Medication info
Omeprazole Capsule (Omeprazole)

Omeprazole Capsule (Omeprazole)

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

MFDS item code 201900638 · Approved 2019.01.24

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease, gastroduodenal disorders (such as ulcers), and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1. Adults 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers heal within 4 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary occasionally from patient to patient. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers heal within 2 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary occasionally from patient to patient. If the ulcer recurs, repeat treatment. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases heal within 4 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary occasionally from patient to patient. If the condition recurs, repeat treatment. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose adjusted appropriately for the individual. More than 90% of patients respond to doses of 20 - 120mg per day; when doses greater than 80mg per day are administered, divide the dose into 2 administrations per day. 5) Maintenance treatment 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. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this drug 20mg with amoxicillin 750 - 1000mg twice daily for 2 weeks. - Triple therapy: Administer this drug 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 effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Healing is generally possible after 2-4 weeks of treatment. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases heal within 4 weeks, although the healing period may vary occasionally from patient to patient. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance prevention of 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 drug whole with at least half a cup of water. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
KMS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastroesophageal reflux disease, gastroduodenal disorders (such as ulcers), and Zollinger-Ellison syndrome

  • Peptic ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • peptic ulcer disease
  • gastric and duodenal ulcer
  • erosion
  • dyspeptic symptoms
View approved original text

This medication is used for the short-term treatment of gastric and duodenal ulcers and alleviates symptoms such as heartburn and regurgitation associated with gastroesophageal reflux disease (GERD). It also aids in the treatment of Zollinger-Ellison syndrome and is used for maintenance therapy in severe gastroesophageal reflux disease and refractory peptic ulcers. It is included in the antibiotic combination therapy for the prevention of recurrence of duodenal ulcers due to Helicobacter pylori infection. It is effective in treating and preventing gastric and duodenal ulcers and erosions that occur due to the use of non-steroidal anti-inflammatory drugs (NSAIDs). This medication is also used to prevent the recurrence of gastroesophageal reflux disease, improving gastrointestinal health.

How to take

Adult dose

1. Adults 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers heal within 4 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary occasionally from patient to patient. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers heal within 2 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary occasionally from patient to patient. If the ulcer recurs, repeat treatment. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases heal within 4 weeks, although the healing period may vary occasionally from patient to patient. 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 preparations, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary occasionally from patient to patient. If the condition recurs, repeat treatment. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose adjusted appropriately for the individual. More than 90% of patients respond to doses of 20 - 120mg per day; when doses greater than 80mg per day are administered, divide the dose into 2 administrations per day. 5) Maintenance treatment 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. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this drug 20mg with amoxicillin 750 - 1000mg twice daily for 2 weeks. - Triple therapy: Administer this drug 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 effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Healing is generally possible after 2-4 weeks of treatment. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases heal within 4 weeks, although the healing period may vary occasionally from patient to patient. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance prevention of 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 drug whole with at least half a cup of water. Adjust the dose appropriately according to age and symptoms.

Precautions

This medication should not be used in patients allergic to any of its components. Care should be taken when administering to gastric ulcer patients suspected of having a malignant tumor, as symptoms may be masked or diagnosis may be delayed. It cannot be taken with certain antiviral agents, so it is essential to confirm any concurrent medications. Patients with a genetic problem that causes lactose intolerance should not take this medication. Dosage should be adjusted for patients with impaired liver function, as it could enhance the drug's effects, especially those with severe liver impairment should limit their daily dose. Elderly patients may be more sensitive to side effects, so caution is advised. This medication may cause central nervous system side effects such as headaches, dizziness, and drowsiness, and in rare cases, mental confusion or hallucinations may occur. If liver enzyme levels rise due to liver dysfunction, the use of this drug should be discontinued. Common gastrointestinal side effects may include diarrhea, abdominal pain, and nausea. Skin rash, itching, and in severe cases, severe skin reactions may occur, requiring immediate discontinuation of the medication. Hypersensitivity reactions such as angioedema or anaphylaxis may occur. Cardiac-related symptoms or blood abnormalities are also reported rarely; consult a physician in case of abnormal symptoms. Long-term use may lead to vitamin B12 absorption impairment or hypomagnesemia, necessitating regular check-ups. This medication lowers gastric acidity, which may increase the risk of bacterial infections; notify healthcare professionals if diarrhea persists. Long-term use may increase the risk of gastric cancer or gastric fundal polyps; regular check-ups are recommended. There are many interactions with other medications, so inform the physician if other medications are being taken, especially when taken with anticoagulants, anticonvulsants, or immunosuppressants. During pregnancy, it may affect the fetus, so use cautiously under medical supervision, and it is advisable to avoid use during breastfeeding. Safety in children has not been established; consult a specialist before administering to pediatric patients. In cases of overdose, symptoms may include vomiting, diarrhea, and headaches, and in severe cases, changes in mental status may occur, requiring immediate hospital visit. This medication should be kept out of 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, feeling faint, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, stools with blood, constipation, nausea, vomiting, abdominal pain, abdominal bloating, dry mouth, stomatitis, gastrointestinal candidiasis, flushing, rash, 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, muscular weakness, myalgia, gynecomastia, cough, asthenia, malaise, peripheral edema, increased sweating, blurred vision, vision impairment, taste disturbance, breast pain, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized pustular psoriasis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polypectomy, hypocalcemia, hypokalemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute interstitial nephritis, nausea, apathy, depression, confusion

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

Storage

This medication may be sensitive to air or moisture, hence it should be stored in a sealed container. It is important to maintain storage temperatures between 1°C and 30°C. Proper storage can help maintain the effectiveness of the drug.

Appearance and packaging

Appearance

A hard capsule consisting of upper reddish-brown and lower pinkish color, filled with pale yellow enteric granules

Package unit

28 capsules/bottle

Same-ingredient medicines

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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.