Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Safecor Health, LLC
MORPHINE SULFATE
MORPHINE SULFATE 20 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. 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
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is available as a clear, light blue liquid with raspberry odor. Supplied as an individual overwrapped and flagged calibrated oral syringe: Syringes of 0.5 mL containing 0.25 mL NDC 48433-200-47 Syringes of 1 mL containing 0.5 mL NDC 48433-200-55 Syringes of 3 mL containing 1 mL NDC 48433-200-01 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. 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- morphine sulfate solution Safecor Health, LLC ---------- MEDICATION GUIDE Morphine Sulfate (mor-pheen) (CII) Oral Solution 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. • Always make sure the dose is measured and administered accurately. • The oral solution comes in several different doses (amount of medicine per mL) and strengths (number of mgs). • Do not take the strongest dose of morphine sulfate oral solution, 100 mg per 5 mL (20 mg/mL) unless you are “opioid tolerant”. Opioid tolerant means that you have been regularly using morphine sulfate oral solution or another opioid medicine for your constant (around the clock) pain and your body is used to it. 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. • M Baca dokumen lengkap
MORPHINE SULFATE- MORPHINE SULFATE SOLUTION SAFECOR HEALTH, LLC ---------- 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 THE 100 MG PER 5 ML (20 MG/ML) CONCENTRATION AND IS INDICATED FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN 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) Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. (1) DOSAGE AND ADMINISTRATION Morphine sulfate oral solution: 10 to 20 mg every 4 hours as needed. (2.2) DOSAGE FORMS AND STRENGTHS Morphine sulfate oral solution: For the 100 mg per 5 mL (20 mg/mL) strength, each mL contains 20 mg of morphine sulfate. (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, hyp Baca dokumen lengkap