Opra Capsule (Omeprazole)

Adult dose

1. Adults 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing period may vary among patients. If healing is not complete 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 among patients. Repeat treatment in the event of recurrence. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may vary among patients. If healing is not complete 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 among patients. Repeat treatment in the event of recurrence. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary among patients. If healing is not complete 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 among patients. Repeat treatment in the event of recurrence. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose individually as appropriate. More than 90% of patients respond to doses of 20 - 120mg daily. If more than 80mg daily is administered, divide the dose into 2 administrations per day. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. The dose may be increased to 40mg once daily in the event of recurrence. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this drug 20mg and 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 for 2-4 weeks is generally sufficient for healing. 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 among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID administration in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. * Swallow this drug whole with at least half a cup of water. Adjust the dose according to age and symptoms.

This medication should not be used in patients with an allergic reaction to any of its components. Care is needed when diagnosing suspected malignant tumors or in patients with gastric ulcers who may have malignant tumor potential as the administration of this drug may alleviate symptoms, leading to delayed diagnosis. Additionally, this drug should not be used in conjunction with certain antiviral medications, including atazanavir, nor administered to patients taking rilpivirine-containing products. It contains lactose, so patients with genetic issues such as lactose intolerance or galactose intolerance should not take it. Patients with liver impairment may experience an increase in the bioavailability and half-life of this medication, requiring dosage adjustments, and particularly severe liver dysfunction patients should be cautious not to exceed 20mg per day. It should be administered with caution in elderly patients. This medication may cause neurological symptoms such as headache, drowsiness, dizziness, and insomnia, and rare instances of liver dysfunction, diarrhea, nausea, skin rash, hypersensitivity reactions, blood abnormalities, and myalgia can occur. If severe side effects are suspected, stop taking it immediately and consult healthcare professionals. Long-term use of this medication may lead to vitamin B12 absorption issues, hypomagnesemia, and increased fracture risk, so regular check-ups are necessary during extended use. It is especially important that patients taking it long-term for over a year use the minimum effective dose for an appropriate period under their doctor's supervision. This medication may interact with other drugs; therefore, it is necessary to consult a specialist and monitor its use when taken with warfarin, diazepam, phenytoin, cyclosporine, or methotrexate. Pregnant women or women who may become pregnant should carefully consider the benefits and risks of administering this medication as it may affect the fetus. Nursing women are advised against taking this medication, and if it must be taken, breastfeeding should be discontinued. Safety in children has not been established, so special caution is required when administering it to them. In the event of overdose, symptoms such as vomiting, diarrhea, headache, and confusion may occur; immediate medical attention is necessary. This medication should be kept out of the reach of children, stored in its original container, and tightly closed after use. Finally, animal studies have shown that long-term administration of this medication may lead to hyperplasia of specific gastric cells or an increased risk of gastric carcinoid tumor, so caution and consultation with a specialist are required during extended use.

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticarial eruptions, 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, arthralgia, muscle weakness, myalgia, gynecomastia, cough, asthenia, malaise, peripheral edema, increased sweating, blurred vision, visual impairment, taste disturbance, breast pain in females, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyps, hypocalcemia, hypokalemia

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should maintain room temperature between 1 degree and 30 degrees. This ensures that the drug maintains its efficacy and can be used safely.

Appearance

A hard capsule with a reddish-brown upper part and a pinkish-red lower part filled with pale yellow enteric-coated granules.

Package unit

28 capsules/bottle