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:

SpecGx LLC

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 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)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [se

Product summary:

Hydromorphone Hydrochloride Tablets USP, 2 mg are available as a flat faced beveled or radius edge white to off-white tablet with one side debossed “M”; other side debossed “2”.             Bottles of 100................................... NDC 0406-3243-01 Hydromorphone Hydrochloride Tablets USP, 4 mg are available as a flat faced beveled edge white to off-white tablet with one side debossed “M”; other side debossed “4”.             Bottles of 100................................... NDC 0406-3244-01 Hydromorphone Hydrochloride Tablets USP, 8 mg are available as a white to off-white arc triangle shaped tablet debossed with a bisected “M” on one side and a split “8” on the other side.             Bottles of 100................................... NDC 0406-3249-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store hydromorphone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SpecGx LLC
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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 tablets:
•
Get emergency help or call 911 right away if you take too many
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. Talk
to your healthcare
provider about naloxone, a medicine for the emergency treatment of an
opioid overdose.
•
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 them. Selling or giving away hydromorphone hydrochloride
tablets is against the
law.
•
Store hydromorphone hydrochloride 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 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:
•
he

Summary of Product characteristics

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
SPECGX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE
HYDROCHLORIDE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HYDROMORPHONE HYDROCHLORIDE TABLETS USP.
HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 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)
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. (5.5)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDA