HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE- hydromorphone hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

INN (International Name):

HYDROMORPHONE HYDROCHLORIDE

Composition:

HYDROMORPHONE HYDROCHLORIDE 8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant 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. 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, 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 ineffective, not tolerated, or

Product summary:

Hydromorphone Hydrochloride Extended-Release Tablets Strengths Strength Color Tablet Description Bottle Count NDC 8 mg Red Round, biconvex, printed with “EXH 8” 100 0406-3308-01 12 mg Dark yellow Round, biconvex, printed with “EXH 12” 100 0406-3312-01 16 mg Yellow Round, biconvex, printed with “EXH 16” 100 0406-3316-01 32 mg White Round, biconvex, printed with “EXH 32” 100 0406-3332-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store hydromorphone hydrochloride extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

EXTENDED RELEASE
SpecGx LLC
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MEDICATION GUIDE
Hydromorphone 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
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 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
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-release 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 hydromorphone hydrochloride extended-release tablets if
you have:
•
severe asthma, trouble breathing, or other l

Summary of Product characteristics

HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE- HYDROMORPHONE
HYDROCHLORIDE TABLET, EXTENDED RELEASE
SPECGX LLC
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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: 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 PROLONGED
PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT