Medication info

Itex Naproxen Sodium Tablets

OTC medicationTablet경구
Ingredient · strength
Naproxen Sodium›275mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Blue oval film-coated tablets
Packaging
10 tablets/PTP
Approval status
Active

MFDS item code 202105152 · Notified 2021.07.08

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Adults should take 275-550 mg of naproxen sodium orally, twice daily (every 12 hours). 2. Acute gout Adults should take an initial dose of 825 mg of naproxen sodium orally and continue with 275 mg every 8 hours until the attack resolves. 3. Musculoskeletal disorders, postoperative pain, post-extraction pain, dysmenorrhea, tendinitis, bursitis Adults

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis

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

This medication is effective for degenerative joint diseases such as rheumatoid arthritis and osteoarthritis, ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also used for the relief of various types of pain such as bursitis, musculoskeletal disorders (sprains, strains, trauma, low back pain), post-surgical pain, migraines, and post-extraction pain. It reduces inflammation and pain in the joints and muscles, making daily life more comfortable for patients. Overall, it helps improve symptoms for both inflammatory and non-inflammatory diseases.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Adults should take 275-550 mg of naproxen sodium orally, twice daily (every 12 hours). 2. Acute gout Adults should take an initial dose of 825 mg of naproxen sodium orally and continue with 275 mg every 8 hours until the attack resolves. 3. Musculoskeletal disorders, postoperative pain, post-extraction pain, dysmenorrhea, tendinitis, bursitis Adults

Precautions

This medication should be consulted with a doctor or pharmacist before taking, especially for individuals who regularly consume more than three alcoholic beverages per day. Those who consume large amounts of alcohol are at higher risk for gastrointestinal bleeding while taking this medication. Nonsteroidal anti-inflammatory drugs including this medication may increase the risk of serious cardiovascular events such as thrombosis, myocardial infarction, and stroke. Caution is particularly necessary for patients with cardiovascular diseases or risk factors, and symptoms should be closely monitored in consultation with a physician. This medication can cause severe gastrointestinal side effects such as bleeding, ulcers, and perforation, therefore, elderly patients or those with a history of gastric disorders should use it with care. If symptoms of gastrointestinal bleeding occur during use, immediate medical consultation is necessary. Patients with peptic ulcers, severe hematological abnormalities, liver dysfunction, heart failure, severe hypertension should not use this medication. Additionally, individuals with allergies to nonsteroidal anti-inflammatory drugs or with a history of asthma, rhinitis, or nasal polyps should avoid taking it. This medication often requires careful use, so individuals with a history of peptic ulcers, blood disorders, bleeding tendencies, liver or kidney disease, heart dysfunction, hypertension, hypersensitivity, asthma, autoimmune diseases, or elderly patients should consult with a physician before taking. During use, abnormal symptoms such as allergic reactions, gastrointestinal bleeding, hematological abnormalities, liver or kidney dysfunction, skin rashes, headaches, dizziness, auditory or visual disturbances, and shortness of breath may occur; if such symptoms appear, discontinue use and consult a healthcare professional immediately. This medication should only be used at the lowest effective dose and for the shortest duration necessary. Regular blood tests and monitoring of liver and kidney function are needed for long-term use. There are many drug interactions that may alter its effectiveness or increase the risk of adverse effects when taken with other medications; therefore, consultation with a physician is necessary when taking antihypertensive drugs, diuretics, anticoagulants, anticonvulsants, lithium, methotrexate, etc. together. Use during pregnancy, particularly in the late stages, should be avoided as it may harm the fetus, and during breastfeeding, it is preferable to avoid use to prevent side effects in newborns. In children, especially in infants under 2 years old, safety has not been established and it is advisable not to use. Elderly patients are at a higher risk for adverse effects, so careful dosing at minimal levels is recommended. In case of overdose, symptoms such as drowsiness, indigestion, and vomiting may occur; immediate medical attention should be sought if such symptoms arise. Keep this medication out of reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, jaundice, extreme lethargy, liver damage (jaundice), sudden and severe

Mild side effects

  • Nausea
  • stomach pain
  • abdominal pain
  • vomiting
  • loss of appetite
  • indigestion
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
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  • abdominal bloating
  • black stools
  • thirst
  • rash
  • itching
  • occasional eczema
  • sweating
  • purpura
  • photosensitivity
  • hair loss
  • redness
  • tinnitus
  • hearing impairment
  • visual disturbances
  • palpitations
  • muscle weakness
  • menstrual disorders
  • chills and fever
  • vasculitis
  • hyperglycemia
  • hypoglycemia
  • drowsiness
  • cognitive impairment
  • dizziness
  • numbness in hands and feet
  • decreased libido
  • fatigue

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

Storage

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

Appearance and packaging

Appearance

Blue oval film-coated tablets

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.