ADVERSE REACTIONS
The adverse reactions caused by morphine are essentially the same as 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, and increased intracranial pressure.
Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alterations, ileus, and intestinal obstruction.
Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension and hypertension.
Genitourinary: Urinary retention or hesitance, reduced libido and/or potency.
Dermatologic: Pruritus, urticaria, other skin rashes, edema and diaphoresis.
Other: Antidiuretic effect, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia miosis, and anaphylaxis.
DRUG ABUSE AND DEPENDENCE
Opioid analgesics may cause psychological and physical dependence. (See WARNINGS). Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with narcotic antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, etc.: see also OVERDOSAGE). Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued narcotic usage. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect, and, subsequently, by decreases in the intensity of analgesia.
In chronic-pain patients and in narcotic-tolerant cancer patients, the administration of MSIR Oral Solution Concentrate and MSIR Tablets should be guided by the degree of tolerance manifested. Physical dependence, per se, is not ordinarily a concern when one is dealing with opioid-tolerant patients whose pain and suffering is associated with an irreversible illness.
If MSIR Oral Solution Concentrate and MSIR Tablets are abruptly discontinued, a moderate to severe abstinence syndrome may occur. The opioid agonist abstinence syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, cutis anserina, restless sleep known as the "yen" and mydriasis during the first 24 hours. These symptoms often increase in severity and over the next 72 hours may be accompanied by increasing irritability, anxiety, weakness, twitching and spasms of muscles; kicking movements; severe backache, abdominal and leg pains; abdominal and muscle cramps; hot and cold flashes; insomnia; nausea, anorexia, vomiting, intestinal spasm, diarrhea; coryza and repetitive sneezing; and increase in body temperature, blood pressure, respiratory rate, and heart rate. Because of excessive loss of fluids through sweating, vomiting and diarrhea, there is usually marked weight loss, dehydration, ketosis, and disturbances in acid-base balance. Cardiovascular
collapse can occur. Without treatment, most observable symptoms disappear in 5-14 days; however, there appears to be a phase of secondary or chronic abstinence which may last for 2-6 months, characterized by insomnia, irritability, and muscular aches.
If treatment of physical dependence on MSIR Oral Solution Concentrate and MSIR Tablets is necessary, the patient may be detoxified by gradual reduction of the dosage. Gastrointestinal disturbances or dehydration should be treated accordingly.
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