Medication info

Medicaid Clofepram (Diclofenac Sodium)

Prescription medication
Ingredient · strength
Diclofenac Sodium›25mg / 1mL
Manufacturer / importer
(주)메디카코리아
Appearance
Brown ampoules containing a colorless transparent liquid
Packaging
50 ampoules (2mL/ampoule x 50)
Approval status
Active

MFDS item code 199001089 · Notified 1990.07.20 · Insurance code 646000661

Summary

Main use
Relief of inflammation and pain from rheumatoid arthritis, osteoarthritis, etc.
Who uses it
Adults · Children
Adult dosage
Oral: The initial dose of diclofenac sodium is 100-150mg per day, and for maintenance or prolonged treatment, it is administered in divided doses of 75-100mg per day, 2-3 times. Injection: Administer 75mg (1 ampoule) as a deep intramuscular injection into one side of the upper buttock once daily. In severe cases, it may be administered twice a day at 75mg (1 ampoule) each, alternating sides. After the initial treatment period, it should be switched to tablets or
Children's dosage
Administer 0.5-3mg per kg of body weight in 2-3 divided doses daily. Adjust according to age, condition, and symptoms.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Relief of inflammation and pain from rheumatoid arthritis, osteoarthritis, etc.

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-surgical 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 effective for chronic joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It can also be used for inflammation and pain due to surgery or trauma, acute gout, non-articular rheumatism, low back pain, toothache, dysmenorrhea, inflammation and pain in the ENT area, and adhesive capsulitis. The injection form also helps treat renal colic and liver colic. This medication improves various inflammatory diseases and pain through multiple routes of administration or injection. Overall, it is very useful for alleviating the symptoms of joint and inflammation-related diseases.

Dosage and Administration

Adult dosage

Oral: The initial dose of diclofenac sodium is 100-150mg per day, and for maintenance or prolonged treatment, it is administered in divided doses of 75-100mg per day, 2-3 times. Injection: Administer 75mg (1 ampoule) as a deep intramuscular injection into one side of the upper buttock once daily. In severe cases, it may be administered twice a day at 75mg (1 ampoule) each, alternating sides. After the initial treatment period, it should be switched to tablets or

Children's dosage

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

Precautions

This medication is a non-steroidal anti-inflammatory drug (NSAID) that has antipyretic, analgesic, and anti-inflammatory effects. Before taking this medication, those who regularly consume more than three glasses of alcohol daily should consult a physician or pharmacist. This is because this medication may cause gastric bleeding. Individuals at risk for cardiovascular disease should be very cautious when taking this medication. NSAIDs can cause serious cardiovascular problems, such as myocardial infarction or stroke, and the risk may increase with prolonged use. During the use of this medication, patients should closely monitor for cardiovascular symptoms, and if any symptoms arise, they should consult a physician immediately. This medication can also exert strain on the stomach, and there is a risk of serious gastrointestinal issues such as gastric bleeding, ulcers, or perforations. This is particularly true for the elderly and those with a history of gastrointestinal disease. If symptoms related to the stomach such as abdominal pain, blood in stool, or vomiting occur during treatment, medical attention should be sought immediately. Allergic reactions can occur with this medication, and in rare cases, severe allergic reactions may lead to chest pain or myocardial infarction. In the case of ampoule injections, there may be a risk of glass fragment contamination, so caution should be exercised during use, and formulations containing benzyl alcohol may pose risks to newborns or premature infants. This medication should not be used in the following patients: those with peptic ulcers, severe blood disorders or liver and kidney dysfunction, severe hypertension or heart failure, those allergic to any ingredient of this medication, those who have had asthma or allergic reactions to aspirin or other NSAIDs, patients undergoing coronary bypass surgery, newborns, and premature infants. In addition, patients with a history of peptic ulcers, blood disorders, liver or kidney dysfunction, hypertension, heart failure, autoimmune diseases, asthma, the elderly, and children should take this medication with caution and pay special attention to the possibility of allergic reactions. Those taking this medication for an extended period should have regular blood tests and liver and kidney function tests, and if any abnormal symptoms appear, they should consult a physician immediately. The risk of side effects is increased when taking this medication with other NSAIDs, so it is best not to use them in combination. This medication can also interact with certain blood pressure medications, diuretics, anticoagulants, lithium, and methotrexate, so patients taking these medications should consult a physician. It is generally advised not to take this medication during pregnancy, especially in the later stages, as it may affect the fetus, and pregnant individuals should definitely consult a physician before use. While breastfeeding, this medication may pass into breast milk and cause adverse reactions in infants, so consideration should be given to stopping breastfeeding or discontinuing the drug administration. In children or the elderly, this medication should be administered cautiously at the minimum necessary dose, observing for any adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied by respiratory abnormalities, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

  • Urticaria
  • rash
  • itching
  • increased blood pressure
  • decreased blood pressure
  • palpitations
  • tachycardia
  • congestive heart failure
  • ventricular premature contractions
  • nasal bleeding
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  • pharyngeal edema
  • interstitial pneumonia
  • polyuria
  • nocturia
  • erectile dysfunction
  • vaginal bleeding
  • edema
  • general malaise
  • sweating
  • drowsiness
  • dizziness
  • nervous hyperactivity
  • confusion
  • hallucinations
  • insomnia
  • depression
  • irritability
  • anxiety
  • diplopia
  • transient pain
  • dryness
  • superficial keratitis
  • etc.

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

Storage

This medication may be sensitive to light, so it should be stored in a sealed container that blocks light. Proper storage will help maintain the effectiveness of the drug for an extended period.

Appearance and packaging

Appearance

Brown ampoules containing a colorless transparent liquid

Package unit

50 ampoules (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

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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.