Orasec Capsule (Omeprazole)

Adult dose

1. Adults 1) Gastric ulcer Administer 1 capsule (20mg) of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing period may vary from patient to patient. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, taking 40mg once daily usually results in healing within 8 weeks, although the healing period may vary from patient to patient. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer Administer 1 capsule (20mg) orally once daily. Most ulcers may heal within 2 weeks, although the healing period may vary from patient to patient. If healing is incomplete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other therapies, taking 40mg once daily usually results in healing within 4 weeks, although the healing period may vary from patient to patient. If the ulcer recurs, repeat treatment. 3) Treatment of symptoms (heartburn, regurgitation, etc.) of reflux esophagitis and gastroesophageal reflux disease (GERD) ⑴ 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 incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, administration of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary from patient to patient. If the condition recurs, repeat treatment. ⑵ Treatment of symptoms (heartburn, regurgitation, etc.) of gastroesophageal reflux disease (GERD): Administer 20mg orally once daily. Healing is generally possible with 2~4 weeks of treatment. 4) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. If the condition recurs, the dose may be increased to 40mg once daily. 5) Zollinger-Ellison syndrome The initial dose is 60mg orally once daily. Adjust the dose as appropriate for each patient and continue treatment. More than 90% of patients respond to doses of 20~120mg per day. If administering more than 80mg per day, divide the daily dose into 2 doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori ⑴ Dual therapy: Administer this medicine 20mg with amoxicillin 750-1000mg twice daily for 2 weeks. ⑵ Triple therapy: Administer this medicine 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 therapeutic effect is inadequate, omeprazole monotherapy may be continued. 7) 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 incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAIDs in patients receiving long-term NSAID therapy with a history of gastric or duodenal lesions: Administer 20mg orally once daily. 9) Prevention of recurrence of reflux esophagitis To prevent recurrence of reflux esophagitis, administer 1/2 capsule (10mg) orally once daily. * Swallow this medicine whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

This medication should not be administered to patients with a known allergy to its components. Caution is required when used in patients with gastric ulcers suspected of malignant tumors, as the symptoms may be masked leading to a delayed diagnosis. Additionally, certain antiviral or antiretroviral agents should not be used concurrently, so it is important to confirm before co-administering. The dosage should be reduced or administered cautiously in patients with impaired liver function or elderly individuals. Side effects, such as headache, dizziness, dyspepsia, diarrhea, and rash, may occur, so any unusual symptoms should be reported immediately. Regular testing is required due to the potential for liver dysfunction, severe skin reactions, or kidney issues. Long-term use may increase fracture risks and decrease magnesium levels, necessitating periodic blood testing. Women who are pregnant or breastfeeding should consult with a physician before using this medication and are advised to avoid its use while breastfeeding. Safety in children has not been established, so it should be used in children with caution. Overdose may lead to symptoms such as vomiting, headache, and dizziness, therefore, prescribed dosages must be adhered to. Store this medication out of reach of children, in its original container, and ensure the cap is tightly closed.

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, vertigo, confusion, agitation, aggression, hallucination, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, melena, constipation, nausea, vomiting, abdominal pain, abdominal bloating, 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, arthralgia, muscle weakness, myalgia, gynecomastia, cough, fatigue, malaise, peripheral edema, increased sweating, blurred vision, visual disturbances, taste disturbances, breast pain, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia, alleviation of malignant tumor symptoms, diagnostic delay, hypochlorhydria, achlorhydria, vitamin B12 absorption disorder, Stevens-Johnson syndrome, toxic epidermal necrosis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, acute interstitial nephritis, nausea, apathy

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Hard capsules with an upper reddish-brown and lower pink color, filled with white to light brown enteric-coated granules.

Package unit

30 capsules/bottle, 100 capsules/bottle