Medication info

Tarasin Injection (Ketorolac Tromethamine)

Prescription medicationInjectionsIntramuscular injection · Intravenous injectionApproval withdrawn
Ingredient · strength
Ketorolac Tromethamine›30mg / 1 ampoule
Manufacturer / importer
ZP Therapeutics Korea Co., Ltd.
Appearance
A clear pale yellow liquid contained in a colorless glass ampoule for injection
Packaging
1ml × 10 ampoules
Approval status
Approval withdrawn

MFDS item code 200612510 · Notified 2006.12.19 · Insurance code 057200121

This product's status changed to Approval withdrawn on 2025.09.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Short-term relief of moderate to severe acute pain (e.g., postoperative pain)
Who receives it
Adults · Children
Adult administration
○ Adults: For intramuscular or intravenous administration, administer an initial dose of 10 mg of ketorolac tromethamine, followed by maintenance doses of 10∼30 mg every 4∼6 hours. Use the lowest effective dose. Do not administer for more than 2 days. The daily dose should not exceed 90 mg (60 mg in elderly patients, patients with renal impairment, and patients weighing 50 kg or less). Do not administer epidurally or intrathecally. The dose or dosing interval may be adjusted according to the symptoms and severity of pain. An opioid may be administered concomitantly if needed.
Child administration
○ Children 2 years of age and older: Administer as a single intravenous dose after surgery. Thereafter, several intravenous bolus doses may be administered as needed. Intravenous administration is recommended for children because intramuscular injection is painful. Administer a single dose of 0.5∼1.0 mg/kg, followed, if needed, by 0.5 mg/kg every 6 hours. Do not administer for more than 2 days. The dose or dosing interval may be adjusted according to the symptoms and severity of pain.

Ingredients

Importer
ZP Therapeutics Korea Co., Ltd.

Efficacy & effects

Short-term relief of moderate to severe acute pain (e.g., postoperative pain)

  • Acute pain
  • postoperative pain
View approved original text

This medication is suitable for short-term use for acute pain ranging from moderate to severe, especially postoperative pain. It can also be safely used for severe postoperative pain in children over 2 years of age where the use of opioid analgesics is not allowed. Therefore, this medication is effectively used for the management of various acute pain.

How it is given

Adult administration

○ Adults: For intramuscular or intravenous administration, administer an initial dose of 10 mg of ketorolac tromethamine, followed by maintenance doses of 10∼30 mg every 4∼6 hours. Use the lowest effective dose. Do not administer for more than 2 days. The daily dose should not exceed 90 mg (60 mg in elderly patients, patients with renal impairment, and patients weighing 50 kg or less). Do not administer epidurally or intrathecally. The dose or dosing interval may be adjusted according to the symptoms and severity of pain. An opioid may be administered concomitantly if needed.

Child administration

○ Children 2 years of age and older: Administer as a single intravenous dose after surgery. Thereafter, several intravenous bolus doses may be administered as needed. Intravenous administration is recommended for children because intramuscular injection is painful. Administer a single dose of 0.5∼1.0 mg/kg, followed, if needed, by 0.5 mg/kg every 6 hours. Do not administer for more than 2 days. The dose or dosing interval may be adjusted according to the symptoms and severity of pain.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three alcoholic beverages per day, so it is essential to consult a doctor or pharmacist. This medication can pose serious risks to the cardiovascular system and may increase the risk of thrombotic events such as myocardial infarction or stroke. The risk increases the longer the administration period, and patients with cardiovascular diseases or risk factors require special caution. When taken with anticoagulants, the risk of bleeding may be increased, so patients with a tendency to bleed or those who have undergone surgeries with a high risk of bleeding should use it cautiously. This medication can cause gastrointestinal adverse reactions such as gastrointestinal bleeding, ulceration, and perforation, and the risks are greater in elderly or frail patients. Immediate medical attention should be sought if gastrointestinal symptoms occur during use. It may affect kidney function, so patients with renal disease or weak kidney function should take it with care, and the daily dosage of the injection should not exceed 60mg. Hypersensitivity reactions such as anaphylaxis, bronchospasm, and skin rash may occur, so patients with a history of hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs should be especially careful. Women planning to become pregnant or who may become pregnant are advised not to take this medication as it may affect fertility. Taking it with other non-steroidal anti-inflammatory drugs may increase the risk of adverse reactions, so combination therapy should be avoided. In the case of injections, care should be taken when cutting the container as glass fragments may enter, especially in children or elderly individuals. Patients with peptic ulcers, gastrointestinal bleeding, bleeding tendency, severe renal failure, bronchial asthma, and a history of hypersensitivity reactions should not take this medication. Elderly patients, patients with hypertension, heart failure, and dehydration should exercise particular caution when taking this medication, and the condition of patients with renal and liver dysfunction should be closely monitored before and after administration. Regular monitoring of blood pressure, kidney function, liver function, and blood tests is important during the use of this medication. In case of overdose, symptoms such as peptic ulcers, nausea, and vomiting may occur, and treatment should proceed as with typical overdose of non-steroidal anti-inflammatory drugs. This medication may interact with specific other drugs, so if you are currently taking any medications, you must inform your doctor or pharmacist. Pregnant or nursing women should not take this medication, especially in the late stages of pregnancy as it may harm the fetus. This medication is not used in children and adolescents under 16 years of age, and safety and efficacy have not been established for infants under 2 years of age. Elderly patients are at greater risk of renal adverse reactions and gastrointestinal bleeding, so the minimum effective dose should be used and the administration intervals extended as needed. This medication may cause dizziness or drowsiness when driving or operating machinery, so caution is advised.

Side effects

Gastrointestinal bleeding, cardiovascular thrombotic reactions, myocardial infarction, stroke, bleeding, postoperative hematoma, wound bleeding, nausea, dyspepsia, gastrointestinal pain, diarrhea, constipation, abdominal distension, vomiting, stomatitis, peptic ulcer, gastrointestinal hemorrhage, perforation, bloody stool, rectal bleeding, gastritis, belching, loss of appetite, increased appetite, pancreatitis, hematemesis, esophagitis, melena, dry mouth, colitis, exacerbation of Crohn's disease, edema, anaphylaxis, bronchospasm, laryngeal edema, tongue swelling, hypotension, flushing, rash, weight gain, fever, infection, asthenia, hypertension, erythema, palpitations, pallor, syncope, bradycardia, chest pain, heart failure, erythema, itching, toxic epidermal necrolysis, mucocutaneous syndrome, exfoliative dermatitis, papular erythema, urticaria, angioedema, sweating, eosinophilia, systemic symptoms associated drug reaction, purpura, surgical site bleeding, thrombocytopenia, nosebleed, anemia, leukopenia, eosinophilia, hematoma, headache, sweating, drowsiness, dizziness, convulsions, tremors, hallucinations, abnormal dreams, dysphoria, extrapyramidal syndrome, perceptual disturbances, depression, insomnia, nervousness, thirst, severe thirst, abnormal thoughts, concentration difficulties, hyperactivity, confusion, myalgia, aseptic meningitis, anxiety, psychotic reactions, hepatitis, liver failure, cholestatic jaundice, abnormal liver function tests, dyspnea, asthma, pulmonary edema, rhinitis, cough, acute renal failure, flank pain, hematuria, hypernitrogenemia, oliguria, nephritis, polyuria, frequent urination, urinary retention, hemolytic uremic syndrome, hyperkalemia, hyponatremia, nephrotic syndrome, elevated serum urea and creatinine levels, injection site pain, taste alterations, visual disturbances, blurred vision, optic neuritis, tinnitus, hearing loss, female infertility, prolonged bleeding time

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

Storage

This medication should be stored in a sealed container to avoid exposure to air and light. It is also recommended to store it at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

A clear pale yellow liquid contained in a colorless glass ampoule for injection

Package unit

1ml × 10 ampoules

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.