Medication info

Ostaren F Injection (Diclofenac β-Dimethylaminoethanol)

Prescription medicationInjections주사
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›45mg / 1mL
Manufacturer / importer
(주)오스코리아제약
Appearance
Transparent liquid that is colorless to pale yellow, contained in a brown ampoule injection.
Packaging
2mL/ampoule X 50
Approval status
Active

MFDS item code 201604657 · Notified 2016.07.28 · Insurance code 629701131

Summary

Main use
Relief of inflammation and pain due to rheumatoid arthritis and osteoarthritis.
Who receives it
Adults
Adult administration
As Diclofenac Beta-Dimethylaminoethanol, inject 90 mg deeply into one side of the upper gluteus daily. In severe cases, it may be administered as 90 mg twice a day, alternating injections into both gluteal sides. After the initial treatment period, consider switching to oral tablets or suppositories. Adjust dosage based on age, disease, and symptoms. To minimize cardiovascular adverse reactions, use the minimum effective dose for the shortest duration.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Relief of inflammation and pain due to rheumatoid arthritis and osteoarthritis.

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-traumatic inflammation
  • post-surgical inflammation
  • post-traumatic pain
  • post-surgical pain
  • acute gout
  • renal colic
  • hepatic colic.
View approved original text

This medication is effective for chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, as well as for inflammation and pain occurring after trauma or surgery, acute gout, and renal and hepatic colic symptoms.

How it is given

Adult administration

As Diclofenac Beta-Dimethylaminoethanol, inject 90 mg deeply into one side of the upper gluteus daily. In severe cases, it may be administered as 90 mg twice a day, alternating injections into both gluteal sides. After the initial treatment period, consider switching to oral tablets or suppositories. Adjust dosage based on age, disease, and symptoms. To minimize cardiovascular adverse reactions, use the minimum effective dose for the shortest duration.

Precautions

This medication can cause gastrointestinal bleeding in individuals who consume three or more alcoholic beverages daily, so it is essential to consult a doctor or pharmacist. The drug can affect the cardiovascular system, increasing the risk of thrombosis, myocardial infarction, and stroke, so patients with cardiovascular diseases or risk factors should exercise special caution. This drug may cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation, and caution is particularly necessary for elderly patients or those with a history of gastrointestinal diseases. Allergic reactions may induce severe myocardial infarction, so if symptoms such as chest pain occur after taking this medication, immediate consultation with medical personnel is required. The ampoule form of this medication poses a risk of glass particle contamination, so the container must be handled carefully during use, especially for children or the elderly. Patients with a history of peptic ulcers, severe blood disorders, liver dysfunction, renal dysfunction, hypertension, or cardiac failure should not take this medication. Patients with hypersensitivity or allergic reactions to aspirin and other non-steroidal anti-inflammatory drugs should also avoid this medication. This drug should be administered cautiously in specific patient groups, including those with a history of peptic ulcers, reduced liver or kidney function, hypertension, asthma, and the elderly, considering the possibility of allergic reactions. During treatment, blood pressure, liver and kidney function, and blood tests should be monitored regularly, and if any abnormal symptoms occur, immediate consultation with a doctor is necessary. This medication may interact with other non-steroidal anti-inflammatory drugs, aspirin, lithium, methotrexate, and warfarin, so use should be discussed with a doctor before administration. Particularly in late pregnancy, the medication could pose risks to the fetus, so it should be avoided, and during breastfeeding, careful consideration must be made regarding drug administration or discontinuation of breastfeeding. Elderly and pediatric patients should be treated at minimal dosages with special attention to adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, shock, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, Lyell's syndrome, severe skin adverse reactions, jaundice, liver dysfunction, acute renal failure, decrease in urine volume, severe edema with elevated blood pressure, asthma attacks, anaphylactic reactions, respiratory issues, myocardial infarction, stroke, severe headache.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • dry mouth
  • constipation
  • headache
  • drowsiness
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  • dizziness
  • insomnia
  • nervousness
  • paresthesia
  • confusion
  • hallucination
  • convulsions
  • blurred vision
  • tinnitus
  • increased blood pressure
  • decreased blood pressure
  • palpitations
  • tachycardia
  • generalized fatigue
  • sweating
  • hair loss
  • rash
  • itching
  • hypotension
  • edema.

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

Storage

This drug should be stored in a sealed container that protects from light, at temperatures between 1 degree to 30 degrees Celsius. This storage method is intended to maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

Transparent liquid that is colorless to pale yellow, contained in a brown ampoule injection.

Package unit

2mL/ampoule X 50

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

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

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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.