Medication info

Diclofenac Sodium Injection

Prescription medicationSolution근육Expired
Ingredient · strength
Diclofenac Sodium›75mg / 1 ampoule
Manufacturer / importer
(주)테라젠이텍스
Appearance
A clear solution that is colorless or pale yellow contained in a brown ampoule
Packaging
1 ampoule (2ml) × 50 ampoules
Approval status
Expired

MFDS item code 201600329 · Notified 2016.01.19

This product's status changed to Expired on 2026.01.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis
Who receives it
Adults
Adult administration
Administer 75mg (1 ampoule) of diclofenac sodium intramuscularly deep into one side of the upper buttock once a day. In severe cases, 75mg (1 ampoule) can be administered twice daily, alternating between both sides of the buttock. After the initial treatment phase, switch to oral tablets or suppositories. Adjust dosage as appropriate based on age, disease, and symptoms.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis

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

This medication is used for chronic joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also effective in alleviating inflammation and pain that occur after surgery or trauma and helps with pain due to acute gout. This medication can improve symptoms related to renal and hepatic colic. It is widely used for managing major inflammatory diseases and pain.

How it is given

Adult administration

Administer 75mg (1 ampoule) of diclofenac sodium intramuscularly deep into one side of the upper buttock once a day. In severe cases, 75mg (1 ampoule) can be administered twice daily, alternating between both sides of the buttock. After the initial treatment phase, switch to oral tablets or suppositories. Adjust dosage as appropriate based on age, disease, and symptoms.

Precautions

This medication may cause gastrointestinal bleeding if taken by individuals who regularly consume more than three alcoholic drinks per day, so it is essential to consult a doctor or pharmacist. If a person has cardiovascular problems or risk factors, the risk of serious cardiovascular diseases such as myocardial infarction or stroke may increase while taking this medication, so caution is required. This medication can cause serious issues such as gastrointestinal bleeding, ulcers, or perforations, so those who are elderly or have a history of gastrointestinal disease should be particularly careful when taking it. Rare allergic reactions leading to severe consequences such as myocardial infarction, termed Kounis syndrome, may occur, so immediate medical consultation is needed if symptoms such as chest pain arise. When using the ampoule injection, care should be taken to handle the ampoule cautiously during opening, as glass fragments may enter the solution, especially for children and the elderly. Individuals with a history of peptic ulcer, severe blood disorders, very poor liver or kidney function, severe hypertension or heart failure, a known allergy to this drug's components, or a history of asthma or hives should not take this medication. Those with a history of peptic ulcers, blood disorders, liver or kidney issues, hypertension, heart failure, autoimmune diseases, bronchial asthma, ulcerative colitis, Crohn's disease, elderly individuals, and children should take this medication with caution, considering the potential for allergic reactions. This medication can rarely cause serious side effects such as shock, gastrointestinal bleeding, blood disorders, severe skin reactions, liver dysfunction, kidney problems, asthma attacks, neurological issues, visual disturbances, heart problems, respiratory issues, and urinary problems, so it is essential to stop taking it and consult a doctor if symptoms arise. It is advisable to use the minimum effective dose for the shortest duration possible, and regular blood tests along with liver and kidney function tests are necessary for extended use. Taking this medication with other non-steroidal anti-inflammatory drugs, aspirin, antihypertensive medications, diuretics, and anticoagulants may increase the risk of side effects, so it is crucial to discuss it with a healthcare professional. Particularly in the late stages of pregnancy, this medication may pose risks to the fetus, so it should be avoided. If breastfeeding, consideration should be given to ceasing breastfeeding or stopping the medication, as the drug may transfer into breast milk and harm the infant. Newborns and young children have underdeveloped temperature regulation abilities, so caution must be taken to avoid excessive drops in body temperature when taking this medication, and the elderly should also use the smallest effective dose with caution. In cases of overdose, symptoms such as hypotension, renal failure, seizures, gastrointestinal disturbances, and respiratory depression may occur, necessitating immediate medical attention for proper treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues with coughing and fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Peptic ulcers
  • gastrointestinal bleeding
  • esophageal ulcers
  • perforations
  • granulocytopenia
  • hemoglobin reduction
  • leukopenia
  • thrombocytopenia
  • anemia
  • aplastic anemia
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  • hemolytic anemia
  • bleeding tendency
  • allergic purpura
  • photosensitivity
  • redness
  • itching
  • eczema
  • dermatitis
  • angioedema
  • erythema multiforme
  • flushing
  • exudative dermatitis
  • hepatitis
  • liver dysfunction
  • GOT/GPT elevation
  • oliguria
  • hematuria
  • proteinuria
  • 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 sealed container to prevent air and moisture from entering, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

A clear solution that is colorless or pale yellow contained in a brown ampoule

Package unit

1 ampoule (2ml) × 50 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.

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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.