Medication info

Phenacil Injection (Diclofenac Beta-Dimethylaminoethanol)

Prescription medicationSolutionExpired
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›45mg / 1mL
Manufacturer / importer
한국프라임제약(주)
Appearance
A brown ampoule containing a colorless or pale yellow transparent solution
Packaging
2mL/ampoule X 50
Approval status
Expired

MFDS item code 200005090 · Notified 2000.11.01

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
Treatment of rheumatoid arthritis and degenerative joint diseases (osteoarthritis, ankylosing spondylitis), alleviation of post-traumatic inflammation and acute gout.
Who uses it
Adults
Adult dosage
As diclofenac beta-dimethylaminoethanol, deep intramuscular injection of 90mg is administered to one side of the upper gluteal region daily. In severe cases, it can be administered 90mg twice a day, alternating between both sides of the gluteal region. After the initial treatment period, it may be switched to tablets or suppositories. The dosage may be adjusted appropriately based on age, condition, and symptoms. To minimize cardiovascular adverse reactions, use the minimum effective dosage for the shortest time necessary.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

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

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

This medication is used for rheumatoid arthritis, degenerative joint diseases such as osteoarthritis, and ankylosing spondylitis. It is also effective in alleviating inflammation and pain occurring after trauma or surgery, acute gout, and colic in the kidney and liver areas. In other words, it is used to improve the symptoms of various joint and inflammatory diseases.

Dosage and Administration

Adult dosage

As diclofenac beta-dimethylaminoethanol, deep intramuscular injection of 90mg is administered to one side of the upper gluteal region daily. In severe cases, it can be administered 90mg twice a day, alternating between both sides of the gluteal region. After the initial treatment period, it may be switched to tablets or suppositories. The dosage may be adjusted appropriately based on age, condition, and symptoms. To minimize cardiovascular adverse reactions, use the minimum effective dosage for the shortest time necessary.

Precautions

This medication may cause gastrointestinal bleeding if taken by individuals who regularly consume more than three glasses of alcohol daily; therefore, it is essential to consult a doctor or pharmacist. This medication may carry risks to the cardiovascular system and could lead to severe thrombotic reactions such as myocardial infarction or stroke, so individuals with cardiovascular diseases or risk factors should exercise caution. This medication may cause ulcers or bleeding in the gastrointestinal tract, so caution is advised when taken by the elderly or those with a history of gastrointestinal diseases. Severe chest pain or allergic myocardial infarction may occur due to allergic reactions, so if any abnormal symptoms arise, immediate consultation with medical personnel is necessary. Injection in ampoule form can lead to glass fragments entering the solution upon opening, thus caution should be taken, particularly for children and the elderly. Products containing benzyl alcohol can cause life-threatening respiratory problems in premature infants, so this should also be noted. Individuals with peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, hypertension, heart failure, and other serious conditions should not take this medication. Those with allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs should not use this medication. Caution is needed in patients with gastrointestinal diseases, blood disorders, impaired liver or kidney function, hypertension, asthma, the elderly, and children as they may require careful use of this medication. During treatment with this medication, rare severe adverse reactions such as shock, gastrointestinal bleeding, blood disorders, skin conditions, liver or kidney dysfunction, hypersensitivity reactions, and neuropsychiatric symptoms may occur; if any abnormal symptoms arise, discontinue the medication immediately and inform healthcare professionals. This medication should be administered for the shortest duration possible and at the lowest effective dose; regular blood tests and liver and kidney function tests are required for prolonged use. Patients with hypertension should monitor their blood pressure regularly as this medication may elevate or worsen it. Patients with heart failure or fluid retention should be cautious as this medication may exacerbate swelling. Pregnant women, especially in late pregnancy, should avoid use as it may harm the fetus. After mid-pregnancy, there is a risk of fetal kidney dysfunction and oligohydramnios, so it should be used at the minimal dose for the shortest duration when necessary. Breastfeeding women should consider discontinuing breastfeeding or the medication as this drug can be transferred to breast milk and cause adverse reactions in infants. When used in conjunction with other non-steroidal anti-inflammatory drugs, aspirin, lithium, methotrexate, warfarin, etc., there may be increased risks of adverse reactions due to interactions, hence consultation with healthcare professionals is advised. The elderly and children may be particularly sensitive to the adverse effects of this medication, so it should be administered cautiously at the minimum necessary dosage.

Side effects and when to seek care immediately

Serious side effects

Chest pain, chills, dyspnea, limb paralysis, hypotension, swelling, rash, itching, peptic ulcers, gastrointestinal bleeding, Stevens-Johnson syndrome, Lyell syndrome, photosensitivity, jaundice, liver dysfunction, acute renal failure, oliguria, hematuria, asthma attacks, urticaria, shock, Kounis syndrome (allergic vasospastic angina/allergic myocardial infarction), DRESS syndrome, angioedema

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • thirst
  • constipation
  • headache
  • drowsiness
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  • dizziness
  • insomnia
  • nervousness
  • numbness
  • confusion
  • hallucinations
  • convulsions
  • blurred vision
  • tinnitus
  • hypertension
  • hypotension
  • palpitations
  • tachycardia
  • general fatigue
  • 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 light-proof, tightly sealed container. Additionally, it is important to keep it at a temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A brown ampoule containing a colorless or pale yellow transparent solution

Package unit

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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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.