Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
McKesson Corporation
MORPHINE SULFATE
MORPHINE SULFATE 15 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 Morphine sulfate extended-release tablets are contraindicated in patients with: Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings and Precautions (5.3)]. Teratogenic Effects (Pregnancy Category C) There are no adequate and well-controlled studies in pregnant women. Morphine sulfate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential r
Morphine Sulfate Extended-Release Tablets 15 mg are oval, film-coated, green tablets debossed "N" on one side and "15" on the other. They are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-899-10 Morphine Sulfate Extended-Release Tablets 30 mg are oval, film-coated, pink tablets, debossed "N" on one side and "30" on the other. They are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-726-10 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant and child-resistant container. CAUTION Manufactured by: Zydus Pharmaceuticals 73 Route 31 N. Pennington, NJ 08534 Distributed by: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd., Concord, NC 28027 IS-4015286 November 2015 DEA FORM REQUIRED
Abbreviated New Drug Application
MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE McKesson Corporation ---------- 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 much 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 • abuse of street or prescription drug Pročitajte cijeli dokument
MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE MCKESSON CORPORATION ---------- 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 TABLETS 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 TABLETS 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 04/2014 Indications and Usage (1) 04/2014 Dosage and Administration (2) 04/2014 Warnings and Precautions (5) 04/2014 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are an opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, lon Pročitajte cijeli dokument