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warnings
WARNINGS IMPAIRED RESPIRATION: Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs more 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 who have a decreased respiratory reserve (e.g., emphysema, severe obesity, kyphoscoliosis, or paralysis of the phrenic nerve). ORAMORPH SR should not be given in cases of chronic asthma, upper airway obstruction, or in any other chronic pulmonary disorder without due consideration of the known risk of acute respiratory failure following morphine administration in such patients. DRUG ABUSE AND DEPENDENCE - CONTROLLED SUBSTANCE: Morphine sulfate is a Schedule II narcotic under the United States Controlled Substance Act (21 U.S.C. 801-886). Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability. A patient may be at risk for developing a dependence to morphine if used improperly or for overly long periods of time. As with all potent opioids which are μ-agonists, tolerance as well as psychological and physical dependence to morphine may develop irrespective of the route of administration (oral, intravenous, intramuscular, intrathecal, or epidural). Individuals with a prior history of opioid or other substance abuse or dependence, being more apt to respond to euphorogenic and reinforcing properties of morphine, would be considered to be at greater risk. Care must be taken to avert withdrawal symptoms when morphine is discontinued abruptly or upon administration of a narcotic antagonist.
ADVERSE REACTIONS NOTE: THE SUSTAINED RELEASE OF MORPHINE FROM ORAMORPH SR SHOULD BE TAKEN INTO CONSIDERATION IN THE EVENT OF OCCURRING ADVERSE REACTIONS. Adverse reactions caused by morphine are essentially those observed with other opioid analgesics. They include the following major hazards : respiratory depression , and less frequently, circulatory depression, apnea, shock and cardiac arrest secondary to respiratory and/or circulatory depression. Most Frequently Observed Reactions: Constipation, nausea, vomiting, lightheadedness, dizziness, sedation, dysphoria, euphoria, and sweating. 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 is in a supine position. Less Frequently Observed Reactions: Body as a Whole: Edema, antidiuretic effect, chills, muscle tremor, muscle rigidity. Cardiovascular : Flushing of the face, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension. Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alterations. Genitourinary: Urine retention or hesitance, reduced libido and/or potency. Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, paresthesia, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, transient hallucination and disorientation, visual disturbances, insomnia, increased intracranial pressure. Skin: Pruritus, urticaria and other skin rashes. Special Senses: Blurred vision, nystagmus, diplopia, miosis.
adverse reactions table
<table width="100%"> <col align="left" width="100.000%"/> <tbody> <tr> <td align="justify" styleCode="Toprule Botrule Lrule Rrule" valign="top"> <content styleCode="bold">NOTE:</content> THE SUSTAINED RELEASE OF MORPHINE FROM ORAMORPH SR SHOULD BE TAKEN INTO CONSIDERATION IN THE EVENT OF OCCURRING ADVERSE REACTIONS.</td> </tr> </tbody> </table>