Medication info

Sophenac Injection (Diclofenac Sodium)

Prescription medication
Ingredient · strength
Diclofenac Sodium›75mg / 1 ampoule
Manufacturer / importer
아주약품(주)
Appearance
Brown ampoules filled with a colorless or slightly yellow liquid.
Packaging
2ml/ampoule x 50
Approval status
Active

MFDS item code 198600424 · Notified 1986.06.28 · Insurance code 654000481

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 if symptoms are relieved or for long-term use, it is divided into 75-100mg per day given 2-3 times. Injection: Inject 75mg (1 ampule) intramuscularly deeply into one side of the upper buttock once a day; in severe cases, 75mg can be injected 2 times a day alternating between both sides of the buttock. After the initial phase of treatment, it should be switched to tablets or suppositories.
Children's dosage
Oral: Divide and administer 0.5-3mg per kg of body weight 2-3 times a day, adjusting appropriately according to age, disease, and symptoms.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Relief of inflammation and pain in 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 to treat chronic joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also effective in alleviating inflammation and pain from various inflammatory conditions such as postoperative and post-traumatic inflammation and pain, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, inflammation and pain in the ENT area, and periprosthetic shoulder syndrome. It can be administered as an injection and is also helpful in treating renal and hepatic colic. With its wide range of effects, this medication is very useful in improving patients' pain and reducing inflammation.

Dosage and Administration

Adult dosage

Oral: The initial dose of diclofenac sodium is 100-150mg per day, and if symptoms are relieved or for long-term use, it is divided into 75-100mg per day given 2-3 times. Injection: Inject 75mg (1 ampule) intramuscularly deeply into one side of the upper buttock once a day; in severe cases, 75mg can be injected 2 times a day alternating between both sides of the buttock. After the initial phase of treatment, it should be switched to tablets or suppositories.

Children's dosage

Oral: Divide and administer 0.5-3mg per kg of body weight 2-3 times a day, adjusting appropriately according to age, disease, and symptoms.

Precautions

Patients who regularly consume three or more glasses of alcohol daily should consult with a doctor or pharmacist before taking this medication. This medication may cause serious gastrointestinal issues such as gastrointestinal bleeding. It can affect the cardiovascular system and increase the risk of thrombosis, myocardial infarction, and stroke. Care should be taken, particularly for those with cardiovascular diseases or risk factors, and cardiovascular symptoms should be closely monitored during treatment. This medication can cause severe damage to the gastrointestinal tract, such as ulcers, bleeding, and perforation. This risk is greater for the elderly or those with a history of gastrointestinal diseases, so gastrointestinal symptoms should be monitored carefully during use. In rare cases, severe allergic reactions can trigger myocardial infarction, so if symptoms such as chest pain occur, immediate consultation with medical personnel is required. When using injectable ampoules, care should be taken to prevent glass fragments from mixing in, especially in children or the elderly who require special attention. This medication should not be used in patients with peptic ulcer disease, severe blood disorders, liver dysfunction, kidney dysfunction, hypertension, or heart failure. Additionally, those with allergies to the ingredients of this medication or with a hypersensitivity reaction to aspirin or other non-steroidal anti-inflammatory drugs should not receive it. Caution should be exercised in patients with a history of peptic ulcers, blood disorders, reduced liver or kidney function, hypertension, heart failure, asthma, the elderly, or children. During use, various adverse reactions may occur, such as shock, gastrointestinal bleeding, blood disorders, skin rashes, liver or kidney dysfunction, asthma attacks, cardiovascular issues, and neuropsychiatric symptoms, so if any abnormal symptoms occur, discontinue use immediately and consult with a medical professional. This medication should be used at the minimum effective dose and for the shortest duration necessary. For long-term use, regular blood tests and liver and kidney function tests should be conducted. Interactions may occur when used in conjunction with other non-steroidal anti-inflammatory drugs, aspirin, anticoagulants, lithium, methotrexate, etc., necessitating caution. During pregnancy, especially in the later stages, it may pose risks to the fetus, so women who are pregnant or potentially pregnant should avoid using this medication or consult with a doctor. If breastfeeding, as this medication may pass into breast milk and affect the baby, it is necessary to either discontinue nursing or stop taking the medication. In children or newborns, the ability to regulate body temperature may be impaired, causing excessive body temperature reduction; therefore, use should be cautious. The elderly should also take the minimum dose cautiously. In case of overdose, symptoms such as hypotension, renal failure, seizures, gastrointestinal disturbances, and respiratory depression may occur, necessitating immediate medical treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever along with respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Gastrointestinal ulcers
  • gastrointestinal bleeding
  • esophageal ulcer
  • perforation
  • agranulocytosis
  • hemoglobin decrease
  • leukopenia
  • thrombocytopenia
  • anemia
  • aplastic anemia
Show 22 more
  • hemolytic anemia
  • bleeding tendency
  • purpura
  • allergic purpura
  • photosensitivity
  • erythema
  • itching
  • eczema
  • dermatitis
  • angioedema
  • erythema multiforme
  • flushing
  • exudative dermatitis
  • hepatitis
  • liver dysfunction
  • elevated GOT and GPT
  • oliguria
  • hematuria
  • urinary protein
  • BUN
  • elevated serum creatinine
  • hyperkalemia

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 tightly sealed container that does not allow light in. Additionally, it is recommended to store it at room temperature between 1 and 30 degrees.

Appearance and packaging

Appearance

Brown ampoules filled with a colorless or slightly yellow liquid.

Package unit

2ml/ampoule x 50

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.