País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
SpecGx LLC
ORAL
PRESCRIPTION DRUG
Morphine Sulfate Tablets are indicated for the management of: - adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. - adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.’s Morphine Sulfate Tablets. However, due to Hikma Pharmaceuticals USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Morphine sulfate t
Morphine Sulfate Tablets are supplied as follows: Each 15 mg tablet for oral administration contains: 15 mg morphine sulfate USP and is a white, biconvex tablet, debossed “M” on one side, and “15” with a score on the other side. 15 mg bottles of 100: NDC 0406-5118-01 15 mg box of 100 unit dose: NDC 0406-5118-62 Each 30 mg tablet for oral administration contains: 30 mg morphine sulfate USP and is a white, biconvex tablet, debossed “M” on one side, and “30” with a score on the other side. 30 mg bottles of 100: NDC 0406-5119-01 30 mg box of 100 unit dose: NDC 0406-5119-62 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store morphine sulfate tablets securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
SpecGx LLC ---------- Medication Guide Morphine Sulfate (mor’ feen sul’ fate) Tablets CII Rx only Morphine sulfate tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain in adults and long-term (chronic) pain in adults severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An 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. Important information about morphine sulfate tablets: • Get emergency help or call 911 right away if you take too many morphine sulfate tablets (overdose). When you first start taking morphine sulfate 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking morphine sulfate 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 tablets. They could die from taking it. Selling or giving away morphine sulfate tablets is against the law. • Store morphine sulfate tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take morphine sulfate tablets if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines. • An allergy to morphine. Before taking morphine sulfate tablets, tell your healthcare provider if you have a history of: • Head injury, seizures. Llegiu el document complet
MORPHINE SULFATE- MORPHINE SULFATE TABLET SPECGX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MORPHINE SULFATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE TABLETS. MORPHINE SULFATE 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._ MORPHINE SULFATE 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. (5.3) ACCIDENTAL INGESTION OF MORPHINE SULFATE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF MORPHINE. (5.3) PROLONGED USE OF MORPHINE SULFATE 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. (5.4) 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 Llegiu el document complet