Medication info

Shinil Diclofenac Sodium Injection 75 Milligrams

Prescription medicationSolution경구 · 근육Expired
Ingredient · strength
Diclofenac Sodium›75mg / 1 ampoule
Manufacturer / importer
신일제약(주)
Appearance
Brown ampoules containing a colorless to pale yellow transparent solution
Packaging
2 Milliliters/Ampoule*50
Approval status
Expired

MFDS item code 199602170 · Notified 1996.04.23

This product's status changed to Expired on 2024.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of inflammation and pain in conditions such as rheumatoid arthritis and osteoarthritis (degenerative joint disease)
Who uses it
Adults · Children
Adult dosage
(Oral) As diclofenac sodium, the initial dose is 100-150 mg daily, and during maintenance or long-term treatment, it is 75-100 mg daily in 2-3 divided doses. (Injection) As diclofenac sodium, administer 75 mg (1 ampoule) intramuscularly deep into one upper side of the buttock once daily. For severe cases, it can be administered up to 75 mg twice daily, alternating buttocks on each administration.
Children's dosage
Administer orally in divided doses of 0.5-3 mg per kg of body weight, 2-3 times daily. Adjust based on age, condition, and symptoms.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Relief of inflammation and pain in conditions such as rheumatoid arthritis and osteoarthritis (degenerative joint disease)

  • Rheumatoid arthritis
  • osteoarthritis
  • degenerative joint disease
  • ankylosing spondylitis
  • postoperative inflammation
  • post-traumatic inflammation
  • pain
  • acute gout
  • non-articular rheumatism
  • low back pain
  • dental pain
  • dysmenorrhea
View approved original text

This medication is used in oral, injection, and slow-release formulations, and is effective for treating rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also used for the relief of inflammation and pain following surgery and trauma, as well as for conditions such as acute gout, non-articular rheumatism, low back pain, dental pain, dysmenorrhea, and inflammation and pain in the ear, nose, and throat areas, and adhesive capsulitis. The injectable form can be applied to renal and hepatic-related pain, and the slow-release form is used for the aforementioned arthritis and inflammatory diseases. This drug treats various inflammatory conditions in multiple forms and helps improve the functionality and relieve pain of patients.

Dosage and Administration

Adult dosage

(Oral) As diclofenac sodium, the initial dose is 100-150 mg daily, and during maintenance or long-term treatment, it is 75-100 mg daily in 2-3 divided doses. (Injection) As diclofenac sodium, administer 75 mg (1 ampoule) intramuscularly deep into one upper side of the buttock once daily. For severe cases, it can be administered up to 75 mg twice daily, alternating buttocks on each administration.

Children's dosage

Administer orally in divided doses of 0.5-3 mg per kg of body weight, 2-3 times daily. Adjust based on age, condition, and symptoms.

Precautions

This drug may increase the risk of gastrointestinal bleeding if taken by individuals who regularly consume more than three glasses of alcohol per day; consultation with a doctor or pharmacist is essential. Those with cardiovascular diseases or risk factors should be cautious as serious cardiovascular issues such as myocardial infarction and stroke may arise while taking this medication. This drug may increase the risk of gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation, especially in the elderly or those with a history of gastrointestinal diseases. If severe allergic reactions occur, they may lead to serious symptoms affecting the heart, and immediate consultation with healthcare professionals is essential. When using ampoule injections, care must be taken to avoid glass fragments contamination, particularly in children and the elderly. Individuals with certain conditions, such as peptic ulcers, severe liver or kidney disease, severe hypertension, and heart failure, should not take this drug. Those with hypersensitivity or previous allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs should also avoid this medication. This drug should be used for the shortest duration possible at the minimum effective dose, and regular blood tests, including liver and kidney function tests, are important during prolonged use. Concurrent use with other non-steroidal anti-inflammatory drugs can increase the risk of adverse effects, so they should not be taken together. It should be avoided during late-stage pregnancy as it may be harmful to the fetus, and nursing mothers should discontinue breastfeeding or the medication. Caution is advised when administering to children and the elderly, and any adverse reactions should be reported to healthcare professionals immediately. Overdose may result in symptoms such as hypotension, renal failure, seizures, and gastrointestinal disturbances, requiring immediate appropriate 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, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues associated with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Granulocytopenia
  • hemoglobin decrease
  • leukopenia
  • thrombocytopenia
  • anemia
  • aplastic anemia
  • hemolytic anemia
  • tendency to bleed
  • purpura
  • allergic purpura
Show 23 more
  • photosensitivity
  • rash
  • itching
  • eczema
  • dermatitis
  • angioedema
  • erythema multiforme
  • flushing
  • exudative dermatitis
  • hepatitis
  • liver dysfunction
  • increased GOT and GPT
  • oliguria
  • hematuria
  • urine protein
  • elevated BUN
  • increased serum creatinine
  • hyperkalemia
  • rash
  • insomnia
  • depression
  • irritability
  • anxiety

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 light-protected container to ensure that the drug remains effective and safe to use.

Appearance and packaging

Appearance

Brown ampoules containing a colorless to pale yellow transparent solution

Package unit

2 Milliliters/Ampoule*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.

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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.