Medication info
Daehan New Pharm Omeprazole Capsule (Omeprazole)

Daehan New Pharm Omeprazole Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
A hard capsule with the upper part being reddish-brown and the lower part pink, filled with light yellow enteric-coated granules
Packaging
28 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 200302518 · Notified 2003.04.23 · Insurance code 669900700

Summary

Main use
Treatment and prevention of reflux disease and gastrointestinal disorders (e.g., ulcers and erosions), including Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
◎ Adults 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers heal within 4 weeks, although the healing period may vary from patient to patient. If the ulcer has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary 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 from patient to patient. If the ulcer has not healed after the initial 2-week course, continue treatment for an additional 2 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 4 weeks, although the healing period may vary from patient to patient. 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 heal within 4 weeks, although the healing period may vary from patient to patient. If the condition has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary from patient to patient. If the condition recurs, repeat treatment. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Treatment for 2~4 weeks is generally sufficient for healing. 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 with the dose adjusted individually as appropriate. More than 90% of patients respond to doses of 20 - 120mg per day. If doses of 80mg or more per day are administered, divide the daily dose into 2 doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer 20mg of this medicine with 750 - 1000mg of amoxicillin twice daily for 2 weeks. - Triple therapy: Administer 40mg of this medicine 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 insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric/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 from patient to patient. If the condition has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. 8) Maintenance therapy to prevent gastric/duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric/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. * When taking this medicine, swallow it whole with at least half a glass of water. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • gastroesophageal reflux disease
  • peptic ulcer
  • recurrence of duodenal 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 helps alleviate symptoms such as heartburn and regurgitation associated with gastroesophageal reflux disease (GERD). It is effective for maintenance therapy in severe gastroesophageal reflux disease and poorly treated peptic ulcers. It is used in the treatment of Zollinger-Ellison syndrome and may be included in combination therapy with antibiotics to prevent the recurrence of duodenal ulcers due to Helicobacter pylori infection. It is suitable for the treatment and prevention of gastric and duodenal ulcers and erosions caused by non-steroidal anti-inflammatory drugs (NSAIDs). Overall, it is used for the treatment and prevention of diseases related to the stomach and esophagus.

How to take

Adult dose

◎ Adults 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Most ulcers heal within 4 weeks, although the healing period may vary from patient to patient. If the ulcer has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary 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 from patient to patient. If the ulcer has not healed after the initial 2-week course, continue treatment for an additional 2 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 4 weeks, although the healing period may vary from patient to patient. 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 heal within 4 weeks, although the healing period may vary from patient to patient. If the condition has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. In patients who have not responded to other therapies, a dose of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary from patient to patient. If the condition recurs, repeat treatment. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Treatment for 2~4 weeks is generally sufficient for healing. 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 with the dose adjusted individually as appropriate. More than 90% of patients respond to doses of 20 - 120mg per day. If doses of 80mg or more per day are administered, divide the daily dose into 2 doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer 20mg of this medicine with 750 - 1000mg of amoxicillin twice daily for 2 weeks. - Triple therapy: Administer 40mg of this medicine 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 insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric/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 from patient to patient. If the condition has not healed after the initial 4-week course, continue treatment for an additional 4 weeks. 8) Maintenance therapy to prevent gastric/duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric/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. * When taking this medicine, swallow it whole with at least half a glass of water. Adjust the dose appropriately according to age and symptoms.

Precautions

This medication should not be administered to patients who are allergic to its components. Caution is needed when administering it to patients with gastric ulcers suspicious for malignancy, as it may mask symptoms or delay diagnosis. It should not be taken with certain antiviral drugs, and patients with lactose intolerance or specific genetic metabolic disorders should not use it. Adjustments in dosage or careful use are necessary for patients with impaired liver function or the elderly. Neurological symptoms such as headaches, dizziness, drowsiness, and gastrointestinal disturbances as well as skin rashes may occur, so consultation with a physician is recommended if abnormal symptoms appear. Severe liver damage, nephritis, or serious skin reactions may rarely occur; patients should immediately notify healthcare providers if symptoms worsen. Regular monitoring for the possibility of malignancies like gastric cancer is needed with long-term use, as well as considering the increased risk of fractures and the potential for hypomagnesemia. There are many interactions with other medications, so it is crucial to inform healthcare providers about any other medications being taken, especially anticoagulants, antibiotics, and immunosuppressants. Women who are pregnant or nursing should carefully assess the risks and benefits of using this medication and should avoid use if possible or discontinue breastfeeding. Safety for use in pediatric patients has not been established, so it is advisable not to use it in children. Suspected overdose may present symptoms such as vomiting, diarrhea, headaches, and psychiatric disorders, requiring immediate medical attention. This medication should be kept out of the reach of children, and it is important not to change the storage container and to securely tightly close the lid after use.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, vertigo, confusion, agitation, aggressiveness, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, soft stools, constipation, nausea, vomiting, abdominal pain, abdominal bloating, 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, malaise, peripheral edema, increased sweating, blurred vision, visual disturbances, taste disturbance, breast pain in women, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized pustular psoriasis, eosinophilia with systemic symptoms drug reaction, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms drug reaction, acute generalized pustular psoriasis, acute interstitial nephritis, nausea, apathy

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

A hard capsule with the upper part being reddish-brown and the lower part pink, filled with light yellow enteric-coated granules

Package unit

28 capsules/bottle, 300 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.