Medication info

Naproxen Sodium 275 mg Tablets (Naproxen Sodium)

OTC medicationApproval withdrawn
Ingredient · strength
Naproxen Sodium›Strength being verified
Manufacturer / importer
(주)제뉴파마
Appearance
Pale blue oval film-coated tablet
Packaging
10 tablets/PTP
Approval status
Approval withdrawn

MFDS item code 200100972 · Notified 2001.01.10

This product's status changed to Approval withdrawn on 2023.07.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of arthritis and pain in conditions such as rheumatoid arthritis and osteoarthritis
Who uses it
Adults
Adult dosage
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Adult dosing of naproxen sodium should be taken orally as a single dose of 275-550 mg twice daily (every 12 hours). 2. Acute gout: An initial dose of 825 mg is administered orally, followed by 275 mg orally every 8 hours until symptoms resolve. 3. Musculoskeletal disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: An initial dose of 550 mg is taken orally.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement of arthritis and pain in conditions such as rheumatoid arthritis and osteoarthritis

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • tendinitis
  • acute gout
  • dysmenorrhea
  • bursitis
  • musculoskeletal disorders
  • sprains
  • strains
  • trauma
  • lumbar pain
View approved original text

This medication is primarily used for rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also effective for various pain and inflammatory conditions such as bursitis, musculoskeletal disorders (sprain, strain, trauma, lumbar pain), postoperative pain, migraine, and pain after tooth extraction. This drug alleviates inflammation and pain in the joints and muscles, thereby improving the quality of life for patients.

Dosage and Administration

Adult dosage

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Adult dosing of naproxen sodium should be taken orally as a single dose of 275-550 mg twice daily (every 12 hours). 2. Acute gout: An initial dose of 825 mg is administered orally, followed by 275 mg orally every 8 hours until symptoms resolve. 3. Musculoskeletal disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: An initial dose of 550 mg is taken orally.

Precautions

Patients who regularly consume more than three glasses of alcohol daily are at risk for gastrointestinal bleeding due to this medication and must consult a physician or pharmacist. Individuals with cardiovascular issues or risk factors should be closely monitored while taking this medication as it may increase the risk of cardiovascular diseases such as myocardial infarction or stroke. This medication can cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation, particularly in the elderly or those with a history of gastrointestinal diseases. Patients with a history of peptic ulcers, severe blood disorders, liver disease, heart failure, kidney disease, severe hypertension, or hypersensitivity to this medication or related drugs should not take it. Those with a history of peptic ulcers, blood disorders, bleeding tendencies, liver disease, kidney disease, cardiac dysfunction, hypertension, hypersensitivity, asthma, autoimmune diseases, and the elderly should take this medication cautiously and follow their physician's instructions. Allergic reactions may manifest as respiratory distress, hypotension, or urticaria, and any symptoms of gastrointestinal bleeding or ulceration must result in immediate discontinuation of this medication. This medication can cause blood abnormalities such as leukopenia and thrombocytopenia, necessitating regular blood tests. Liver function abnormalities or deterioration of renal function may occur; therefore, liver and kidney conditions should be monitored continuously. Neurological symptoms such as headache, insomnia, drowsiness, and depression may present; if any abnormal symptoms arise, the healthcare provider should be consulted. Skin rashes, eczema, and severe skin reactions such as Stevens-Johnson syndrome can occur, hence vigilance is necessary for any skin changes. This medication may cause sensory disturbances such as hearing or vision impairments and tinnitus. Symptoms like swellings or respiratory distress may manifest; medical staff must be informed as these symptoms occur. This medication should be used at the lowest effective dose and for the shortest duration necessary; patients being treated for chronic conditions should undergo regular blood tests and assessments of liver and kidney function. Pediatric patients with high fevers and elderly or frail patients should be closely monitored after taking this medication. In the treatment of infectious inflammation, this medication should be used in conjunction with antibiotics and the progression of infection should be monitored diligently. Patients with hypertension should frequently check their blood pressure as it may increase or worsen with this medication. Patients with heart failure or fluid retention must exercise caution, as this medication may exacerbate swelling. This medication can cause kidney damage, so patients with impaired renal function must take it cautiously and must report any abnormal symptoms immediately. Pregnant women, especially in late pregnancy, should not take this medication, and women who may become pregnant should consult a physician before use. Nursing mothers are advised against taking this medication due to its potential transmission to breast milk affecting the infant. This medication is not recommended for infants under 2 years of age due to the lack of established safety; and in children, it should be administered at minimal doses with caution. Elderly patients have a higher risk of gastrointestinal bleeding and should start with a low dose and be monitored accordingly. It is advisable not to take this medication with other non-steroidal anti-inflammatory drugs, and there may be interactions with specific medications; if any other medications are being taken, they should be disclosed. In case of overdose, symptoms such as drowsiness, chest discomfort, nausea, and vomiting may occur, and immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, coma.

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • indigestion
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
  • abdominal distension
  • thirst
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  • tinnitus
  • hearing impairment
  • visual impairment
  • drowsiness
  • cognitive dysfunction
  • dizziness
  • headache
  • tingling in extremities
  • decreased libido
  • fatigue
  • depression
  • abnormal dreams
  • loss of concentration
  • disorientation
  • insomnia
  • myalgia
  • weakness
  • sweating
  • purpura
  • hair loss
  • redness
  • menstrual irregularities
  • chills and fever
  • vasculitis
  • hyperglycemia
  • hypoglycemia
  • palpitations
  • muscle weakness.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale blue oval film-coated tablet

Package unit

10 tablets/PTP

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.