Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Nostrum Laboratories, Inc.
MORPHINE SULFATE
MORPHINE SULFATE 10 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Morphine sulfate oral solution (10 mg per 5 mL and 20 mg per 5 mL ) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. Morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. No formal studies to assess the teratogenic effects of morphine in animals have been conducted. It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Morphine should be given to a pregnant woman only if clearly needed. In humans, the frequency
Morphine Sulfate Oral Solution Morphine sulfate oral solution is a blue-green solution available in two strengths as follows: 10 mg per 5 mL Oral Solution NDC 70408-358-31 Bottles of 100 mL with a dosing cup NDC 70408-358-35 Bottles of 500 mL with a dosing cup 20 mg per 5 mL Oral Solution NDC 70408-359-31 Bottles of 100 mL with a dosing cup NDC 70408-359-35 Bottles of 500 mL with a dosing cup Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.
Abbreviated New Drug Application
MORPHINE SULFATE ORAL SOLUTION- MORPHINE SULFATE ORAL SOLUTION SOLUTION MORPHINE SULFATE- MORPHINE SULFATE SOLUTION Nostrum Laboratories, Inc. ---------- MEDICATION GUIDE Morphine Sulfate (mor-phen) Oral Solution CII IMPORTANT: Keep Morphine Sulfate Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Morphine Sulfate Oral Solution, get emergency help right away. Read the Medication Guide that comes with Morphine Sulfate Oral Solution before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Morphine Sulfate Oral Solution? Morphine Sulfate Oral Solution can cause serious side effects, including death. • Take Morphine Sulfate Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose or strength of Morphine Sulfate Oral Solution, you could overdose and die. • It is especially important when you take Morphine Sulfate Oral Solution that you know exactly what dose and strength to take, and the right way to measure your medicine. Your healthcare provider or pharmacist should show you the right way to measure your medicine. • The oral solution comes in several different doses (amount of medicine per mL) and strengths (number of mgs). What is Morphine Sulfate Oral Solution? Morphine Sulfate Oral Solution is in a group of drugs called narcotic pain relievers. Morphine Sulfate Oral Solution is only for adults who have moderate to severe pain. • Morphine Sulfate Oral Solution is a prescription medicine that is used to manage moderate to severe pain that is expected to last a short period of time (acute), and pain that continues around-the- clock and is expected to last for a long period of time (chronic). • Morphine Sulfate Oral Solution is a federally co Lire le document complet
MORPHINE SULFATE ORAL SOLUTION- MORPHINE SULFATE ORAL SOLUTION SOLUTION MORPHINE SULFATE- MORPHINE SULFATE SOLUTION NOSTRUM LABORATORIES, 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, CII INITIAL U.S. APPROVAL: 1941 WARNING: RISK OF MEDICATION ERRORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ MORPHINE SULFATE ORAL SOLUTION IS AVAILABLE IN 10 MG PER 5 ML AND 20 MG PER 5 ML CONCENTRATIONS. TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN DIFFERENT CONCENTRATIONS AND BETWEEN MG AND ML, WHICH COULD RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (5.1) KEEP MORPHINE SULFATE ORAL SOLUTION OUT OF THE REACH OF CHILDREN. INDICATIONS AND USAGE Morphine sulfate is an opioid agonist indicated for the relief of moderate to severe acute and chronic pain where an opioid analgesic is appropriate. (1) DOSAGE AND ADMINISTRATION Morphine sulfate oral solution: 10 to 20 mg every 4 hours as needed. (2.2) DOSAGE FORMS AND STRENGTHS Oral Solution: For the 10 mg per 5 mL or 20 mg per 5 mL strengths, each mL contains 2 mg or 4 mg of morphine s ulfate .(3) CONTRAINDICATIONS Known hypersensitivity to morphine. (4) Respiratory depression in the absence of resuscitative equipment. (4) Acute or severe bronchial asthma or hypercarbia. (4) Paralytic ileus. (4) WARNINGS AND PRECAUTIONS Risk of Medication Errors: Use caution when prescribing, dispensing, and administering to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. (5.1) Respiratory depression: Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction. (5.2) Controlled substance: Morphine sulfate is a Schedule II controlled substance with an abuse liability sim Lire le document complet