FDA label 24656fba-7347-4932-b087-0e0851af5cd7

NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.

WARNINGS Morphine sulfate injection administration should be limited to use by those familiar with the management of respiratory depression, and in the case of epidural or intrathecal administration, familiar with the techniques and patient management problems associated with epidural or intrathecal drug administration. Because epidural administration has been associated with lessened potential for immediate or late adverse effects than intrathecal administration, the epidural route should be used whenever possible. Rapid intravenous administration may result in chest wall rigidity. FACILITIES WHERE MORPHINE SULFATE INJECTION IS ADMINISTERED MUST BE EQUIPPED WITH RESUSCITATIVE EQUIPMENT, OXYGEN, NALOXONE INJECTION, AND OTHER RESUSCITATIVE DRUGS. WHEN THE EPIDURAL OR INTRATHECAL ROUTE OF ADMINISTRATION IS EMPLOYED, PATIENTS MUST BE OBSERVED IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS. SEVERE RESPIRATORY DEPRESSION UP TO 24 HOURS FOLLOWING EPIDURAL OR INTRATHECAL ADMINISTRATION HAS BEEN REPORTED. Morphine sulfate may be habit forming. (See DRUG ABUSE AND DEPENDENCE.)

ADVERSE REACTIONS The most serious side effect is respiratory depression. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid administration may result in overdosing. Bolus administration by the epidural or intrathecal route may result in early respiratory depression due to direct venous redistribution of morphine to the respiratory centers in the brain. Late (up to 24 hours) onset of acute respiratory depression has been reported with administration by the epidural or intrathecal route and is believed to be the result of rostral spread. Reports of respiratory depression following intrathecal administration have been more frequent, but the dosage used in most of these cases has been considerably higher than that recommended. This depression may be severe and could require intervention (see WARNINGS and OVERDOSAGE). Even without clinical evidence of ventilatory inadequacy, a diminished CO 2 ventilation response may be noted for up to 22 hours following epidural or intrathecal administration. While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and an increase in circulating catecholamines. Excitation of the central nervous system resulting in convulsions may accompany high doses of morphine given intravenously. Dysphoric reactions may occur and toxic psychoses have been reported. Epidural or intrathecal administration is accompanied by a high incidence of pruritus which is dose related but not confined to site of administration. Nausea and vomiting are frequently seen in patients following morphine administration. Urinary retention which may persist for 10 to 20 hours following single epidural or intrathecal administration has been reported in approximately 90% of males. Incidence is somewhat lower in females. Patients may require catheterization (see PRECAUTIONS). Pruritus, nausea/vomiting and urinary retention frequently can be alleviated by the intravenous administration of low doses of naloxone (0.2 mg). Tolerance and dependence to chronically administered morphine, by whatever route, is known to occur (see DRUG ABUSE AND DEPENDENCE). Miscellaneous side effects include constipation, headache, anxiety, depression of cough reflex, interference with thermal regulation and oliguria. Evidence of histamine release such as urticaria, wheals and/or local tissue irritation may occur. In general, side effects are amenable to reversal by narcotic antagonists. NALOXONE HYDROCHLORIDE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE EFFECTS.