FDA label b3b32fb1-08e7-41fd-96b0-4e1ae926a570

WARNINGS Drug Dependence Morphine sulfate can produce drug dependence and, therefore, has a potential for being abused. Tolerance, psychological dependence and physical dependence may develop upon repeated administration. Abrupt cessation after prolonged use may result in withdrawal symptoms and morphine sulfate should be WITHDRAWN GRADUALLY from any patient known to be taking excessive dosage over long periods of time (see DRUG ABUSE AND DEPENDENCE ). Infants born to mothers physically dependent on morphine sulfate may also be physically dependent and exhibit respiratory depression and withdrawal symptoms (see DRUG ABUSE AND DEPENDENCE ). Respiratory Depression Dose related respiratory depression is produced by morphine acting directly on brain stem respiratory centers. Morphine also affects centers controlling respiratory rhythm and may produce irregular or periodic breathing. If significant respiratory depression occurs, it may be reversed by the use of naloxone hydrochloride (see OVERDOSAGE ). Head Injury and Increased Intracranial Pressure Respiratory depressant effects produced by narcotics and their tendency to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, narcotics can produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, morphine must be used with extreme caution and only if its use is deemed essential. Acute Abdominal Conditions Administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Contains sodium metabisulfite, 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.

ADVERSE REACTIONS Central Nervous System: Sedation, drowsiness, mental clouding, dizziness, lethargy, impairment of mental and physical performance, anxiety, convulsion, fear, miosis, dysphoria, psychic dependence, mood changes, and respiratory depression. Gastrointestinal System: Nausea, vomiting, increased pressure in the biliary tract, constipation. Cardiovascular System: Orthostatic hypotension, fainting, tachycardia, circulatory depression, peripheral circulatory collapse, and cardiac arrest have occurred after rapid intravenous injection. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Other: Flushing, sweating, pruritus, allergic reactions, suppressed cough reflex.