Medication info

Dilaudid Tablets 4 mg (Hydromorphone Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Hydromorphone Hydrochloride›Strength being verified
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Yellow round tablet
Packaging
Proprietary packaging unit
Approval status
Approval withdrawn

MFDS item code 200210690 · Approved 2002.12.18

This product's status changed to Approval withdrawn on 2023.04.06. 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
(Tablets) * 2, 4 mg The initial dose is 2 mg of hydromorphone hydrochloride orally every 4 ∼ 6 hours, depending on pain severity. Adjust the dose as appropriate according to pain severity, patient response, and body size. For more severe pain, administer 4 mg or more every 4 ∼ 6 hours. If tolerance develops or pain worsens, gradual dose increases may be necessary. If pain becomes severe or immediate intervention is required, initially use an appropriate amount of an injectable product for pain control. Patients with renal impairment For patients with moderate (creatinine clearance 40 ~ 60 mL/min) or severe (creatinine clearance < 30 mL/min) renal impairment, use 1/4 ~ 1/2 of the usual hydromorphone hydrochloride dose (see section 10. Administration to patients with renal impairment under Precautions for Use). For patients with severe renal impairment, consider additionally increasing the dosing interval and monitor for opioid-related adverse reactions during maintenance treatment.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of severe pain requiring opioid analgesics

  • Severe pain
View approved original text

This medication is used to relieve severe pain that requires narcotic analgesics.

Dosage and Administration

Adult dosage

(Tablets) * 2, 4 mg The initial dose is 2 mg of hydromorphone hydrochloride orally every 4 ∼ 6 hours, depending on pain severity. Adjust the dose as appropriate according to pain severity, patient response, and body size. For more severe pain, administer 4 mg or more every 4 ∼ 6 hours. If tolerance develops or pain worsens, gradual dose increases may be necessary. If pain becomes severe or immediate intervention is required, initially use an appropriate amount of an injectable product for pain control. Patients with renal impairment For patients with moderate (creatinine clearance 40 ~ 60 mL/min) or severe (creatinine clearance < 30 mL/min) renal impairment, use 1/4 ~ 1/2 of the usual hydromorphone hydrochloride dose (see section 10. Administration to patients with renal impairment under Precautions for Use). For patients with severe renal impairment, consider additionally increasing the dosing interval and monitor for opioid-related adverse reactions during maintenance treatment.

Precautions

This medication is a powerful analgesic that acts on the central nervous system, and caution should be taken when used in combination with other central nervous system depressants or alcohol, as it may cause serious respiratory depression, coma, or even death. Patients with allergic reactions or certain conditions such as increased intracranial pressure, severe respiratory depression, chronic pulmonary disease, or asthma attacks should not take this medication. Elderly patients or those with impaired kidney function, hypothyroidism, or adrenal insufficiency may be more sensitive to the side effects of this medication, so caution is advised. Prolonged use of this medication may result in dependence, and abrupt discontinuation may lead to withdrawal symptoms; therefore, the dosage should be gradually reduced according to the doctor's instructions. As respiratory depression symptoms may occur, breathing status should be closely monitored, and professional treatment may be necessary if needed. Caution is required when performing activities that require mental or physical concentration, such as driving or operating machinery, as this medication may cause drowsiness or confusion. Pregnant women or those who might become pregnant should not take this medication, and breastfeeding should be discontinued if using this medication. The safety and efficacy of this medication in children have not been sufficiently confirmed, so it should be administered with caution in pediatric patients. In cases of overdose, severe respiratory depression and loss of consciousness may occur, so the dosage should be strictly adhered to, and medical attention should be sought immediately in case of overdose. This medication may interact with various drugs, so if other medications are being taken, it is essential to notify and consult with a doctor or pharmacist.

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, breathlessness, palpitations, difficulty breathing, slow breathing, irregular breathing, apnea, coma, confusion, delirium, head injury, low blood pressure, shock, intestinal obstruction, toxic megacolon, sedation, drowsiness, mental cloudiness, impairment of mental and physical performance, craving, fear, discomfort, psychological dependence, emotional changes, mental unrest, dizziness, weakness, agitation, muscular incoordination, muscle rigidity, abnormal sensations, muscle twitching, visual disturbances, nystagmus, miosis, diplopia, temporary hallucinations, flushing, euphoria, sweating, dry mouth, constipation, biliary colic, loss of appetite, gastric cramps, taste changes, coldness, tachycardia, bradycardia, hypertension, circulatory disorders, peripheral circulatory collapse, cardiac arrest, orthostatic hypotension, syncope, ureteral spasms, bladder sphincter spasms, urinary retention, bronchospasm, laryngeal spasm, itching, urticaria, skin rash, myoclonic seizures, 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 is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Yellow round tablet

Package unit

Proprietary 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.