Medication info
Lapius Tablet 10 mg (Rabeprazole Sodium)

Lapius Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
Pale yellow round enteric-coated tablet
Packaging
For domestic use - 28 tablets/box [14 tablets/Alu Alu packaging * 2]
Approval status
Active

MFDS item code 201908287 · Approved 2019.12.08

Summary

Main use
Effective relief of symptoms related to gastric ulcers and gastroesophageal reflux disease and treatment of Helicobacter pylori infection
Who takes it
Adults
Adult dose
Gastric ulcer, duodenal ulcer: For adults, administer 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, can also administer 20 mg orally once daily. Generally, treatment is for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. After 8 weeks of proton pump inhibitor (PPI) therapy if not resolved, an additional 8 weeks of 10 mg or 20 mg can be administered twice daily, provided that 20 mg twice daily is only for patients confirmed to have severe mucosal damage. Symptom relief for gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms do not resolve after 4 weeks, additional medical treatment may be necessary. After symptoms disappear, an on-demand treatment with 10 mg once daily may be used to manage any subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should receive eradication therapy. The recommended regimen is to administer this drug at 20 mg with clarithromycin at 500 mg and amoxicillin at 1 g, twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg daily depending on individual patient needs. Doses up to 100 mg can be given once daily, while a 120 mg dose should be divided into two doses of 60 mg per day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ Patients with liver disorders Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ◯ Pediatrics Safety has not been established in pediatric patients. ◯ Elderly Administer cautiously due to common reductions in liver function.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Effective relief of symptoms related to gastric ulcers and gastroesophageal reflux disease and treatment of Helicobacter pylori infection

  • Gastric ulcer
  • duodenal ulcer
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • symptoms of gastroesophageal reflux disease
  • Helicobacter pylori infection digestive ulcer
  • Zollinger-Ellison syndrome
View approved original text

This medication is used to treat ulcers in the stomach and duodenum and is also effective for symptom relief and long-term maintenance therapy for gastroesophageal reflux disease. Additionally, it is used in combination with antibiotics to treat digestive ulcers in patients infected with Helicobacter pylori, and it helps with conditions related to excessive stomach acid secretion, such as Zollinger-Ellison syndrome. Thus, it is broadly used for the treatment of various gastrointestinal disorders.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: For adults, administer 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, can also administer 20 mg orally once daily. Generally, treatment is for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. After 8 weeks of proton pump inhibitor (PPI) therapy if not resolved, an additional 8 weeks of 10 mg or 20 mg can be administered twice daily, provided that 20 mg twice daily is only for patients confirmed to have severe mucosal damage. Symptom relief for gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms do not resolve after 4 weeks, additional medical treatment may be necessary. After symptoms disappear, an on-demand treatment with 10 mg once daily may be used to manage any subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should receive eradication therapy. The recommended regimen is to administer this drug at 20 mg with clarithromycin at 500 mg and amoxicillin at 1 g, twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg daily depending on individual patient needs. Doses up to 100 mg can be given once daily, while a 120 mg dose should be divided into two doses of 60 mg per day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ Patients with liver disorders Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ◯ Pediatrics Safety has not been established in pediatric patients. ◯ Elderly Administer cautiously due to common reductions in liver function.

Precautions

This medication should not be used by patients with specific allergic reactions or those who have experienced hypersensitivity to this drug or its components. Patients with allergies to penicillin and macrolide antibiotics, as well as those taking certain heart-related medications, should avoid taking this drug. Women who are pregnant or breastfeeding should not take this medication. Patients with liver function issues, elderly patients, and those with a history of drug hypersensitivity should use this medication with caution. This drug may cause allergic symptoms such as skin rash, hives, or itching, and if symptoms occur, it should be discontinued immediately. Regular blood tests may be necessary as changes in red blood cell or white blood cell counts can occur. Liver function abnormalities may also develop, thus periodic liver function tests are recommended. This medication can affect the cardiovascular system; thus, caution is advised if heart-related symptoms occur. Gastrointestinal symptoms such as diarrhea, constipation, stomach pain, and nausea may occur, so if discomfort persists, consult a healthcare professional. Central nervous system symptoms may include headache, dizziness, and insomnia, with rare reports of confusion or depression. Respiratory symptoms such as cough or difficulty breathing may occur, so notify your healthcare provider if any unusual symptoms arise. Musculoskeletal symptoms such as muscle pain or joint pain may also be experienced. Severe skin reactions such as rash or hair loss, and in severe cases, Stevens-Johnson syndrome may occur. Abnormal symptoms related to the eyes have been reported, and caution should be taken if there are visual disturbances or eye pain. Urinary symptoms such as difficulty urinating or hematuria may appear, so inform your healthcare provider if any abnormalities occur. This medication may increase the risk of bone fractures when used long-term, so caution is advised when using it for an extended period. Additionally, prolonged use may result in hypomagnesemia, so regular monitoring of serum magnesium levels is recommended. This drug suppresses stomach acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract, so consult a healthcare provider if diarrhea persists. Caution is needed when driving or operating machinery due to potential drowsiness. Interactions may occur with other medications, so it is essential to inform your healthcare provider of any medications being taken. Particularly, caution is required when used in conjunction with antibiotics, antiviral agents, and anticoagulants. The safety of this drug has not been established in pregnant or breastfeeding women, so it is advisable not to use it. Elderly patients may be more likely to experience side effects due to reduced liver function, so they should inform healthcare providers immediately if symptoms occur. The safety in pediatric patients has not been established, and experience with use is limited. In case of overdose, there is no specific antidote, and treatment and supportive care should be based on the symptoms. This medication should be swallowed whole and not chewed or crushed, and it should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mouth/eyes, severe skin adverse reactions, breathlessness or difficulty breathing, asthma attacks, respiratory complications accompanying coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache, vomiting

Mild side effects

  • Rash
  • itching
  • hives
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
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  • petechiae
  • lymphadenopathy
  • hypopigmented anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart block

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 exposure to air or moisture. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

For domestic use - 28 tablets/box [14 tablets/Alu Alu packaging * 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.

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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.