Chungbuk Pharm Diclofenac Sodium Injection

Adult administration

Administer 75 mg (1 ampoule) of diclofenac sodium as a deep intramuscular injection into the upper outer quadrant of the buttock once a day. In severe cases, it may be administered 75 mg (1 ampoule) twice a day, alternating injection sites in both buttocks. After initial treatment, it should be converted to tablets or suppositories. Adjust the dosage according to age, condition, and symptoms. To minimize cardiovascular adverse reactions of this medication, use the minimum effective dose for the shortest duration.

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three drinks per day, so consultation with a doctor or pharmacist is essential. Non-steroidal anti-inflammatory drugs including this medication may increase the risk of cardiovascular disease, so patients with cardiovascular disease or risk factors should use it with extra caution. Serious gastrointestinal adverse reactions like gastrointestinal bleeding, ulcers, and perforation may occur, thus elderly patients or those with a history of gastrointestinal diseases should take special care. This medication may cause Kounis syndrome, which can lead to myocardial infarction in cases of severe allergic reactions, so if hypersensitivity symptoms appear, consultation with healthcare professionals is needed immediately. When using the ampoule injection, great care should be taken to avoid glass fragment contamination, and special attention is needed particularly for children and the elderly. Patients with specific conditions such as peptic ulcers, severe liver dysfunction, renal dysfunction, hypertension, and heart failure should not receive this medication. This medication should not be administered to patients with a history of allergic reactions to non-steroidal anti-inflammatory drugs such as asthma and urticaria. When administering this medication, the decision should be made cautiously depending on the patient's condition, particularly using the minimum dose for the elderly, children, and patients with impaired liver or kidney function, while monitoring for adverse reactions. Regular monitoring of blood pressure, liver function, renal function, and blood tests should be conducted during treatment, and if abnormal symptoms occur, the medication should be discontinued immediately and the healthcare team consulted. The risk of adverse reactions may increase when combined with other non-steroidal anti-inflammatory drugs or specific medications, so a consultation with an expert is required before combination therapy. During pregnancy, especially in late pregnancy, this medication should be avoided as it may pose risks to the fetus, and in nursing mothers, there is a possibility of adverse reactions in infants, suggesting consideration of stopping breastfeeding or discontinuing the medication.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blistering, skin sloughing, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and very severe headaches, lightning headaches, seizures, loss of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

• Peptic ulcer
• gastrointestinal bleeding
• esophageal ulcer
• perforation
• granulocytopenia
• hemoglobin decrease
• leukopenia
• thrombocytopenia
• anemia
• aplastic anemia

This medication is sensitive to light, so it should be stored in a container that prevents light exposure and sealed to prevent air entry.

Appearance

A clear liquid that is colorless to almost colorless in a brown ampoule.

Package unit

50 ampoules/box [2 milliliters/ampoule * 50]