OXYMORPHONE HYDROCHLORIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Oxymorphone Hydrochloride (UNII: 5Y2EI94NBC) (Oxymorphone - UNII:9VXA968E0C)

Dostupno od:

Aurolife Pharma, LLC

INN (International ime):

Oxymorphone Hydrochloride

Sastav:

Oxymorphone Hydrochloride 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Oxymorphone Hydrochloride Tablets are indicated for the management of acute 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 Oxymorphone 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 Oxymorphone 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 [see Warnings and Precautions (5.6)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see W

Proizvod sažetak:

Oxymorphone Hydrochloride Tablets are supplied as follows: Oxymorphone Hydrochloride Tablets, 5 mg are light blue to blue colored, mottled, round, uncoated tablets, debossed with 'U85' on one side and plain on the other side.                                            Bottles of 30                    NDC 13107-103-30                                             Bottles of 100                  NDC 13107-103-01                                            Bottles of 1000                NDC 13107-103-99 Oxymorphone Hydrochloride Tablets, 10 mg are light peach to peach colored, mottled, round, uncoated tablets, debossed with 'U86' on one side and plain on the other side.                                           Bottles of 30                     NDC 13107-104-30                                            Bottles of 100                   NDC 13107-104-01                                               Bottles of 1000                 NDC 13107-104-99 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store Oxymorphone Hydrochloride Tablets securely and dispose of properly [see Patient Counseling Information (17)].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Aurolife Pharma, LLC
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MEDICATION GUIDE
Oxymorphone Hydrochloride Tablets (ox" i mor' fone hye" droe klor'
ide) tablets, for oral use, CII
Oxymorphone Hydrochloride Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage 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.
•
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 Oxymorphone Hydrochloride Tablets:
•
Get emergency help or call 911 right away if you take too much
Oxymorphone Hydrochloride Tablets (overdose). When you first start
taking
Oxymorphone 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 Oxymorphone 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 your Oxymorphone Hydrochloride Tablets. They could
die from taking it. Selling or giving away Oxymorphone Hydrochloride
Tablets is against the law.
•
Store Oxymorphone 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 Oxymorphone Hydrochloride Tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking Oxymorphone Hydrochloride Tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures

Svojstava lijeka

OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE TABLET
AUROLIFE PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYMORPHONE
HYDROCHLORIDE TABLETS.
OXYMORPHONE HYDROCHLORIDE TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1959
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL
OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYMORPHONE HYDROCHLORIDE TABLETS EXPOSES USERS TO RISKS OF ADDICTION,
ABUSE, AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENTS 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 OXYMORPHONE HYDROCHLORIDE TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYMORPHONE. (5.3)
PROLONGED USE OF OXYMORPHONE 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)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCT CONTAINING
ALCOHOL WHILE TAKING
OXYMORPHONE HYDROCHLORIDE TABLETS BECAUSE CO-INGESTION CAN RESULT IN
FATAL PLASMA OXYMORPHO