Medication info
Esomeprazole Magnesium Trihydrate 40 mg Tablets

Esomeprazole Magnesium Trihydrate 40 mg Tablets

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets × 2 EA (Alu-Alu))
Approval status
Active

MFDS item code 201500108 · Approved 2015.01.12 · Insurance code 660702760

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs and prevention and treatment of 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: 20 mg once daily - Symptomatic treatment: 20 mg once daily, possible additional doses as needed after symptom relief.
Children's dosage
Adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Symptomatic treatment: 20 mg once daily,

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment and prevention of recurrence of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs and prevention and treatment of gastric ulcers.

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

This medication is used for the long-term maintenance therapy for the treatment of gastroesophageal reflux disease, particularly erosive esophagitis, and to prevent recurrence in patients with esophagitis. It also helps alleviate symptoms in gastroesophageal reflux disease without esophagitis. This medication is combined with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcer disease associated with Helicobacter pylori infection. It is used short-term for treating upper gastrointestinal pain or discomfort related to the use of non-steroidal anti-inflammatory drugs and is effective for treating gastric ulcers and preventing ulcers in patients requiring long-term treatment. It can also be used for maintaining therapy after preventing rebleeding caused by gastric or duodenal ulcers in Zollinger-Ellison syndrome. This medication is utilized for treating various gastrointestinal diseases and improving symptoms.

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: 20 mg once daily - Symptomatic treatment: 20 mg once daily, possible additional doses as needed after symptom relief.

Children's dosage

Adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks - Symptomatic treatment: 20 mg once daily,

Precautions

This medication should not be administered to certain patients. It is not to be used in patients who have shown hypersensitivity to this drug or any of its components, or to benzimidazole derivatives. Additionally, patients with hypersensitivity to penicillin or macrolide antibiotics, which are used in combination for the eradication of Helicobacter pylori, should not take this medication. Patients taking specific heart-related drugs or antiviral agents, and nursing mothers should also refrain from using this medication. When taking this drug, various adverse reactions may occur. For instance, reports have included decreased blood cell counts, allergic reactions, electrolyte imbalances, mental changes, headaches, dizziness, gastrointestinal disturbances, etc. Rarely, serious skin diseases or liver dysfunction, muscle damage, and other symptoms may occur, so if unusual symptoms arise, consult a physician promptly. Regular check-ups are necessary for long-term use of this medication. Particularly for those who have been on this medication for more than one year, health status should be confirmed through blood tests or electrolyte tests. Additionally, if symptoms change or new symptoms appear while taking this medication, it is essential to consult a physician. This medication lowers stomach acid secretion, which may slightly increase the risk of bacterial infections within the stomach. Hospitalized patients or those with weakened immune systems should be cautious of symptoms of infections, such as diarrhea. Patients at risk of osteoporosis or fractures should monitor bone health when taking this medication for extended periods. Moreover, hypomagnesemia may occur with prolonged use, so it is important to periodically check magnesium levels. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your healthcare provider. In particular, when taken with anticoagulants, anticonvulsants, antidepressants, and antiviral agents, it is crucial to closely observe for changes in blood concentrations or possible side effects. Data on the safety of this medication during pregnancy is limited; thus, pregnant women should carefully discuss its use with their doctors. Nursing mothers are advised not to take this medication. In case of overdose, since there is no specific antidote, symptomatic treatment based on the symptoms is necessary, and this medication is not removed through dialysis, so treatment should be followed as per medical staff's instructions. This medication should be kept out of reach of children, and transferring it to another container may lead to a decline in quality or pose risks, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, jaundice, hepatitis, hepatic failure, Steven-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, severe edema, asthma attacks, respiratory distress, rhabdomyolysis, severe neurological symptoms (seizures, altered consciousness, visual disturbances, paralysis), severe

Mild side effects

Headache, dizziness, sensory disturbance, drowsiness, taste disorder, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, joint pain, muscle pain, interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, retrosternal pain, facial edema, facial flushing,

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

Storage

This medication is prone to being easily affected by air or moisture, so it must be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets × 2 EA (Alu-Alu))

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.