DrugBuyers.Com: Dilaudid (hydromorphone hydrochloride)

Dilaudid (hydromorphone hydrochloride)

DILAUDID is a narcotic analgesic; its principal therapeutic effect is relief of pain. The precise mechanism of action of DILAUDID and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. There is no intrinsic limit to the analgesic effect of DILAUDID; like morphine, adequate doses will relieve even the most severe pain. Clinically, however, dosage limitations are imposed by the adverse effects, primarily respiratory depression, nausea, and vomiting, which can result from high doses.

DILAUDID has diverse additional actions. It may produce drowsiness, changes in mood and mental clouding, depress the respiratory center and the cough center, stimulate the vomiting center, produce pinpoint constriction of the pupil, enhance parasympathetic activity, elevate cere- brospinal fluid pressure, increase biliary pressure, produce transient hyperglycemia.

Generally, the analgesic action of parenterally administered DILAUDID is apparent within 15 minutes and usually remains in effect for more than five hours. The onset of action of oral DILAUDID is somewhat slower, with measurable analgesia occurring within 30 minutes.
In human plasma the half-life of a DILAUDID 4 mg tablet is 2.6 hours. In a random crossover study in six subjects, 4 mg of oral DILAUDID produced a mean concentration/ time curve similar to that of 2 mg DILAUDID I.V., after the first hour.

WARNINGS

Respiratory Depression: DILAUDID produces dose-related respiratory depression by acting directly on brain stem respiratory centers. DILAUDID also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebra-spinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce effects which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

PRECAUTIONS

Special Risk Patients: DILAUDID should be used with caution in elderly or debilitated patients and those with impaired renal or hepatic function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. As with any narcotic analgesic agent, the usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Cough Reflex: DILAUDID suppresses the cough reflex; as with all narcotics, caution should be exercised when DILAUDID is used postoperatively and in patients with pulmonary disease.

Usage in Ambulatory Patients: Narcotics may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with DILAUDID may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Parenteral Administration: The parenteral form of DILAUDID may be given intravenously, but the injection should be given very slowly. Rapid intravenous injection of narcotic analgesics increases the possibility of side effects such as hypotension and respiratory depression.

Pregnancy: Pregnancy Category C. DILAUDID has been shown to be teratogenic in hamsters when given in doses 600 times the human dose. There are no adequate and well-controlled studies in pregnant women. DILAUDID should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexea, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q.h. phenobarbital 2 mg/kg q.h. and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration ot therapy is 4 to 28 days, with the dosages decreased as tolerated.

Labor and Delivery: As with all narcotics, administration of DILAUDID to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers: it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from DILAUDID, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children have not been established.

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