Medication info
Omeprazole Magnesium Trihydrate 40 mg Tablets

Omeprazole Magnesium Trihydrate 40 mg Tablets

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
(주)새한제약
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201905244 · Approved 2019.07.23 · Insurance code 651300750

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis) and treatment of Helicobacter pylori-positive peptic ulcers, with effects on treatment and prevention of NSAID-related gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid, such as water, and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily - If needed, 20 mg once daily
Children's dosage
Adolescents aged 12 years and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily - Symptoms

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis) and treatment of Helicobacter pylori-positive peptic ulcers, with effects on treatment and prevention of NSAID-related gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • Helicobacter pylori infection
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication helps treat erosive esophagitis caused by gastroesophageal reflux disease and prevents recurrence, as well as improves symptoms. It is also effective in the eradication of Helicobacter pylori when used in combination with antibiotic therapy, and in the treatment and prevention of duodenal ulcers and peptic ulcers. It provides short-term relief of upper gastrointestinal symptoms associated with NSAID use and is used for the treatment and prevention of gastric ulcers that may occur with long-term administration. Additionally, it is used in the maintenance therapy for Zollinger-Ellison syndrome and for the prevention of rebleeding in gastric or duodenal ulcers. Thus, it aids in the treatment and prevention of various gastrointestinal diseases, improving patient health.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, such as water, and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily - If needed, 20 mg once daily

Children's dosage

Adolescents aged 12 years and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily - Symptoms

Precautions

This medication should not be administered to certain patients. Avoid use if there is a history of allergy or hypersensitivity to this medication, its ingredients, or similar drugs. Patients currently taking specific antibiotics or antiviral medications, those with a history of myocardial infarction, and breastfeeding women should also avoid this medication. When taking this medication, various side effects may occur, so caution is necessary. Common gastrointestinal symptoms include headache, abdominal pain, diarrhea, nausea, and vomiting, while rare but serious symptoms may include blood abnormalities, allergic reactions, mental changes, liver function abnormalities, and skin rash. Particularly, long-term use may lead to electrolyte imbalances such as hypomagnesemia, so regular blood tests are necessary. This medication inhibits gastric acid secretion, which may slightly increase the risk of bacterial infections in the stomach. Moreover, long-term use may increase the risk of fractures, so patients with osteoporosis risk should consult with their doctors. This medication can interact with various drugs; therefore, it is crucial to inform healthcare professionals about any other medications being taken, particularly anticoagulants, antibiotics, antiviral medications, and anticonvulsants. Due to limited data on safety during pregnancy, it should be used only under a doctor's guidance when necessary, and use should be avoided while breastfeeding. In case of overdose, no specific antidote is available, requiring symptomatic treatment and general management. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, hepatic jaundice, hepatitis, liver failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalized exanthematous pustulosis, DRESS syndrome, interstitial nephritis, Clostridium difficile-associated diarrhea, sudden and severe headache, lightning headache, seizure, confusion, visual disturbances, paralysis, markedly reduced urine output, generalized severe edema

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reactions, back pain, chest pain, sternal pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP x 2)

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.

Questions about this medicine

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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.