Medication info
Celltrion Omeprazole Capsule 20 Milligrams (Omeprazole)

Celltrion Omeprazole Capsule 20 Milligrams (Omeprazole)

Prescription medicationHard capsuleOral
Ingredient · strength
Omeprazole Enteric Coated Granules›233mg / 1 capsule
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a reddish-brown upper part and a pinkish-red lower part filled with pale yellow delayed-release granules.
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201704833 · Approved 2017.06.27 · Insurance code 693902540

Summary

Main use
Treatment and prevention of gastroesophageal reflux, ulcers, erosions, dyspepsia, and Zollinger-Ellison syndrome
Who takes it
Adults
Adult dose
1) Gastric ulcer Administer 1 capsule (20mg) of omeprazole orally once daily. Most cases may heal within 4 weeks, although the healing time may vary 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 medicines, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. 2) Short-term treatment of duodenal ulcer Administer 1 capsule (20mg) orally once daily. Most cases may heal within 2 weeks, although the healing time may vary 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 medicines, taking 2 capsules (40mg) once daily generally results in healing within 4 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): ㆍ Reflux esophagitis: Administer 1 capsule (20mg) orally once daily. Most cases may heal within 4 weeks, although the healing time may vary 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 medicines, administering 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. ㆍ Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 1 capsule (20mg) orally once daily. Healing is generally possible after 2~4 weeks of treatment. 4) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 1 capsule (20mg) orally once daily. If the condition recurs, the dose may be increased to 2 capsules (40mg) once daily. 5) Zollinger-Ellison syndrome The initial dose is 3 capsules (60mg) orally once daily. Adjust the dose as appropriate for the individual patient and continue treatment. More than 90% of patients respond to doses of 1~6 capsules (20~120mg) daily. If more than 4 capsules (80mg) daily are administered, divide the dose into 2 administrations per day. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori ㆍ Dual therapy: Administer 1 capsule (20mg) of this medicine with 750-1000mg of amoxicillin twice daily for 2 weeks. ㆍ Triple therapy: In combination with the following antibiotics, administer 2 capsules (40mg) of this medicine once daily or 1 capsule (20mg) twice daily. 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 gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 1 capsule (20mg) orally once daily. Most cases may heal within 4 weeks, although the healing time may vary among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Prevention and maintenance treatment of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients with a history of gastric or duodenal lesions who are receiving long-term NSAID treatment: Administer 1 capsule (20mg) orally once daily. 9) Prevention of recurrence of reflux esophagitis To prevent recurrence of reflux esophagitis, administer 1/2 capsule (10mg) orally once daily. * When taking this medicine, swallow it whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of gastroesophageal reflux, ulcers, erosions, dyspepsia, and Zollinger-Ellison syndrome

  • Gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease symptoms
  • heartburn
  • expulsion
  • peptic ulcer
  • Zollinger-Ellison syndrome
  • Helicobacter pylori infection
  • gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug (NSAID) treatment
  • erosions
  • dyspeptic symptoms.
View approved original text

This medication is used for the short-term treatment of gastric and duodenal ulcers, effectively relieving symptoms of gastroesophageal reflux disease (GERD) such as heartburn and expulsion. It is also used as maintenance therapy for severe gastroesophageal reflux disease and poorly healing peptic ulcers, and it assists in the treatment of Zollinger-Ellison syndrome. It is used in combination with antibiotics to prevent the recurrence of duodenal ulcers caused by Helicobacter pylori infection. Additionally, it is effective in treating and preventing gastric and duodenal ulcers or erosions due to non-steroidal anti-inflammatory drugs (NSAIDs). This medication helps prevent dyspeptic symptoms in patients with a history of gastric and duodenal lesions when on long-term NSAID therapy. Overall, it is used to maintain the health of the digestive system and to treat and prevent related diseases.

How to take

Adult dose

1) Gastric ulcer Administer 1 capsule (20mg) of omeprazole orally once daily. Most cases may heal within 4 weeks, although the healing time may vary 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 medicines, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. 2) Short-term treatment of duodenal ulcer Administer 1 capsule (20mg) orally once daily. Most cases may heal within 2 weeks, although the healing time may vary 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 medicines, taking 2 capsules (40mg) once daily generally results in healing within 4 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): ㆍ Reflux esophagitis: Administer 1 capsule (20mg) orally once daily. Most cases may heal within 4 weeks, although the healing time may vary 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 medicines, administering 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. Repeat treatment if the condition recurs. ㆍ Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 1 capsule (20mg) orally once daily. Healing is generally possible after 2~4 weeks of treatment. 4) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 1 capsule (20mg) orally once daily. If the condition recurs, the dose may be increased to 2 capsules (40mg) once daily. 5) Zollinger-Ellison syndrome The initial dose is 3 capsules (60mg) orally once daily. Adjust the dose as appropriate for the individual patient and continue treatment. More than 90% of patients respond to doses of 1~6 capsules (20~120mg) daily. If more than 4 capsules (80mg) daily are administered, divide the dose into 2 administrations per day. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori ㆍ Dual therapy: Administer 1 capsule (20mg) of this medicine with 750-1000mg of amoxicillin twice daily for 2 weeks. ㆍ Triple therapy: In combination with the following antibiotics, administer 2 capsules (40mg) of this medicine once daily or 1 capsule (20mg) twice daily. 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 gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 1 capsule (20mg) orally once daily. Most cases may heal within 4 weeks, although the healing time may vary among patients. If healing is incomplete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) Prevention and maintenance treatment of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID use in patients with a history of gastric or duodenal lesions who are receiving long-term NSAID treatment: Administer 1 capsule (20mg) orally once daily. 9) Prevention of recurrence of reflux esophagitis To prevent recurrence of reflux esophagitis, administer 1/2 capsule (10mg) orally once daily. * When taking this medicine, swallow it whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication should not be administered to patients with allergies to any of its components. For patients with gastric ulcers suspected of being malignant, caution is warranted, as this medication can temporarily alleviate symptoms and delay diagnosis. This medication cannot be used in conjunction with certain antiviral agents, so it must be discussed with healthcare professionals before combined administration. Patients with genetic metabolic issues such as lactose intolerance or glucose-galactose malabsorption should not take this medication. Patients with impaired liver function should use this medication cautiously, reducing the dosage, especially those with severe liver impairment who should not exceed 20mg per day. Elderly patients should also use this medication with caution. This medication may lead to neurological symptoms such as headache, drowsiness, dizziness, and, rarely, severe psychiatric symptoms. Liver enzyme levels may increase or liver function abnormalities may occur, so if any unusual symptoms arise, the medication should be discontinued immediately. Gastrointestinal issues such as diarrhea, nausea, abdominal pain may frequently occur, so careful observation is necessary during episodes. Severe skin reactions such as rash, itching, and, in severe cases, Stevens-Johnson syndrome may occur, necessitating immediate discontinuation if skin abnormalities develop. Allergic reactions can result in angioedema or shock, requiring prompt treatment if any unusual symptoms arise. This medication has also been reported to cause side effects including a decrease in blood cell counts, myalgia, and gynecomastia. Long-term use may lead to electrolyte disturbances such as hypomagnesemia, requiring regular blood tests. This medication may suppress gastric acid secretion, increasing the risk of certain bacterial infections, so if symptoms of infections like diarrhea persist, consultation with a healthcare provider is necessary. There are many drug interactions, particularly with anticoagulants, anticonvulsants, immunosuppressants, etc., so adjustments in dosage and monitoring as directed by healthcare providers is needed when taken together. During pregnancy, it may affect the fetus, so it should only be administered after consulting with a physician, and it should be avoided during breastfeeding or breastfeeding should be stopped while taking it. Safety for pediatric use has not been established, thus it is not recommended for use in children. In case of overdose, symptoms such as vomiting, diarrhea, and headaches may occur, requiring immediate visit to a medical facility if symptoms are severe. This medication should be kept out of reach of children, should not be transferred to another container, and the cap should be securely closed after use.

Side effects

Headache, drowsiness, dizziness, insomnia, paresthesia, presyncope, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, loose 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, fatigue, peripheral edema, increased sweating, visual disturbance, vision impairment, taste disturbance, breast pain, 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, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, 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, avoiding exposure to air or moisture. It is best to maintain a room temperature between 1 and 30 degrees to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

A hard capsule with a reddish-brown upper part and a pinkish-red lower part filled with pale yellow delayed-release granules.

Package unit

28 capsules/bottle

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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.