Medication info
Esomel 40 mg (Esomeprazole Magnesium Trihydrate)

Esomel 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Pink rectangular film-coated tablets
Packaging
28 tablets per box [(14 tablets/Alu-Alu x 2)]
Approval status
Active

MFDS item code 201600759 · Approved 2016.02.05 · Insurance code 646204190

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, etc.
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; if symptoms persist, an additional 4 weeks of treatment. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - For treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily for 4 weeks; if symptoms do not improve, further medical advice is necessary.
Children's dosage
Adolescents aged 12 and above: - For the treatment of erosive esophagitis: 40 mg once daily for 4 weeks; if symptoms persist, an additional 4 weeks of treatment. - For the treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

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

This medicine is used for the treatment of gastroesophageal reflux disease, especially erosive esophagitis, and to prevent recurrence in patients with esophagitis. It also helps treat and prevent recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It is effective in treating and preventing gastrointestinal symptoms and ulcers related to non-steroidal anti-inflammatory drugs. It is also used to treat Zollinger-Ellison syndrome and to prevent rebleeding from gastric or duodenal ulcers. Thus, it is widely used for the treatment and prevention of various gastrointestinal diseases.

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; if symptoms persist, an additional 4 weeks of treatment. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - For treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily for 4 weeks; if symptoms do not improve, further medical advice is necessary.

Children's dosage

Adolescents aged 12 and above: - For the treatment of erosive esophagitis: 40 mg once daily for 4 weeks; if symptoms persist, an additional 4 weeks of treatment. - For the treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Precautions

This medication should not be administered to certain patients. It should not be used in individuals with known allergies or hypersensitivity to this drug, its ingredients, or benzimidazole derivatives. Patients who have allergies to antibiotics like amoxicillin or clarithromycin, when used to eradicate Helicobacter pylori, should also avoid this medication. Patients taking specific heart-related medications or antiviral agents, nursing women, and those with a history of myocardial infarction should also refrain from using this drug. This medication can cause various side effects; therefore, caution is needed. Gastrointestinal symptoms like headache, abdominal pain, diarrhea, nausea, and vomiting can occur frequently. Rarely, various symptoms such as blood abnormalities, hypersensitivity reactions, hypomagnesemia, mental confusion, skin rashes, and muscle pain may arise. Particularly with prolonged use, magnesium deficiency may worsen, so periodic checks of magnesium levels in the blood are necessary. If severe skin reactions or muscle-related symptoms occur, immediate consultation with healthcare professionals is necessary. Due to its acid-suppressing action, the risk of bacterial infections in the gastrointestinal tract may slightly increase with prolonged use. Furthermore, for patients with osteoporosis or a high risk of fractures, long-term use may increase the risk of fractures, which may require bone density testing. This medication has many drug interactions; therefore, care should be taken with other medications being taken. In particular, when used with anticoagulants, anticonvulsants, certain antibiotics, antivirals, and immunosuppressants, there may be an increased risk of changes in drug concentrations or side effects, so consultation with a doctor or pharmacist is essential. When using this drug during pregnancy, safety data is limited, so caution is warranted; during breastfeeding, it is recommended to avoid use as the excretion of this drug into breast milk is unknown. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and general supportive care is necessary; it should be stored out of reach of children. Additionally, it is safer to keep it in its original packaging without transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, hypomagnesemia, mental confusion, anxiety, fever, jaundice, hepatitis, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), muscle weakness, interstitial nephritis, Clostridium difficile-associated diarrhea, severe skin reactions.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
Show 28 more
  • abdominal bloating
  • 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
  • abdominal bloating
  • allergic reactions
  • back pain
  • chest pain
  • sternal pain
  • facial edema
  • facial flushing
  • fatigue
  • fever
  • influenza.

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

Storage

This medicine must be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1°C to 30°C at room temperature.

Appearance and packaging

Appearance

Pink rectangular film-coated tablets

Package unit

28 tablets per 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.