Hydromorphone Hydrochloride
Generic Name: hydromorphone hydrochloride
Brand Names:
Hydromorphone Hydrochloride
DESCRIPTION Hydromorphone Hydrochloride Injection, USP is a sterile solution intended for subcutaneous, intramuscular or slow intravenous injection. Each mL contains hydromorphone hydrochloride 2 mg, edetate disodium 0.5 mg, methylparaben 1.8 mg and propylparaben 0.2 mg in Water for Injection. The pH range is 3.5-5.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.
Overview
DESCRIPTION Hydromorphone Hydrochloride Injection, USP is a sterile solution intended for subcutaneous, intramuscular or slow intravenous injection. Each mL contains hydromorphone hydrochloride 2 mg, edetate disodium 0.5 mg, methylparaben 1.8 mg and propylparaben 0.2 mg in Water for Injection. The pH range is 3.5-5.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.
Uses
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
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.
Side Effects
ADVERSE REACTIONS The major hazards of hydromorphone, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock and cardiac arrest have occurred, particularly with overdosage or rapid intravenous administration. Anaphylactoid reactions have been reported when phenanthrene alkaloids of opium are administered intravenously. CENTRAL NERVOUS SYSTEM: Sedation, drowsiness, mental clouding, headache, tremor, visual disturbances, weakness, agitation, lethargy, impairment of mental and physical performance, uncoordinated muscle movements, anxiety, fear, euphoria, dysphoria, dizziness, psychological dependence and mood changes.
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.
Warnings
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. CONTRAINDICATIONS Hydromorphone Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to hydromorphone, in the presence of an intracranial lesion associated with increased intracranial pressure and whenever ventilatory function is depressed (chronic obstructive pulmonary disease, cor pulmonale, emphysema, kyphoscoliosis, status asthmaticus). [See WARNINGS .
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 regularly during pregnancy.
Storage
HOW SUPPLIED Hydromorphone Hydrochloride Injection, USP is available in the following: 2 mg/mL 20 mL Multiple Dose vials packaged individually (NDC 0641-2341-41) STORAGE PROTECT FROM LIGHT: Keep covered in carton. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Hydromorphone Hydrochloride used for?▼
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.
What are the side effects of Hydromorphone Hydrochloride?▼
ADVERSE REACTIONS The major hazards of hydromorphone, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock and cardiac arrest have occurred, particularly with overdosage or rapid intravenous administration. Anaphylactoid reactions have been reported when phenanthrene alkaloids of opium are administered intravenously. CENTRAL NERVOUS SYSTEM: Sedation, drowsiness, mental clouding, headache, tremor, visual disturbances, weakness, agitation, lethargy, impairment of mental and physical performance, uncoordinated muscle movements, anxiety, fear, euphoria, dysphoria, dizziness, psychological dependence and mood changes.
Can I take Hydromorphone Hydrochloride during 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 regularly during pregnancy.
What are the important warnings for Hydromorphone Hydrochloride?▼
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. CONTRAINDICATIONS Hydromorphone Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to hydromorphone, in the presence of an intracranial lesion associated with increased intracranial pressure and whenever ventilatory function is depressed (chronic obstructive pulmonary disease, cor pulmonale, emphysema, kyphoscoliosis, status asthmaticus). [See WARNINGS .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.