OPANA- oxymorphone hydrochloride tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)

Saatavilla:

Endo Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

OXYMORPHONE HYDROCHLORIDE

Koostumus:

OXYMORPHONE HYDROCHLORIDE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

OPANA is 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 OPANA 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 OPANA is 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 Warnings and Precautions (5.11) ] - Hypersensitivity to oxymorphone (e.g., anaphylaxis, an

Tuoteyhteenveto:

OPANA (oxymorphone hydrochloride) tablets are supplied as follows: 5 mg Tablet: Blue, round, convex tablets debossed with E612 over 5 on one side and plain on the other. Bottles of 100 tablets with child-resistant closure                 NDC 63481-612-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only)                  NDC 63481-612-75 10 mg Tablet: Red, round, convex tablets debossed with E613 over 10 on one side and plain on the other. Bottles of 100 tablets with child-resistant closure                 NDC 63481-613-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only)                  NDC 63481-613-75 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store OPANA Tablets securely and dispose of properly [see Patient Counseling Information (17) ].

Valtuutuksen tilan:

New Drug Application

Pakkausseloste

OPANA- OXYMORPHONE HYDROCHLORIDE TABLET
Endo Pharmaceuticals Inc.
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Medication Guide
OPANA® (Ō-pan-a) (oxymorphone hydrochloride) tablets, for oral use,
CII
OPANA is:
•
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 OPANA:
•
Get emergency help right away if you take too much OPANA (overdose).
When you first start taking
OPANA, 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 OPANA 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 OPANA Tablets. They could die from taking
it. Selling or giving away
OPANA Tablets is against the law.
•
Store OPANA 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 OPANA if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking OPANA, tell your healthcare provider if you have a
history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. Prolonged use of OPANA during
pregnancy can cause
withdrawal symptoms in your new

Valmisteyhteenveto

OPANA- OXYMORPHONE HYDROCHLORIDE TABLET
ENDO PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPANA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OPANA .
OPANA (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_.
OPANA EXPOSES 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 OPANA, ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYMORPHONE.
(5.3)
PROLONGED USE OF OPANA 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 OPANA
BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA OXYMORPHONE LEVELS.
(5.5)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATIO