Medication info
Omeprazole Capsule 20mg (Omeprazole)

Omeprazole Capsule 20mg (Omeprazole)

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

MFDS item code 201906572 · Approved 2019.09.19 · Insurance code 055800280

Summary

Main use
Treatment and prevention of gastrointestinal disorders (such as ulcers and indigestion), reflux disease, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1. Adults 1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most ulcers may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 4) 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 respond to doses of 20 - 120mg per day. If administering more than 80mg per day, divide the dose into 2 administrations per day. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to heal: Administer 20mg orally once daily. If recurrence occurs, 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 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 treatment response is inadequate, 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 may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Preventive maintenance therapy for gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients requiring long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. * When taking this medicine, swallow it whole with at least half a cup of water. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Selvion Co., Ltd.

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • heartburn
  • regurgitation
  • peptic ulcer
  • gastric and duodenal ulcer
  • erosion
  • dyspepsia.
View approved original text

This medication is used for the short-term treatment of gastric ulcers and duodenal ulcers. It is also effective for relieving symptoms of gastroesophageal reflux disease (GERD) and reflux esophagitis. It can be used in the treatment of Zollinger-Ellison syndrome and as maintenance therapy for severe reflux esophagitis and difficult-to-treat peptic ulcers. It is included in the antibiotic combination therapy to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. It is effective for the treatment and prevention of gastric and duodenal ulcers or erosions that may occur due to non-steroidal anti-inflammatory drugs (NSAIDs). Thus, this medication is used for the treatment and prevention of various gastrointestinal-related diseases.

How to take

Adult dose

1. Adults 1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most ulcers may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete 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 occasionally vary by patient. If recurrence occurs, repeat treatment. 4) 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 respond to doses of 20 - 120mg per day. If administering more than 80mg per day, divide the dose into 2 administrations per day. 5) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to heal: Administer 20mg orally once daily. If recurrence occurs, 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 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 treatment response is inadequate, 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 may heal within 4 weeks, although the healing period may occasionally vary by patient. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Preventive maintenance therapy for gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients requiring long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. * When taking this medicine, swallow it whole with at least half a cup of water. Adjust the dose appropriately according to age and symptoms.

Precautions

This medicine should not be used in patients with hypersensitivity to its ingredients. Caution is needed when administering to patients with gastric ulcers suspected of being malignant, as symptoms may improve or diagnosis may be delayed. This medicine should not be used in conjunction with certain antiviral agents such as Atazanavir and Rilpivirine. It should not be administered to patients with congenital lactose intolerance. Patients with impaired liver function should adjust the dose of this medicine, and particularly those with severe liver dysfunction should not exceed 20mg per day. Caution should be exercised when administering to the elderly. While taking this medication, symptoms such as headache, drowsiness, dizziness, and insomnia may occur. If abnormal symptoms appear, such as an increase in liver enzyme levels or severe liver diseases like hepatitis or liver failure, the medication should be discontinued. It may rarely cause renal tubular inflammation, affecting the kidneys and urinary tract. Gastrointestinal side effects such as diarrhea, nausea, and abdominal pain may commonly occur. Allergic reactions may occur, such as skin rash, itching, and hives, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may occur, so immediate discontinuation is required if symptoms appear. Hypersensitivity reactions, including angioedema and anaphylactic shock, may rarely occur. Cardiac symptoms such as chest pain or palpitations may occur. Blood abnormalities such as leukopenia and thrombocytopenia have been reported rarely. Musculoskeletal pain or muscle weakness may occur. Prolonged use may lead to hypomagnesemia, so regular blood tests are necessary. This medication can suppress gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract, so if diarrhea persists, medical consultation should be sought. Prolonged use may increase the risk of gastric fundic polyps, so the minimum dose and treatment duration should be observed. This medication may interact with various drugs, so if other medications are being taken, it is essential to inform healthcare providers. Pregnant women should use it cautiously under medical supervision due to potential risks to the fetus, and nursing mothers should avoid administration or discontinue breastfeeding. Safety in pediatrics has not been established. In case of overdose, symptoms such as vomiting, diarrhea, and headache may appear but are generally temporary. This medicine should be kept out of the reach of children and should not be stored in changing containers.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, vertigo, confusion, excitement, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, hepatic 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, blurry vision, vision impairment, taste disturbance, breast pain in females, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

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

Storage

This medicine should be stored in a tightly sealed container to prevent contact with air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help to maintain the efficacy and safety of the medication for a longer time.

Appearance and packaging

Appearance

A hard capsule with an upper reddish-brown and lower pink color filled with pale yellow enteric-coated granules.

Package unit

28 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.