OPANA ER- oxymorphone hydrochloride tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Endo Pharmaceuticals Inc.

INN (Mezinárodní Name):

OXYMORPHONE HYDROCHLORIDE

Složení:

OXYMORPHONE HYDROCHLORIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

OPANA ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term 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, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve OPANA ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - OPANA ER is not indicated as an as-needed (prn) analgesic. OPANA ER 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)] - Hypersensitivity t

Přehled produktů:

OPANA ER extended-release tablets are supplied as follows: 5 mg Pink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-812-60 Bottles of 100 with child-resistant closure                      NDC 63481-812-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-20 7.5 mg Gray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-813-60 Bottles of 100 with child-resistant closure                      NDC 63481-813-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-20 10 mg Light orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-814-60 Bottles of 100 with child-resistant closure                      NDC 63481-814-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-20 15 mg White, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-815-60 Bottles of 100 with child-resistant closure                      NDC 63481-815-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-20 20 mg Light green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-816-60 Bottles of 100 with child-resistant closure                      NDC 63481-816-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-20 30 mg Red, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-817-60 Bottles of 100 with child-resistant closure                      NDC 63481-817-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-20 40 mg Light yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side. Bottles of 60 with child-resistant closure                        NDC 63481-818-60 Bottles of 100 with child-resistant closure                      NDC 63481-818-70 Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20 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 ER securely and dispose of properly [see Patient Counseling Information (17)] .

Stav Autorizace:

New Drug Application

Informace pro uživatele

Endo Pharmaceuticals Inc.
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Medication Guide
OPANA ® ER (Ō-pan-a) (oxymorphone hydrochloride) extended-release
tablets, for
oral use, CII
OPANA ER is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used
to manage pain severe enough to require daily around-the-clock,
long-term
treatment with an opioid, when other pain treatments such as
non-opioid pain
medicines or immediate-release opioid 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.
•
Not for use to treat pain that is not around-the-clock.
Important information about OPANA ER:
•
Get emergency help right away if you take too much OPANA ER (overdose)
.
When you first start taking OPANA ER, 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 ER 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 ER. They could die from taking it.
Selling
or giving away OPANA ER is against the law.
•
Store OPANA ER 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 ER 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 ER , 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
hea

Charakteristika produktu

OPANA ER- OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE
ENDO PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPANA ER SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OPANA ER.
OPANA ER (OXYMORPHONE HYDROCHLORIDE) EXTENDED-RELEASE 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 AND OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OPANA ER 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. INSTRUCT PATIENTS TO SWALLOW
OPANA ER TABLETS WHOLE TO AVOID
EXPOSURE TO A POTENTIALLY FATAL DOSE OF OXYMORPHONE. (5.3)
ACCIDENTAL INGESTION OF OPANA ER, ESPECIALLY BY CHILDREN, CAN RESULT
IN FATAL OVERDOSE OF
OXYMORPHONE. (5.3)
PROLONGED USE OF OPANA ER DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME,
WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF OPIOID
USE IS REQUIRED FOR A PROLONGED
PERIOD 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 ER
BECAUSE CO-INGESTION CAN RESULT IN FA