Medication info
Aju Omeprazole Capsule

Aju Omeprazole Capsule

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›230mg / 1 capsule
Manufacturer / importer
Aju Pharmaceutical Co., Ltd.
Appearance
Hard capsules with a dark reddish upper part and a pink lower part, filled with white to grayish-white enteric-coated granules
Packaging
Domestic - 30 capsules/bottle, Domestic - 100 capsules/bottle, Export - 30 capsules/box [10 capsules/PTP*3]
Approval status
Active

MFDS item code 199700918 · Notified 1997.09.01 · Insurance code 654001100

Summary

Main use
Treatment and prevention of gastrointestinal disorders (e.g., ulcers and erosions), reflux disease, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
◎ Adults 1) Gastric ulcer: Administer 20 mg of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 8 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20 mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may vary between patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 4 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20 mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 8 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20 mg orally once daily. Treatment for 2–4 weeks generally leads to healing. 4) Maintenance treatment for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20 mg orally once daily. If recurrence occurs, the dose may be increased to 40 mg once daily. 5) Zollinger-Ellison syndrome: The initial dose is 60 mg orally once daily. Continue treatment, adjusting the dose as appropriate for each patient. More than 90% of patients respond to doses of 20 - 120 mg per day. If more than 80 mg per day is administered, divide the dose into 2 doses per day. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20 mg with amoxicillin 750 - 1000 mg twice daily for 2 weeks. - Triple therapy: Administer this medicine 40 mg once daily or 20 mg twice daily in combination with the following antibiotics. ① Administer clarithromycin 250 mg and metronidazole 400 mg twice daily for 1 week, or ② Administer amoxicillin 1 g and clarithromycin 500 mg twice daily for 1 week. If the therapeutic 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 20 mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Maintenance therapy to prevent NSAID-induced gastric or duodenal ulcers or erosions and dyspeptic symptoms in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20 mg orally once daily. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, administer 10 mg orally once daily. * Take this medicine whole with at least half a glass of water. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Aju Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastrointestinal disorders (e.g., ulcers and erosions), reflux disease, and Zollinger-Ellison syndrome

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • gastroesophageal reflux disease
  • peptic ulcer
  • recurrence of duodenal ulcer
  • gastric and duodenal ulcers
  • erosion
  • dyspepsia
View approved original text

This medication is used for the short-term treatment of gastric ulcers and duodenal ulcers and is also effective in treating symptoms of gastroesophageal reflux disease, including heartburn and regurgitation. Additionally, it helps in the maintenance therapy of severe gastroesophageal reflux disease and difficult-to-treat peptic ulcers. It can also be used in the treatment of Zollinger-Ellison syndrome and can be combined with antibiotics to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. It is also used for the treatment and prevention of gastric and duodenal ulcers and erosions due to nonsteroidal anti-inflammatory drugs (NSAIDs). In particular, it contributes to the prevention of gastrointestinal disorders during long-term NSAID administration in patients with a history of gastric or duodenal disease. It is widely used for the treatment of various symptoms and diseases related to gastrointestinal disorders.

How to take

Adult dose

◎ Adults 1) Gastric ulcer: Administer 20 mg of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 8 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20 mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may vary between patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 4 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20 mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. For patients who have not responded to other medicines, administration of 40 mg once daily generally results in healing within 8 weeks, although the healing period may vary between patients. Repeat treatment if recurrence occurs. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20 mg orally once daily. Treatment for 2–4 weeks generally leads to healing. 4) Maintenance treatment for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20 mg orally once daily. If recurrence occurs, the dose may be increased to 40 mg once daily. 5) Zollinger-Ellison syndrome: The initial dose is 60 mg orally once daily. Continue treatment, adjusting the dose as appropriate for each patient. More than 90% of patients respond to doses of 20 - 120 mg per day. If more than 80 mg per day is administered, divide the dose into 2 doses per day. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20 mg with amoxicillin 750 - 1000 mg twice daily for 2 weeks. - Triple therapy: Administer this medicine 40 mg once daily or 20 mg twice daily in combination with the following antibiotics. ① Administer clarithromycin 250 mg and metronidazole 400 mg twice daily for 1 week, or ② Administer amoxicillin 1 g and clarithromycin 500 mg twice daily for 1 week. If the therapeutic 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 20 mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Maintenance therapy to prevent NSAID-induced gastric or duodenal ulcers or erosions and dyspeptic symptoms in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20 mg orally once daily. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, administer 10 mg orally once daily. * Take this medicine whole with at least half a glass of water. Adjust the dose appropriately according to age and symptoms.

Precautions

This medication should not be used in patients who have an allergic reaction to any of its components. Caution is advised when administering to patients with gastric ulcers suspected of malignancy, as symptoms may be masked, delaying diagnosis. It should not be used in conjunction with certain antiviral medications, thus concurrent administration should be avoided. Patients with impaired liver function may experience prolonged absorption and action of this medication, so the dosage should be reduced, and particularly for severe liver impairment, no more than 1 capsule a day should be taken. Care should be taken when administering to the elderly, as neurological side effects such as headache, dizziness, and drowsiness may occur. If there is an increase in liver enzyme levels or symptoms of hepatitis or liver failure, administration should be stopped immediately. Gastrointestinal side effects such as diarrhea, abdominal pain, and nausea may occur frequently. Skin rashes or itching may occur, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may develop, so if symptoms occur, the medication should be discontinued. Hypersensitivity reactions such as angioedema, respiratory distress, and anaphylactic shock may rarely occur. Cardiac symptoms such as chest pain or irregular heartbeats may appear. Blood abnormalities such as leukopenia or thrombocytopenia have been reported rarely. Prolonged use may lead to hypomagnesemia, thus regular blood tests are necessary. This medication inhibits gastric acid secretion, which may interfere with the absorption of certain drugs, so it is advisable to consult with a physician or pharmacist when taking with other medications. Women who are pregnant or may become pregnant should carefully consider the administration of this medication due to potential effects on the fetus. It is recommended that breastfeeding women avoid taking this medication or discontinue breastfeeding. Safety in pediatric patients has not been established, thus it is advisable not to use it in children. In the case of overdose, symptoms such as vomiting, dizziness, and headaches may occur, although serious side effects have not been reported; immediate medical consultation is advised. This medication should be kept out of reach of children, not transferred to other containers, and stored with the lid tightly closed after use. Prolonged administration may increase the risk of gastric cancer or gastric polyps, thus regular check-ups are necessary.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feelings of faintness, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, weight changes, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticaria, pruritus, 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, muscular weakness, myalgia, gynecomastia, cough, asthenia, fatigue, peripheral edema, increased sweating, visual obscurations, vision disturbances, taste disorders, breast pain in women, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized pustular psoriasis, drug reactions with eosinophilia and systemic symptoms, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyps, hypocalcemia, hypokalemia

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. Additionally, it is advisable to keep it away from direct sunlight and store it at room temperature.

Appearance and packaging

Appearance

Hard capsules with a dark reddish upper part and a pink lower part, filled with white to grayish-white enteric-coated granules

Package unit

Domestic - 30 capsules/bottle, Domestic - 100 capsules/bottle, Export - 30 capsules/box [10 capsules/PTP*3]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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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.