Medication info
Naproxen Tablets (Sodium Naproxen)

Naproxen Tablets (Sodium Naproxen)

OTC medicationTablet경구
Ingredient · strength
Naproxen Sodium›275mg / 1 tablet
Manufacturer / importer
오스템파마주식회사
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201701248 · Notified 2017.03.13 · Insurance code 053500020

Summary

Main use
Improvement of arthritis including rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 275-550mg of sodium naproxen orally twice a day (every 12 hours). 2. Acute gout: For the initial dose, administer 825mg orally and administer 275mg every 8 hours until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: For the initial dose, administer 550mg orally, followed by 275mg every 6-8 hours. Do not exceed a total daily dose of 1350mg. 4. Migraine: For the initial dose, administer 825mg of sodium naproxen orally. If needed, an additional 275-550mg can be given within 30 minutes after the initial dose. Do not exceed a total daily dose of 1350mg. Adjust the dosage according to age and symptoms.

Ingredients

Manufacturer
오스템파마주식회사

Efficacy & effects

Improvement of arthritis including rheumatoid arthritis and osteoarthritis

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • tendinitis
  • acute gout
  • dysmenorrhea
  • bursitis
  • skeletal muscle disorders
  • strains
  • contusions
  • trauma
  • low back pain
View approved original text

This medication is used to treat various inflammatory conditions and pain such as rheumatoid arthritis, osteoarthritis, degenerative joint diseases, ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also effective for bursitis, muscle strains and bruises, pain due to trauma, postoperative pain, migraine, and pain relief after tooth extraction. This medication reduces inflammation and alleviates pain, making patients' daily lives more comfortable. It is widely used to improve symptoms related to different types of pain and inflammatory diseases.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 275-550mg of sodium naproxen orally twice a day (every 12 hours). 2. Acute gout: For the initial dose, administer 825mg orally and administer 275mg every 8 hours until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: For the initial dose, administer 550mg orally, followed by 275mg every 6-8 hours. Do not exceed a total daily dose of 1350mg. 4. Migraine: For the initial dose, administer 825mg of sodium naproxen orally. If needed, an additional 275-550mg can be given within 30 minutes after the initial dose. Do not exceed a total daily dose of 1350mg. Adjust the dosage according to age and symptoms.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three glasses of alcohol daily, so it is essential to consult with a doctor or pharmacist before use. Individuals with cardiovascular diseases or risk factors may experience an increased risk of cardiovascular diseases such as myocardial infarction and stroke when taking this medication; therefore, careful monitoring of symptoms is necessary. This medication can increase the risk of gastrointestinal bleeding, ulceration, and perforation, so caution is especially needed in the elderly or those with a history of gastrointestinal diseases. It is safest for those with serious conditions such as peptic ulcers, severe blood disorders, liver dysfunction, kidney dysfunction, heart failure, high blood pressure not to take this medication. Individuals with hypersensitivity or allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs should not use this medication. Those with a history of peptic ulcers, bleeding tendencies, impaired kidney or liver function, asthma, hypertension, the elderly should be carefully monitored when using this medication. Rarely, various adverse reactions such as shortness of breath, rash, gastrointestinal bleeding, hepatitis, kidney dysfunction, headache, dizziness, skin rash may occur, and if symptoms appear, the medication should be discontinued immediately and a doctor consulted. This medication should be administered at the minimum effective dose for the shortest duration possible, and periodic blood tests along with liver and kidney function tests are required during prolonged use. It is recommended not to take this medication with other non-steroidal anti-inflammatory drugs, and since the effects may change or the risk of side effects may increase when used with specific medications, it is crucial to consult healthcare professionals. This medication should be avoided during late pregnancy as it may pose a risk to the fetus, and nursing mothers should also refrain from using this medication. It is not recommended for children, especially infants younger than 2 years, as safety has not been established. Elderly patients have a higher risk of gastrointestinal bleeding, so they should start with a small amount and use with caution. In the case of overdose, symptoms such as drowsiness, indigestion, and vomiting may occur, and immediate emergency treatment is needed. Keep this medication out of reach of children and avoid transferring it to other containers as it may affect the quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), cold sweat → severe allergic reactions
  • Shock symptoms (shortness of breath, low blood pressure, bradycardia), PIE syndrome (fever, wheezing, cough, phlegm), anaphylactic reactions
  • Severe skin reactions with high fever, severe rashes, blistering, peeling skin, pain in oral/eye mucous membranes → severe skin adverse reactions
  • Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, drug reactions associated with hypereosinophilia and systemic symptoms
  • Shortness of breath or

Mild side effects

  • Occasionally
  • symptoms such as stomach discomfort
  • stomach pain
  • abdominal pain
  • nausea
  • vomiting
  • loss of appetite
  • indigestion
  • heartburn
  • diarrhea
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  • constipation
  • stomatitis
  • abdominal bloating
  • dark stools
  • thirst
  • drowsiness
  • cognitive dysfunction
  • dizziness
  • headaches
  • numbness in hands and feet
  • reduced strength
  • fatigue
  • depression
  • abnormal dreams
  • loss of concentration
  • disorientation
  • insomnia
  • muscle pain
  • muscle weakness
  • eczema
  • sweating
  • purpura
  • photosensitivity
  • hair loss
  • erythema
  • necrotizing fasciitis
  • erythema multiforme
  • tinnitus
  • and auditory changes may occur.

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

Interactions

Drug interactions

Do not take this medication with other non-steroidal anti-inflammatory drugs, naproxen derivatives, or high doses of methotrexate. Avoid concomitant use with hydantoin antiepileptic drugs, sulfonamides, sulfonylurea hypoglycemic agents, propranolol and other beta-blockers, ACE inhibitors (such as captopril), loop diuretics, thiazide diuretics, probenecid, aspirin, lithium, low-dose methotrexate, and coumarin anticoagulants (such as warfarin).

Storage

This medication should be stored in an airtight, closed container, preferably at room temperature between 1°C and 30°C. Storing it this way helps maintain its effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

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.