Medication info
SOPIRAZOLE Tablet 20mg (Esomeprazole Magnesium Trihydrate)

SOPIRAZOLE Tablet 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
케이엠에스제약(주)
Appearance
Pale pink round film-coated tablet
Packaging
Domestic - 28 tablets/PPT [28 tablets (14 tablets/Alu-Alu×2)], Domestic - 28 tablets/PPT [28 tablets (7 tablets/Alu-Alu×4)]
Approval status
Active

MFDS item code 201907091 · Approved 2019.10.07 · Insurance code 654702020

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 and duodenal ulcers, treatment of Zollinger-Ellison syndrome, efficacy of maintenance therapy for the prevention of gastric ulcer rebleeding
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophageal reflux disease: 40 mg once daily for 4 weeks. For those not cured or with lingering symptoms, an additional 4 weeks of treatment. - Maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: once daily,
Children's dosage
Adolescents over 12 years old 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophageal reflux disease: 40 mg once daily for 4 weeks. For those not cured or with lingering symptoms, an additional 4 weeks of treatment.

Ingredients

Manufacturer
케이엠에스제약(주)

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 and duodenal ulcers, treatment of Zollinger-Ellison syndrome, efficacy of maintenance therapy for the prevention of gastric ulcer rebleeding

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

This medication is used for the treatment of gastroesophageal reflux disease, erosive gastroesophageal reflux disease, and maintenance therapy to prevent recurrence in patients with esophagitis. It is also effective for the treatment of duodenal ulcers and peptic ulcers in combination with antibiotics to eradicate Helicobacter pylori. It helps treat and prevent gastrointestinal symptoms due to the use of non-steroidal anti-inflammatory drugs. It is also used in the treatment of Zollinger-Ellison syndrome and is suitable for maintenance therapy to prevent rebleeding after bleeding from gastric or duodenal ulcers. Overall, it is widely used to treat various symptoms and diseases related to gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophageal reflux disease: 40 mg once daily for 4 weeks. For those not cured or with lingering symptoms, an additional 4 weeks of treatment. - Maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: once daily,

Children's dosage

Adolescents over 12 years old 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophageal reflux disease: 40 mg once daily for 4 weeks. For those not cured or with lingering symptoms, an additional 4 weeks of treatment.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this medication or its components, or have had hypersensitivity reactions, should not take it. Also, caution is needed for those allergic to penicillin antibiotics or macrolide antibiotics. This medication may interact with certain antiviral or cardiac-related medications, so if you are taking these medications, you must consult a physician. It is advisable for breastfeeding women not to take this medication. This medication contains yellow pigments, so individuals with allergic reactions to these pigments should use it with caution. Various side effects may occur during use; if unusual symptoms such as headache, dizziness, abdominal pain, diarrhea, rash, muscle pain arise, immediate consultation with medical personnel is necessary. Particularly, if muscle pain or weakness worsens, it could be a serious condition such as rhabdomyolysis, requiring prompt action. If this medication is taken for a long time, regular check-ups are necessary to monitor health status, as the risk of gastrointestinal infections may slightly increase; so if diarrhea persists, inform a physician. Additionally, long-term use may increase the risk of bone fractures, and caution is needed for those at risk of osteoporosis. This medication can interact with other medications, so if you are currently taking any medications, you must inform medical personnel, especially when combined with anticoagulants, antiviral drugs, and antibiotics. The safety of this medication during pregnancy has not been fully confirmed, so if you are pregnant or planning to become pregnant, the decision to use it should be made after consulting a physician. It is safest not to take this medication while breastfeeding. There is no specific antidote in the case of overdose, so if symptoms occur, immediately seek appropriate medical treatment. This medication should be kept out of reach of children, and transferring it to another container is discouraged.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, shock, severe allergic reactions, microscopic colitis, jaundice, hepatitis, hepatic failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction, DRESS syndrome, nephritis, severe swelling, severe edema or urinary abnormalities, severe neurological symptoms, seizures

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, 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, nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile associated diarrhea, allergic reactions, back pain, chest pain, substernal pain, eye discomfort

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

Storage

This medication is easily affected by air or moisture, so it must be stored in a tightly closed container. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. It is safe to avoid extremely hot or cold places.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

Domestic - 28 tablets/PPT [28 tablets (14 tablets/Alu-Alu×2)], Domestic - 28 tablets/PPT [28 tablets (7 tablets/Alu-Alu×4)]

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.