HYDROMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride tablet, film coated, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)

Saatavilla:

Actavis Pharma, Inc.

INN (Kansainvälinen yleisnimi):

HYDROMORPHONE HYDROCHLORIDE

Koostumus:

HYDROMORPHONE HYDROCHLORIDE 8 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in o p i o i d - t o l e r a n t  patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. L i m i tat i o ns   of   U s e - 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, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom  alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are inef

Tuoteyhteenveto:

Hydromorphone hydrochloride Extended-Release Tablet Strengths Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

RELEASE
Actavis Pharma, Inc.
Reference Label Set Id: d7b696ba-7438-4b10-9fa3-407ac3381e46
----------
Medication Guide
Hydromorphone (HYE-droe-MOR-fone) Hydrochloride Extended-Release
Tablets, CII
Hydromorphone hydrochloride extended-release tablets are:
•
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
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 hydromorphone hydrochloride
extended-release tablets:
•
Get emergency help right away if you take too many hydromorphone
hydrochloride extended-release
tablets (overdose). When you first start taking hydromorphone
hydrochloride extended-release 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 hydromorphone hydrochloride extended-release
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
•
Never give anyone else your hydromorphone hydrochloride
extended-release tablets. They could die from
taking it. Store hydromorphone hydrochloride extended-release tablets
away from children and in a safe
place to prevent stealing or abuse. Selling or giving away
hydromorphone hydrochloride extended-release tablets
against the law.
Do not take hydromorphone hydrochloride extended-release tablets if
you have:
•
severe asthma, trouble breathing, or o

Valmisteyhteenveto

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
ACTAVIS PHARMA, INC.
REFERENCE LABEL SET ID: D7B696BA-7438-4B10-9FA3-407AC3381E46
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
HYDROMORPHONE HCL EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1984
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL
OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE 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. INSTRUCT PATIENTS TO SWALLOW
HYDROMORPHONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY
FATAL DOSE OF HYDROMORPHONE. (5.3)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN FATAL OVERDOSE OF HYDROMORPHONE. (5.3)
PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
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