WARNINGS
(See also: CLINICAL PHARMACOLOGY)
IMPAIRED RESPIRATION
Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs most frequently in elderly and debilitated patients, and 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 LNTRACRANIAL 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 increase in pressure in patients with head injuries.
HYPOTENSIVE EFFECTS
MSIR Oral Solution Concentrate and MSIR 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.) MSIR Oral Solution Concentrate and MSIR Tablets may produce orthostatic hypotension in ambulatory patients.
MSIR Oral Solution Concentrate and MSIR 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
MSIR Oral Solution Concentrate and MSIR 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.
LNTERACTIONS 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 agonist opioid 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 and 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 patient 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).
PRECAUTIONS
(See also: CLINICAL PHARMACOLOGY)
GENERAL
MSIR Oral Solution Concentrate and MSIR Tablets are intended for use in patients who require a potent opioid analgesic for relief of moderate to severe pain.
Selection of patients for treatment with MSIR Oral Solution Concentrate and MSIR Tablets should be governed by the same principles that apply to the use of morphine and other potent opioid analgesics. Specifically, the increased risks associated with its use in the following populations should be considered: the elderly or debilitated and those with severe impairment of hepatic, pulmonary, or renal function; myxedema or hypothyroidism; adrenocortical insufficiency (e.g., Addison's Disease); CNS depression or coma; toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; kyphoscoliosis, or inability to swallow.
The administration of morphine, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Morphine may aggravate pre-existing convulsions in patients with convulsive disorders.
Morphine should be used with caution in patients about to undergo surgery of the biliary tract, since it may cause spasm of the sphincter of Oddi. Similarly, morphine should be used with caution in patients with acute pancreatitis secondary to biliary tract disease.
INFORMATION FOR PATIENTS
If clinically advisable, patients receiving MSIR Oral Solution Concentrate and MSIR Tablets should be given the following instructions by the physician.
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Morphine may produce physical and/or psychological dependence. For this reason, the dose of the drug should not be adjusted without consulting a physician.
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Morphine may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery).
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Morphine should not be taken with alcohol or other CNS depressants (sleep aids, tranquilizers) because additive effects including CNS depression may occur. A physician should be consulted if other prescription medications are currently being used or are prescribed for future use.
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For women of childbearing potential who become or are planning to become pregnant, a physician should be consulted regarding analgesics and other drug use.
Drug Interactions (See also WARNINGS)
The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Opioid analgesics, including MSIR Oral Solution Concentrate and MSIR Tablets may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
CARCINOGENICITY/MUTAGENICITY/IMPAIRMENT OF FERTILITY
Studies of morphine sulfate in animals to evaluate the drug's carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
PREGNANCY
Teratogenic effects-- Category C: Adequate animal studies on reproduction have not been performed to determine whether morphine affects fertility in males or females. There are no well-controlled studies in women, but marketing experience does not include any evidence of adverse effects on the fetus following routine (short-term) clinical use of morphine sulfate products. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. MSIR Oral Solution Concentrate and MSIR Tablets should be used in pregnant women only when clearly needed. (See also: PRECAUTIONS: Labor and Delivery, and DRUG ABUSE AND DEPENDENCE.)
Nonteratogenic effects: Infants born from mothers who have been taking morphine chronically may exhibit withdrawal symptoms.
LABOR AND DELIVERY
MSIR Oral Solution Concentrate and MSIR Tablets are not recommended for use in women during and immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation which tends to shorten labor.
Neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate.
NURSING MOTHERS
Low levels of morphine have been detected in human milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of morphine sulfate is stopped. Nursing should not be undertaken while a patient is receiving MSIR Oral Solution Concentrate and MSIR Tablets since morphine may be excreted in the milk.
PEDIATRIC USE
MSIR Oral Solution Concentrate and MSIR Tablets have not been evaluated systematically in children.
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