Medication info

Diclofenac EF injection (Diclofenac β-Dimethylaminoethanol)

Prescription medicationExpired
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›Strength being verified
Manufacturer / importer
(주)넥스팜코리아
Appearance
A brown ampoule injection containing a colorless to pale yellow transparent liquid.
Packaging
2mL × 50 ampoules
Approval status
Expired

MFDS item code 201802612 · Notified 2018.06.21

This product's status changed to Expired on 2023.06.21. 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 (degenerative joint disease).
Who uses it
Adults
Adult dosage
Administer 90mg of Diclofenac β-Dimethylaminoethanol deeply injected into one side of the upper buttock once daily. In severe cases, 90mg may be administered twice daily, alternating the injections between both sides of the buttock. After the initial treatment, the administration can be switched to tablets or suppositories, adjusted appropriately based on age, condition, and symptoms. To minimize the risk of cardiovascular reactions, use the minimum effective dose for the shortest period necessary.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

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

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

This medication is effective for joint-related conditions such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It also alleviates inflammation and pain occurring after trauma or surgery, and is used for acute gout and renal and hepatic colic. In summary, this drug is used to improve various forms of arthritis and inflammatory pain.

Dosage and Administration

Adult dosage

Administer 90mg of Diclofenac β-Dimethylaminoethanol deeply injected into one side of the upper buttock once daily. In severe cases, 90mg may be administered twice daily, alternating the injections between both sides of the buttock. After the initial treatment, the administration can be switched to tablets or suppositories, adjusted appropriately based on age, condition, and symptoms. To minimize the risk of cardiovascular reactions, use the minimum effective dose for the shortest period necessary.

Precautions

This medication may cause gastric bleeding in individuals who regularly consume more than three alcoholic drinks per day, so it is essential to consult a doctor or pharmacist before use. It may affect the cardiovascular system and increase the risk of serious thrombotic events such as myocardial infarction and stroke. Patients with existing cardiovascular diseases or risk factors should exercise caution, and close monitoring of cardiovascular symptoms is necessary during use. This medication can also affect the gastrointestinal tract, potentially leading to severe adverse reactions such as bleeding, ulcers, or perforation in the stomach or intestines. Elderly patients or those with a history of gastrointestinal disease are at greater risk, requiring careful monitoring of gastrointestinal symptoms during treatment. In cases of severe allergic reactions, serious anaphylactic vascular spasms that can lead to myocardial infarction may occur; thus, any unusual symptoms such as chest pain must be reported to medical personnel immediately. When using ampoule injections, especially in children or the elderly, care should be taken due to the potential for glass fragments. This medication should not be administered to patients with peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, high blood pressure, or heart failure, nor should it be used by those with certain allergic histories. Patients with a history of peptic ulcers or decreased liver or kidney function, high blood pressure, heart failure, or asthma should use this medication with caution, and elderly individuals and children should take it at the minimum effective dose with care. Rarely, this medication may cause shock, gastrointestinal bleeding, blood disorders, severe skin reactions, liver and kidney dysfunction, allergic reactions, headaches, dizziness, blood pressure changes, and other adverse effects; if unusual symptoms occur, discontinue use and consult medical personnel immediately. This medication should be used at the minimum effective dose for the shortest duration possible, and regular blood tests and liver and kidney function checks should be performed during long-term use. Particularly, patients with high blood pressure or those at risk for cardiovascular diseases should carefully monitor their blood pressure and heart condition. Taking this medication along with other non-steroidal anti-inflammatory drugs or certain medications may increase the risk of adverse effects, so it is crucial to inform healthcare providers. Use during late pregnancy may pose risks to the fetus, so it should be avoided; women of childbearing potential must carefully consider the benefits and risks. During breastfeeding, the medication may be transmitted through breast milk, so it is advisable to discontinue breastfeeding or the medication itself. Elderly patients and children may be particularly sensitive to side effects, so they should use the minimum dose with caution, and if unusual symptoms arise, they must consult medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, consciousness disturbances, visual disturbances, paralysis, urination.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • thirst
  • constipation
  • granulocytopenia
  • thrombocytopenia
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  • anemia
  • aplastic anemia
  • hemolytic anemia
  • bleeding tendency
  • photosensitivity
  • elevated GOT
  • GPT
  • abnormal kidney function tests
  • rash
  • itching
  • headache
  • drowsiness
  • dizziness
  • insomnia
  • irritability
  • tingling
  • confusion
  • hallucinations
  • convulsions
  • blurred vision
  • tinnitus
  • increased blood pressure
  • decreased blood pressure
  • palpitations
  • tachycardia
  • general malaise
  • sweating
  • hair loss

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is best kept at room temperature between 1°C and 30°C. Proper storage will maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

A brown ampoule injection containing a colorless to pale yellow transparent liquid.

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.