Morphine Sulfate Oral Solution, CII 100 mg per 5 mL (20 mg/mL)
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND USAGE
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) (CII) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
IMPORTANT RISK INFORMATION
WARNING: RISK OF MEDICATION ERRORS
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 when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.
Keep morphine sulfate oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.
- Morphine sulfate is contraindicated in patients with:
- Known hypersensitivity to morphine.
- Respiratory depression in the absence of resuscitative equipment.
- Acute or severe bronchial asthma or hypercarbia.
- Paralytic ileus.
WARNINGS AND PRECAUTIONS
- Use caution to ensure the dose is communicated clearly and dispensed accurately. Always use the enclosed calibrated oral syringe when administering morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) to ensure the dose is measured and administered accurately.
- Respiratory depression is the primary risk of morphine sulfate. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
- Morphine sulfate, an opioid agonist and a Schedule II controlled substance, can be abused in a manner similar to other opioid agonists, legal or illicit.
- Morphine sulfate may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, profound sedation, coma or death may result.
- In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of morphine sulfate and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated.
- Morphine sulfate may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as phenothiazines or general anesthetics. Morphine sulfate may produce orthostatic hypotension and syncope in ambulatory patients.
- Do not administer morphine sulfate to patients with gastrointestinal obstruction, especially paralytic ileus because morphine sulfate diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction.
- Morphine sulfate may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.
- Morphine sulfate can impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
- Accidental consumption of morphine sulfate, especially in children, can result in a fatal overdose of morphine.
- Use morphine sulfate with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients.
- Exercise caution in the administration of morphine sulfate to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens.
- All opioids may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
- Serious adverse reactions associated with morphine sulfate use include: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
- The most common adverse effects are constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Chronic maternal use of morphine during pregnancy can affect the fetus with subsequent withdrawal signs.
- Breast Feeding: Morphine is excreted in breast milk.
- The safety and effectiveness in pediatric patients below the age of 18 have not been established.
||Clear, light blue, liquid w/ Raspberry odor
||Roxanol™ Morphine Sulfate (Immediate Release) Oral Solution (Concentrate)
For additional information on Morphine Sulfate Oral Solution, CII 100 mg per 5 mL (20 mg/mL), call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
Roxanol is a trademark of Xanodyne Pharmaceuticals, Inc.