bottles of 100............................. NDC 0406-8510-01 Unit Dose (10 x 10)................... NDC 0406-8510-62 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 20 mg is available as a mottled gray round convex tablet with a  on one side and “20” above a bisect on the other. Bottles of 100............................. NDC 0406-8520-01 Unit Dose (10 x 10)................... NDC 0406-8520-62 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]. Store oxycodone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

SpecGx LLC
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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 or call 911 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. Talk to your healthcare
provider about naloxone,
a medicine for the emergency treatment of an opioid overdose.
•
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.
Selling or giving away oxycodone hydrochloride tablets is against the
law.
•
Store oxycodone hydrochloride tablets 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 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 inju

Ficha técnica

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
SPECGX LLC
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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; 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