FDA label c319b764-38e9-48df-94d2-7eae70d6913c

*200 mg for use in opioid-tolerant patients only

WARNINGS (See also: CLINICAL PHARMACOLOGY ) Impaired Respiration Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs most frequently in the elderly and debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Morphine should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of morphine may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of morphine with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or pre-existing increase in intracranial pressure. Morphine produces effects which may obscure neurologic signs of further increases in pressure in patients with head injuries. Hypotensive Effect Morphine Sulfate Controlled-Release Tablets, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics. (See also: PRECAUTIONS; Drug Interactions .) Morphine Sulfate Controlled-Release Tablets may produce orthostatic hypotension in ambulatory patients. Morphine Sulfate Controlled-Release Tablets, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Interactions with other CNS Depressants Morphine Sulfate Controlled-Release Tablets, like all opioid analgesics, should be used with great caution and in reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result. Interactions with Mixed Agonist/Antagonist Opioid Analgesics From a theoretical perspective, agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should NOT be administered to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic. In these patients, mixed agonist/antagonist analgesics may reduce the analgesic effect or may precipitate withdrawal symptoms. Drug Dependence Morphine can produce drug dependence and has a potential for being abused. Tolerance as well as psychological and physical dependence may develop upon repeated administration. Physical dependence, however, is not of paramount importance in the management of terminally ill patients or any patients in severe pain. Abrupt cessation or a sudden reduction in dose after prolonged use may result in withdrawal symptoms. After prolonged exposure to opioid analgesics, if withdrawal is necessary, it must be undertaken gradually. (See DRUG ABUSE AND DEPENDENCE .) Infants born to mothers physically dependent on opioid analgesics may also be physically dependent and exhibit respiratory depression and withdrawal symptoms. (See DRUG ABUSE AND DEPENDENCE .) Other Although extremely rare, cases of anaphylaxis have been reported.

ADVERSE REACTIONS The adverse reactions caused by morphine are essentially those observed with other opioid analgesics. They include the following major hazards: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. Most Frequently Observed Constipation, lightheadedness, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoria. Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down. Less Frequently Observed Reactions Central Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, muscle rigidity, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alteration, constipation, ileus, intestinal obstruction, increases in hepatic enzymes. Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension Genitourinary: Urine retention or hesitance, reduced libido and/or potency Dermatologic: Pruritus, urticaria, other skin rashes, edema, diaphoresis Other: Antidiuretic effect, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia, miosis, anaphylaxis