Medication info
Omex Capsule (Omeprazole)

Omex Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Youngpoong Pharmaceutical Co., Ltd.
Appearance
It is a hard capsule with a reddish-brown upper part and a pinkish-red lower part, filled with enteric-coated granules that are white to light brown in color.
Packaging
For export - 16 capsules/box [(8 capsules/pouch × 2)], for domestic use - 32 capsules/box [(8 capsules/pouch × 4)], for domestic use - 30 capsules/bottle, for domestic use - 100 capsules/bottle
Approval status
Active

MFDS item code 199802675 · Notified 1998.04.24 · Insurance code 661901360

Summary

Main use
Treatment and prevention of gastroesophageal reflux, gastrointestinal disorders (including ulcers and erosions), and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 8 weeks, although the healing period may vary in some patients. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most cases may heal within 2 weeks, although the healing period may vary in some patients. If not completely healed after the initial 2 weeks of treatment, continue treatment for another 2 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 4 weeks, although the healing period may vary in some patients. If the ulcer recurs, repeat treatment. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 8 weeks, although the healing period may vary in some patients. If the condition recurs, repeat treatment. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Healing is generally possible with treatment for 2~4 weeks. 4) Maintenance therapy 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. 5) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose appropriately for each individual. More than 90% of patients can be effectively treated with a dose of 20 - 120mg per day; when administering more than 80mg per day, divide the dose into 2 administrations per day. 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 effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric or duodenal ulcers or erosions caused by administration of nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. 8) 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. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, administer 10mg orally once daily. Swallow this medicine whole with at least half a cup of water. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Youngpoong Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Symptoms of gastric ulcer
  • duodenal ulcer
  • reflux esophagitis
  • gastroesophageal reflux disease
  • heartburn
  • emesis
  • severe reflux esophagitis
  • peptic ulcer
  • Zollinger-Ellison syndrome
  • Helicobacter pylori infection
  • gastric or duodenal ulcers due to NSAID use
  • erosions
View approved original text

This medication is used for the short-term treatment of gastric ulcers and duodenal ulcers. It is also effective in alleviating symptoms of gastroesophageal reflux disease (GERD) and reflux esophagitis. It is utilized as a maintenance therapy for severe reflux esophagitis or hard-to-treat peptic ulcers. It is used in the treatment of Zollinger-Ellison syndrome and serves as part of combination antibiotic therapy to prevent recurrence of duodenal ulcers caused by Helicobacter pylori infection. It is also helpful in treating and preventing gastric and duodenal ulcers or erosions that may occur due to the administration of nonsteroidal anti-inflammatory drugs (NSAIDs). Overall, it is effectively used in the treatment and recurrence prevention of gastric and duodenal lesions as well as reflux esophagitis.

How to take

Adult dose

1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 8 weeks, although the healing period may vary in some patients. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most cases may heal within 2 weeks, although the healing period may vary in some patients. If not completely healed after the initial 2 weeks of treatment, continue treatment for another 2 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 4 weeks, although the healing period may vary in some patients. If the ulcer recurs, repeat treatment. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to treatment with other preparations, administering 40mg once daily usually results in healing within 8 weeks, although the healing period may vary in some patients. If the condition recurs, repeat treatment. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Healing is generally possible with treatment for 2~4 weeks. 4) Maintenance therapy 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. 5) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose appropriately for each individual. More than 90% of patients can be effectively treated with a dose of 20 - 120mg per day; when administering more than 80mg per day, divide the dose into 2 administrations per day. 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 effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric or duodenal ulcers or erosions caused by administration of nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary in some patients. If not completely healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. 8) 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. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, administer 10mg orally once daily. Swallow this medicine whole with at least half a cup of water. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication should not be used in patients who are allergic to its components. It should not be administered to patients with gastric ulcers suspected of being malignant, as symptom relief may delay diagnosis. Drug interactions may occur if taken with certain antiviral or antituberculosis medications; therefore, co-administration should be avoided. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication due to lactose inclusion. Patients with impaired liver function may have elevated concentrations of this medication, thus requiring dosage adjustments, particularly in patients with severe liver disease. Elderly patients should be carefully monitored as drug metabolism and excretion may be delayed. Symptoms such as headache, dizziness, and drowsiness may occur while taking this medication; rare but serious mental health symptoms can also occur. If symptoms of liver dysfunction appear, discontinue the medication immediately, as severe hepatitis or liver failure may lead to encephalopathy. This medication may affect renal function; therefore, prompt treatment is required if symptoms of renal impairment arise. Gastrointestinal side effects such as diarrhea, nausea, and abdominal pain can frequently occur, necessitating caution if these symptoms arise. Skin rashes, itching, and in severe cases, serious skin reactions may occur, necessitating discontinuation if atypical symptoms arise. Allergic reactions such as angioedema, bronchospasm, and anaphylaxis can rarely occur. Cardiovascular symptoms such as chest pain or palpitations may arise; thus, monitoring for symptoms is necessary. Hematological adverse reactions, including leukopenia, have been rarely reported, and blood tests may be necessary. Long-term use may increase the risk of fractures; therefore, dosage and treatment duration should be minimized. Hypomagnesemia may occur, necessitating regular blood tests and supplementation when used long-term or in combination with certain drugs. This medication reduces gastric acidity and may increase the risk of certain bacterial infections, so if diarrhea persists, inform a healthcare provider. During pregnancy, it should only be used when absolutely necessary due to potential effects on the fetus, and during breastfeeding, administration should be avoided or breastfeeding should be discontinued. Safety in pediatric patients has not been established, thus caution is necessary when administering to children. In case of overdose, symptoms such as vomiting, dizziness, and headache may occur, but these are usually temporary and serious consequences are rare. This medication should be kept out of reach of children, not stored in another container, 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, hematochezia, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, 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, muscle weakness, myalgia, gynecomastia, cough, asthenia, lethargy, peripheral edema, increased sweating, blurred vision, visual disturbances, taste disturbances, mastalgia, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction, 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 must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

It is a hard capsule with a reddish-brown upper part and a pinkish-red lower part, filled with enteric-coated granules that are white to light brown in color.

Package unit

For export - 16 capsules/box [(8 capsules/pouch × 2)], for domestic use - 32 capsules/box [(8 capsules/pouch × 4)], for domestic use - 30 capsules/bottle, for domestic use - 100 capsules/bottle

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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.