Medication info
OcuZole Capsule (Omeprazole)

OcuZole Capsule (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Aprogen Biologics Co., Ltd.
Appearance
A hard capsule with a brown upper part and a reddish lower part filled with yellowish enteric-coated granules.
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 200400949 · Notified 2004.06.26 · Insurance code 645202260

Summary

Main use
Treatment and prevention of gastrointestinal disorders (ulcers, erosions, etc.), gastroesophageal reflux disease, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 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 among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose individually adjusted as appropriate. More than 90% of patients respond to doses of 20 - 120mg daily. If a dose of 80mg or more per day is administered, divide the daily dose into 2 doses. 5) Maintenance treatment of 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. 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 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 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 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 among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance therapy for prevention of 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. * Take this medicine whole with at least half a glass of water. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Aprogen Biologics Co., Ltd.

Efficacy & effects

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

  • Gastric ulcers
  • duodenal ulcers
  • heartburn
  • regurgitation
  • peptic ulcers
  • gastric and duodenal ulcers
  • erosions
  • dyspeptic symptoms
View approved original text

This medication is used for the short-term treatment of gastric ulcers and duodenal ulcers. It also helps in the treatment of gastroesophageal reflux disease (GERD) which is associated with symptoms such as heartburn and regurgitation. It is effective as maintenance therapy for severe gastroesophageal reflux disease and peptic ulcers that are not adequately treated, and is used in combination with antibiotics for the prevention of recurrence of duodenal ulcers caused by Zollinger-Ellison syndrome and Helicobacter pylori infection. It is also helpful in the treatment and prevention of gastric and duodenal ulcers or erosions caused by non-steroidal anti-inflammatory drugs (NSAIDs) and for gastrointestinal lesions and dyspeptic symptoms that may occur during long-term use of these medications. Additionally, it is effective in preventing the recurrence of gastroesophageal reflux disease, thus it is widely used for the treatment and prevention of various gastrointestinal disorders.

How to take

Adult dose

1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 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 among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary among patients. 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 medicines, a dose of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary among patients. Repeat treatment if the condition recurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose individually adjusted as appropriate. More than 90% of patients respond to doses of 20 - 120mg daily. If a dose of 80mg or more per day is administered, divide the daily dose into 2 doses. 5) Maintenance treatment of 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. 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 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 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 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 among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance therapy for prevention of 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. * Take this medicine 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. Caution should be taken in administering this medication to gastric ulcer patients suspected of having malignant tumors, as it may mask symptoms and delay diagnosis. Additionally, it should be avoided in patients taking specific antiviral agents such as atazanavir or rilpivirine. Patients with impaired liver function or the elderly should have their doses adjusted or be administered with caution. Various side effects such as headache, drowsiness, dizziness, dyspepsia, skin rashes may occur, and any unusual symptoms should be reported to healthcare professionals immediately. Long-term use may increase the risk of fracture, hypomagnesemia, and vitamin B12 malabsorption, thus regular check-ups are necessary. Long-term use of this medication may slightly increase the risk of gastrointestinal bacterial infections, so if diarrhea persists, consult a doctor. It may interact with other medications, particularly anticoagulants, anticonvulsants, and immunosuppressants, so it is essential to inform healthcare professionals if these medications are being taken. Women who are pregnant or breastfeeding should carefully consider the risks and benefits before using this medication, and it is recommended to avoid it if possible. It is recommended not to use in children as safety has not been established. In case of overdose, symptoms such as vomiting, diarrhea, and headache may occur, so immediate medical attention is necessary. This medication should be stored out of reach of children and should not be transferred to another container; after use, the cap should be tightly closed.

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, abdominal pain, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticarial, 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 impairment, taste disturbance, mastalgia, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it should be kept away from extreme temperatures, ideally at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with a brown upper part and a reddish lower part filled with yellowish 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.