Prazole Capsule (Omeprazole Delayed-Release Granules)

Adult dose

1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers heal within 4 weeks, although healing time may vary among patients. 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 medicines, administration of 40mg once daily usually results in healing within 8 weeks, although healing time may vary among patients. Repeat treatment if the ulcer recurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers heal within 2 weeks, although healing time may vary among patients. 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 medicines, administration of 40mg once daily usually results in healing within 4 weeks, although healing time may vary among patients. Repeat treatment if the ulcer recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20mg orally once daily. Most cases heal within 4 weeks, although healing time may vary among patients. 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 medicines, administration of 40mg once daily usually results in healing within 8 weeks, although healing time may vary among patients. Repeat treatment if the condition recurs. - 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. 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. Continue treatment, adjusting the dose as appropriate for each patient. More than 90% of patients respond to doses of 20 - 120mg daily. If doses of 80mg or more per day are administered, divide the daily dose into 2 doses. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20mg and amoxicillin 750 - 1000mg together twice daily for 2 weeks. - 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 treatment response is inadequate, omeprazole monotherapy may be continued. 7) Treatment of gastric or duodenal ulcers or erosions caused by administration of nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases heal within 4 weeks, although healing time may vary among patients. 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 NSAID administration in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. 9) Prevention of recurrence of reflux esophagitis: Administer 10mg orally once daily to prevent recurrence of reflux esophagitis. * 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 known allergies to specific components. Caution is needed when prescribing to patients with gastric ulcers that may be malignant, as this medication may mask symptoms or delay diagnosis. Additionally, there may be interactions with certain antiviral or antiretroviral drugs, so concomitant use should be avoided. Patients with impaired liver function or the elderly may experience slowed metabolism and excretion of this medication, so dosages should be reduced and administered cautiously. While taking this medication, neurological symptoms such as headache, dizziness, and drowsiness may occur, and there may be an increase in liver enzyme levels, or rare serious liver diseases such as hepatitis may develop. It may also affect kidney function, so if there are abnormal kidney-related symptoms, medical consultation should be sought immediately. Gastrointestinal discomfort may arise, including diarrhea, constipation, nausea, abdominal pain, and allergic reactions such as skin rashes or itching. Rarely, decreases in blood cell counts, muscle pain, and gynecomastia have also been reported, and if severe allergic reactions or skin diseases occur, administration should be halted immediately. Long-term use can lead to Vitamin B12 absorption disorders and an increased risk of fractures, so regular testing is necessary. Women who are pregnant or may become pregnant should use this medication only after consulting a physician, as it may affect the fetus. For nursing mothers, it is advisable to avoid administration or to discontinue breastfeeding if necessary. Safety has not been established in children, so use is not recommended. Overdose may result in symptoms such as vomiting, diarrhea, headache, and confusion, so the recommended dosage should be adhered to, and if symptoms arise, medical personnel should be informed immediately. This medication must be kept out of reach of children, the container should not be changed, and the cap should be tightly closed after use.

Headache, drowsiness, dizziness, insomnia, paresthesia, fainting sensation, vertigo, confusion, agitation, aggressiveness, hallucination, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, melena, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, papules, hives, 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, lethargy, peripheral edema, increased sweating, blurred vision, visual impairment, taste disorders, 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, cutaneous lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature at room temperature, avoiding extremes of heat or cold.

Appearance

A hard capsule with the upper part in reddish-brown and the lower part in pink, filled with white to off-white enteric-coated granules.

Package unit

28 capsules/bottle, 100 capsules/bottle