Medication info

New Phenac Injection 2 Milliliters (Diclofenac β-Dimethylaminoethanol)

Prescription medicationInjections주사
Ingredient · strength
Diclofenac Beta-Dimethylaminoethanol›45mg / 1mL
Manufacturer / importer
아주약품(주)
Appearance
A brown ampoule injection containing a transparent light yellow solution
Packaging
2ml/ampoule x 50
Approval status
Active

MFDS item code 200001074 · Notified 2000.11.23 · Insurance code 654000071

Summary

Main use
Relief of inflammation and pain in conditions such as rheumatoid arthritis and osteoarthritis (degenerative joint disease)
Who receives it
Adults
Adult administration
As diclofenac beta-dimethylaminoethanol, inject 90mg deeply into one side of the upper buttock once a day. In severe cases, it can be administered as 90mg twice a day, alternating injections into both sides of the buttocks. After the initial treatment, it should be switched to oral tablets or suppositories. Adjust dosage appropriately according to age, condition, and symptoms. To minimize cardiovascular adverse reactions, the minimum effective dose should be used for the shortest duration.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

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

This medication is used for chronic inflammatory joint diseases such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is also effective for inflammation and pain that occur after trauma or surgery, acute gout, as well as renal and hepatic colic. Therefore, it helps alleviate various pains associated with chronic and acute inflammatory conditions.

How it is given

Adult administration

As diclofenac beta-dimethylaminoethanol, inject 90mg deeply into one side of the upper buttock once a day. In severe cases, it can be administered as 90mg twice a day, alternating injections into both sides of the buttocks. After the initial treatment, it should be switched to oral tablets or suppositories. Adjust dosage appropriately according to age, condition, and symptoms. To minimize cardiovascular adverse reactions, the minimum effective dose should be used for the shortest duration.

Precautions

This medication may cause gastrointestinal bleeding if taken by individuals who regularly consume more than three drinks a day, so it is essential to consult with a doctor or pharmacist. This medication can affect the cardiovascular system, increasing the risk of serious thrombotic reactions such as myocardial infarction or stroke, so individuals with heart conditions or risk factors should be particularly cautious. Serious issues such as ulcers or bleeding in the stomach may occur, so especially elderly individuals or those with a history of gastrointestinal disease should carefully monitor their symptoms while taking this medication. In cases of severe allergic reactions, heart problems may arise, so if symptoms of allergy or chest pain occur, immediate consultation with medical personnel is required. When using ampoule injections, care must be taken to avoid glass fragments mixing in, and extra caution should be exercised, especially for children or the elderly. Products containing benzyl alcohol may cause serious respiratory issues in preterm infants, so they should not be used in newborns or premature infants. Patients with peptic ulcers, severe blood disorders, liver dysfunction, renal dysfunction, hypertension, or severe heart failure, or those who are allergic to the ingredients of this medication should not take it. Patients with an allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs, or those with a history of asthma should also avoid using this medication. Those with a history of peptic ulcers or liver, kidney, or blood-related diseases, elderly individuals, children, and asthma patients should use this medication cautiously and remain alert for possible allergic reactions. This medication may rarely cause various side effects, including shock, gastrointestinal bleeding, blood disorders, serious skin reactions, decreased liver and kidney function, asthma attacks, neurological symptoms, etc., so if any abnormal symptoms occur, the medication should be stopped immediately, and consultation with medical personnel is necessary. This medication should be used at the minimum effective dose for the shortest duration possible; if used over a long period, regular blood tests and liver and kidney function tests should be conducted. This medication can interact with other non-steroidal anti-inflammatory drugs or specific medications, so if taking other medications, it is paramount to inform the doctor. During pregnancy, especially in the late stages, this medication should be avoided, and even in early or mid-pregnancy, it should only be used at the minimum effective dose when absolutely necessary, as it may affect fetal kidney function. While breastfeeding, this medication can be transferred through breast milk, potentially causing side effects in the infant, so it may be considered to stop either breastfeeding or the medication. Elderly individuals and children are at a higher risk for side effects, so they should use the required minimum dose carefully and attentively monitor for adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, breathlessness or difficulty in breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • stomatitis
  • thirst
  • constipation
  • granulocytopenia
  • thrombocytopenia
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  • anemia
  • aplastic anemia
  • hemolytic anemia
  • tendency to bleed
  • photosensitivity
  • liver dysfunction
  • elevated GOT
  • elevated GPT
  • hematuria
  • proteinuria
  • elevated BUN
  • increased serum creatinine
  • hyperkalemia
  • rash
  • itching
  • headache
  • drowsiness
  • dizziness
  • insomnia
  • nervousness
  • numbness
  • confusion
  • hallucinations
  • seizures
  • blurred vision
  • tinnitus
  • blood.

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

Storage

This medication should be stored in a tightly sealed container that blocks light and at temperatures between 1 and 30 degrees Celsius. This way of storage helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A brown ampoule injection containing a transparent light yellow 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.