Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Mylan Pharmaceuticals Inc.
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: Prolonged use of opioid analgesics during pregnancy may cause neonatal withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with morphine sulfate extended-release tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data]. In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HD
Morphine Sulfate Extended-Release Tablets are available containing 15 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate, USP. The 15 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 15 on the other side. They are available as follows: NDC 0378-2658-01 bottles of 100 tablets The 30 mg tablets are purple, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 30 on the other side. They are available as follows: NDC 0378-2659-01 bottles of 100 tablets The 60 mg tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 60 on the other side. They are available as follows: NDC 0378-2660-01 bottles of 100 tablets The 100 mg tablets are gray, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 100 on the other side. They are available as follows: NDC 0378-2661-01 bottles of 100 tablets The 200 mg tablets are light green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and MS 200 on the other side. They are available as follows: NDC 0378-2662-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Morphine Sulfate Extended-Release (ER) Tablets CII (mor' feen sul' fate) Morphine Sulfate ER 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 ER Tablets: • Get emergency help right away if you take too many Morphine Sulfate ER Tablets (overdose). When you first start taking Morphine Sulfate ER Tablets, when your dose is changed, or if you take too many (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking Morphine Sulfate ER Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your Morphine Sulfate ER Tablets. They could die from taking it. Store Morphine Sulfate ER Tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away Morphine Sulfate ER Tablets is against the law. Do not take Morphine Sulfate ER 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 ER Tablets, tell your healthcare provider if you have a history of: • head injury, seizures • • liver, kidney, thyroid problems • problems urinati Lestu allt skjalið
MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE MYLAN PHARMACEUTICALS INC. ---------- 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; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • RECENT MAJOR CHANGES Boxed Warning 09/2018 Warnings and Precautions (5.2) 09/2018 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are an opioid agonist 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. (1) Limitations of Use • • DOSAGE AND ADMINISTRATION • MORPHINE SULFATE EXTENDED-RELEASE TABLETS EXPOSE USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2) 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. (5.3) ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS, ESPECIALLY BY CHILD Lestu allt skjalið