Medication info

Subiradi Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ranitidine Hydrochloride›168mg / 1 tabletTripotassium Bismuth Dicitrate›200mg / 1 tabletSucralfate Hydrate›600mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Greenish rectangular film-coated tablet
Packaging
10 tablets - 10 tablets/bottle, 30 tablets - 30 tablets/bottle, 300 tablets - 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201903718 · Approved 2019.06.04

This product's status changed to Approval withdrawn on 2024.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric and duodenal ulcers and gastritis (including gastroesophageal reflux) and prevention of Mendelson's syndrome
Who takes it
Adults
Adult dose
Typically taken orally, 1 tablet twice a day in the morning and before bedtime, regardless of meals. 1) Gastric and duodenal ulcers Take 1 tablet twice a day or 2 tablets once a day before bedtime. 2) Gastroesophageal reflux Take 1 tablet twice a day for 8 weeks or 2 tablets once a day before bedtime. 3) Zollinger-Ellison syndrome Begin with an initial dose of 1 tablet three times a day.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Treatment of gastric and duodenal ulcers and gastritis (including gastroesophageal reflux) and prevention of Mendelson's syndrome

  • Gastric and duodenal ulcers
  • gastritis
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux
  • Mendelson's syndrome
  • postoperative ulcers
  • gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs
View approved original text

This medication is used for gastric and duodenal ulcers, gastritis, and conditions related to excessive gastric acid secretion such as Zollinger-Ellison syndrome. It is also effective in treating gastroesophageal reflux and helps prevent Mendelson's syndrome when administered before anesthesia. It is used to prevent and treat ulcers that may occur postoperatively and gastric/duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). This medication is effective in improving various gastrointestinal diseases.

How to take

Adult dose

Typically taken orally, 1 tablet twice a day in the morning and before bedtime, regardless of meals. 1) Gastric and duodenal ulcers Take 1 tablet twice a day or 2 tablets once a day before bedtime. 2) Gastroesophageal reflux Take 1 tablet twice a day for 8 weeks or 2 tablets once a day before bedtime. 3) Zollinger-Ellison syndrome Begin with an initial dose of 1 tablet three times a day.

Precautions

This medication should not be used in patients undergoing dialysis or those with severely impaired kidney function. Patients who have had an allergic reaction to this medication or its components should also avoid it. Patients who have had a rare disease called acute porphyria should exercise caution as this medication may exacerbate symptoms. It is best not to use this medication in patients who have undergone gastrointestinal surgery, are pregnant or may become pregnant, and in premature infants or newborns. Patients who need to restrict potassium intake should also avoid this medication. Patients with liver impairment, a history of drug allergies, elderly patients, and those who have had kidney issues should use this medication with caution. If taken together with non-steroidal anti-inflammatory drugs, there may be an increased risk of gastrointestinal bleeding, necessitating regular tests. This medication may mask symptoms of gastric cancer; therefore, patients over middle age with a newly occurring or changing dyspepsia should verify the absence of malignancy before use. Patients with gastric or duodenal ulcers infected with Helicobacter pylori should also receive eradicating therapy. Patients in severe intensive care may be at risk for gastric stones, hence caution is necessary. Patients with low phosphate levels should be careful as the aluminum content in this medication may hinder phosphate absorption. Patients who have difficulty swallowing may experience respiratory complications after taking this medication, thus caution is advised. While taking this medication, severe allergic reactions, skin rashes, blood disorders, liver dysfunction, cardiac arrhythmias, digestive disorders, and neurological abnormalities may occur rarely. If such symptoms appear, consult a doctor immediately and stop taking the medication. Long-term use of this medication should be avoided, and if there is no therapeutic effect, it should be changed to another medication. Regular blood tests, liver function tests, and kidney function tests are required. Elderly patients or those with chronic lung diseases, diabetes, or weakened immune systems may be at an increased risk of pneumonia while on this medication, thus caution is necessary. If dizziness or drowsiness occurs after taking, avoid driving or operating dangerous machinery. This medication may interact with other drugs, so inform your doctor or pharmacist of any other medications you are taking. Special caution is needed when taken with some antibiotics, anticonvulsants, anticoagulants, etc. It is safest for pregnant or breastfeeding women to avoid using this medication. Safety and efficacy in children have not been sufficiently documented, so its use is not recommended. In case of overdose, emergency measures such as vomiting or gastric lavage may be needed, and in certain cases, blood dialysis may be beneficial. This medication reduces gastric acid secretion, which may promote bacterial proliferation in the gastrointestinal tract, so regular check-ups including ophthalmological exams are necessary during prolonged use.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema (severe swelling), chest pain (tightness in the chest), bronchospasm, hypotension, anaphylactic shock (severe allergic reaction), jaundice, liver dysfunction (hepatitis, hepatocellular, cholestatic or mixed type), dizziness, confusion, convulsions, insomnia, mental confusion, seizures, consciousness disorders, convulsions, myoclonus, rhabdomyolysis, blood disorders (granulocytopenia, leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia)

Mild side effects

  • Skin rash
  • urticaria
  • angioedema
  • fever
  • bronchospasm
  • hypotension
  • chest pain
  • nausea
  • vomiting
  • constipation
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  • diarrhea
  • abdominal bloating
  • abdominal pain
  • loss of appetite
  • dizziness
  • drowsiness
  • confusion
  • excitement
  • insomnia
  • headache
  • heaviness
  • malaise
  • anxiety
  • depression
  • hallucinations
  • blurred vision
  • involuntary movement disorders
  • gynecomastia
  • galactorrhea
  • erectile dysfunction
  • decreased libido
  • joint pain
  • muscle pain
  • itching
  • glossitis
  • hair loss

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

Storage

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Greenish rectangular film-coated tablet

Package unit

10 tablets - 10 tablets/bottle, 30 tablets - 30 tablets/bottle, 300 tablets - 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.

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.