Medication info

Dilaudid Injection 10 mg (Hydromorphone Hydrochloride)

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

MFDS item code 200308474 · 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 in patients tolerant to opioid analgesics
Who uses it
Adults
Adult dosage
(Injection) * 10 mg/mL This medicine should be administered only to patients with prior experience using high doses of opioid analgesics. This medicine relieves pain in patients who are tolerant to opioid analgesics. When switching from the low-concentration injectable formulation of this medicine to the high-concentration injectable formulation, administer a similar dose based on the patient's response to this medicine. When this medicine is used in place of another opioid analgesic, the total daily dose should be determined conservatively because of individual patient variability and differences between formulations; adjust the dose according to the patient's response. Administer this medicine by intramuscular or subcutaneous injection. Experience with intravenous administration of this medicine is limited. If intravenous administration is necessary, however, infuse it 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 in patients tolerant to opioid analgesics

  • Severe pain
View approved original text

This medication is used for individuals experiencing severe pain among patients with opioid tolerance. It is particularly suitable for patients who have not had their pain controlled despite receiving more than a certain dosage of oral morphine, fentanyl patches, oxycodone, and other opioid analgesics for more than one week. This medication provides appropriate pain relief for those who do not respond adequately to standard analgesic doses. It is used when continuous opioid analgesics are required for 24 hours and helps effectively alleviate severe pain. Therefore, this medication is utilized for the relief of severe pain due to opioid tolerance.

Dosage and Administration

Adult dosage

(Injection) * 10 mg/mL This medicine should be administered only to patients with prior experience using high doses of opioid analgesics. This medicine relieves pain in patients who are tolerant to opioid analgesics. When switching from the low-concentration injectable formulation of this medicine to the high-concentration injectable formulation, administer a similar dose based on the patient's response to this medicine. When this medicine is used in place of another opioid analgesic, the total daily dose should be determined conservatively because of individual patient variability and differences between formulations; adjust the dose according to the patient's response. Administer this medicine by intramuscular or subcutaneous injection. Experience with intravenous administration of this medicine is limited. If intravenous administration is necessary, however, infuse it 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 is administered via injection. Care must be taken to avoid the incorporation of glass fragments when cutting a glass ampoule. Extra caution is necessary, especially for children and the elderly. This medication should not be taken with opioids or benzodiazepine medications that affect the central nervous system, or alcohol, as it may lead to severe sedation, respiratory suppression, coma, or even death, so it should either be avoided or used with extreme caution. This medication should not be administered to patients who are not accustomed to opioid analgesics, patients with allergies, those with elevated intracranial pressure, severe respiratory suppression, heart failure due to chronic lung disease, or patients with ongoing asthma attacks. Additionally, it should not be given to women who are pregnant or may become pregnant, patients with liver disorders, or those with acute alcohol intoxication. Particular caution should be exercised when administering this medication to elderly or frail patients, patients with impaired kidney function, hypothyroidism, adrenal insufficiency, patients under central nervous system depression, those with mental health issues, and patients with urination difficulties. Long-term use of this medication may lead to drug dependence, requiring continuous monitoring of the patient's condition, and sudden discontinuation may provoke withdrawal symptoms. Moreover, if symptoms of respiratory depression appear, immediate treatment is essential. This medication may cause various side effects, including drowsiness, dizziness, insomnia, headaches, dyspepsia, constipation, blood pressure changes, respiratory issues, and others, so if unusual symptoms occur, it is important to consult a physician. This medication may impair the ability to operate vehicles or hazardous machinery, so caution is necessary during treatment. This medication can interact with specific drugs, and taking it with MAO inhibitors, other opioid analgesics, benzodiazepines, alcohol, etc., may exacerbate side effects; hence consulting healthcare professionals is essential. Pregnant or breastfeeding women are advised against using this medication, and breastfeeding should be suspended if the medication is used. Safety and effectiveness in children have not been sufficiently established, so administration to children should be undertaken with caution. In case of overdose, serious symptoms such as respiratory depression, loss of consciousness, and blood pressure drop may occur, necessitating immediate emergency treatment. This medication should be administered slowly during intravenous injection, and rapid administration raises the risk of hypotension or respiratory depression.

Side effects

Drug dependence, yawning, sneezing, tearfulness, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, hallucinations, convulsions, trembling, pain in muscles and joints throughout the body, shortness of breath, palpitations, respiratory distress, slow breathing, irregular breathing, apnea, confusion, forgetfulness, hypotension, shock, sedation, drowsiness, mental confusion, impairment of mental and physical performance, craving, fear, discomfort, psychological dependence, mood changes, mental unease, dizziness, weakness, agitation, muscle incoordination, rigidity, abnormal sensations, muscle twitching, visual disturbances, nystagmus, miosis, diplopia, temporary hallucinations, flushing, euphoria, sweating, thirst, constipation, biliary colic, intestinal obstruction, loss of appetite, taste changes, coldness, tachycardia, bradycardia, flushing, fainting, hypertension, circulatory disorders, peripheral circulation failure, cardiac arrest, orthostatic hypotension, ureteral spasm, bladder sphincter spasm, urinary retention, antidiuretic effect, bronchospasm, laryngeal spasm, itching, urticaria, skin rash, swelling and redness at the intravenous injection site, myoclonic jerks, unconsciousness, coma, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest

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

Storage

This medication should be stored in a sealed container that can block light, and the storage temperature should be kept between 1 degree and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Brown ampoule containing a colorless transparent solution

Package unit

Company 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.