Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
VistaPharm, Inc.
MORPHINE SULFATE
MORPHINE SULFATE 10 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2) ], reserve Morphine Sulfate Oral Solution 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 Morphine Sulfate Oral Solution is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.4) ]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resus
Morphine Sulfate Oral Solution 10 mg per 5 mL (2 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution. NDC 66689-032-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-032-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-032-04: Bottles of 100 mL; supplied with calibrated measuring cup NDC 66689-032-16: Bottles of 500 mL; supplied with calibrated measuring cup 20 mg per 5 mL (4 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution. NDC 66689-033-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-033-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-033-04: Bottles of 100 mL; supplied with calibrated measuring cup NDC 66689-033-16: Bottles of 500 mL; supplied with calibrated measuring cup Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
VistaPharm, Inc. ---------- MEDICATION GUIDE Medication Guide Morphine (mor-pheen) Sulfate Oral Solution, CII Morphine Sulfate Oral Solution is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) and long term (chronic) pain 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 Oral Solution: • Get emergency help right away if you take too much Morphine Sulfate Oral Solution (overdose). When you first start taking Morphine Sulfate Oral Solution, 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 Oral Solution 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 Oral Solution. They could die from taking it. Store Morphine Sulfate Oral Solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away Morphine Sulfate Oral Solution is against the law. Do not take Morphine Sulfate Oral Solution 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 Oral Solution, tell your healthcare provider if you have a history of: • head injury, seizures • problems urinating • liver, kidney, thyroid problems • pancreas or gallbladder problems • abuse of street or prescription drugs, alc Прочитајте комплетан документ
MORPHINE SULFATE- MORPHINE SULFATE SOLUTION VISTAPHARM, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MORPHINE SULFATE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE ORAL SOLUTION, FOR ORAL USE CII INITIAL U.S. APPROVAL: 1941 WARNING: RISK OF MEDICATION ERRORS; 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._ ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING MORPHINE SULFATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER MORPHINE SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1, 5.1) MORPHINE SULFATE ORAL SOLUTION EXPOSES 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. (5.2) 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. (5.3) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.4) ACCIDENTAL INGESTION OF MORPHINE SULFATE ORAL SOLUTION, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF MORPHINE. (5.4) PROLONGED USE OF MORPHINE SULFATE ORAL SOLUTION 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 THA Прочитајте комплетан документ