Medication info

Daehan Diclofenac Injection (Sodium Diclofenac)

Prescription medicationSolution
Ingredient · strength
Diclofenac Sodium›37.5mg / 1mL
Manufacturer / importer
대한약품공업(주)
Appearance
It is a colorless, transparent solution filled in a brown ampoule.
Packaging
2ml × 50 ampoules
Approval status
Active

MFDS item code 199600344 · Notified 1996.09.20 · Insurance code 645100491

Summary

Main use
Relief of inflammation and pain from rheumatoid arthritis and osteoarthritis (degenerative joint disease), etc.
Who uses it
Adults · Children
Adult dosage
(Oral) For sodium diclofenac, the initial dose is 100-150mg per day, and in cases of relief or long-term use, 75-100mg per day divided into 2-3 doses should be taken. (Injection) For sodium diclofenac, administer a deep intramuscular injection of 75mg (1 ampoule) once daily in one side of the upper buttock. In severe cases, it can be administered 75mg (1 ampoule) twice a day, alternating between the two sides of the buttock.
Children's dosage
(Oral) Administer 0.5-3mg per kg of body weight divided into 2-3 doses per day. Adjust according to age, disease, and symptoms.

Ingredients

Manufacturer
대한약품공업(주)

Efficacy & effects

Relief of inflammation and pain from rheumatoid arthritis and osteoarthritis (degenerative joint disease), 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 area
View approved original text

This medication is primarily used for the treatment of rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also effective for relieving inflammation and pain after surgery and trauma, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, inflammation and pain in the ENT area, and shoulder periartritis. In injection form, it can be used for renal and hepatic colic. Thus, various formulations of this drug help treat various joint and pain-related conditions, making it widely used for improving inflammation and pain.

Dosage and Administration

Adult dosage

(Oral) For sodium diclofenac, the initial dose is 100-150mg per day, and in cases of relief or long-term use, 75-100mg per day divided into 2-3 doses should be taken. (Injection) For sodium diclofenac, administer a deep intramuscular injection of 75mg (1 ampoule) once daily in one side of the upper buttock. In severe cases, it can be administered 75mg (1 ampoule) twice a day, alternating between the two sides of the buttock.

Children's dosage

(Oral) Administer 0.5-3mg per kg of body weight divided into 2-3 doses per day. Adjust according to age, disease, and symptoms.

Precautions

This medication may cause gastrointestinal bleeding if taken by individuals who regularly consume more than three alcoholic beverages a day, so consultation with a doctor or pharmacist is essential. Patients with a history of heart disease or stroke, or those with risk factors should be cautious as the risk of cardiovascular disease may increase. This medication can cause serious problems like gastrointestinal bleeding, ulcers, and perforation, so elderly patients or those with a history of gastrointestinal disease should be particularly careful. Allergic reactions may lead to Kounis syndrome, a serious heart problem, so if symptoms like chest pain occur, seek medical attention immediately. When using ampoule injections, handle containers carefully during cutting to avoid glass fragmentation, especially for children and the elderly. Patients with peptic ulcers, severe blood disorders, liver or kidney failure, hypertension, or heart failure should avoid taking this medication. Those who have had allergic reactions to any of its components or have previously shown hypersensitivity to non-steroidal anti-inflammatory drugs should not also receive it. Patients with a history of asthma or allergic reactions, elderly individuals, children, pregnant women, especially in late pregnancy, should avoid or use it cautiously. Regular blood tests and liver and kidney function tests are necessary during prolonged use, and if unusual symptoms occur, stop taking it immediately and consult a doctor. Taking this medication with other non-steroidal anti-inflammatory drugs increases the risk of side effects, so concurrent use should be avoided and inform your healthcare provider about any medications you are currently taking that may interact with it. During pregnancy, especially in late stages, it may pose risks to the fetus, so it is advised not to use this medication. If breastfeeding, consider stopping breastfeeding or the medication as adverse reactions may occur in infants. In elderly and pediatric patients, administer at the minimum dose with careful observation for adverse reactions. In case of overdose, symptoms may include hypotension, renal failure, seizures, gastrointestinal disturbances, respiratory depression, thus seek medical assistance immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin desquamation, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine retention.

Mild side effects

  • Headache
  • nausea
  • vomiting
  • insomnia
  • irritability
  • anxiety
  • diplopia
  • drowsiness
  • dizziness
  • nervousness
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  • confusion
  • hallucinations
  • seizures
  • blurred vision
  • tinnitus
  • transient pain
  • dryness
  • itching
  • superficial keratitis
  • elevated blood pressure
  • lowered blood pressure
  • palpitations
  • tachycardia
  • congestive heart failure
  • ventricular extrasystole
  • epistaxis
  • asthma
  • pharyngeal edema
  • interstitial pneumonia
  • frequent urination
  • nocturnal enuresis
  • erectile dysfunction
  • vaginal bleeding
  • edema
  • general fatigue
  • sweating

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

Storage

This medication should be stored in a light-blocking, sealed container at a temperature between 1 to 30 degrees Celsius. Storing it in this manner helps to maintain its efficacy and prevent deterioration.

Appearance and packaging

Appearance

It is a colorless, transparent solution filled in a brown ampoule.

Package unit

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.

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.