openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Impaired Respiration: Respiratory depression is the chief hazard of hydromorphone hydrochloride. Respiratory depression occurs most frequently in overdose situations, in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Hydromorphone hydrochloride should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or in patients with preexisting respiratory depression. In such patients even usual therapeutic doses of opioid analgesics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Drug Dependence Hydromorphone hydrochloride is a Schedule II narcotic. Hydromorphone hydrochloride can produce drug dependence of the morphine type and therefore have the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of hydromorphone hydrochloride, which should be prescribed and administered with the degree of caution appropriate to the use of morphine. Abrupt discontinuance in the administration of hydromorphone hydrochloride in patients who are physically dependent on opioids is likely to result in a withdrawal syndrome (see DRUG ABUSE AND DEPENDENCE ). Sulfites Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
ADVERSE REACTIONS The adverse effects of hydromorphone hydrochloride are similar to those of other agonist opioid 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.