Medication info

PR Diclofenac Injection (Diclofenac Sodium)

Prescription medicationInjections경구 · 근육Approval withdrawn
Ingredient · strength
Diclofenac Sodium›75mg / 1 ampoule
Manufacturer / importer
(주)파마리서치
Appearance
Colorless or pale yellow solution in brown ampoules
Packaging
50 ampoules/box[(2 milliliters/ampoule)]
Approval status
Approval withdrawn

MFDS item code 202106241 · Notified 2021.08.30

This product's status changed to Approval withdrawn on 2026.02.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of inflammation and pain due to rheumatoid arthritis and osteoarthritis (degenerative joint disease), etc.
Who uses it
Adults · Children
Adult dosage
Oral: The initial dose of diclofenac sodium is 100-150 mg per day; if symptoms are alleviated or for long-term use, it is administered at 75-100 mg per day divided into 2-3 doses. Injection: Administer 75 mg (1 ampoule) intramuscularly deep into one side of the upper buttock once a day. In severe cases, it may be given twice a day at 75 mg (1 ampoule) each time, alternating between both buttocks. Sustained-release formulation: 100 mg once daily orally
Children's dosage
Administer 0.5-3 mg per kg of body weight divided into 2-3 oral doses per day. Adjust according to age, condition, and symptoms.

Ingredients

Manufacturer
(주)파마리서치

Efficacy & effects

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

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • postoperative inflammation
  • trauma-related inflammation
  • pain
  • acute gout
  • non-articular rheumatism
  • low back pain
  • dental pain
  • menstrual pain
  • inflammation in the ENT area
View approved original text

This drug primarily targets the treatment of rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis, and is also used for inflammation and pain following surgery or trauma, acute gout, non-articular rheumatism, lower back pain, dental pain, menstrual pain, inflammation and pain in the ENT area, and periarthritis of the shoulder. It effectively treats diseases associated with rheumatoid arthritis in oral, injectable, and sustained-release formulations, and can assist with renal and liver colic. This drug significantly improves the quality of life of patients by reducing inflammation and pain, so taking it regularly can effectively manage symptoms.

Dosage and Administration

Adult dosage

Oral: The initial dose of diclofenac sodium is 100-150 mg per day; if symptoms are alleviated or for long-term use, it is administered at 75-100 mg per day divided into 2-3 doses. Injection: Administer 75 mg (1 ampoule) intramuscularly deep into one side of the upper buttock once a day. In severe cases, it may be given twice a day at 75 mg (1 ampoule) each time, alternating between both buttocks. Sustained-release formulation: 100 mg once daily orally

Children's dosage

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

Precautions

This drug may cause gastrointestinal bleeding in individuals who regularly consume more than three glasses of alcohol daily, so it is essential to consult with a doctor or pharmacist. This drug may affect the cardiovascular system, increasing the risk of serious issues such as heart attack or stroke. Individuals with cardiovascular diseases or risk factors should exercise additional caution and seek immediate medical advice if symptoms occur. This drug can cause severe issues like gastrointestinal bleeding, ulcers, and perforations; thus, elderly individuals or those with a history of gastrointestinal diseases should use it cautiously. If symptoms of gastrointestinal bleeding occur during medication, immediate treatment should be sought. Severe allergic reactions may manifest symptoms such as chest pain; therefore, if allergic symptoms appear, inform healthcare personnel immediately and discontinue use. When using ampoule injections, care should be taken to avoid glass fragments; particularly so for children and the elderly. Patients with peptic ulcers, severe liver or kidney disease, severe hypertension, heart failure, or allergies to any of the components of this drug should not use it. Patients with a history of peptic ulcers or abnormalities in liver, kidneys, blood, hypertensive or cardiac patients, asthmatics, the elderly, and children should use this drug with caution. This drug can rarely cause a range of side effects including shock, gastrointestinal bleeding, blood abnormalities, skin rashes, liver dysfunction, kidney damage, asthma attacks, central nervous system abnormalities, visual disturbances, and heart issues; any unusual symptoms should lead to immediate cessation of use and consultation with a doctor. This drug should be used at the minimum effective dose for the shortest duration possible, and regular blood tests and liver and kidney function tests should be conducted during prolonged use. The risk of side effects may increase when taken with other non-steroidal anti-inflammatory drugs or certain medications, so it is essential to consult with an expert before concomitant use. During pregnancy, especially in the late stages, this medication may pose risks to the fetus, so it should be avoided, and during lactation, it can pass into breast milk and harm the infant, necessitating cessation of breastfeeding or discontinuation of the medication. Neonates or children may have difficulty regulating body temperature, hence it is necessary to be cautious due to the risk of excessive hypothermia. The elderly also face a higher risk of side effects and should take the minimum dose with caution. In cases of overdose, symptoms such as hypotension, renal failure, seizures, gastrointestinal disorders, and respiratory depression may occur, in which case immediate medical care should be sought.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory disturbances accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary symptoms

Mild side effects

  • Rash
  • itching
  • thrombocytopenia
  • anemia
  • leukopenia
  • agranulocytosis
  • aplastic anemia
  • hemolytic anemia
  • purpura
  • allergic purpura
Show 24 more
  • photosensitivity
  • erythema
  • eczema
  • dermatitis
  • polymorphic erythema
  • flushing
  • exudative dermatitis
  • hepatitis
  • liver dysfunction
  • increased GOT/GPT
  • oliguria
  • hematuria
  • urinary protein
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • insomnia
  • depression
  • irritability
  • anxiety
  • diplopia
  • drowsiness
  • dizziness
  • neuroexcitation

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

Storage

This medication should be stored in a sealed container that blocks light and kept at room temperature between 1 and 30 degrees Celsius. This storage condition helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Colorless or pale yellow solution in brown ampoules

Package unit

50 ampoules/box[(2 milliliters/ampoule)]

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.