Medication info

Omep Capsule (Omeprazole)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Geonil Biopharm Co., Ltd.
Appearance
A hard capsule with upper reddish brown and lower pink parts filled with light yellow enteric-coated granules.
Packaging
28 capsules/bottle
Approval status
Expired

MFDS item code 201902129 · Approved 2019.04.08

This product's status changed to Expired on 2024.04.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of gastric and duodenal disorders, gastroesophageal reflux disease, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 8 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 4 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 8 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose as appropriate for the individual patient. 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. Maintenance treatment 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. Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: Dual therapy: Administer this medicine 20mg with amoxicillin 750 - 1000mg 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 therapeutic effect is inadequate, omeprazole monotherapy may be continued. 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 administration. 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 time may vary from patient to patient. If healing is not complete after the initial 4 weeks of treatment, continue treatment for another 4 weeks. Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAIDs in patients receiving long-term NSAID treatment with 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
Geonil Biopharm Co., Ltd.

Efficacy & effects

Treatment and prevention of gastric and duodenal disorders, gastroesophageal reflux disease, and Zollinger-Ellison syndrome

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • gastroesophageal reflux disease
  • 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 also alleviates symptoms such as heartburn and regurgitation associated with gastroesophageal reflux disease (GERD). It aids in the treatment of Zollinger-Ellison syndrome and is used in maintenance therapy for severe gastroesophageal reflux disease and hard-to-treat peptic ulcers. It is also part of antibiotic combination therapy to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. It is effective in treating or preventing gastric and duodenal ulcers or erosions that may arise from the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Thus, it is widely used for the treatment of gastrointestinal diseases and symptom relief.

How to take

Adult dose

Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers may heal within 4 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 8 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 4 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing time may vary from patient to patient. 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, administration of 40mg once daily usually results in healing within 8 weeks, although the healing time may vary from patient to patient. If the condition recurs, repeat treatment. Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose as appropriate for the individual patient. 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. Maintenance treatment 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. Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: Dual therapy: Administer this medicine 20mg with amoxicillin 750 - 1000mg 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 therapeutic effect is inadequate, omeprazole monotherapy may be continued. 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 administration. 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 time may vary from patient to patient. If healing is not complete after the initial 4 weeks of treatment, continue treatment for another 4 weeks. Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAIDs in patients receiving long-term NSAID treatment with 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 who exhibit allergic reactions to its components. Care should be taken in gastric ulcer patients suspected of having malignant tumors, as this medication may relieve symptoms and delay diagnosis. Patients taking atazanavir or rilpivirine must inform their doctors as they cannot take this medication together. It should not be administered to patients with lactose intolerance or genetic lactose metabolism disorders. Patients with impaired liver function may have increased serum levels of this medication, so dosing should be adjusted, particularly in severe liver impairment, where the dosage must not exceed 20 mg per day. Caution is advised when administering to elderly patients due to the possibility of adverse reactions. Symptoms such as headaches, drowsiness, dizziness, and insomnia may occur, and, rarely, severe symptoms such as confusion or hallucinations may develop. Abnormal liver function may occur, so if liver enzyme tests show abnormalities, the medication should be discontinued, and in severe liver disease, encephalopathy may occur. Kidney function may be affected, so any kidney-related symptoms should be discussed immediately with healthcare professionals. Gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain may commonly occur, and rarely, dry mouth or stomatitis may also occur. Skin rashes, itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may develop, and if such symptoms occur, medication should be stopped immediately. Rare allergic reactions such as angioedema and anaphylactic shock may require caution. Cardiac symptoms such as chest pain, tachycardia, or bradycardia may occur. Blood abnormalities such as leukopenia or thrombocytopenia are reported rarely, and testing is needed if any abnormal symptoms arise. Musculoskeletal symptoms like myalgia or arthralgia may also occur. Gynecomastia may develop rarely. Other symptoms such as cough, fatigue, and vision disturbances have also been reported. Long-term use may lead to hypomagnesemia, so it is advisable to regularly check serum magnesium levels. Prolonged administration can decrease gastric acidity, increasing the risk of gastrointestinal bacterial infections; therefore, if diarrhea persists, consultation with healthcare professionals is necessary. Long-term use may lead to vitamin B12 absorption disorders, necessitating supplementation if needed. Autoimmune diseases like lupus erythematosus may occur, so if related symptoms manifest, medication should be stopped immediately, and consultation with a specialist is advised. The risk of gastric polyps exists with long-term use, so regular endoscopic examinations are recommended. If serious skin reactions occur, administration should be stopped immediately, and consultation with healthcare professionals should be sought. Pregnant women or those who may become pregnant should carefully weigh the risks and benefits of using this medication. Breastfeeding women should avoid administration if possible, and if necessary, breastfeeding should be discontinued. Safety for children has not been established, so caution is required. Overdose may present symptoms such as vomiting, diarrhea, and headaches, and while severe side effects are rare, immediate medical assistance should be sought. This medication should be kept out of reach of children and stored tightly sealed and in its original container.

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, fecal incontinence, 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, muscle weakness, myalgia, gynecomastia, cough, asthenia, lethargy, peripheral edema, increased sweating, blurred vision, visual impairment, taste disorders, breast pain in women, breast lump in women, 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 polyps, hypocalcemia, hypokalemia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with upper reddish brown and lower pink parts filled with light yellow enteric-coated granules.

Package unit

28 capsules/bottle

Same-ingredient medicines

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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.