Medication info
Roputine Tablet 10mg (Rabeprazole)

Roputine Tablet 10mg (Rabeprazole)

Prescription medicationTabletOral
Ingredient · strength
Lafutidine›10mg / 1 tablet
Manufacturer / importer
NBK Pharmaceuticals Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201908447 · Approved 2019.12.16 · Insurance code 054800600

Summary

Main use
Treatment of gastrointestinal disorders (ulcers, gastritis, gastroesophageal reflux disease), preanesthetic medication, and use in combination for eradication therapy
Who takes it
Adults
Adult dose
1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine per dose, administered orally twice daily in the morning and at bedtime. Clinical trials in which treatment was administered for up to 8 weeks showed that most ulcers healed within 8 weeks, although the healing period may occasionally vary among patients. 2. Short-term treatment of duodenal ulcers: The usual dose is 10mg of lafutidine per dose, administered orally twice daily in the morning and at bedtime. Clinical trials in which treatment was administered for up to 6 weeks showed that most ulcers healed within 6 weeks, although the healing period may occasionally vary among patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis: The usual dose is 10mg of lafutidine orally once daily at bedtime. Clinical trials in which treatment was administered for up to 2 weeks showed that most lesions healed within 2 weeks, although the healing period may occasionally vary among patients. 4. Combination therapy with antibiotics for patients with peptic ulcers infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 days or 14 days. 5. Premedication before anesthesia: The usual dose is 10mg of lafutidine per dose, administered orally twice (at bedtime on the day before surgery and 2 hours before administration of anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer 10mg of lafutidine per dose orally twice daily.

Ingredients

Manufacturer
NBK Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (ulcers, gastritis, gastroesophageal reflux disease), preanesthetic medication, and use in combination for eradication therapy

  • Gastric ulcer
  • duodenal ulcer
  • acute gastritis
  • chronic gastritis mucosal lesions
  • peptic ulcer
  • gastroesophageal reflux disease
View approved original text

This medication is used for the treatment of gastric ulcers and duodenal ulcers, and helps improve gastric mucosal damage caused by acute and chronic gastritis. Additionally, it is used in conjunction with antibiotics for patients with peptic ulcers infected by Helicobacter pylori to enhance treatment effectiveness. It is also used to suppress gastric acid secretion when administered before anesthesia and to alleviate symptoms of gastroesophageal reflux disease. It is effectively used for the treatment and symptom improvement of various gastrointestinal-related diseases.

How to take

Adult dose

1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine per dose, administered orally twice daily in the morning and at bedtime. Clinical trials in which treatment was administered for up to 8 weeks showed that most ulcers healed within 8 weeks, although the healing period may occasionally vary among patients. 2. Short-term treatment of duodenal ulcers: The usual dose is 10mg of lafutidine per dose, administered orally twice daily in the morning and at bedtime. Clinical trials in which treatment was administered for up to 6 weeks showed that most ulcers healed within 6 weeks, although the healing period may occasionally vary among patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis: The usual dose is 10mg of lafutidine orally once daily at bedtime. Clinical trials in which treatment was administered for up to 2 weeks showed that most lesions healed within 2 weeks, although the healing period may occasionally vary among patients. 4. Combination therapy with antibiotics for patients with peptic ulcers infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 days or 14 days. 5. Premedication before anesthesia: The usual dose is 10mg of lafutidine per dose, administered orally twice (at bedtime on the day before surgery and 2 hours before administration of anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer 10mg of lafutidine per dose orally twice daily.

Precautions

This medication should not be used in patients who are allergic to its components. It also contains lactose; therefore, patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid taking it. Caution is advised when administering to patients with a history of allergic reactions to medication, those with impaired liver or kidney function, patients undergoing dialysis, and elderly patients, and their conditions must be closely monitored. This medication can rarely cause a severe allergic reaction called anaphylactic shock; if symptoms such as facial pallor, hypotension, skin flushing, or breathing difficulties occur after administration, it should be immediately discontinued, and appropriate treatment should be provided. There may be symptoms of liver dysfunction or jaundice, so regular liver function tests should be conducted, and the medication should be discontinued if abnormalities are found. Blood-related adverse symptoms such as agranulocytosis or thrombocytopenia may arise, so if symptoms such as sore throat, general malaise, or fever occur, consult a doctor immediately. This medication has been reported to cause various side effects such as skin rash, seizures, and heart block, so it's vital to notify medical staff if any unusual symptoms occur. Diverse side effects in the gastrointestinal, central nervous, circulatory, blood, liver, and kidney systems have been reported in clinical trials and post-marketing surveys, so careful monitoring is necessary. Patients suspected of having malignant tumors must undergo diagnostic tests before taking this medication, and if malignant gastric cancer is identified, it should be discontinued immediately. During treatment, the progress of the disease should be closely monitored, and if not effective, it is advisable to switch to another treatment method. Elderly patients must be careful with dosing and intervals due to reduced physical functions. Dialysis patients may have increased blood concentration, so it should be started at a low dose and monitored. Pregnant women or women who may become pregnant should take it carefully according to the doctor's judgment, and breastfeeding women should avoid taking it as it may be excreted in breast milk. Safety for children has not been established; therefore, it is preferable not to administer this medication to children. This medication should be kept out of reach of children and stored in its original container to maintain its quality. Carcinogenicity has not been observed in animal experiments; however, hyperplasia of neuroendocrine cells has been reported at high doses, and some side effects appeared in reproductive toxicity tests, although no fetal malformations were observed.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • pallor
  • hypotension
  • generalized urticaria
  • dyspnea
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • generalized fatigue
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Lyell syndrome
  • rhabdomyolysis
  • heart block
  • inadequate contraction
  • constipation
  • diarrhea
  • hard stool
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • altered consciousness
  • dizziness
  • chills
  • heat sensation
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • anemia
  • decreased hematocrit
  • increased ALT
  • increased AST
  • increased Al-P
  • increased γ-GTP
  • increased T-Bil
  • increased LDH
  • increased TTT
  • abnormal urine protein
  • increased BUN
  • elevated serum uric acid
  • increased Cl
  • delayed maturation
  • increased Na
  • decreased K
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • nasopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea corporis
  • carotid artery stenosis
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • productive cough
  • fatigue
  • chest pain
  • limb pain
  • arthralgia
  • neck pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic fatty liver disease

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

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.