Medication info

Diclofenac Beta-Dimethylaminoethanol Injection 2 Milliliters

Prescription medication주사
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›45mg / 1mL
Manufacturer / importer
명문제약(주)
Appearance
A transparent colorless to pale yellow liquid in a brown ampoule
Packaging
1 ampoule (2 mL) × 100
Approval status
Active

MFDS item code 200103036 · Notified 2001.02.05 · Insurance code 649800311

Summary

Main use
Treatment of rheumatoid arthritis and degenerative joint diseases (osteoarthritis, ankylosing spondylitis), relief of post-traumatic inflammation and acute gout
Who receives it
Adults
Adult administration
As Diclofenac Beta-Dimethylaminoethanol, inject 90 mg deeply into one side of the upper buttocks daily. In severe cases, it may be administered as 90 mg twice a day, alternating between both buttocks each time. After the initial treatment period, switch to oral tablets or suppositories. Adjust dosage appropriately based on age, condition, and symptoms. To minimize cardiovascular adverse reactions, the lowest effective dose should be used for the shortest duration.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Treatment of rheumatoid arthritis and degenerative joint diseases (osteoarthritis, ankylosing spondylitis), relief of post-traumatic inflammation and acute gout

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • post-traumatic inflammation
  • post-surgical inflammation
  • pain
  • acute gout
  • renal colic
  • hepatic colic
View approved original text

This medication is used for chronic inflammatory joint diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), and ankylosing spondylitis. It also helps relieve inflammation and pain that occur after trauma or surgery, acute gout attacks, and renal and hepatic colic. It is used to reduce inflammation and alleviate pain in various conditions to improve patient comfort.

How it is given

Adult administration

As Diclofenac Beta-Dimethylaminoethanol, inject 90 mg deeply into one side of the upper buttocks daily. In severe cases, it may be administered as 90 mg twice a day, alternating between both buttocks each time. After the initial treatment period, switch to oral tablets or suppositories. Adjust dosage appropriately based on age, condition, and symptoms. To minimize cardiovascular adverse reactions, the lowest effective dose should be used for the shortest duration.

Precautions

This medication should be discussed with a doctor or pharmacist before use by individuals who regularly consume more than three glasses of alcohol daily, as taking it may increase the risk of gastrointestinal bleeding. This medication may pose risks to the cardiovascular system. As a non-steroidal anti-inflammatory drug, it may increase the risk of serious cardiovascular events such as myocardial infarction or stroke. Patients with cardiovascular diseases or risk factors should be more cautious and must inform their healthcare provider immediately if symptoms arise. This medication can also cause serious adverse reactions such as gastrointestinal bleeding, ulcers, and perforations. Elderly patients have a higher risk of these complications and should closely monitor gastrointestinal symptoms and consult medical personnel if abnormalities are suspected. This medication may trigger Kounis syndrome, a rare condition that can cause myocardial infarction if severe allergic reactions occur. Therefore, immediate treatment should be sought if allergic symptoms or chest pain occur. If in ampoule form, precautions must be taken to avoid glass fragments during container cutting, especially for children and elderly patients. This medication should not be administered to patients with peptic ulcers, severe blood disorders, liver failure, renal failure, hypertension, or cardiac insufficiency. Additionally, patients allergic to the components of this medication or hypersensitive to aspirin or other non-steroidal anti-inflammatory drugs should not use it. Patients with a history of gastrointestinal bleeding or ulcers, blood disorders, liver or kidney dysfunction, hypertension, cardiac insufficiency, asthma, elderly patients, and children should use this medication with caution. During treatment, rare side effects such as shock, gastrointestinal bleeding, blood disorders, skin rashes, liver and kidney dysfunction, hypersensitivity reactions, and neurological symptoms may occur. If any abnormal symptoms arise, the medication should be discontinued immediately and medical assistance sought. This medication should be taken at the lowest effective dose for the shortest duration necessary, and regular blood tests and liver and kidney function tests should be performed during prolonged use. Moreover, it is advisable not to take this medication with other non-steroidal anti-inflammatory drugs due to potential drug interactions; inform your healthcare provider of any other medications being taken. In pregnant women, especially in the later stages, it should be avoided as it may harm the fetus. In breastfeeding mothers, this medication can be passed into breast milk and affect the infant, so either breastfeeding or medication should be stopped. Elderly patients and children are at higher risk for side effects and should use the minimal necessary dose with caution.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • High fever with severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, coughing with fever accompanying respiratory abnormalities
  • Yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headaches

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • thirst
  • constipation
  • photosensitivity
  • headache
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  • dizziness
  • insomnia
  • nervousness
  • paresthesia
  • confusion
  • hallucinations
  • seizures
  • blurred vision
  • tinnitus
  • elevated blood pressure
  • low blood pressure
  • palpitations
  • tachycardia
  • generalized fatigue
  • sweating
  • hair loss

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 tightly sealed container that blocks light. Additionally, it must be maintained at room temperature between 1 to 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

A transparent colorless to pale yellow liquid in a brown ampoule

Package unit

1 ampoule (2 mL) × 100

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.