HYDROMORPHONE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RedPharm Drug, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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)] - Acute or severe bronchial asthma in an unmonitored setting or i

Produkt oversigt:

Hydromorphone Hydrochloride Tablets USP, 2 mg are white, round, flat-faced beveled edge tablets debossed with “LCI” over “1353” on one side and “2” on the other side. Available in bottles of 100 (NDC 0527-1353-01). Hydromorphone Hydrochloride Tablets USP, 4 mg are white, round, flat-faced beveled edge tablets debossed with “LCI” over “1354” on one side and “4” on the other side. Available in bottles of 100 (NDC 0527-1354-01). Hydromorphone Hydrochloride Tablets USP, 8 mg are white, round, flat-faced beveled edge, scored, tablets debossed with “LCI” over “1355” on one side and plain on the other side. Available in bottles of 100 (NDC 0527-1355-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

RedPharm Drug, Inc.
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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:
•
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

Produktets egenskaber

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
HYDROMORPHONE 2MG
BOXED WARNING
ADDICTION, ABUSE, AND MISUSE
HYDROMORPHONE HYDROCHLORIDE TABLETS EXPOSE PATIENTS AND OTHER USERS TO
THE RISKS OF
OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS EACH
PATIENT’S RISK PRIOR TO PRESCRIBING HYDROMORPHONE HYDROCHLORIDE
TABLETS, AND MONITOR ALL
PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND
CONDITIONS _[SEE WARNINGS AND_
_PRECAUTIONS ( 5.2)] _.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
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 REMS FOR
THESE PRODUCTS
_[SEE WARNINGS AND PRECAUTIONS ( 5.3)]. _UNDER THE REQUIREMENTS OF THE
REMS, DRUG COMPANIES
WITH APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT
EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
HYDROMORPHONE HYDROCHLORIDE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF HYDROMORPHONE HYDROCHLORIDE TABLETS OR FOLLOWING
A DOSE INCREASE _[SEE_
_WARNINGS AND PRECAUTIONS ( 5.4)]._
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF HYDROMORPHONE HYDROCHLORIDE
TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROMORPHONE _[SEE
WARNINGS AND PRECAUTIONS (_
_5.4)] _.
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF HYDROMORPHONE