Medication info

Ostarene Injection (Diclofenac Sodium)

Prescription medication근육
Ingredient · strength
Diclofenac Sodium›37.5mg / 1mL
Manufacturer / importer
(주)오스코리아제약
Appearance
A brown ampoule containing a colorless and transparent liquid.
Packaging
2ml / ampoule x 50
Approval status
Active

MFDS item code 201604658 · Notified 2016.07.28 · Insurance code 629701151

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis, osteoarthritis, etc.
Who receives it
Adults
Adult administration
As Diclofenac Sodium, administer 75mg (1 ampoule) by deep intramuscular injection into one side of the upper buttock once a day. In severe cases, it can be administered as 75mg (1 ampoule) twice a day, alternately injecting into both buttocks once each. After the initial treatment period, switch to oral tablets or suppositories. Adjust dosages appropriately based on age, disease, and symptoms. To minimize cardiovascular adverse reactions of this medication, it should be used at the lowest effective dose for the shortest period.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis, osteoarthritis, etc.

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • postoperative inflammation
  • post-traumatic inflammation
  • pain
  • acute gout
  • non-articular rheumatism
  • low back pain
  • toothache
  • dysmenorrhea
  • inflammation in the ENT region
View approved original text

This medication is used for chronic joint and inflammatory diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also effective for the inflammation and pain occurring after surgery or trauma, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, and various inflammatory and painful conditions in the ENT region, including periscapular inflammation. The injection formulation is also used for kidney and liver pain treatment. Thus, this medication helps alleviate and improve various inflammatory and painful diseases, contributing to enhancing the quality of life of patients.

How it is given

Adult administration

As Diclofenac Sodium, administer 75mg (1 ampoule) by deep intramuscular injection into one side of the upper buttock once a day. In severe cases, it can be administered as 75mg (1 ampoule) twice a day, alternately injecting into both buttocks once each. After the initial treatment period, switch to oral tablets or suppositories. Adjust dosages appropriately based on age, disease, and symptoms. To minimize cardiovascular adverse reactions of this medication, it should be used at the lowest effective dose for the shortest period.

Precautions

This medication may increase the risk of gastric bleeding in individuals who regularly consume more than three glasses of alcohol per day, so it must be discussed with a doctor or pharmacist. This medication can increase the risk of cardiovascular diseases, so individuals with a history or risk factors for heart disease or stroke should be cautious when taking it. Serious gastrointestinal adverse reactions such as gastric bleeding, ulcers, and perforation may occur, so elderly individuals and those with a history of gastrointestinal diseases should be particularly careful. Severe allergic reactions can cause a myocardial infarction, so if you experience chest pain or allergic symptoms while taking this medication, consult medical personnel immediately. When using ampoule injections, care must be taken to avoid glass fragmentation, and caution is particularly required when administering to children or the elderly. Patients with peptic ulcers, severe liver or kidney disorders, severe hypertension, heart failure, or hypersensitivity to any component of this medication should not take it. Patients with a history of asthma or allergic reactions may experience life-threatening anaphylaxis upon taking this medication, so it should be avoided. This medication should be used at the minimum effective dose for the shortest duration possible, and regular blood tests and liver and kidney function tests are required if taken for an extended period. The risk of adverse reactions increases when taken with other non-steroidal anti-inflammatory drugs, so it is preferable not to combine them. This medication should be avoided during pregnancy, especially in late pregnancy as it may harm the fetus, and breastfeeding should be stopped or medication discontinued during lactation. Children and the elderly may have impaired temperature regulation, hence should be more cautious of adverse reactions after taking this medication. In case of overdose, symptoms such as hypotension, kidney failure, seizures, gastrointestinal disturbance, and respiratory depression may occur, and immediate medical attention is required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Peptic ulcer
  • gastric bleeding
  • esophageal ulcer
  • perforation
  • granulocytopenia
  • hemoglobin decrease
  • leukopenia
  • thrombocytopenia
  • anemia
  • aplastic anemia
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  • hemolytic anemia
  • bleeding tendency
  • purpura
  • allergic purpura
  • photosensitivity
  • erythema
  • itching
  • eczema
  • dermatitis
  • angioedema
  • polymorphic erythema
  • flushing
  • exudative dermatitis
  • hepatitis
  • elevated GOT and GPT
  • oliguria
  • hematuria
  • urine protein
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • rash

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

Storage

This medication should be stored in a tightly sealed container that can block light, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

A brown ampoule containing a colorless and transparent liquid.

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.