Medication info

Diclofenac Sodium Injection

Prescription medicationInjections
Ingredient · strength
Diclofenac Sodium›37.5mg / 1mL
Manufacturer / importer
(주)비씨월드제약
Appearance
A brown ampoule containing a colorless and transparent solution
Packaging
50 ampoules/box [2 milliliters/1 ampoule]
Approval status
Active

MFDS item code 199201852 · Notified 1992.01.10 · Insurance code 653100431

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis (degenerative joint disease), etc.
Who uses it
Adults · Children
Adult dosage
Oral: The initial dose of diclofenac sodium is 100-150mg per day, and in cases of reduction or long-term treatment, it is administered as 75-100mg per day in 2-3 divided doses. Injection: 75mg (1 ampoule) should be administered deeply as a single intramuscular injection into one side of the upper buttock once a day. In severe cases, 75mg can be administered twice daily, alternating sides of the buttock for each injection. Extended-release preparation: 100mg once daily.
Children's dosage
Oral: 0.5-3mg per kg body weight per day, split into 2-3 doses. Adjust according to age, condition, and symptoms.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis (degenerative joint disease), etc.

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-surgical inflammation
  • post-trauma inflammation
  • pain
  • acute gout
  • non-articular rheumatism
  • back pain
  • toothache
  • dysmenorrhea
  • inflammation in the ENT regions
View approved original text

This medication is effectively used for major joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It also helps with inflammation and pain occurring post-surgery and post-trauma, acute gout, non-articular rheumatism, back pain, toothache, dysmenorrhea, inflammation and pain in the ENT regions, and periarticular shoulder inflammation. In injectable form, it can be used for renal and hepatic colic. The medication is available in various oral forms (standard preparations, extended-release preparations) and injectable forms, allowing selection based on the patient's condition. Overall, it is used to relieve pain and inflammation in joint and inflammatory diseases, improving quality of life.

Dosage and Administration

Adult dosage

Oral: The initial dose of diclofenac sodium is 100-150mg per day, and in cases of reduction or long-term treatment, it is administered as 75-100mg per day in 2-3 divided doses. Injection: 75mg (1 ampoule) should be administered deeply as a single intramuscular injection into one side of the upper buttock once a day. In severe cases, 75mg can be administered twice daily, alternating sides of the buttock for each injection. Extended-release preparation: 100mg once daily.

Children's dosage

Oral: 0.5-3mg per kg body weight per day, split into 2-3 doses. Adjust according to age, condition, and symptoms.

Precautions

This medication can increase the risk of gastrointestinal bleeding for those who regularly consume more than three glasses of alcohol per day, so it is essential to consult a doctor or pharmacist. Non-steroidal anti-inflammatory drugs, including this medication, can cause cardiovascular issues, potentially increasing the risk of myocardial infarction or stroke, so caution is particularly necessary for those with cardiovascular diseases or risk factors. This medication can cause severe problems such as gastrointestinal bleeding, ulcers, and perforation, so caution is especially required for the elderly or individuals with a history of gastrointestinal diseases. Severe allergic reactions may produce symptoms similar to myocardial infarction, so if chest pain or allergic symptoms appear during treatment, immediate consultation with a healthcare professional is essential. For injectable forms, there is a risk of glass fragment contamination, so it must be handled carefully, especially for children and the elderly. Patients with peptic ulcers, severe liver or kidney disorders, severe hypertension, heart failure, or hypersensitivity should not take this medication. Individuals with a past history of asthma, urticaria, or allergic reactions should avoid this medication, and it should not be used for patients before or after coronary artery bypass surgery, newborns, or premature infants. This medication should be used with caution in those with peptic ulcers, blood abnormalities, liver or kidney disorders, hypertension, cardiac dysfunction, asthma, ulcerative colitis, Crohn's disease, and in the elderly or children. Long-term usage of this medication requires regular blood tests and liver and kidney function tests, and treatment should be stopped immediately while consulting a healthcare professional if any abnormal symptoms occur. If severe skin rashes, fever, difficulty breathing, swelling, headaches, insomnia, depression, or visual disturbances appear during treatment, immediate medical attention is necessary. This medication may interact with other non-steroidal anti-inflammatory drugs, aspirin, anticoagulants, diuretics, lithium, methotrexate, and so forth, so any concurrent medications must be disclosed. During pregnancy, especially in late stages, it may pose risks to the fetus, so it should be avoided if pregnant; during breastfeeding, this medication may pass into breast milk and affect infants, so caution is required. Children and the elderly may have weaker body functions, so it should be used with minimal doses and caution; in case of overdose, contact healthcare professionals immediately for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, chest pain, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, a significant decrease in urine output

Mild side effects

  • Rash
  • itching
  • peptic ulcer
  • esophageal ulcer
  • thrombocytopenia
  • anemia
  • aplastic anemia
  • hemolytic anemia
  • purpura
  • photosensitivity
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  • erythema
  • dermatitis
  • erythema multiforme
  • flushing
  • exudative dermatitis
  • hepatitis
  • elevated GOT/GPT
  • oliguria
  • hematuria
  • proteinuria
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • urticaria
  • insomnia
  • depression
  • irritability
  • anxiety
  • diplopia
  • headache
  • drowsiness
  • dizziness
  • nervousness
  • paralysis
  • confusion

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

Storage

This medication should be stored in a container that blocks light and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will ensure the medication's efficacy is safely maintained.

Appearance and packaging

Appearance

A brown ampoule containing a colorless and transparent solution

Package unit

50 ampoules/box [2 milliliters/1 ampoule]

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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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.