Medication info

Barentac Injection (Diclofenac Sodium)

Prescription medication
Ingredient · strength
Diclofenac Sodium›37.5mg / 1mL
Manufacturer / importer
환인제약(주)
Appearance
A brown ampoule containing a colorless transparent liquid
Packaging
1 ampoule (2 mL) × 50
Approval status
Active

MFDS item code 198600666 · Notified 1986.06.28 · Insurance code 657200301

Summary

Main use
Relief of pain in inflammatory diseases such as rheumatoid arthritis and osteoarthritis (degenerative joint disease)
Who uses it
Adults · Children
Adult dosage
(Oral) As diclofenac sodium, the initial dose is 100-150mg daily, and during long-term treatment or after reduction, it should be administered at a dosage of 75-100mg daily divided into 2-3 doses. (Injection) As diclofenac sodium, inject 75mg (1 ampoule) deeply into one side of the upper part of the gluteus once daily. In severe cases, it may be administered 75mg twice daily, alternating between both sides of the gluteus.
Children's dosage
Administer 0.5-3mg per kg of body weight divided into 2-3 doses daily, adjusting as necessary based on age, condition, and symptoms.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Relief of pain in inflammatory diseases such as rheumatoid arthritis and osteoarthritis (degenerative joint disease)

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-operative inflammation
  • post-traumatic inflammation
  • acute gout
  • non-articular rheumatism
  • back pain
  • toothache
  • dysmenorrhea
  • inflammation in the ear
  • nose
View approved original text

This medication is primarily used for joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It is also effective for various pain and inflammation conditions including inflammation and pain occurring after surgery or trauma, acute gout, non-articular rheumatism, lumbago, toothache, dysmenorrhea, inflammation and pain in the ear, nose, and throat areas, and periarthritis of the shoulder. It is available in oral, injectable, and sustained-release formulations, each of which may apply to different diseases, but all excel in reducing inflammation and managing pain. This medication can also aid in pain relating to the kidneys and liver, making it useful for various pain treatments. Overall, this medication effectively improves inflammation and pain, contributing to an enhancement of the quality of life for patients.

Dosage and Administration

Adult dosage

(Oral) As diclofenac sodium, the initial dose is 100-150mg daily, and during long-term treatment or after reduction, it should be administered at a dosage of 75-100mg daily divided into 2-3 doses. (Injection) As diclofenac sodium, inject 75mg (1 ampoule) deeply into one side of the upper part of the gluteus once daily. In severe cases, it may be administered 75mg twice daily, alternating between both sides of the gluteus.

Children's dosage

Administer 0.5-3mg per kg of body weight divided into 2-3 doses daily, adjusting as necessary based on age, condition, and symptoms.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume three or more alcoholic beverages daily, so it is essential to consult with a doctor or pharmacist. There is a risk of cardiovascular complications, leading to serious issues such as myocardial infarction or stroke, therefore individuals with a history of cardiovascular disease or with risk factors should be especially cautious. Due to the possibility of serious gastrointestinal issues such as gastrointestinal bleeding, ulcers, or perforation, the elderly or those with a history of gastrointestinal disorders should use this medication with care. Severe allergic reactions can manifest symptoms such as chest pain, so individuals with hypersensitivity should avoid taking this medication. When using ampoule injections, caution should be taken as glass fragments may be mixed in, and special care is needed for children and the elderly. Individuals with peptic ulcers, severe liver or kidney impairment, cardiovascular disorders, or allergies to aspirin or other NSAIDs should not take this medication. This medication should be administered with caution in children, the elderly, individuals with bronchial asthma, or those with autoimmune diseases, and precautions are necessary due to the potential for allergic reactions. If symptoms such as headache, rash, breathing difficulties, severe abdominal pain, or bleeding occur during treatment, the medication should be stopped immediately and a doctor consulted. Long-term use requires regular blood tests and liver-kidney function assessments, and dosage adjustments or cessation may be necessary if abnormalities are detected. Especially in late pregnancy, this medication may pose risks to the fetus, so pregnant women should avoid it. Additionally, caution is needed for breastfeeding mothers as the drug can be transmitted through breast milk and affect the baby. Interactions may occur when taken with other NSAIDs or specific medications, so it's essential to inform the doctor or pharmacist of any other medications being taken. In case of overdose, symptoms such as low blood pressure, kidney failure, convulsions, gastrointestinal disturbances, and respiratory depression may occur, requiring immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, seizures, altered consciousness, visual disturbances, paralysis, significantly reduced urine output.

Mild side effects

  • Esophageal ulcers
  • thrombocytopenia
  • anemia
  • rash
  • itching
  • eczema
  • dermatitis
  • angioedema
  • erythema multiforme
  • flushing
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  • exudative dermatitis
  • hepatitis
  • elevated GOT/GPT
  • hematuria
  • urinary protein
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • rash
  • urticaria
  • insomnia
  • depression
  • irritability
  • anxiety
  • diplopia
  • drowsiness
  • dizziness
  • nervousness
  • confusion
  • hallucinations
  • seizures
  • blurred vision
  • tinnitus
  • transient pain
  • dryness
  • frequent urination
  • night.

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 place where it is not exposed to light. Additionally, it should be kept at room temperature avoiding excessively hot or cold environments.

Appearance and packaging

Appearance

A brown ampoule containing a colorless transparent liquid

Package unit

1 ampoule (2 mL) × 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.