Medication info
Banzelis Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Banzelis Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

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

MFDS item code 201904444 · Approved 2019.06.28 · Insurance code 697100830

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance therapy effect for preventing rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
The tablet should be swallowed whole with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks is recommended. - Maintenance therapy to prevent recurrence: 20 mg once daily. - Treatment of symptoms without esophagitis: 20 mg once daily. After symptom relief,
Children's dosage
Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks of treatment may be necessary. - Treatment of symptoms without esophagitis

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance therapy effect for preventing rebleeding from gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive reflux 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 is used for the treatment of gastroesophageal reflux disease, particularly for long-term maintenance therapy to treat erosive reflux esophagitis and prevent recurrence. It is also effective for treating and preventing recurrence of duodenal ulcers and peptic ulcers associated with Helicobacter pylori infection. It helps alleviate upper gastrointestinal symptoms or treat and prevent gastric ulcers due to the use of non-steroidal anti-inflammatory drugs. It is used in the treatment of Zollinger-Ellison syndrome, and can also be utilized as maintenance therapy after preventing rebleeding from gastric or duodenal ulcers. Overall, it is used to improve symptoms and prevent recurrence of various conditions related to gastrointestinal diseases.

Dosage and Administration

Adult dosage

The tablet should be swallowed whole with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks is recommended. - Maintenance therapy to prevent recurrence: 20 mg once daily. - Treatment of symptoms without esophagitis: 20 mg once daily. After symptom relief,

Children's dosage

Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks of treatment may be necessary. - Treatment of symptoms without esophagitis

Precautions

This medication should not be administered to certain patients. Patients with a known allergy to this medication or its components, or with a history of hypersensitivity to benzimidazoles, should not take it. Patients with hypersensitivity to antibiotics such as amoxicillin or clarithromycin when undergoing Helicobacter pylori eradication therapy should exercise caution. Additionally, it is advisable for patients taking certain heart-related medications or antivirals, those with a history of myocardial infarction, and nursing women to avoid using this medication. Various adverse reactions may occur during treatment, with common symptoms reported including headache, abdominal pain, diarrhea, and dizziness. Rarely, blood abnormalities, liver function abnormalities, skin rashes, myalgia, and neurological symptoms may occur, and if any symptoms are severe or persist, immediate consultation with healthcare providers is advised. Particularly with prolonged use, electrolyte imbalances such as hypomagnesemia can occur, necessitating regular blood tests. Moreover, this medication suppresses gastric acid secretion, which may increase the risk of bacterial overgrowth in the gastrointestinal tract, so patients should inform their healthcare provider if diarrhea persists for an extended period. This medication has a high potential for interactions with other drugs, especially when used in combination with anticoagulants, anticonvulsants, antidepressants, and antivirals, so caution is advised. Data on safety during pregnancy is limited, so pregnant women should only take this medication after consulting with their doctor, and it is recommended that breastfeeding women do not take this medication. In case of overdose, there is no specific antidote, and symptomatic treatment based on the symptoms is necessary, and it is important to keep this medication out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, fever, angioedema, anaphylactic reactions, agranulocytosis, pancytopenia, hyponatremia, hypomagnesemia, hepatitis, liver failure, jaundice, skin and mucosal adverse reactions (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, Clostridium difficile

Mild side effects

Headache, insomnia, agitation, confusion, depression, aggression, hallucinations, dizziness, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, asthenia, increased sweating, Clostridium difficile-associated diarrhea, facial swelling, facial flushing,

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

Storage

This medication may be sensitive to air and moisture; therefore, it is important to store it in a tightly closed container. Additionally, it should be stored at room temperature, between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations. This will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink circular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu*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.