MORPHINE SULFATE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Доступно од:

RedPharm Drug, Inc.

INN (Међународно име):

MORPHINE SULFATE

Састав:

MORPHINE SULFATE 15 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Morphine Sulfate Tablets are indicated for the management of acute and chronic 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 Morphine Sulfate 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. Morphine Sulfate 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)]. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or

Резиме производа:

Morphine Sulfate Tablets 15 mg tablet: white, biconvex tablets scored on one side and product identification "54 733" debossed on the other side. NDC 0054-0235-24: 100 (4 x 25) Unit-Dose Tablets NDC 0054-0235-25: Bottle of 100 Tablets 30 mg tablets: white, biconvex tablets scored on one side and product identification "54 262" debossed on the other side. NDC 0054-0236-24: 100 (4 x 25) Unit-Dose Tablets NDC 0054-0236-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.

Статус ауторизације:

New Drug Application

Информативни летак

MORPHINE SULFATE- morphine sulfate tablet
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Morphine Sulfate (mor-pheen) Tablets CII
Rx only
Morphine Sulfate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short term
(acute) and long term (chronic) pain severe enough to require an
opioid pain medicine, 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 Morphine Sulfate Tablets:
•
Get emergency help right away if you take too much Morphine Sulfate
Tablets (overdose). When you first
start taking Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate Tablets. They could die
from taking it. Store Morphine
Sulfate Tablets away from children and in a safe place to prevent
stealing or abuse. Selling or giving away
Morphine Sulfate Tablets is against the law.
Do not take Morphine Sulfate Tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
•
An allergy to morphine.
Before taking Morphine Sulfate Tablets, tell your healthcare provider
if you have a history of:
•
Head injury, seizures.
•
Liver, kidney, thyroid problems.
•
Problems urinating.
•
Pancreas or gallbladder problems.
•
Abuse of street or prescription drugs, alcohol addiction, or mental

Карактеристике производа

MORPHINE SULFATE- MORPHINE SULFATE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
Morphine Sulfate 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 Morphine Sulfate Tablets, and
monitor all patients
regularly for the development of these behaviors and conditions [see
Warnings and
Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
Morphine Sulfate Tablets. Monitor for respiratory depression,
especially during
initiation of Morphine Sulfate Tablets or following a dose increase
[see Warnings
and Precautions (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of Morphine Sulfate Tablets,
especially by
children, can result in a fatal overdose of morphine [see Warnings and
Precautions
(5.2)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Morphine Sulfate Tablets during pregnancy can result
in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and
treated, and requires management according to protocols developed by
neonatology experts. If opioid use is required for a prolonged period
in a pregnant
woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and
ensure that appropriate treatment will be available [see Warnings and
Precautions
(5.3)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS
Depressants
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 [see Warnings and Precautions (5.4), Drug
Interactions (7)].
•
Reserve concom