HYDROMORPHONE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

RedPharm Drug, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 gastrointe

Produktbesonderheiten:

Hydromorphone Hydrochloride Tablets USP, 2 mg are available as a flat faced beveled 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)] .

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

RedPharm Drug, Inc.
----------
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 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.
•
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:
•
head injury, seizures
•
problems urinating
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problems

Fachinformation

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
HYDROMORPHONE HYDROCHLORIDE 2MG TABLETS
BOXED WARNING SECTION
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 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 d