Medication info
Neomazole 40 mg (Esomeprazole Magnesium Trihydrate)

Neomazole 40 mg (Esomeprazole Magnesium Trihydrate)

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

MFDS item code 201506666 · Approved 2015.09.21 · Insurance code 652903830

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (NSAIDs), treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effectiveness of maintenance therapy to prevent rebleeding from 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 reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks should be taken. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily.
Children's dosage
For adolescents aged 12 and older: - Treatment for gastroesophageal reflux disease (GERD) erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks should be taken. - Symptom treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (NSAIDs), treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effectiveness of maintenance therapy to prevent rebleeding from gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive reflux 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 treatment of gastroesophageal reflux disease, particularly erosive reflux esophagitis, and for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps alleviate symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers confirmed to be associated with Helicobacter pylori infection. It is effective as a short-term therapy for the treatment of gastrointestinal pain, discomfort, burning sensation, and other symptoms related to the use of non-steroidal anti-inflammatory drugs. Additionally, it is used for the treatment and prevention of gastric ulcers in patients requiring continuous use of non-steroidal anti-inflammatory drugs. This medication is effectively used for a variety of gastrointestinal disorders.

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 reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks should be taken. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily.

Children's dosage

For adolescents aged 12 and older: - Treatment for gastroesophageal reflux disease (GERD) erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks should be taken. - Symptom treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily.

Precautions

This medication should not be administered to certain patients. Patients with hypersensitivity to this drug or its components, or to benzimidazole derivatives, should not use it. In addition, when used in combination with amoxicillin or clarithromycin for the eradication of Helicobacter pylori, it should not be given to patients who have hypersensitivity to penicillin antibiotics or macrolide antibiotics. Patients who are taking specific heart-related medications, or those taking atazanavir and nelfinavir, nursing mothers, and patients with a history of myocardial infarction should not use this medication. This medication may cause various adverse reactions. Gastrointestinal symptoms such as headache, abdominal pain, diarrhea, nausea, and vomiting are frequently reported, with rare occurrences of blood abnormalities, skin rashes, liver function abnormalities, and neurological symptoms. Very rarely, serious adverse effects such as severe skin reactions or rhabdomyolysis may occur, so medical advice should be sought immediately if symptoms occur. Regular monitoring is important during long-term use. Particularly, with prolonged use exceeding one year, blood magnesium levels may be decreased, necessitating periodic monitoring. Additionally, as this medication inhibits gastric acid secretion, it may increase the risk of bacterial overgrowth in the gastrointestinal tract; therefore, if symptoms such as diarrhea persist, notify medical personnel. This medication may interact with other drugs. Changes in blood concentration can affect the efficacy of other medications, especially when used in conjunction with warfarin, phenytoin, diazepam, methotrexate, atazanavir, etc., so caution is required. Additionally, when used with certain antibiotics, it may affect the heart, so it must be used strictly according to a doctor's instructions. The safety of this medication during pregnancy has not been fully established, so it should be used with caution; it is advisable not to take this medication while nursing. In cases of overdose, there is no specific antidote, so appropriate treatment should be administered according to symptoms. This medication is not removed by dialysis, so care should be taken. Finally, this medication should be stored out of reach of children, and transferring it to other containers is not recommended as it may negatively affect quality.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions such as urticaria, angioedema, anaphylactic reactions/shock, severe skin reactions such as angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, eosinophilia, and drug reaction with systemic symptoms (DRESS syndrome), respiratory problems such as bronchospasm, shortness of breath, asthma attacks, hepatitis, hepatic failure, and jaundice.

Mild side effects

  • Frequent headaches
  • occasional dizziness
  • paresthesia
  • drowsiness
  • agitation
  • confusion
  • depression
  • insomnia
  • hallucinations
  • abdominal pain
Show 28 more
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • elevated liver enzymes
  • dermatitis
  • itching
  • rash
  • urticaria
  • hair loss
  • photosensitivity
  • arthralgia
  • myalgia
  • weakness
  • increased sweating
  • elevated blood pressure
  • exacerbation of asthma
  • cough
  • shortness of breath
  • abnormal urination
  • dysuria
  • albuminuria
  • cystitis
  • fungal infections
  • hematuria.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air or moisture exposure. It is important to maintain storage temperatures between 1° and 30°C to ensure the drug's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

PTP - 28 tablets/box [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.