FDA label 72bd41c3-5628-4ed0-b034-153fcd3c81f8

WARNING HYDROMORPHONE HYDROCHLORIDE INJECTION, USP 10 mg/mL IS A HIGHLY CONCENTRATED SOLUTION OF HYDROMORPHONE INTENDED FOR USE IN NARCOTIC-TOLERANT PATIENTS. DO NOT CONFUSE HYDROMORPHONE HYDROCHLORIDE INJECTION, USP WITH STANDARD PARENTERAL FORMULATIONS OF HYDROMORPHONE HYDROCHLORIDE OR OTHER NARCOTICS. OVERDOSE AND DEATH COULD RESULT.

WARNINGS Drug Dependence Hydromorphone Hydrochloride Injection can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of Hydromorphone Hydrochloride Injection and it should be prescribed and administered with the same degree of caution appropriate for the use of morphine. Since Hydromorphone Hydrochloride Injection is indicated for use in patients who are already tolerant to and hence physically dependent on narcotics, abrupt discontinuance in the administration of Hydromorphone Hydrochloride Injection is likely to result in a withdrawal syndrome. (See Drug Abuse and Dependence ). Infants born to mothers physically dependent on Hydromorphone Hydrochloride Injection will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms. (See Drug Abuse and Dependence ). Impaired Respiration Respiratory depression is the chief hazard of Hydromorphone Hydrochloride Injection. Respiratory depression occurs most frequently 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 Injection 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 preexisting respiratory depression. In such patients even usual therapeutic doses of narcotic analgesics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of Hydromorphone Hydrochloride Injection with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure. Narcotic analgesics including Hydromorphone Hydrochloride Injection may produce effects which can obscure the clinical course and neurologic signs of further increase in pressure in patients with head injuries. Hypotensive Effect Narcotic analgesics, including Hydromorphone Hydrochloride Injection, may cause severe hypotension in an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics (see also Precautions - Drug Interactions ). Hydromorphone Hydrochloride Injection may produce orthostatic hypotension in ambulatory patients. Hydromorphone Hydrochloride Injection should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

ADVERSE REACTIONS The adverse effects of Hydromorphone Hydrochloride Injection are similar to those of other narcotic 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 lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. 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 with Narcotic Analgesics General and CNS - Dysphoria, euphoria, 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. *Hallucinations, although unusual with pure agonist narcotics, have been observed in one patient following both a 6 mg and a 4 mg Hydromorphone Hydrochloride Injection dose. However, the patient was receiving several concomitant medications during the second episode and a causal relationship cannot be established. Cardiovascular - Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension and hypertension have been reported. Respiratory - Bronchospasm and laryngospasm have been known to occur. Gastrointestinal - Dry mouth, constipation, biliary tract spasm, anorexia, diarrhea, cramps and taste alterations have been reported. Genitourinary - Urinary retention or hesitancy, and antidiuretic effects have been reported. Dermatologic - Pruritis, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection, and diaphoresis have been reported with narcotic analgesics. Other - In clinical trials, neither local tissue irritation nor induration was observed at the site of subcutaneous injection of Hydromorphone Hydrochloride Injection; pain at the injection site was rarely observed. However, local irritation and induration have been seen following parenteral injection of other narcotic drug products.