MORPHINE SULFATE- morphine sulfate capsule, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Morphine Sulfate (UNII: X3P646A2J0) (Morphine - UNII:76I7G6D29C)

Sẵn có từ:

Lake Erie Medical DBA Quality Care Products LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Morphine Sulfate Extended-release Capsules, USP is an 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, reserve Morphine Sulfate Extended-release Capsules 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 Capsules are not indicated as an as-needed (prn) analgesic. Morphine Sulfate Extended-release Capsules are contraindicated in patients with - Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitativ

Tóm tắt sản phẩm:

Morphine Sulfate Extended-release Capsules, USP contain white to tan polymer coated extended-release pellets of morphine sulfate and are available in seven dose strengths: 10 mg size 4 capsule, light blue opaque cap and body printed with "UPSHER-SMITH" over "0225" on the cap and "10 mg" on the body in black ink.  20 mg size 4 capsule, yellow opaque cap and body printed with "UPSHER-SMITH" over "0226" on the cap and "20 mg" on the body in black ink.  30 mg size 2 capsule, blue violet opaque cap and body printed with "UPSHER-SMITH" over "0227" on the cap and "30 mg" on the body in black ink.  50 mg size 2 capsule, blue opaque cap and body printed with "UPSHER-SMITH" over "0228" on the cap and "50 mg" on the body in black ink.  55700-552-60 60 mg size 1 capsule, pink opaque cap and body printed with "UPSHER-SMITH" over "0229" on the cap and "60 mg" on the body in black ink.  80 mg size 1 capsule, light orange opaque cap and body printed with "UPSHER-SMITH" over "0230" on the cap and "80 mg" on the body in black ink. 100 mg size 0 capsule, green opaque cap and body printed with "UPSHER-SMITH" over "0233" on the cap and "100 mg" on the body in black ink.  Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a sealed tamper-evident, childproof, light-resistant container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Morphine Sulfate (mor∙feen sul∙fate) Extended-release Capsules,
CII
Morphine Sulfate Extended-release Capsules 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
Capsules:
•
Get emergency help right away if you take too much Morphine Sulfate
Extended-release Capsules
(overdose). When you first start taking Morphine Sulfate
Extended-release Capsules, 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.
•
Never give anyone else your Morphine Sulfate Extended-release
Capsules. They could die from
taking it. Store Morphine Sulfate Extended-release Capsules away from
children and in a safe
place to prevent stealing or abuse. Selling or giving away Morphine
Sulfate Extended-release
Capsules is against the law.
Do not take Morphine Sulfate Extended-release Capsules if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking Morphine Sulfate Extended-release Capsules, tell your
healthcare provider if you have a
history of:
•
head injury, seizures
•
problems urinating
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problem

Đặc tính sản phẩm

MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE EXTENDED-RELEASE
CAPSULE S.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME; AND
INTERACTION WITH
ALCOHOL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK
BEFORE PRESCRIBING, AND MONITOR
REGULARLY FOR DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
MORPHINE SULFATE EXTENDED-RELEASE
CAPSULES WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF
MORPHINE. (5.2)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES,
ESPECIALLY IN CHILDREN, CAN RESULT
IN FATAL OVERDOSE OF MORPHINE. (5.3)
PROLONGED USE OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES DURING
PREGNANCY CAN RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT RECOGNIZED AND TREATED. 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 (5.3).
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE TAKING MORPHINE
SULFATE EXTENDED-RELEASE CAPSULES BECAUSE CO-INGESTION CAN RESULT IN
FATAL PLASMA MORPHINE LEVELS.
(5.4 )
INDICAT