Country: United States
Language: English
Source: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
American Health Packaging
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 - 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 tablets 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 tablets are not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release tablets are contraindicated in patients with: - Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipmen
Morphine sulfate extended-release tablets 15 mg are blue, round tablets, debossed “E652” on one side, and “15” on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-403-01 Morphine sulfate extended-release tablets 30 mg are green, round tablets, debossed “E653” on one side, and “30” on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-404-01 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. CAUTION DEA FORM REQUIRED
Abbreviated New Drug Application
American Health Packaging ---------- MEDICATION GUIDE 8240301/0318 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 drugs, alcohol addiction, o Read the complete document
MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE AMERICAN HEALTH PACKAGING ---------- 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 EXPOSE 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-t Read the complete document