Medication info

OPM Capsule (Omeprazole)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Mothers Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a red-brown upper part and a pink lower part filled with pale yellow enteric-coated granules.
Packaging
28 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 201310408 · Approved 2013.11.29

This product's status changed to Expired on 2023.11.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of gastrointestinal disorders (ulcers, erosions, and indigestion), reflux disease, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1) Gastric ulcer: Administer omeprazole 20mg per dose orally once daily. Most ulcers may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 8 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg per dose orally once daily. Most ulcers may heal within 2 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 4 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 3) Reflux esophagitis: Administer 20mg per dose orally once daily. Most cases may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 8 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg per dose orally once daily. Continue treatment with the dose adjusted as appropriate for each individual. More than 90% of patients respond to doses of 20 - 120mg daily. If administering more than 80mg daily, 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 per dose orally once daily. If recurrence occurs, the dose may be increased to 40mg per dose once daily. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcer 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 response is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg per dose orally once daily. Treatment is generally effective after 2-4 weeks of use. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg per dose orally once daily. Most cases may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg per dose orally once daily. * Take this medicine whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastrointestinal disorders (ulcers, erosions, and indigestion), 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 drug is used for the short-term treatment of gastric and duodenal ulcers. It alleviates and treats symptoms such as heartburn and regurgitation caused by gastroesophageal reflux disease (GERD). It is also effective for Zollinger-Ellison syndrome. It is used as maintenance therapy for severe gastroesophageal reflux disease and difficult-to-treat peptic ulcers. It can be administered together with antibiotics to prevent the recurrence of duodenal ulcers associated with Helicobacter pylori infection. Additionally, it helps treat and prevent gastric and duodenal ulcers or erosions caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the treatment and prevention of various digestive disorders.

How to take

Adult dose

1) Gastric ulcer: Administer omeprazole 20mg per dose orally once daily. Most ulcers may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 8 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg per dose orally once daily. Most ulcers may heal within 2 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 4 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 3) Reflux esophagitis: Administer 20mg per dose orally once daily. Most cases may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administering 40mg per dose once daily generally results in healing within 8 weeks, although healing time may vary occasionally among patients. Repeat treatment if recurrence occurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg per dose orally once daily. Continue treatment with the dose adjusted as appropriate for each individual. More than 90% of patients respond to doses of 20 - 120mg daily. If administering more than 80mg daily, 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 per dose orally once daily. If recurrence occurs, the dose may be increased to 40mg per dose once daily. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcer 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 response is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg per dose orally once daily. Treatment is generally effective after 2-4 weeks of use. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg per dose orally once daily. Most cases may heal within 4 weeks, although healing time may vary occasionally among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg per dose orally once daily. * Take this medicine whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

Precautions

This drug should not be used in patients with allergic reactions to its ingredients. It should not be administered to patients with gastric ulcers that may be malignant, as it may conceal symptoms or delay diagnosis. Certain antiviral or antiretroviral agents cannot be taken with this drug, so it is essential to consult a doctor. Patients who are genetically unable to digest lactose should not take this drug. Patients with impaired liver function should use this drug with caution and reduce the dosage, especially in cases of severe liver dysfunction. Elderly patients require extra caution when being administered this drug. Taking this drug may cause neurological symptoms such as headache, drowsiness, dizziness, insomnia, and, rarely, mental confusion or hallucinations. Regular monitoring of liver enzyme levels is necessary, and the drug should be discontinued if any abnormalities arise, as liver function may be affected. It may also impact kidney function, so caution is advised for patients with potential kidney issues. Common digestive system symptoms may include diarrhea, nausea, abdominal pain, etc. Skin reactions such as rashes, itching, and severe reactions like Stevens-Johnson syndrome may occur, so immediate discontinuation is required if any abnormal symptoms arise. Rarely, allergic reactions such as angioedema or anaphylaxis shock may occur. Cardiac symptoms like chest pain or palpitations may develop. Adverse reactions such as decreased blood cell count have been reported rarely. Muscle or joint pain may also occur. Gynecomastia may rarely develop as well. Long-term use of this drug can lead to electrolyte imbalances like hypomagnesemia, requiring regular blood tests. As this drug decreases gastric acidity, which can increase the risk of bacterial infections, medical attention is advised if diarrhea persists for an extended period. Long-term use may lead to gastric gland polyps or skin conditions associated with autoimmune diseases, necessitating periodic examinations. Women who are pregnant or may become pregnant should use this drug with caution as it may affect the fetus. Breastfeeding mothers are advised to avoid taking this drug, and if necessary, should discontinue breastfeeding. Safety in children has not been established, so it is preferable not to use it in pediatric patients. Overdosage may result in symptoms such as vomiting, dizziness, and headache, with serious side effects reported rarely. This drug should be stored out of the reach of children and not transferred to other containers but kept in its original container.

Side effects

headache, drowsiness, dizziness, insomnia, paresthesia, fainting sensation, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, flatulence, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticaria, pruritus, 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, fatigue, peripheral edema, increased sweating, blurred vision, visual impairment, taste disturbance, breast pain in women, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized pustular psoriasis, eosinophilia and systemic symptoms associated drug reaction, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

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

Storage

This drug should be stored in a tightly sealed container to avoid exposure to air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius. This helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A hard capsule with a red-brown upper part and a pink lower part filled with pale yellow enteric-coated granules.

Package unit

28 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

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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.