HYDROMORPHONE HYDROCHLORIDE tablet, extended release

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Trigen Laboratories, LLC

INN (Alþjóðlegt nafn):

HYDROMORPHONE HYDROCHLORIDE

Samsetning:

HYDROMORPHONE HYDROCHLORIDE 16 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic 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. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions (5.1 )] , reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immed

Vörulýsing:

How Supplied Hydromorphone Hydrochloride Extended-Release Tablets Strengths Store at 25ºC (77ºF); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
Trigen Laboratories, LLC
----------
MEDICATION GUIDE
Medication Guide
Hydromorphone Hydrochloride Extended-Release Tablets, CII
(hy-druh-mor-fon hy-druh-klawr-ahyd)
Hydromorphone hydrochloride extended-release tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain that requires an extended treatment period
with a daily opioid pain
medicine, 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 to be taken on an “as needed” basis.
Important information about hydromorphone hydrochloride
extended-release tablets:
•
Get emergency help or call 911 right away if you take too much
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. Talk to your healthcare
provider about naloxone, a medicine for the emergency treatment of an
opioid overdose.
•
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 death.
•
Never give anyone else your hydromorphone hydrochloride
extended-release tablets. They could
die from taking it. Selling or giving away hydromorphone hydrochloride
extended-release tablets
is against the law.
•
Store hydromorphone hydrochloride extended-rele

Vara einkenni

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
TRIGEN LABORATORIES, LLC
----------
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 HYDROCHLORIDE EXTENDED-RELEASE TABLETS,
FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1984
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS
_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)
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. (5.2)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF HYDROMORPHONE.
(5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE
IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES
AND DURATIONS
TO THE MINIMUM REQUIRED; AND FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF
RESPIRATORY
DEPRESSION AND SEDATION. (5.3, 7) 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