Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Hikma Pharmaceuticals USA Inc.
MORPHINE SULFATE
MORPHINE SULFATE 20 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult 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]: Morphine Sulfate Oral Solution is contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . There are no available data with Morphine Sulfate Oral Solution 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
Morphine Sulfate Oral Solution: 20 mg per 5 mL (4 mg/ mL) Oral Solution is supplied as a clear, blue-green solution. Each 1 mL of clear, blue-green oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store Morphine Sulfate Oral Solution securely and dispose of properly [see Patient Counseling Information (17)].
New Drug Application
Hikma Pharmaceuticals USA 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 or call 911 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • 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. Selling or giving away Morphine Sulfate Oral Solution is against the law. • Store Morphine Sulfate Oral Solution 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 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 Прочетете целия документ
MORPHINE SULFATE- MORPHINE SULFATE SOLUTION HIKMA PHARMACEUTICALS USA 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._ • • • • • • • RECENT MAJOR CHANGES Indications and Usage (1) 06/2021 Dosage and Administration (2.1, 2.2, 2.4) 06/2021 Dosage and Administration (2.3) 03/2021 Warnings and Precautions (5.2, 5.4, 5.6) 03/2021 INDICATIONS AND USAGE Morphine Sulfate Oral Solution is an opioid agonist. Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management of • 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, ESPEC Прочетете целия документ