País: Estados Unidos
Idioma: inglés
Fuente: 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 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
NDC:55700-350-60 in a BOTTLE of 60 CAPSULE, EXTENDED RELEASES 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.
Abbreviated New Drug Application
MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE Lake Erie Medical DBA Quality Care Products LLC ---------- 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: • 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. Get emergency help right away if you take too much Morphine Sulfate Extended-release Capsules (overdose). • 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 Leer el documento completo
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 CAPSULES. 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 Leer el documento completo