OXYCODONE HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Sun Pharmaceutical Industries, Inc.

INN (nemzetközi neve):

OXYCODONE HYDROCHLORIDE

Összetétel:

OXYCODONE HYDROCHLORIDE 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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): Oxycodone hydrochloride tablets are contraindicated in patients with: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . Available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the

Termék összefoglaló:

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 57664-223-88         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 57664-370-88         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 57664-187-88          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 57664-371-88         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 57664-224-88          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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Sun Pharmaceutical Industries, Inc.
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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.
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 gallbladde

Termékjellemzők

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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._
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
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)
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
CHILDRE