Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Par Pharmaceutical
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 [see Warnings and Precautions (5.1)] , 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 [see Warnings and Precautions (5.2)] - Acute or severe bronchial
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: NDC 60951-652-70: bottles containing 100 tablets 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: NDC 60951-653-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 60 mg are orange, capsule-shaped tablets, debossed “E655” on one side, and “60” on the other side. They are supplied as follows: NDC 60951-655-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 100 mg are blue, capsule-shaped tablets, debossed “E658” on one side, and “100” on the other side. They are supplied as follows: NDC 60951-658-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 200 mg are green, oval tablets, debossed “E659” on one side and “200” on the other side. They are supplied as follows: NDC 60951-659-70: bottles containing 100 tablets Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. CAUTION DEA FORM REQUIRED
Abbreviated New Drug Application
Par Pharmaceutical ---------- MEDICATION GUIDE 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. • Taking morphine sulfate extended-release 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 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 t Прочетете целия документ
MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE PAR PHARMACEUTICAL ---------- 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; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS _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 PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR 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 BY CHILDREN, CAN RESULT IN A 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 PROLONGED OPIOID USE IS REQUIRED 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) CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE IN Прочетете целия документ