OXYMORPHONE HYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)

Disponível em:

SpecGx LLC

DCI (Denominação Comum Internacional):

OXYMORPHONE HYDROCHLORIDE

Composição:

OXYMORPHONE HYDROCHLORIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Oxymorphone hydrochloride tablets are indicated for the management of acute 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 oxymorphone 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 Oxymorphone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - 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 ileus [see W

Resumo do produto:

Oxymorphone hydrochloride tablets are supplied as follows: 5 mg Tablet: Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side. Bottles of 100 tablets…………………NDC 0406-1009-01 10 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side. Bottles of 100 tablets…………………NDC 0406-1010-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

SpecGx LLC
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Medication Guide
Oxymorphone Hydrochloride (ox" i mor' fone hye" droe klor' ide)
Tablets, for oral use, CII
Oxymorphone hydrochloride tablets are:
• A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage short-term
(acute) pain when other pain treatments such as non-opioid pain
medicines do not treat your pain well
enough or you cannot tolerate them.
• An opioid pain medicine 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 oxymorphone hydrochloride tablets:
• Get emergency help right away if you take too many oxymorphone
hydrochloride tablets (overdose).
When you first start taking oxymorphone 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 oxymorphone 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 your oxymorphone hydrochloride tablets. They
could die from taking them. Store
oxymorphone hydrochloride tablets away from children and in a safe
place to prevent stealing or abuse.
Selling or giving away oxymorphone hydrochloride tablets is against
the law.
Do not take oxymorphone 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 oxymorphone hydrochloride tablets, tell your healthcare
provider if you have a history of:
• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or
mental health problems.
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
Tell your

Características técnicas

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET
SPECGX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE HYDROCHLORIDE
TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXYMORPHONE HYDROCHLORIDE
TABLETS USP.
OXYMORPHONE HYDROCHLORIDE TABLETS USP, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1959
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION
WITH
ALCOHOL; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• OXYMORPHONE 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. (5.1)
• SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY
OCCUR. MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
• ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF OXYMORPHONE. (5.2)
• PROLONGED USE OF OXYMORPHONE 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.
(5.3)
• INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCT CONTAINING
ALCOHOL WHILE TAKING OXYMORPHONE
HYDROCHLORIDE TABLETS BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA
OXYMORPHONE LEVELS. (5.4)
• 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