Ometazole Capsule (Omeprazole)

Adult dose

1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other drugs, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most cases may heal within 2 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other drugs, administration of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary from patient to patient. Repeat treatment if recurrence occurs. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other drugs, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if recurrence occurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose adjusted individually as appropriate. More than 90% of patients respond to doses of 20 - 120mg per day. If administering 80mg or more per day, divide the daily dose into 2 administrations. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. If recurrence occurs, the dose may be increased to 40mg once daily. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this drug 20mg with amoxicillin 750 - 1000mg twice daily for 2 weeks. - Triple therapy: Administer this drug 40mg once daily or 20mg twice daily in combination with the following antibiotics. ① Administer clarithromycin 250mg and metronidazole 400mg twice daily for 1 week, or ② Administer amoxicillin 1g and clarithromycin 500mg twice daily for 1 week. If the treatment effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Treatment is generally effective after 2-4 weeks of use. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. * Take this drug whole with at least half a glass of water. The dose may be adjusted as appropriate according to age and symptoms.

This medication should not be used in patients with a known allergic reaction to any of its components. In cases of suspected malignant tumors in gastric ulcer patients, caution is required as this medication may alleviate symptoms and complicate diagnosis. It should not be combined with certain antivirals such as atazanavir or rilpivirine. Patients with genetic lactose-related disorders should also avoid this medication. Patients with liver dysfunction should have their dosage reduced and should be administered cautiously, particularly in severe liver impairment, where the daily dose should not exceed 20 mg. Elderly patients also require caution when using this medication. Neuropsychiatric symptoms such as headache, dizziness, drowsiness, insomnia may occur while taking this medication, and occasionally, symptoms such as confusion or hallucination may also occur. Liver function abnormalities may arise, and if elevated liver enzyme levels are observed, this medication should be discontinued, as severe cases may present with symptoms of hepatitis or liver failure. Renal effects may occur, and renal inflammation may rarely be exacerbated, so caution is needed. Common gastrointestinal symptoms may include diarrhea, constipation, nausea, abdominal pain, etc. Allergic reactions such as rashes or itching may develop, and rare but severe skin reactions can occur; if these symptoms arise, the medication should be stopped immediately. Hypersensitivity reactions may lead to angioedema, fever, bronchospasm, or anaphylactic shock. Cardiac symptoms such as chest pain or palpitation have been reported, and hematologic abnormalities like leukopenia or thrombocytopenia may occur infrequently. Muscle pain or joint pain can also be experienced by some patients. Prolonged use may lead to hypomagnesemia, necessitating regular blood tests and magnesium supplementation as needed. This medication suppresses gastric acid secretion, which may promote bacterial growth in the stomach, and if diarrhea persists, Clostridium difficile infection should be suspected. In cases where a malignant tumor is suspected, confirmation through examination is essential, and if diagnosed with gastric cancer, this medication should be discontinued. Regular check-ups and limiting treatment duration to the minimum effective dose during long-term use is crucial. This medication may interact with certain drugs; if other medications are being taken concurrently, it is imperative to consult with a physician or pharmacist. Women who are pregnant or may become pregnant should carefully consider the benefits and risks before using this medication, and those who are breastfeeding should avoid usage or discontinue nursing. Safety in pediatric populations has not been established, so caution is necessary. In cases of overdose, symptoms such as vomiting, diarrhea, headache may occur, though these are generally transient and severe side effects are rare. This medication should be stored out of reach of children, kept in its original container, and the cap should be tightly closed after use. Finally, some animal studies have reported hypertrophy of certain gastric cells with prolonged administration, highlighting the need for caution with long-term use.

Headache, drowsiness, dizziness, insomnia, sensory disturbance, feeling faint, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, abdominal cramping, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticaria, itching, dermatitis, vesicular rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity, alopecia, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, chest pain, tachycardia, bradycardia, palpitations, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, back pain, joint pain, muscle weakness, myalgia, gynecomastia, cough, asthenia, fatigue, peripheral edema, increased sweating, blurred vision, visual disturbances, taste disturbances, breast tenderness in women, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, eosinophilia, systemic symptoms associated with drug reactions, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

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

Appearance

A hard capsule with an upper reddish-brown and a lower pink color filled with pale yellow enteric-coated granules.

Package unit

28 capsules per bottle