País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Lake Erie Medical DBA Quality Care Products LLC
MORPHINE SULFATE
MORPHINE SULFATE 30 mg
ORAL
PRESCRIPTION DRUG
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, 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 - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - Known or suspecte
Morphine sulfate extended-release tablets are available as follows: 15 mg – Each round, white to off white, film-coated tablet is debossed with on one side and 270 on the other side contain 15 mg of morphine sulfate, USP. 30 mg – Each round, yellow, film-coated tablet is debossed with on one side and 271 on the other side contain 30 mg of morphine sulfate, USP. 55700-367-30 55700-367-60 55700-367-90 55700-367-01 60 mg – Each round, pink, film-coated tablet is debossed with on one side and 311 on the other side contain 60 mg of morphine sulfate, USP. 100 mg – Each round, red, film-coated tablet is debossed with on one side and 323 on the other side contain 100 mg of morphine sulfate, USP. 200 mg – Each capsule-shaped, red, film-coated tablet is debossed with on one side and 347 on the other side contain 200 mg of morphine sulfate, USP. Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container as defined in the USP. CAUTION DEA FORM REQUIRED
Abbreviated New Drug Application
MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE Lake Erie Medical DBA Quality Care Products LLC ---------- 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. • 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 taking morphine sulfate extended-release tablets, tell your healthcare provider if you have a history of: • head injury, seizures • liver, kidney, thyroid problems • problems urinating • pancreas or gallbladder problems Leia o documento completo
MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MORPHINE SULFATE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE EXTENDED-RELEASE TABLETS. MORPHINE SULFATE EXTENDED-RELEASE TABLETS, FOR ORAL USE CII INITIAL U.S. APPROVAL: 1941 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; AND NEONATAL OPIOID WITHDRAWAL SYNDROME _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ MORPHINE SULFATE EXTENDED-RELEASE 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 AND 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 TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF MORPHINE. (5.2) ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS, ESPECIALLY IN CHILDREN, CAN RESULT IN FATAL OVERDOSE OF MORPHINE. (5.2) 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. 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) RECENT MAJOR CHANGES Boxed Warning 4/2014 Indications and Usage (1) 4/2014 Dosage and Administration (2) 4/2014 Warnings and Precautions (5) 4/2014 INDICATIONS AND USAGE Morphine sulfate extended-release is an opioid agonist product indicated for the management of pain severe enough to require daily, around-t Leia o documento completo