OXYCODONE HYDROCHLORIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Golden State Medical Supply

Designació comuna 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

Resumen del producto:

Oxycodone hydrochloride tablets, USP are available as follows: 5 mg: White colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘223’ on one side and scored on the other side. NDC 60429-516-01 Bottles of 100 CRC 10 mg: Pink colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘370’ on one side and scored on the other side. NDC 60429-517-01 Bottles of 100 CRC 15 mg: Green colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘187’ on one side and scored on the other side. NDC 60429-519-01 Bottles of 100 CRC 20 mg: Gray colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘371’ on one side and scored on the other side. NDC 60429-520-01 Bottles of 100 CRC 30 mg: Blue colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘224’ on one side and scored on the other side. NDC 60429-521-01 Bottles of 100 CRC Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Store at 20° to 25°C (68° to 77°F). (See USP for Controlled Room Temperature). Protect from moisture.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Golden State Medical Supply
----------
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.
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 injury, seizures • liver, kidney, thyroid problems
•
problems urinating • pancreas or gallbladder proble

Fitxa tècnica

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
OXYCODONE HYDROCHLORIDE TABLETS.
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