FDA label 38ee80ff-04da-4881-b764-82503564b9c4

WARNINGS Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Morphine is a potent medicinal agent of great utility but also with considerable potential for harmful effect, including psychological and physical tolerance and dependence. Withdrawal will occur on abrupt discontinuation or administration of a narcotic antagonist. Morphine and other opiates produce relaxation, indifference to pain and stress, lethargy, and euphoria. Patients who receive narcotics regularly for more than a few days may exhibit mild symptoms upon discontinuation of therapy, which may not be recognized as withdrawal. However, the majority of patients who receive opiates for medical reasons do not develop drug seeking behavior or compulsive drug use. Personality characteristics play a major role in determining which patients are likely to abuse drugs. Morphine should be used only if other drugs with fewer hazards are inadequate, and with the recognition of the possibility that it may mask significant manifestations of disease which should be identified for proper diagnosis and treatment.

ADVERSE REACTIONS The major hazards associated with morphine therapy include the following: respiratory depression, apnea, and, to a lesser degree, circulatory depression. Respiratory arrest, shock, and cardiac arrest have occurred. The most frequent adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering from severe pain. In such individuals, lower doses are advisable. Other adverse reactions include: CNS: Euphoria, dysphoria, delirium, weakness, headache, somnolence, drowsiness, miosis, pinpoint pupils, coma, insomnia, agitation, tremor, uncoordinated muscle movements, impairment of mental and physical performance, mental clouding, lethargy, anxiety, fear, psychic dependence, mood changes, transient hallucinations, disorientation, confusion, and visual disturbances have been reported. GI: Dry mouth, anorexia, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; toxic dilatation has been reported in patients with acute ulcerative colitis. Cardiovascular: Flushing of the face, peripheral circulatory collapse, tachycardia, bradycardia, palpitation, faintness, hypotension, syncope, and phlebitis following I.V. injection. Genito-urinary: Ureteral spasm and spasm of vesical sphincters, urinary retention or hesitancy, oliguria, antidiuretic effect, reduced libido and/or potency. Allergic: Pruritus, urticaria, other skin rashes, edema, and (rarely) hemorrhagic urticaria. Wheal and flare over the vein with I.V. injection may occur. Anaphylactoid reactions have been reported following I.V. administration. An isolated case of thrombocytopenia has been reported to be induced by morphine.