Medication info
Omeprazole Capsule (Omeprazole)

Omeprazole Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Austin Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a reddish-brown upper part and a pink lower part filled with white to light brown enteric-coated granules.
Packaging
30 capsules, 100 capsules
Approval status
Active

MFDS item code 200402023 · Notified 2004.06.17 · Insurance code 654302050

Summary

Main use
Treatment and prevention of gastrointestinal disorders (including ulcers and erosions), gastroesophageal reflux, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1. Adults: 1) Gastric ulcer: Take 1 capsule (20mg) of omeprazole once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Take 1 capsule (20mg) once daily. Healing can be achieved within 2 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 4 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. 3) Treatment of symptoms (heartburn, regurgitation, etc.) of reflux esophagitis and gastroesophageal reflux disease (GERD): - Reflux esophagitis: Take 1 capsule (20mg) once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. - Treatment of symptoms (heartburn, regurgitation, etc.) of gastroesophageal reflux disease (GERD): Take 1 capsule (20mg) 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: Take 1 capsule (20mg) once daily. If the condition recurs, the dose may be increased to 2 capsules (40mg) once daily. 5) Zollinger-Ellison syndrome: The initial dose is 3 capsules (60mg) once daily. Continue treatment with the dose adjusted appropriately for each patient. More than 90% of patients respond to doses of 1~6 capsules (20~120mg) daily. If taking 4 capsules (80mg) or more per day, divide the daily dose into 2 administrations. 6) Concomitant antibiotic therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Take 1 capsule (20mg) of this drug with amoxicillin 750~1000mg twice daily for 2 weeks. - Triple therapy: Take 2 capsules (40mg) of this drug once daily or 1 capsule (20mg) twice daily in combination with the following antibiotics: ① Take clarithromycin 250mg and metronidazole 400mg twice daily for 1 week, or ② Take 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 nonsteroidal anti-inflammatory drugs (NSAIDs): Take 1 capsule (20mg) once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Take 1 capsule (20mg) once daily. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, take 1/2 capsule (10mg) once daily. * Swallow this drug whole with at least half a glass of water. The dose may be adjusted appropriately according to age and symptoms.

Ingredients

Manufacturer
Austin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastrointestinal disorders (including ulcers and erosions), gastroesophageal reflux, and Zollinger-Ellison syndrome

  • Gastric ulcers
  • duodenal ulcers
  • heartburn
  • regurgitation
  • peptic ulcers
  • gastric and duodenal ulcers
  • erosions
  • 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 improving the symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation. Furthermore, it assists in maintenance treatment of severe gastroesophageal reflux disease and difficult-to-treat peptic ulcers. It is applicable to patients with Zollinger-Ellison syndrome and is used in combination therapy with antibiotics to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. It is also effective in treating gastric and duodenal ulcers or erosions caused by the administration of non-steroidal anti-inflammatory drugs (NSAIDs) and in preventing gastric and duodenal ulcers and dyspeptic symptoms during long-term use of NSAIDs. Additionally, it is used for preventing the recurrence of gastroesophageal reflux disease.

How to take

Adult dose

1. Adults: 1) Gastric ulcer: Take 1 capsule (20mg) of omeprazole once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Take 1 capsule (20mg) once daily. Healing can be achieved within 2 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 4 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. 3) Treatment of symptoms (heartburn, regurgitation, etc.) of reflux esophagitis and gastroesophageal reflux disease (GERD): - Reflux esophagitis: Take 1 capsule (20mg) once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other agents, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing period may occasionally vary by patient. If the condition recurs, repeat treatment. - Treatment of symptoms (heartburn, regurgitation, etc.) of gastroesophageal reflux disease (GERD): Take 1 capsule (20mg) 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: Take 1 capsule (20mg) once daily. If the condition recurs, the dose may be increased to 2 capsules (40mg) once daily. 5) Zollinger-Ellison syndrome: The initial dose is 3 capsules (60mg) once daily. Continue treatment with the dose adjusted appropriately for each patient. More than 90% of patients respond to doses of 1~6 capsules (20~120mg) daily. If taking 4 capsules (80mg) or more per day, divide the daily dose into 2 administrations. 6) Concomitant antibiotic therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Take 1 capsule (20mg) of this drug with amoxicillin 750~1000mg twice daily for 2 weeks. - Triple therapy: Take 2 capsules (40mg) of this drug once daily or 1 capsule (20mg) twice daily in combination with the following antibiotics: ① Take clarithromycin 250mg and metronidazole 400mg twice daily for 1 week, or ② Take 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 nonsteroidal anti-inflammatory drugs (NSAIDs): Take 1 capsule (20mg) once daily. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If healing is incomplete after the first 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Take 1 capsule (20mg) once daily. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, take 1/2 capsule (10mg) once daily. * Swallow this drug whole with at least half a glass of water. The dose may be adjusted appropriately according to age and symptoms.

Precautions

This medication should not be used by patients who are allergic to its components. In patients with gastric ulcers where a malignant tumor is suspected, using this medication may alleviate symptoms and delay diagnosis, so caution is required. This medication cannot be used together with the specific antiviral drug Atazanavir, and patients taking Rilpivirine should also not use this drug. Since it contains lactose, patients with lactose intolerance or related genetic disorders should not take it. Patients with reduced liver function should reduce the dosage of this medication, as its bioavailability and half-life are increased. Particularly, patients with severe hepatic impairment should not exceed 20mg per day. Use in elderly patients should be done carefully. Central nervous system symptoms such as headache, drowsiness, dizziness, insomnia, may commonly occur, and severe mental symptoms may rarely occur. If there is an increase in liver enzyme levels or severe liver disease, liver function abnormalities may occur, so treatment should be discontinued if any abnormal symptoms appear. Caution is required in patients with kidney and urinary tract conditions, as it may affect renal function. Gastrointestinal symptoms such as diarrhea, constipation, nausea, and abdominal pain may commonly occur, and very rarely dry mouth or stomatitis may appear. Severe skin reactions such as rashes, itching, and in severe cases Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so treatment should be immediately stopped if any symptoms appear. Rarely, allergic reactions such as angioedema or anaphylactic shock may occur. Cardiac symptoms may include chest pain, rapid heartbeat, and slow pulse. Blood abnormalities such as leukopenia or thrombocytopenia have been reported. Muscle pain or joint pain may occur. Long-term use may lead to hypomagnesemia, especially if taken for more than one year, so regular blood tests are necessary. This medication lowers gastric acidity and may increase the risk of some bacterial infections, particularly in hospitalized patients, with an increased risk of Clostridium difficile diarrhea. Women who are pregnant or may become pregnant should use this medication cautiously only when necessary, and breastfeeding women should ideally avoid use or discontinue breastfeeding. Safety in children has not been established, so caution is required in usage. In case of overdose, symptoms such as vomiting, headache, and diarrhea may appear, but they are generally temporary. This medication must be kept out of reach of children, not stored in a different container, and tightly closed after use. Long-term usage may increase the risk of gastric gland polyps, so the minimum dosage and treatment duration should be observed. Due to numerous drug interactions, consult a doctor or pharmacist if you are taking other medications.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, bloody stools, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, wheals, 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, asthenia, 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, cutaneous lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, acute interstitial nephritis, nausea, flatulence, depression, confusion

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, and it is advisable to avoid extremely hot or cold places.

Appearance and packaging

Appearance

A hard capsule with a reddish-brown upper part and a pink lower part filled with white to light brown enteric-coated granules.

Package unit

30 capsules, 100 capsules

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.