ADVERSE REACTIONS
The adverse effects of DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS are similar to those of other opioid agonist analgesics, and represent established pharmacological effects of the drug class. The major hazards include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.
The most frequently observed adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Syncopal reactions and related symptoms in ambulatory patients may be alleviated if the patient lies down.
Less Frequently Observed with Opioid Analgesics
General and CNS
Weakness, headache, agitation, tremor, uncoordinated muscle movements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia and increased intracranial pressure may occur.
Cardiovascular
Chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension and hypertension have been reported.
Respiratory
Bronchospasm and laryngospasm have been known to occur.
Gastrointestinal
Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps and taste alteration have been reported.
Genitourinary
Urinary retention or hesitancy, and antidiuretic effects have been reported.
Dermatologic
Urticaria, other skin rashes, and diaphoresis.
DRUG ABUSE AND DEPENDENCE
DILAUDID is a Schedule II narcotic, similar to morphine. Opioid analgesics may cause psychological and physical dependence (see WARNINGS). Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal symptoms also may be precipitated in the patient with physical dependence by the administration of a drug with opioid antagonist activity, e.g., naloxone (see OVERDOSAGE).
Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage, but it may become clinically detectable after as little as a week. Tolerance, in which increasingly larger 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 opioid-tolerant cancer patients, the dose of DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS should be guided by the degree of tolerance manifested.
In chronic pain patients in whom opioid analgesics including DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS are abruptly discontinued, a severe abstinence syndrome should be anticipated. This may be similar to the abstinence syndrome noted in patients who withdraw from heroin. The latter abstinence syndrome may be characterized by restlessness, lacrimation, rhinorrhea, yawning, perspiration, gooseflesh, restless sleep or "yen" and mydriasis during the first 24 hours. These symptoms may 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, increase in body temperature, blood pressure, respiratory rate and heart rate.
Because of excessive loss of fluids through sweating, or vomiting and diarrhea, patients experiencing the syndrome usually exhibit 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, muscular aches, and autonomic instability.
In the treatment of physical dependence on DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS, the patient may be detoxified by gradual reduction of the dosage, although this is unlikely to be necessary in the terminal cancer patient. If abstinence symptoms become severe, the patient may be detoxified with methadone. Temporary administration of tranquilizers and sedatives may aid in reducing patient anxiety. Gastrointestinal disturbances or dehydration should be treated accordingly.
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