HYDROMORPHONE HYDROCHLORIDE - hydromorphone hydrochloride tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

TAGI Pharma, Inc.

Designación común internacional (DCI):

HYDROMORPHONE HYDROCHLORIDE

Composición:

HYDROMORPHONE HYDROCHLORIDE 8 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydromorphone Hydrochloride Tablets, USP 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 (5.1)] , reserve Hydromorphone Hydrochloride Tablets, USP 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, USP are contraindicated in patients with: •  Significant respiratory depression [see Warnings and Precautions (5.6)] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6)] • Known or suspected gastrointestinal obstruction, including paralyti

Resumen del producto:

Bottles of 100 - NDC# 51224-102-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

HYDROMORPHONE HYDROCHLORIDE - HYDROMORPHONE HYDROCHLORIDE TABLET
TAGI Pharma, Inc.
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MEDICATION GUIDE
Hydromorphone Hydrochloride Tablets, USP CII
Hydromorphone Hydrochloride Tablets, USP 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, USP
(overdose). When you first start taking Hydromorphone Hydrochloride
Tablets, USP, 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, USP 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,
USP. They could die from taking it.
Store Hydromorphone Hydrochloride Tablets, USP away from children and
in a safe place to prevent
stealing or abuse. Selling or giving away Hydromorphone Hydrochloride
Tablets, USP is against the law.
Do not take Hydromorphone Hydrochloride Tablets, USP 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, USP, tell your
healthcare provider if you have a
history of:
• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction,

Ficha técnica

HYDROMORPHONE HYDROCHLORIDE - HYDROMORPHONE HYDROCHLORIDE TABLET
TAGI PHARMA, INC.
----------
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
RX ONLY
INITIAL U.S. APPROVAL: JANUARY 1984
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTIONS; 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 TABLETS, USP EXPOSES 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. (5.3)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE TABLETS, USP,
ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF HYDROMORPHONE. (5.3)
PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE TABLETS, USP 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. (5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PR