Medication info
Omeprazole Capsules (Omeprazole)

Omeprazole Capsules (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›230mg / 1 capsule
Manufacturer / importer
(Co., Ltd.) Donggu Bio Pharmaceutical
Appearance
A hard capsule with a reddish-brown upper part and a pink lower part filled with white to grayish-white delayed-release granules.
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 200401456 · Notified 2004.09.23 · Insurance code 657302850

Summary

Main use
Treatment and prevention of gastrointestinal disorders (ulcers, erosions, etc.), gastroesophageal reflux, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1. Adults 1) Gastric ulcer Administer omeprazole 20mg orally once a day. Most ulcers may heal within 4 weeks, although the healing period may vary from patient to patient. If not healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the ulcer recurs. 2) Short-term treatment of duodenal ulcer Administer 20mg orally once a day. Most ulcers may heal within 2 weeks, although the healing period may vary from patient to patient. If not healed after the initial 2 weeks of treatment, continue treatment for another 2 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 4 weeks, although the healing period may vary from patient to patient. Repeat treatment if the ulcer recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.) ⑴ Reflux esophagitis Administer 20mg orally once a day. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If not healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the condition recurs. ⑵ Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.) Administer 20mg orally once a day. 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 a day. If the condition recurs, the dose may be increased to 40mg once a day. 5) Zollinger-Ellison syndrome The initial dose is 60mg orally once a day. Continue treatment, adjusting the dose appropriately for each individual. More than 90% of patients respond to doses of 20~120mg per day. If administering more than 80mg per day, divide the dose into 2 doses per day. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: ⑴ Dual therapy Administer this medicine 20mg and amoxicillin 750 ~ 1000mg twice a day for 2 weeks. ⑵ Triple therapy Administer this medicine 40mg once a day or 20mg twice a day in combination with the following antibiotics. ① Administer clarithromycin 250mg and metronidazole 400mg twice a day for 1 week, or ② Administer amoxicillin 1g and clarithromycin 500mg twice a day for 1 week. If the therapeutic effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs) Administer 20mg orally once a day. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If not 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 a day. 9) Prevention of recurrence of reflux esophagitis To prevent recurrence of reflux esophagitis, administer 10mg orally once a day. 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
(Co., Ltd.) Donggu Bio Pharmaceutical

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • severe gastroesophageal reflux disease
  • peptic ulcer
  • duodenal ulcer
  • gastric ulcer
  • duodenal ulcer
  • erosion
  • dyspepsia symptoms
  • gastroesophageal reflux disease
View approved original text

This medication is used for the short-term treatment of gastric and duodenal ulcers. It also helps in relieving symptoms associated with gastroesophageal reflux disease (GERD) such as heartburn and regurgitation. It is effective as maintenance therapy for severe gastroesophageal reflux disease and difficult-to-treat peptic ulcers. It is also used to prevent recurrence of duodenal ulcers due to Zollinger-Ellison syndrome and Helicobacter pylori infection, and is beneficial in the treatment and prevention of gastric and duodenal ulcers and erosions caused by non-steroidal anti-inflammatory drugs (NSAIDs). Additionally, it helps in the prevention of gastric lesions and dyspepsia symptoms in patients receiving NSAIDs, and in preventing the recurrence of gastroesophageal reflux disease. This medication is used for the treatment and prevention of various gastrointestinal diseases.

How to take

Adult dose

1. Adults 1) Gastric ulcer Administer omeprazole 20mg orally once a day. Most ulcers may heal within 4 weeks, although the healing period may vary from patient to patient. If not healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the ulcer recurs. 2) Short-term treatment of duodenal ulcer Administer 20mg orally once a day. Most ulcers may heal within 2 weeks, although the healing period may vary from patient to patient. If not healed after the initial 2 weeks of treatment, continue treatment for another 2 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 4 weeks, although the healing period may vary from patient to patient. Repeat treatment if the ulcer recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.) ⑴ Reflux esophagitis Administer 20mg orally once a day. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If not healed after the initial 4 weeks of treatment, continue treatment for another 4 weeks. In patients who have not responded to other preparations, administration of 40mg once a day usually results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the condition recurs. ⑵ Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.) Administer 20mg orally once a day. 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 a day. If the condition recurs, the dose may be increased to 40mg once a day. 5) Zollinger-Ellison syndrome The initial dose is 60mg orally once a day. Continue treatment, adjusting the dose appropriately for each individual. More than 90% of patients respond to doses of 20~120mg per day. If administering more than 80mg per day, divide the dose into 2 doses per day. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: ⑴ Dual therapy Administer this medicine 20mg and amoxicillin 750 ~ 1000mg twice a day for 2 weeks. ⑵ Triple therapy Administer this medicine 40mg once a day or 20mg twice a day in combination with the following antibiotics. ① Administer clarithromycin 250mg and metronidazole 400mg twice a day for 1 week, or ② Administer amoxicillin 1g and clarithromycin 500mg twice a day for 1 week. If the therapeutic effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs) Administer 20mg orally once a day. Most cases may heal within 4 weeks, although the healing period may vary from patient to patient. If not 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 a day. 9) Prevention of recurrence of reflux esophagitis To prevent recurrence of reflux esophagitis, administer 10mg orally once a day. 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 used in patients who are allergic to its components. It should be used with caution in patients with gastric ulcers suspected of malignancy, as symptoms may be concealed leading to delayed diagnosis. It may interact with certain antiviral or antitubercular agents; thus, co-administration should be avoided. In patients with reduced liver function, metabolism of this medication may be slower; therefore, dosage should be adjusted and used cautiously, particularly in patients with severe hepatic impairment, where the dosage should not exceed 20 mg per day. Elderly patients should also be administered this medication with caution. This medication may cause neurological symptoms such as headache, dizziness, and drowsiness, and may raise liver enzyme levels or present hepatitis symptoms. If any abnormalities occur, the medication should be discontinued immediately. Rarely, inflammation of the kidneys may occur, leading to renal failure; hence, kidney function should also be monitored carefully. Common gastrointestinal symptoms include diarrhea, nausea, and abdominal pain. If a skin rash or severe allergic reaction occurs, medication should be stopped immediately. Other reported side effects include irregular heartbeat, decreased blood cells, muscle pain, and gynecomastia. Prolonged use may cause vitamin B12 absorption impairment or hypomagnesemia, necessitating regular monitoring. This medication may reduce gastric acidity, increasing the risk of bacterial infections in the gastrointestinal tract; hence, if diarrhea persists, medical attention should be sought. Women who are pregnant or may become pregnant should consult a physician, as its use may affect the fetus. It is advisable to avoid this medication during breastfeeding; if necessary to take it, breastfeeding should be discontinued. Safety in children has not been established, so caution is advised when administering to children. In cases of overdose, symptoms may include vomiting, diarrhea, and headache; in severe cases, changes in mental status may occur, necessitating immediate medical intervention. Store the medication out of reach of children, do not change the container, and ensure the lid is tightly closed after use.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feelings of faintness, vertigo, confusion, excitation, aggressiveness, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, melena, 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, joint pain, muscle weakness, myalgia, gynecomastia, cough, asthenia, malaise, peripheral edema, increased sweating, visual blurriness, vision impairment, taste disturbance, mastalgia, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized pustular psoriasis, drug reactions with eosinophilia and systemic symptoms, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyps, hypocalcemia, hypokalemia

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

Storage

This medication may be sensitive to air or moisture, thus should be stored in a sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

A hard capsule with a reddish-brown upper part and a pink lower part filled with white to grayish-white delayed-release granules.

Package unit

30 capsules/bottle

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.