Medication info
New Vera Tablet 10 mg (Rabeprazole Sodium)

New Vera Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
Pale yellow round enteric-coated tablet
Packaging
28 tablets (28 tablets/PTP × 1)
Approval status
Active

MFDS item code 201603478 · Approved 2016.06.15 · Insurance code 053600050

Summary

Main use
Relief of symptoms of gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease, and treatment of Helicobacter pylori infection
Who takes it
Adults · Children
Adult dose
Gastric ulcer, duodenal ulcer: The usual dosage for adults is 10 mg of rabeprazole sodium administered orally once daily. Depending on the symptoms, 20 mg may be administered orally once daily. The duration of treatment is generally up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer either 10 mg or 20 mg once daily for 4 to 8 weeks. If the condition has not improved after 8 weeks of treatment, additional therapy may be warranted.
Child dose
Safety in pediatric patients has not been established.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Relief of symptoms of gastric ulcers, duodenal 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
  • gastrointestinal ulcer with Helicobacter pylori infection
  • Zollinger-Ellison syndrome
View approved original text

This medicine is used to treat gastric and duodenal ulcers, and is effective in alleviating uncomfortable symptoms caused by gastroesophageal reflux disease. It is also used for long-term maintenance therapy of gastroesophageal reflux disease and is administered with antibiotics for patients with gastrointestinal ulcers infected with Helicobacter pylori to assist in cure. It is also used to treat conditions associated with excessive gastric acid secretion, such as Zollinger-Ellison syndrome. Overall, it is a very useful drug for treating various gastrointestinal related diseases and improving symptoms.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: The usual dosage for adults is 10 mg of rabeprazole sodium administered orally once daily. Depending on the symptoms, 20 mg may be administered orally once daily. The duration of treatment is generally up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer either 10 mg or 20 mg once daily for 4 to 8 weeks. If the condition has not improved after 8 weeks of treatment, additional therapy may be warranted.

Child dose

Safety in pediatric patients has not been established.

Precautions

This medication should not be used by patients who have had allergic reactions or hypersensitivity to specific components. Additionally, this medication should not be administered to patients taking certain antibiotics or antivirals, or to pregnant or breastfeeding women. Patients with impaired liver function, elderly patients, and those with a history of drug allergies should use this medication with extra caution. If allergic reactions such as skin rashes or itching occur while taking this medication, use should be discontinued immediately. Regular blood tests are necessary as changes in red or white blood cell counts may occur. Symptoms of liver dysfunction can also appear, so liver function tests should be carried out periodically. This medication may affect the heart or blood vessels and gastrointestinal symptoms such as abdominal pain, diarrhea, or nausea may occur. There may be central nervous system effects causing headaches, insomnia, or dizziness, so caution is needed. Respiratory symptoms, muscle pain, skin rashes, and visual disturbances have also been reported. Long-term use of this medicine may increase the risk of bone fractures, and low blood magnesium levels may require periodic monitoring. Suppression of gastric acid secretion may increase the risk of certain bacterial infections, so if diarrhea persists, consult a healthcare provider. Caution is advised when driving or operating machinery as drowsiness may occur. There may be interactions with other medications, especially when taken with anticoagulants, antibiotics, antifungals, or antivirals, so consultation with a professional is necessary. It is safer for pregnant and breastfeeding women to avoid this medication, and caution is needed with elderly patients as side effects may be more easily apparent due to decreased liver function. Safety has not been established in pediatrics, so it is advisable not to use it in children. This medication should be swallowed whole and not chewed or crushed, and it should be stored out of the reach of children. In cases of overdose, there is no specific antidote, so treatment should be symptomatic. Long-term use of this drug may result in impaired absorption of vitamin B12, so care is required.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, migraine, seizures, confusion, visual disturbances, paralysis, acute interstitial nephritis, toxic epidermal necrolysis (Lyell's syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), respiratory distress, asthma attacks, elevated blood pressure, systemic allergic reactions (hypotension, difficulty breathing, facial swelling, etc.), sudden death, coma, anaphylaxis,

Mild side effects

  • Rash
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
  • petechial hemorrhage
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  • lymphadenopathy
  • hypopigmented anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • increased ALT
  • increased AST
  • increased ALP
  • increased GTP
  • increased LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal ECG
  • migraine
  • syncope
  • angina
  • cardiac block
  • palpitations

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This ensures that the drug's efficacy is well maintained and degradation is prevented.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets (28 tablets/PTP × 1)

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

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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.