Medication info

Dilaudid Injection 4 mg (Hydromorphone Hydrochloride)

Prescription medicationExpired
Ingredient · strength
Hydromorphone Hydrochloride›Strength being verified
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Brown ampoule containing a colorless and transparent solution
Packaging
In-house packaging unit
Approval status
Expired

MFDS item code 200308473 · Approved 2003.04.12

This product's status changed to Expired on 2023.07.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of severe pain requiring opioid analgesics
Who uses it
Adults
Adult dosage
* 1, 2, 4 mg/mL The initial dose is 1 ∼ 2 mg administered subcutaneously or intramuscularly every 4 ∼ 6 hours, depending on the severity of pain. Adjust the dose appropriately according to the severity of pain, the patient's underlying conditions, age, and body size. Patients with terminal cancer may develop strong tolerance to opioid analgesics and may require higher doses for adequate pain relief. Intravenous administration may be used if necessary, but the injection must be given slowly over at least 2 ∼ 3 minutes. Rapid intravenous administration of opioid analgesics may increase the risk of hypotension and respiratory depression. If tolerance develops or the pain worsens, gradual dose escalation may be necessary. The first sign of developing tolerance is generally a shorter duration of the medication's effect.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of severe pain requiring opioid analgesics

  • Severe pain
View approved original text

This injectable medication is used to alleviate severe pain requiring the use of narcotic analgesics. In other words, it effectively reduces strong pain, relieving the discomfort of patients. It allows for dose adjustment in 1, 2, or 4 mg/mL as necessary, enabling personalized treatment. It safely assists in pain control when needed, enhancing therapeutic effects. Therefore, it is suitable for patients with severe acute or chronic pain.

Dosage and Administration

Adult dosage

* 1, 2, 4 mg/mL The initial dose is 1 ∼ 2 mg administered subcutaneously or intramuscularly every 4 ∼ 6 hours, depending on the severity of pain. Adjust the dose appropriately according to the severity of pain, the patient's underlying conditions, age, and body size. Patients with terminal cancer may develop strong tolerance to opioid analgesics and may require higher doses for adequate pain relief. Intravenous administration may be used if necessary, but the injection must be given slowly over at least 2 ∼ 3 minutes. Rapid intravenous administration of opioid analgesics may increase the risk of hypotension and respiratory depression. If tolerance develops or the pain worsens, gradual dose escalation may be necessary. The first sign of developing tolerance is generally a shorter duration of the medication's effect.

Precautions

This medication can result in glass fragments when breaking the glass ampoule for injection, so extreme caution must be exercised to ensure that glass shards do not enter, particularly when administering to children or the elderly. This medication, when used in combination with narcotics that affect the central nervous system or benzodiazepine drugs, as well as alcohol, may cause severe sedation, respiratory depression, coma, and even death. Therefore, it must be used only when absolutely necessary at the minimum dose and for the shortest duration, while closely monitoring the patient's condition. It should not be administered to patients with allergies to this medication or its components, those with elevated intracranial pressure, patients with severe respiratory depression, heart failure due to chronic lung disease, those enduring asthma attacks, patients with acute abdominal diseases, pregnant women, or women who may become pregnant. It should also be used with caution in patients with liver dysfunction or specific neurological diseases. Elderly or frail patients, those with respiratory illnesses, patients with kidney or thyroid dysfunction, individuals with adrenal insufficiency, those with psychiatric disorders, and patients with urination difficulties should be observed more carefully when using this medication. This medication can cause addiction and dependence, so patients must be closely monitored during long-term use, and abrupt cessation of administration may lead to withdrawal symptoms, requiring gradual tapering of the dose. Since it can suppress respiration, if symptoms such as respiratory distress, slow breathing, or apnea occur, appropriate treatment must be sought immediately. Patients with head injuries are at risk for increased intracranial pressure, so caution is warranted. Patients may experience hypotension or shock symptoms; therefore, extreme care is required for patients with unstable blood pressure. Additionally, sudden standing after administration can result in orthostatic hypotension and fainting, so patients should move slowly. This medication suppresses the cough reflex, so special caution is needed when using it in patients with lung diseases. Patients may experience drowsiness, mental cloudiness, and dizziness, which necessitate avoiding driving or operating dangerous machinery. If combined with specific drugs such as MAO inhibitors, benzodiazepine medications, other central nervous system depressants, or narcotic analgesics, the risk of increased central nervous system depressant effects may arise; thus, dosage adjustments and patient monitoring are required during combined use. Pregnant or nursing women should avoid using this medication, as it may pose risks during childbirth or to newborns, requiring special attention. Safety and efficacy in pediatric patients have not been established; therefore, caution is necessary when administering to children, and elderly individuals may experience increased risk of respiratory depression due to diminished physiological functions, requiring careful monitoring starting with low doses. In cases of overdose, severe respiratory depression, decreased consciousness, hypotension, or cardiac arrest may occur, necessitating immediate emergency treatment. Particularly in cases of respiratory depression, administration of narcotic antagonists and respiratory support may be required. This medication must be administered slowly when given intravenously, as rapid injection can cause serious side effects such as hypotension and respiratory depression.

Side effects

yawning, sneezing, tearing, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, hallucinations, convulsions, tremors, pain in muscles and joints throughout the body, respiratory distress, palpitations, shortness of breath, slow breathing, irregular breathing, apnea, head injury, low blood pressure, shock, sedation, drowsiness, confusion, mental and physical performance impairment, cravings, fear, discomfort, psychological dependence, mood changes, mental unrest, dizziness, weakness, excitement, tremors, muscle movement disorders, muscle rigidity, paresthesia, muscle twitching, visual disturbances, nystagmus, miosis, diplopia, transient hallucinations, flushing, euphoria, sweating, dry mouth, constipation, biliary colic, bowel obstruction, loss of appetite, diarrhea, gastric cramps, taste changes, chills, tachycardia, bradycardia, flushing, palpitations, syncope, hypotension, hypertension, circulatory disorders, peripheral circulatory failure, cardiac arrest, orthostatic hypotension, ureter spasms, bladder sphincter spasms, urinary retention, bronchospasm, laryngeal spasms, itching, urticaria, other skin rashes, convulsions, myoclonic jerks, unconsciousness, coma, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a closed container that blocks light, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

Brown ampoule containing a colorless and transparent solution

Package unit

In-house packaging unit

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.