Medication info
Omeprazone Capsule (Omeprazole)

Omeprazone Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Korea Huitex Pharmaceutical Co., Ltd.
Appearance
A hard capsule with the upper part in reddish-brown and the lower part in pink, filled with light yellow enteric-coated granules.
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201308902 · Approved 2013.08.20 · Insurance code 649102110

Summary

Main use
Treatment and prevention of gastrointestinal diseases (e.g., ulcers), gastroesophageal reflux, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1) Gastric ulcer: Administer 1 capsule (20mg) of omeprazole 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 another 4 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 2) Short-term treatment of duodenal ulcer: Administer 1 capsule (20mg) orally once daily. Most cases 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 another 2 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 4 weeks, although the healing period may vary among patients. Repeat treatment if the condition 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 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 another 4 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 8 weeks, although the healing period 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 poorly responsive peptic ulcers: 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 with the dose adjusted appropriately for each patient. More than 90% of patients respond to doses of 20~120mg daily. If administering more than 80mg daily, divide the dose into two daily doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20mg and amoxicillin 750~1000mg twice daily for 2 weeks. - Triple therapy: When used in combination with the following antibiotics, administer this medicine 40mg once daily or 20mg twice daily. 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 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 another 4 weeks. 8) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID treatment in patients with a history of gastric or duodenal lesions receiving long-term NSAID treatment: 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.

Ingredients

Manufacturer
Korea Huitex Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastrointestinal diseases (e.g., ulcers), gastroesophageal reflux, and Zollinger-Ellison syndrome

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • reflux
  • peptic ulcer
  • gastric and duodenal ulcer
  • erosion
  • dyspeptic symptoms
View approved original text

This medication is used for the short-term treatment of gastric ulcers and duodenal ulcers. It is also effective in treating chest pain and reflux symptoms due to gastroesophageal reflux disease (GERD) and reflux esophagitis. It is utilized in the treatment of Zollinger-Ellison syndrome and is also used as maintenance therapy for severe reflux esophagitis and refractory peptic ulcers. It is included in the treatment regimen combined with antibiotics to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. This medication is effective in treating gastric and duodenal ulcers or erosions caused by the administration of non-steroidal anti-inflammatory drugs (NSAIDs) and in preventing ulcers and dyspeptic symptoms in patients undergoing long-term NSAID therapy. Lastly, it is used to prevent the recurrence of reflux esophagitis.

How to take

Adult dose

1) Gastric ulcer: Administer 1 capsule (20mg) of omeprazole 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 another 4 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 2) Short-term treatment of duodenal ulcer: Administer 1 capsule (20mg) orally once daily. Most cases 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 another 2 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 4 weeks, although the healing period may vary among patients. Repeat treatment if the condition 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 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 another 4 weeks. In patients who have not responded to other medicines, taking 40mg once daily usually leads to healing within 8 weeks, although the healing period 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 poorly responsive peptic ulcers: 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 with the dose adjusted appropriately for each patient. More than 90% of patients respond to doses of 20~120mg daily. If administering more than 80mg daily, divide the dose into two daily doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20mg and amoxicillin 750~1000mg twice daily for 2 weeks. - Triple therapy: When used in combination with the following antibiotics, administer this medicine 40mg once daily or 20mg twice daily. 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 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 another 4 weeks. 8) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID treatment in patients with a history of gastric or duodenal lesions receiving long-term NSAID treatment: 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.

Precautions

This medication should not be used in patients with hypersensitivity to any component of this medication. Caution should be taken when administering to patients with gastric ulcers suspicious of malignancy, as symptom relief may delay diagnosis. This medication should not be used in conjunction with certain antiviral agents such as atazanavir or rilpivirine-containing preparations. It contains lactose, so patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with liver dysfunction or the elderly should have their dosages adjusted or should be administered with caution. Psychoneurological side effects such as headache, drowsiness, dizziness, and insomnia may occur; rarely, severe symptoms like confusion or hallucinations may also appear. Since liver enzyme levels may rise or liver-related abnormalities such as hepatitis and liver failure may occur, administration should be stopped if abnormal symptoms appear. Gastrointestinal side effects like diarrhea, nausea, and abdominal pain are common. Skin rashes, itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may occur, so administration should be immediately stopped if symptoms appear. Allergic reactions such as angioedema and anaphylactic shock have been reported rarely and may require urgent treatment. This medication may interact with other drugs, so caution is needed if taking anticoagulants such as warfarin, phenytoin, digoxin, or methotrexate. Long-term use may increase the risk of hypomagnesemia or fractures, so regular checks are recommended. Pregnant women or those who may become pregnant should consult with a physician if treatment with this medicine is necessary. If breastfeeding, it is advisable to avoid this medication or to discontinue breastfeeding. Safety in children has not been established, so caution should be exercised when using it. In case of overdose, symptoms like vomiting, diarrhea, and headache may occur but are usually temporary. This medication should be kept out of the reach of children, should not be transferred to other containers, and the cap should be tightly closed after use.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, fainting, vertigo, confusion, excitement, aggressiveness, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, abdominal pain, constipation, nausea, vomiting, abdominal pain, abdominal bloating, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, wheals, 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, fatigue, peripheral edema, increased sweating, blurred vision, visual disturbances, taste disturbances, breast pain in women, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, eosinophilia, systemic symptoms associated drug reaction, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric adenomatous polyp, hypocalcemia, hypokalemia

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, avoid storing it in extremely hot or cold places and it is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

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

Package unit

28 capsules/bottle

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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.