HYDROMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation

INN (International Name):

HYDROMORPHONE HYDROCHLORIDE

Composition:

HYDROMORPHONE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydromorphone hydrochloride tablets are indicated for the management of 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 (5.2)] , reserve hydromorphone hydrochloride tablets 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 been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.7)] Significant respiratory depression [see Warnings and Precautions (5.7)] -

Product summary:

Product: 63739-275 NDC: 63739-275-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-791 NDC: 63739-791-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

McKesson Corporation
----------
MEDICATION GUIDE
Hydromorphone Hydrochloride (hy-dro-MOR-fone hy-dro-KLOR-īd) Tablets,
CII
Hydromorphone hydrochloride tablets are:
•
Strong prescription pain medicines that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid analgesic, when other pain
treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
•
Opioid pain medicines 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 hydromorphone hydrochloride:
•
Get emergency help right away if you take too much hydromorphone
hydrochloride tablets
(overdose).
When you first start taking hydromorphone hydrochloride 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 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 tablets. They
could die from taking it.
Store hydromorphone hydrochloride tablets away from children and in a
safe place to prevent
stealing or abuse. Selling or giving away hydromorphone hydrochloride
tablets is against the law.
Do not take hydromorphone hydrochloride tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
Before taking hydromorphone hydrochloride tablets, tell your
healthcare provider if you have a history
of:
•
head injury, seizures
•
problems urinating
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or m

Summary of Product characteristics

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
MCKESSON CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HYDROMORPHONE HYDROCHLORIDE
TABLETS. HYDROMORPHONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: JANUARY 1984
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION
AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
HYDROMORPHONE HYDROCHLORIDE 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. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
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. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.4)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF HYDROMORPHONE. (5.4)
PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE TABLETS 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.