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warnings
WARNINGS Interactions with Other Central Nervous System Depressants Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics or other CNS depressants (including alcohol) concomitantly with NUMORPHAN may exhibit an additive CNS depression (see PRECAUTIONS; Drug Interactions ). Respiratory Depression NUMORPHAN should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma. Head Injury and Increased Intracranial Pressure The possible respiratory depressant effects of potent analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO 2 retention) may be markedly exaggerated in the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, NUMORPHAN should be used in these circumstances only when essential, and then should be administered with extreme caution. Acute Abdominal Conditions The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Drug Dependence NUMORPHAN, as with other opioid drugs, can produce tolerance, psychological dependence, and physical dependence and has the potential for being abused (see DRUG ABUSE AND DEPENDENCE ). Pregnancy Safe use in pregnancy has not been established (relative to possible adverse effects on fetal development). As with other analgesics, the use of NUMORPHAN in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child (see PRECAUTIONS ).
ADVERSE REACTIONS As with all potent opioid analgesics, possible side effects when using NUMORPHAN include: Central Nervous System Drowsiness, sedation, lightheadedness, unusual tiredness or weakness, headache, dysphoria, euphoria, miosis, diplopia, blurred vision, nervousness, restlessness, confusion, mental clouding, trouble sleeping, paradoxical CNS stimulation, hallucinations, mental depression. Gastrointestinal System Nausea, vomiting, dry mouth, constipation, biliary tract spasm, cramps or pain, loss of appetite, paralytic ileus or toxic megacolon in patients with inflammatory bowel disease. Cardiovascular System Hypotension, orthostatic hypotension particularly in ambulatory patients, tachycardia, bradycardia, palpitations, flushing. Respiratory System Respiratory depression, atelectasis, allergic bronchospastic reaction, allergic laryngeal edema, allergic laryngospasm. Genitourinary System Ureteral spasm, urinary hesitancy or retention, antidiuretic effect. Dermatologic Itching, sweating, injection site reaction, allergic reaction (such as skin rash, hives, and/or itching, swelling of the face).