HYRDOMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Hydromorphone Hydrochloride (UNII: L960UP2KRW) (Hydromorphone - UNII:Q812464R06)

Disponibbli minn:

Precision Dose Inc.

INN (Isem Internazzjonali):

Hydromorphone Hydrochloride

Kompożizzjoni:

Hydromorphone Hydrochloride 8 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 (5.5)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)] - Known or suspected gastrointestinal obstruction, including paralytic il

Sommarju tal-prodott:

Protect from light. Hydromorphone Hydrochloride Tablets, USP 8 mg are white to off white, bisected, triangular tablets debossed with "EL 14" on the bisected side. They are available as follows: NDC 68094-852-61 Unit Dose Packages of 100 Tablets (10×10) per carton Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

HYRDOMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
Precision Dose 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,

Karatteristiċi tal-prodott

HYRDOMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET
PRECISION DOSE INC.
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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, C-II
INITIAL U.S. APPROVAL: 1984
RX ONLY
_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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE TABLETS, USP,
ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF HYDROMORPHONE. (5.2)
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. (5.3)
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 DEPRESSION AND SEDATION. (5.4, 7).
RECENT MAJOR CHANGES
Boxed Warning
01/2017
Indications and Usage
01/2017
Dosage and Administration
01/2017
Warnings and Precautions
01/2017
INDICATIONS AND USAGE
Hydromorphone Hydrochlorid