Medication info

Nexomera Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2)
Approval status
Active

MFDS item code 201604088 · Approved 2016.06.29

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment of benign peptic ulcer associated with Helicobacter pylori, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, and prevention and treatment of gastrointestinal disorders.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid, such as water, and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further clinical assessment is needed. · Once symptoms are alleviated, any ongoing symptoms should be managed with 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer on an as-needed basis for patients at high risk of developing gastric and duodenal ulcers due to NSAID use.
Children's dosage
Adolescents aged 12 years and over - Treatment of gastroesophageal reflux disease (GERD) - Erosive esophagitis treatment: 40 mg orally once daily for 4 weeks - If symptoms persist, additional 4 weeks of treatment.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment of benign peptic ulcer associated with Helicobacter pylori, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, and prevention and treatment of gastrointestinal disorders.

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

This medication helps treat gastroesophageal reflux disease and erosive esophagitis and prevents recurrence. It is also used for the treatment and prevention of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection and alleviates abdominal pain or discomfort associated with the short-term use of non-steroidal anti-inflammatory drugs (NSAIDs). It is effective for the treatment and prevention of gastric and duodenal ulcers potentially caused by prolonged NSAID use. The medication may be used as maintenance therapy for Zollinger-Ellison syndrome and to prevent rebleeding from gastric or duodenal ulcers. Overall, it is utilized broadly in the treatment and prevention of gastrointestinal-related diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, such as water, and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further clinical assessment is needed. · Once symptoms are alleviated, any ongoing symptoms should be managed with 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer on an as-needed basis for patients at high risk of developing gastric and duodenal ulcers due to NSAID use.

Children's dosage

Adolescents aged 12 years and over - Treatment of gastroesophageal reflux disease (GERD) - Erosive esophagitis treatment: 40 mg orally once daily for 4 weeks - If symptoms persist, additional 4 weeks of treatment.

Precautions

This medication should not be used in specific patients. For instance, patients who are allergic or have experienced hypersensitivity reactions to this medication or its components, patients allergic to certain antibiotics, patients currently taking specific heart-related medications, and breastfeeding females or patients with a history of myocardial infarction should not take this medication. This medication contains the pigment yellow No. 5, and patients with allergies or hypersensitivity to this ingredient should use it with caution. This medication may cause various side effects. Common symptoms include headache, abdominal pain, diarrhea, constipation, and nausea, while rare symptoms can include blood abnormalities, skin rashes, liver function abnormalities, muscle pain, and neurological symptoms. Serious side effects such as severe skin reactions or muscle damage have also been reported, and if symptoms appear, immediate consultation with medical personnel is required. Regular testing is necessary during long-term use, particularly if used for over one year, as electrolyte imbalances such as hypomagnesemia may occur; hence magnesium levels should be checked periodically. This medication may interact with other drugs; therefore, it is imperative to inform healthcare personnel about any medications currently being taken, particularly when using antiviral agents, anticoagulants, antibiotics, or anticonvulsants. If pregnant or breastfeeding, it is crucial to consult with a doctor before using this medication, and it is not recommended during breastfeeding. In the case of overdose, there is no specific antidote, so appropriate treatment should be administered according to symptoms, and it should be kept out of reach of children. When using this medication, it is essential to follow the doctor's instructions regarding the minimum dosage and appropriate duration of use.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, shock, severe allergic reactions, jaundice, hepatitis, liver failure, encephalopathy, abnormal liver function, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, severe skin reactions, deep vein thrombosis, QT prolongation, ventricular tachycardia, ventricular fibrillation, Torsades de pointes, serious cardiac side effects.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, 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 avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius to safely preserve the effectiveness of the medication over time.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.