Medication info

Espenac Injection (Diclofenac Sodium)

Prescription medication
Ingredient · strength
Diclofenac Sodium›37.5mg / 1 ampoule
Manufacturer / importer
삼성제약(주)
Appearance
Brown ampoule filled with a colorless or yellowish liquid
Packaging
2 milliliters x 50 ampoules
Approval status
Active

MFDS item code 199600297 · Notified 1996.01.09 · Insurance code 642302861

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis, osteoarthritis, etc.
Who uses it
Adults · Children
Adult dosage
Oral: As Diclofenac Sodium, the initial dose is 100-150 mg per day, and in cases of relief or long-term use, 75-100 mg per day in 2-3 divided oral doses. Injection: Administer 75 mg (1 ampoule) deeply intramuscularly in one side of the upper buttock once daily. In severe cases, 75 mg can be administered twice daily, alternating between both buttocks. Sustained-release preparation: Administer 100 mg once daily.
Children's dosage
Administer 0.5-3 mg per kg of body weight in 2-3 divided oral doses per day. Adjust according to age, condition, and symptoms.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis, osteoarthritis, 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 otolaryngology area
View approved original text

This medication is primarily used to treat degenerative joint diseases such as rheumatoid arthritis and osteoarthritis, and ankylosing spondylitis. It also helps relieve various pains and inflammation caused by surgery or trauma, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, inflammation and pain in the otolaryngology area, and periacromial bursitis. The injection formulation is used to relieve renal and hepatic colic. Through these various uses, it effectively improves patients' pain and inflammation.

Dosage and Administration

Adult dosage

Oral: As Diclofenac Sodium, the initial dose is 100-150 mg per day, and in cases of relief or long-term use, 75-100 mg per day in 2-3 divided oral doses. Injection: Administer 75 mg (1 ampoule) deeply intramuscularly in one side of the upper buttock once daily. In severe cases, 75 mg can be administered twice daily, alternating between both buttocks. Sustained-release preparation: Administer 100 mg once daily.

Children's dosage

Administer 0.5-3 mg per kg of body weight in 2-3 divided oral doses per day. Adjust according to age, condition, and symptoms.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three glasses of alcohol daily; it is essential to consult a doctor or pharmacist. Individuals with cardiovascular diseases or risk factors need to be cautious as this medication may cause severe cardiovascular issues such as myocardial infarction or stroke. This medication can lead to serious adverse reactions such as gastrointestinal bleeding, ulcers, or perforation, particularly in seniors or those with a history of gastrointestinal diseases. In cases of severe allergic reactions, Kounis syndrome, a serious allergic symptom that can provoke myocardial infarction, may occur, necessitating immediate consultation with medical personnel if symptoms appear. When using this injectable ampoule, care should be taken to avoid the risk of glass particle contamination, especially in children and the elderly. Individuals with peptic ulcers, severe liver or kidney diseases, severe hypertension, heart failure, or hypersensitivity to any components of this drug should not take it. During treatment, regular blood tests and liver and kidney function tests should be conducted, and any abnormal symptoms should be reported immediately. This medication should be avoided by pregnant women, especially in late pregnancy, as it may be harmful to the fetus. Additionally, breastfeeding mothers should be cautious, as the drug can be passed into the breast milk and affect the baby. Children and the elderly should use this medication at the minimal effective dose with appropriate caution and be vigilant for any adverse reactions. The risk of adverse reactions may increase when this medication is taken in conjunction with other nonsteroidal anti-inflammatory drugs or specific medications, so it is crucial to inform a doctor or pharmacist of any concurrently used medications. In the event of an overdose, symptoms such as hypotension, renal failure, convulsions, gastrointestinal disturbances, and respiratory depression may occur, requiring immediate medical assistance.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Peptic ulcers
  • gastrointestinal bleeding
  • esophageal ulcers
  • perforation
  • granulocytopenia
  • hemoglobin decrease
  • leukopenia
  • thrombocytopenia
  • anemia
  • aplastic anemia
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  • hemolytic anemia
  • bleeding tendency
  • purpura
  • allergic purpura
  • photosensitivity
  • erythema
  • itching
  • eczema
  • dermatitis
  • angioedema
  • polymorphic erythema
  • flushing
  • exudative dermatitis
  • hepatitis
  • liver dysfunction
  • elevated GOT and GPT levels
  • oliguria
  • hematuria
  • urine protein
  • BUN
  • increased serum creatinine
  • hyperkalemia

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

Storage

This medication should be stored in a light-blocking container and kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the drug and prevents deterioration.

Appearance and packaging

Appearance

Brown ampoule filled with a colorless or yellowish liquid

Package unit

2 milliliters 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.