Hydromorphone Hydrochloride

Clinical summary

Indications and usage INDICATIONS AND USAGE Hydromorphone Hydrochloride Injection is indicated for the relief of moderate to severe pain such as that due to: surgery, cancer, trauma (soft tissue and bone), biliary colic, myocardial infarction, burns, renal colic. Dosage and administration DOSAGE AND ADMINISTRATION The usual starting dose is 1-2 mg subcutaneously or intramuscularly every 4 to 6 hours as necessary for pain control. The dose should be adjusted according to severity of pain, as well as the patient’s underlying disease, age and size. Severe pain can usually be controlled by 3-4 mg every 4 to 6 hours as required. Patients with terminal cancer may become tolerant to narcotic analgesics and may, therefore, require higher doses for adequate pain relief. Should intravenous administration be necessary, the injection should be given very slowly (over at least 3 to 5 minutes, depending on the dose) [see WARNINGS, INTRAVENOUS USE ]. A gradual increase in dosage may be required if analgesia is inadequate, tolerance occurs or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warnings and cautions WARNINGS RESPIRATORY DEPRESSION Hydromorphone produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Hydromorphone 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 hydromorphone and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, hydromorphone produces adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, hydromorphone must be used with extreme caution and only if its use is deemed essential. ACUTE ABDOMINAL CONDITIONS The administration of hydromorphone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. ASTHMA AND OTHER RESPIRATORY CONDITIONS Hydromorphone should be used with extreme caution in patients having an acute asthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve and patients with pre-existing respiratory depression, hypoxia or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. INTRAVENOUS USE If necessary, hydromorphone may be given intravenously, but the injection should be given very slowly (over a period of at least 3 to 5 minutes). Rapid intravenous injection of narcotic analgesics, including hydromorphone, increases the incidence of adverse reactions; severe respiratory depression, apnea, hypotension, peripheral circulatory collapse, cardiac arrest, as well as anaphylactoid reactions, have occurred. Hydromorphone should not be administered intravenously unless a narcotic antagonist and the facilities for resuscitation and assisted or controlled respiration are immediately available. When hydromorphone is given parenterally, especially intravenously, the patient should be lying down. HYPOTENSIVE EFFECT The administration of hydromorphone may result in severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as the phenothiazines or certain anesthetics. Hydromorphone may produce orthostatic hypotension in ambulatory patients. Drug interactions DRUG INTERACTIONS Hydromorphone should be administered cautiously and in reduced dosage to avoid additive effects when other central nervous system depressants including other narcotic analgesics, general anesthetics, phenothiazines, tricyclic antidepressants, sedative-hypnotics or other CNS depressants (including alcohol) are given concomitantly. Whenever concomitant therapy with MAO inhibitors and narcotic analgesics, including hydromorphone is to be used, an initial small test dose is advisable to allow observation of excessive narcotic effects or MAOI interaction. Pregnancy PREGNANCY Teratogenic Effects - Pregnancy Category C. Hydromorphone has been shown to be teratogenic in golden hamsters with a minimal effective teratogenic dose of 19 mg/kg, when given in doses 600 times the usual therapeutic dose in humans. There are no adequate and well-controlled studies in pregnant women. Hydromorphone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects. Dependence has been reported in newborns whose mothers took opiates regu