Medication info

Cafenac Injection (Diclofenac Sodium)

Prescription medicationSolution
Ingredient · strength
Diclofenac Sodium›37.5mg / 1mL
Manufacturer / importer
하나제약(주)
Appearance
Brown ampoules containing a colorless, transparent solution
Packaging
2mL/ampoule x 50 ampoules
Approval status
Active

MFDS item code 199702363 · Notified 1997.02.20 · Insurance code 657801731

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis (degenerative joint disease), etc.
Who uses it
Adults · Children
Adult dosage
(Orally) The initial dose of diclofenac sodium is 100-150 mg per day; for those who have achieved relief or are on long-term treatment, it is 75-100 mg divided into 2-3 doses per day. (Injection) Diclofenac sodium 75 mg (1 ampoule) should be deeply injected into the upper part of one buttock once daily. In severe cases, 75 mg can be administered twice a day, alternating between both buttocks.
Children's dosage
(Orally) Administer 0.5-3 mg per kg of body weight divided into 2-3 doses per day. Adjust according to age, condition, and symptoms.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

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

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-surgical inflammation
  • post-traumatic inflammation
  • pain
  • acute gout
  • non-articular rheumatism
  • low back pain
  • toothache
  • dysmenorrhea
  • inflammation in the ear
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 inflammation and pain occurring after surgery or trauma, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, inflammation and pain in the ear, nose and throat area, and pericapsulitis. In the form of injection, it can be used for renal colic and hepatic colic, thus addressing various inflammatory conditions. This medication is utilized to improve symptoms associated with various joint and inflammatory diseases according to its different forms.

Dosage and Administration

Adult dosage

(Orally) The initial dose of diclofenac sodium is 100-150 mg per day; for those who have achieved relief or are on long-term treatment, it is 75-100 mg divided into 2-3 doses per day. (Injection) Diclofenac sodium 75 mg (1 ampoule) should be deeply injected into the upper part of one buttock once daily. In severe cases, 75 mg can be administered twice a day, alternating between both buttocks.

Children's dosage

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

Precautions

This medication should not be taken regularly by individuals who consume three or more alcoholic drinks daily without consulting a doctor or pharmacist prior to use, as it may increase the risk of gastrointestinal bleeding when taken with alcohol. It can affect the heart and blood vessels, so caution is necessary for individuals with cardiovascular diseases or risk factors. Serious issues such as myocardium infarction or stroke may occur, so symptoms should be carefully monitored. Serious problems like gastrointestinal bleeding, ulcers, or perforation may develop, so those with a history of gastrointestinal diseases or the elderly should be particularly careful. If gastrointestinal bleeding symptoms appear during treatment with this medication, consult a doctor immediately. Severe allergic reactions can lead to myocardial infarction, so if abnormal symptoms such as chest pain occur, immediate notification to medical personnel is required. This medication is not recommended for premature infants or newborns, especially preparations containing benzyl alcohol should be used with even more caution. When using ampoule injections, strict cleanliness and safety should be maintained as glass fragments may be mixed in. Special care is required when administering to children or the elderly. Patients with peptic ulcers, severe liver or kidney impairment, severe hypertension, heart failure, or hypersensitivity to any components of this medication should not use it. Patients with a history of asthma or allergic reactions should be cautious when using this medication, especially those sensitive to aspirin or other non-steroidal anti-inflammatory drugs may be at risk. Prolonged use of this medication may result in adverse reactions in several areas such as the liver, kidneys, blood, and skin; therefore, regular testing is necessary. This medication may increase blood pressure, so patients with hypertension should frequently monitor their blood pressure while taking it, and patients with heart failure or edema should also be cautious. There may be interactions with other medications; therefore, consultation with a doctor is necessary when taking this medication alongside other non-steroidal anti-inflammatory drugs, anticoagulants, diuretics, lithium, methotrexate, etc. During pregnancy, particularly in the late stages, it should be avoided as it may harm the fetus, and nursing mothers should consult their doctor before taking this medication to decide whether to discontinue breastfeeding. When administering this medication to children or the elderly, it should be given at the minimum effective dose with great caution, particularly being attentive to signs of adverse reactions. In case of overdose, severe symptoms such as hypotension, renal failure, seizures, and respiratory depression may occur, necessitating immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction.
  • Severe rash with high fever, blistering, skin peeling, oral/ocular mucosal pain → severe skin reactions.
  • Shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever → respiratory problems.
  • Skin or eyes turning yellow (jaundice), profound fatigue → liver abnormalities (jaundice).

Mild side effects

Hives, rash, itching, eczema, dermatitis, angioedema, erythema multiforme, flushing, exudative dermatitis, photosensitivity, redness, elevated blood pressure, decreased blood pressure, palpitations, tachycardia, congestive heart failure, ventricular extrasystole, epistaxis, asthma, oropharyngeal edema, interstitial pneumonia, frequent urination, nocturia, erectile dysfunction, vaginal bleeding, edema, general malaise, sweating, symptoms of aseptic meningitis (nausea, vomiting, insomnia, stiffness of the neck, fever, altered consciousness).

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

Storage

This medication is sensitive to light, so it should be stored in a container that prevents light exposure. Additionally, it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication safely.

Appearance and packaging

Appearance

Brown ampoules containing a colorless, transparent solution

Package unit

2mL/ampoule x 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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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.