Medication info
Omeprazole Capsule (Omeprazole)

Omeprazole Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Sungwon Adcock Pharmaceutical Co., Ltd.
Appearance
A hard capsule filled with pale yellow enteric-coated granules, with the upper part reddish-brown and the lower part pinkish.
Packaging
28 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201602713 · Approved 2016.05.17 · Insurance code 664901230

Summary

Main use
Treatment and prevention of reflux disease, gastrointestinal disorders (ulcers, erosions, etc.), and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
Ⅰ) Adults 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 not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 8 weeks, although healing time 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 heal within 2 weeks, although healing time may vary among patients. If healing is not achieved after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 4 weeks, although healing time may vary among patients. Repeat treatment in the event of recurrence. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases heal within 4 weeks, although healing time may vary among patients. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 8 weeks, although healing time 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 with the dose adjusted as appropriate for the individual. 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. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. In the event of recurrence, the dose may be increased to 40mg once daily. 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 insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Treatment is generally effective after 2-4 weeks of use. 8) 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 not achieved 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 medicine whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Sungwon Adcock Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • peptic ulcer
  • gastric and duodenal ulcer
  • erosion
  • dyspepsia symptoms
View approved original text

This medication is used for the short-term treatment of gastric and duodenal ulcers. It also improves symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation. It is effective in treating Zollinger-Ellison syndrome, and is used for maintenance therapy of severe gastroesophageal reflux disease and difficult-to-treat peptic ulcers. Antibiotics are used in combination to prevent recurrence of duodenal ulcers caused by Helicobacter pylori infection. It helps in the treatment of gastric and duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs), and also aids in the prevention of gastrointestinal disorders and dyspepsia symptoms due to long-term NSAID use. Lastly, it is effective in preventing recurrence of gastroesophageal reflux disease, and is used in the treatment and prevention of various gastrointestinal related diseases.

How to take

Adult dose

Ⅰ) Adults 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 not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 8 weeks, although healing time 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 heal within 2 weeks, although healing time may vary among patients. If healing is not achieved after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 4 weeks, although healing time may vary among patients. Repeat treatment in the event of recurrence. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases heal within 4 weeks, although healing time may vary among patients. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other treatments, administration of 40mg once daily generally results in healing within 8 weeks, although healing time 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 with the dose adjusted as appropriate for the individual. 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. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. In the event of recurrence, the dose may be increased to 40mg once daily. 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 insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Treatment is generally effective after 2-4 weeks of use. 8) 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 not achieved 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 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 an allergy to its ingredients. Caution is required when administering to patients with gastric ulcers suspected of being malignant, as symptoms may be masked or diagnosis delayed. Certain antiviral agents cannot be used in combination, so consult a physician before co-administration. Patients with lactose intolerance or genetic lactose metabolism disorders should not take this medication. Patients with impaired liver function should use this medication with caution and possibly at a reduced dose; particularly, severely liver-impaired patients should not exceed the recommended dosage. Elderly patients should also exercise caution when using this medication. This medication may cause neurological symptoms such as headache, drowsiness, dizziness, and insomnia. Liver function abnormalities may occur, thus liver enzyme levels should be monitored regularly; patients with severe liver disease are at risk for encephalopathy. Gastrointestinal side effects such as diarrhea, abdominal pain, and nausea may occur, and rarely dry mouth or oral inflammation can also develop. Skin rash, itching, and in severe cases serious skin reactions like Stevens-Johnson syndrome may occur, necessitating immediate discontinuation if any abnormal symptoms arise. Rarely, hypersensitivity reactions like angioedema or anaphylactic shock can occur, and preparations for emergencies should be in place. Cardiac symptoms such as chest pain or palpitations may arise. Blood disorders, myalgia, gynecomastia as side effects have also been reported in rare cases. Long-term use may lead to electrolyte imbalances such as hypomagnesemia, necessitating regular blood tests. This medication inhibits gastric acid secretion, which may interfere with the absorption of some other drugs; consult a healthcare provider when taking with other medications. Caution is particularly required for interactions with antibiotics, anticoagulants, and anticonvulsants. Pregnant women or those who may become pregnant should use this medication cautiously, as it may affect the fetus. Breastfeeding women should either avoid taking this medication or discontinue breastfeeding while on it. Safety in children has not been sufficiently established, thus caution is warranted. In case of overdose, symptoms such as vomiting, diarrhea, headache, and confusion may occur, and in severe cases, although rare, immediate medical attention should be sought. This medication should be stored out of reach of children, should not be kept in a changed container, and should be tightly closed after use.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feelings of faintness, vertigo, disorientation, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, diarrhea, melena, 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, malaise, peripheral edema, increased sweating, blurred vision, vision impairment, taste disturbance, 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, cutaneous lupus erythematosus, gastric polyp, 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 should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness and prevent degradation.

Appearance and packaging

Appearance

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

Package unit

28 capsules/bottle, 100 capsules/bottle

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.