XARTEMIS XR- oxycodone hydrochloride and acetaminophen tablet, coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

SpecGx LLC

INN (Nama Internasional):

OXYCODONE HYDROCHLORIDE

Komposisi:

OXYCODONE HYDROCHLORIDE 7.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

XARTEMIS XR is indicated for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options 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 XARTEMIS XR for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia. XARTEMIS XR tablets are contraindicated in patients with - Significant respiratory depression [see Warnings and Precautions (5.2)] Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipmen

Ringkasan produk:

XARTEMIS XR (oxycodone hydrochloride and acetaminophen) extended-release tablets are oval shaped tablets with a blue coating, debossed with “M” in a box over “115” on one side of the tablet. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen and is packaged in bottles and blister packs. Bottles of 100             NDC 23635-115-01 Unit dose (10 x 10)    NDC 23635-115-62 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

New Drug Application

Selebaran informasi

SpecGx LLC
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MEDICATION GUIDE
XARTEMIS® XR (ZAR-tem-iss) (oxycodone hydrochloride and
acetaminophen) Extended-Release Tablets, CII
XARTEMIS XR is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
and the medicine acetaminophen.
XARTEMIS XR is used to treat certain types of short term (acute) pain
when other pain treatments such as non-
opioid pain medicines do not treat your pain well enough or you cannot
tolerate them.
•
A long-acting (extended-release) 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 XARTEMIS XR:
•
Get emergency help right away if you take too much XARTEMIS XR
(overdose). When you first start taking
XARTEMIS XR, 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 XARTEMIS XR 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 XARTEMIS XR. They could die from taking
it. Store XARTEMIS XR away from
children and in a safe place to prevent stealing or abuse. Selling or
giving away XARTEMIS XR is against the
law.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day. Taking
XARTEMIS XR with other products that contain acetaminophen can lead to
serious liver problems and death.
Do not take XARTEMIS XR if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
allergy to acetaminophen or oxycodone.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking XARTEMIS XR, tell your healthcare provider if you have a
history of:
•
head injury, seizures
•
problems urinating
•
abuse of street or prescription drugs, alc

Karakteristik produk

XARTEMIS XR- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET, COATED
SPECGX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XARTEMIS XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR XARTEMIS XR.
XARTEMIS XR (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN)
EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1976
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P450 3A4
INTERACTION; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
XARTEMIS XR EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS 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. INSTRUCT PATIENTS TO SWALLOW
TABLETS WHOLE TO AVOID EXPOSURE TO
A POTENTIALLY FATAL DOSE OF OXYCODONE. (5.2)
ACCIDENTAL INGESTION OF XARTEMIS XR, ESPECIALLY IN CHILDREN, CAN
RESULT IN FATAL OVERDOSE OF
OXYCODONE. (5.2)
PROLONGED USE OF XARTEMIS XR 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. (5.3)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.4, 7, 12.3)
XARTEMIS XR CONTAINS ACETAMINOPHEN. ACETAMINOPHEN HAS BEEN ASSOCIATED
WITH CASES OF ACUTE LIVER
FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE
CASES OF LIVER INJURY ARE ASSOCIATED
WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4,0