Medication info

Roti-Lac Beta Injection (Diclofenac β-Dimethylaminoethanol)

Prescription medicationInjections
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›45mg / 1mL
Manufacturer / importer
알리코제약(주)
Appearance
Brown ampoule injection containing a transparent light yellow solution
Packaging
2mL/ampoule, 50 ampoules (2 mL/ampoule X 50)
Approval status
Active

MFDS item code 200200686 · Notified 2002.06.11

Summary

Main use
Improvement of rheumatoid arthritis and degenerative joint diseases (osteoarthritis, ankylosing spondylitis) and relief of post-traumatic inflammation and pain
Who uses it
Adults
Adult dosage
Administer 90mg of Diclofenac beta-Dimethylaminoethanol deeply in one side of the upper gluteus daily. In severe cases, it may be given 90mg twice a day while alternating injections in both sides of the gluteus. After the initial treatment period, it should be changed to pills or suppositories. Adjust dosage as appropriate according to age, disease, and symptoms. To minimize cardiovascular adverse reactions of this medication, use the minimum effective dose for the shortest duration.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of rheumatoid arthritis and degenerative joint diseases (osteoarthritis, ankylosing spondylitis) and relief of post-traumatic inflammation and pain

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

This medication is used to treat chronic joint diseases such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It also alleviates inflammation and pain occurring after trauma or surgery, and is effective for acute gout attacks and colicky symptoms in the kidneys and liver. This medication helps improve various inflammatory diseases and pain.

Dosage and Administration

Adult dosage

Administer 90mg of Diclofenac beta-Dimethylaminoethanol deeply in one side of the upper gluteus daily. In severe cases, it may be given 90mg twice a day while alternating injections in both sides of the gluteus. After the initial treatment period, it should be changed to pills or suppositories. Adjust dosage as appropriate according to age, disease, and symptoms. To minimize cardiovascular adverse reactions of this medication, use the minimum effective dose for the shortest duration.

Precautions

This medicine should be used with caution, especially for those who regularly consume more than three alcoholic drinks a day, as there is a risk of gastrointestinal bleeding, and it is necessary to consult a physician or pharmacist. This medication can affect the cardiovascular system and may increase the risk of serious cardiovascular diseases like myocardial infarction or stroke. Therefore, patients with a history of cardiovascular disease or risk factors should take extra caution and consult medical personnel immediately if symptoms occur. This drug can cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation. Elderly patients and those with a history of gastrointestinal disease should be particularly cautious and seek immediate treatment if gastrointestinal symptoms occur during use. In cases of severe allergic reactions, Kounis syndrome, which can cause myocardial infarction, may occur, so immediately inform medical personnel if chest pain or allergic symptoms develop. Special attention should be paid to avoid glass particles when using ampoule injections, and particular care is needed when administering to children or the elderly. Products containing benzyl alcohol can cause life-threatening respiratory symptoms in premature infants, so caution is advised. Patients with specific conditions such as peptic ulcers, severe blood disorders, liver or kidney impairment, hypertension, and heart failure should not take this medication. Patients with asthma or hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs should also avoid this medication, and it should be avoided in patients before and after coronary artery bypass surgery. Patients with a history of peptic ulcers, liver or kidney disease, hypertension, heart failure, asthma, the elderly, and children should be especially careful when taking this medication, taking potential allergic reactions into account. This medication can cause various side effects, including severe allergic reactions, skin rashes, liver or kidney dysfunction, blood abnormalities, neuropsychiatric symptoms, so if any atypical symptoms occur, discontinue use immediately and consult medical personnel. This medication should be used at the minimum effective dose for the shortest duration possible, and regular blood tests and liver and kidney function tests are required during prolonged treatment. Patients with hypertension or heart failure should be cautious regarding changes in blood pressure and fluid retention while taking this medication, and those with reduced renal function should be observed closely. In pregnant women, especially in late pregnancy, this medication may pose risks to the fetus, and it should be avoided. Women of childbearing potential should consult a physician before use. Nursing mothers taking this medication should consider stopping breastfeeding or discontinuing the medication since it can pass into breast milk and cause serious side effects in the baby. Elderly and children are at higher risk of side effects, so they should take the minimum dose carefully and observe for any adverse reactions.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • swelling
  • chest tightness
  • difficulty breathing
  • rash
  • blistering
  • skin peeling
  • pain in mucous membranes of mouth/eyes
  • jaundice
  • extreme drowsiness
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  • severe headache
  • seizure
  • confusion
  • visual disturbances
  • paralysis
  • decreased urine output
  • increased blood pressure
  • shock symptoms
  • peptic ulcer
  • gastrointestinal bleeding
  • agranulocytosis
  • thrombocytopenia
  • anemia
  • aplastic anemia
  • hemolytic anemia
  • bleeding tendency
  • Stevens-Johnson syndrome
  • Lyell syndrome
  • phototoxicity
  • liver impairment

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • thirst
  • constipation
  • headache
  • drowsiness
Show 16 more
  • dizziness
  • insomnia
  • irritability
  • tingling
  • confusion
  • hallucinations
  • convulsions
  • blurred vision
  • tinnitus
  • increased blood pressure
  • decreased blood pressure
  • palpitations
  • tachycardia
  • general malaise
  • sweating
  • hair loss

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

Storage

This medication is sensitive to light, so it should be stored in a container that prevents light exposure. Additionally, to maintain the efficacy of the drug, it should be stored at a cool room temperature, specifically between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Brown ampoule injection containing a transparent light yellow solution

Package unit

2mL/ampoule, 50 ampoules (2 mL/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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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.