MORPHINE SULFATE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS AND PRECAUTIONS (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine sulfate extended-release is not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release is contraindicated in patients with: Significant respiratory depression [see WARNINGS AND PRECAUTIONS (5.2)] Acute or severe bronchial asthma in an unmonitored setting or

Product summary:

Morphine sulfate extended-release tablets are available as follows: 15 mg – Each round, white to off white, film-coated tablet debossed with [logo] on one side and 270 on the other side contains 15 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4270-11) and 500 (NDC 0228-4270-50). 30 mg – Each round, yellow, film-coated tablet debossed with [logo] on one side and 271 on the other side contains 30 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4271-11) and 500 (NDC 0228-4271-50). 60 mg – Each round, pink, film-coated tablet debossed with [logo] on one side and 311 on the other side contains 60 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4311-11). 100 mg – Each round, red, film-coated tablet debossed with [logo] on one side and 323 on the other side contains 100 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4323-11). 200 mg – Each capsule-shaped, red, film-coated tablet debossed with [logo] on one side and 347 on the other side contains 200 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4347-11). Store at 25°C (77°F); excursions permitted between 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. CAUTION DEA FORM REQUIRED

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MORPHINE SULFATE- morphine sulfate tablet, film coated, extended
release
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide
Morphine Sulfate (mor' feen sul' fate) Extended-Release Tablets, CII
Morphine sulfate extended-release tablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments
such as non-opioid pain medicines or immediate-release opioid
medicines do not treat your pain well enough
or you cannot tolerate them.
A long-acting (extended-release) 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.
Not for use to treat pain that is not around-the-clock.
Important information about morphine sulfate extended-release tablets:
Get emergency help right away if you take too many morphine sulfate
extended-release tablets (overdose).
When you first start taking morphine sulfate extended-release 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 extended-release 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 extended-release tablets.
They could die from taking it. Store
morphine sulfate extended-release tablets away from children and in a
safe place to prevent stealing or abuse.
Selling or giving away morphine sulfate extended-release tablets is
against the law.
Do not take morphine sulfate extended-release tablets if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
Before taki

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
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 extended-release exposes 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
extended-release, 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 extended-release. Monitor for respiratory depression,
especially
during initiation of morphine sulfate extended-release or following a
dose increase.
Instruct patients to swallow morphine sulfate extended-release tablets
whole;
crushing, chewing, or dissolving morphine sulfate extended-release
tablets can
cause rapid release and absorption of a potentially fatal dose of
morphine [see
WARNINGS AND PRECAUTIONS (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of morphine sulfate
extended-release
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 extended-release 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 Conco