Medication info
Siren Tablets

Siren Tablets

Prescription medicationTablet경구
Ingredient · strength
Ranitidine Hydrochloride›84mg / 1 tabletSucralfate Hydrate›300mg / 1 tabletTripotassium Bismuth Dicitrate›100mg / 1 tablet
Manufacturer / importer
(주)퍼슨
Appearance
Green round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201707215 · Approved 2017.09.22

Summary

Main use
Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, gastritis
Who takes it
Adults
Adult dose
Typically administered orally as 2 tablets twice a day, regardless of meals, in the morning and at bedtime. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day, or 4 tablets once a day at bedtime. In particular, for patients with duodenal ulcers, administering 4 tablets twice a day in the morning and at bedtime can achieve a higher cure rate. This is the same dosage for the combination therapy to prevent the occurrence of gastric and duodenal ulcers due to the administration of non-steroidal anti-inflammatory drugs (NSAIDs) or long-term use of NSAIDs. Usually, diseases caused by NSAIDs are healed within 8 weeks, but occasionally, healing time may be extended depending on the patient. For patients with recurrent ulcers, where the short-term therapy has shown excellent effectiveness, maintenance therapy of 2 tablets once a day at bedtime is recommended. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks, or 4 tablets once a day at bedtime. However, for patients with severe gastroesophageal reflux disease, the dosage may be increased to 4 tablets four times a day. 3) Zollinger-Ellison syndrome: Start treatment with an initial dosage of 2 tablets three times a day, and adjust as needed. In severe cases, under the guidance of a physician, a daily dosage of up to 6 g as ranitidine may be provided. 4) Peptic ulcers, acute stress ulcer, and upper gastrointestinal bleeding due to acute mucosal lesions: Once oral administration becomes feasible, switch from injection to oral administration, administering 2 tablets twice a day. 5) Pre-anesthetic medication (for prevention of Mendelson syndrome): Administer 2 tablets 2 hours prior to induction of anesthesia. In this case, administering 2 tablets on the night before surgery is also advisable.

Ingredients

Manufacturer
(주)퍼슨

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, gastritis

  • Gastric and duodenal ulcers
  • gastritis
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson syndrome
  • postoperative ulcers
View approved original text

This medication is used to treat various gastrointestinal diseases such as ulcers in the stomach and duodenum, gastritis, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It can also be administered prior to anesthesia to prevent Mendelson syndrome and is effective for treating ulcers after surgery. It can be used for gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). It helps to treat multiple gastrointestinal disorders and improve symptoms.

How to take

Adult dose

Typically administered orally as 2 tablets twice a day, regardless of meals, in the morning and at bedtime. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day, or 4 tablets once a day at bedtime. In particular, for patients with duodenal ulcers, administering 4 tablets twice a day in the morning and at bedtime can achieve a higher cure rate. This is the same dosage for the combination therapy to prevent the occurrence of gastric and duodenal ulcers due to the administration of non-steroidal anti-inflammatory drugs (NSAIDs) or long-term use of NSAIDs. Usually, diseases caused by NSAIDs are healed within 8 weeks, but occasionally, healing time may be extended depending on the patient. For patients with recurrent ulcers, where the short-term therapy has shown excellent effectiveness, maintenance therapy of 2 tablets once a day at bedtime is recommended. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks, or 4 tablets once a day at bedtime. However, for patients with severe gastroesophageal reflux disease, the dosage may be increased to 4 tablets four times a day. 3) Zollinger-Ellison syndrome: Start treatment with an initial dosage of 2 tablets three times a day, and adjust as needed. In severe cases, under the guidance of a physician, a daily dosage of up to 6 g as ranitidine may be provided. 4) Peptic ulcers, acute stress ulcer, and upper gastrointestinal bleeding due to acute mucosal lesions: Once oral administration becomes feasible, switch from injection to oral administration, administering 2 tablets twice a day. 5) Pre-anesthetic medication (for prevention of Mendelson syndrome): Administer 2 tablets 2 hours prior to induction of anesthesia. In this case, administering 2 tablets on the night before surgery is also advisable.

Precautions

This medication should not be used in patients with poor kidney function or those undergoing dialysis. Patients with a history of allergic reactions to this medication or its ingredients should avoid administration. Patients with a history of acute porphyria may experience worsening symptoms with this medication and should not use it. Patients who have had gastrointestinal surgery or are pregnant or could become pregnant, as well as premature infants and newborns, should not be administered this medication for safety reasons. Patients on a dietary regimen that restricts potassium intake should use this medication with caution. Patients with impaired liver function, a history of drug allergies, elderly patients, and those with previous kidney issues need to exercise extra caution when using this drug. If used in conjunction with non-steroidal anti-inflammatory drugs, regular check-ups are necessary, especially in elderly patients or those with a history of peptic ulcers. This medication can mask symptoms of gastric cancer, so patients with gastric ulcers or those over middle age with recent dyspepsia should start treatment only after confirming malignancy. Patients with Helicobacter pylori infections and ulcers in the stomach or duodenum must undergo bacterial eradication therapy. In critically ill patients receiving treatment in an intensive care unit, caution is required as this medication may cause gastric stones. The aluminum content of this drug may interfere with phosphate absorption, so it should be administered cautiously in patients with hypophosphatemia. Patients who have difficulty swallowing may experience respiratory complications after taking this medication, requiring caution. While using this medication, severe allergic reactions such as anaphylactic shock may occur infrequently, and if symptoms arise, administration must be stopped immediately, and appropriate treatment sought. If allergic symptoms such as skin rash, urticaria, angioedema, fever, bronchospasm, hypotension, or chest pain occur, the medication should be discontinued. Abnormal blood test results may occur, so if symptoms like fatigue, bleeding, or fever appear, immediate testing should be conducted, and drug discontinuation may be necessary if warranted. Deterioration of liver function can lead to hepatitis or jaundice, so if such symptoms appear, intake should be stopped immediately. Cardiac arrhythmias or vasculitis have been reported rarely, requiring caution if cardiac-related symptoms present. Gastrointestinal symptoms may include nausea, vomiting, constipation, diarrhea, and abdominal pain, and feces color may change but does not require specific treatment. Dizziness, drowsiness, confusion, seizures, insomnia, headache, heaviness, malaise, anxiety, mental confusion, depression, hallucinations, blurred vision, involuntary movement disorders, gynecomastia, galactorrhea, erectile dysfunction, and decreased libido may occur rarely, particularly in patients with poor kidney function. Endocrine symptoms such as gynecomastia or sexual dysfunction have been reported rarely, though the causal relationship is unclear. Myalgia or arthralgia, and in severe cases, rhabdomyolysis may present, requiring discontinuation upon unusual symptoms. Skin rashes, erythema multiforme, and hair loss may occur rarely. If used for a prolonged period without effect, it is advisable to switch to a different medication, and regular tests of blood, liver, and kidney function should be conducted. Elderly patients, patients with chronic lung disease, diabetic patients, and immunocompromised patients may have an increased risk of pneumonia and should exercise caution. If dizziness or drowsiness occur during administration, driving or operating dangerous machinery should be avoided. This drug can interact with others, so always consult healthcare providers regarding concomitant medications. It is safest for pregnant or breastfeeding women to not use this medication. Safety and efficacy in pediatrics have not been established, so it is advisable not to administer it to children. In case of overdose, emergency measures such as vomiting or gastric lavage may be necessary, and blood dialysis can be performed if needed.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • shock (anaphylactic shock)
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • skin rash
  • blisters
  • skin peeling
  • pain in mucous membranes of mouth/eyes
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  • jaundice
  • hepatitis
  • sudden and severe headache
  • seizures
  • confusion
  • vision abnormalities
  • paralysis
  • serious neurological symptoms
  • hypertension accompanied by edema
  • agranulocytosis
  • pancytopenia
  • bone marrow suppression
  • bone marrow aplasia
  • aplastic anemia
  • secondary

Mild side effects

  • Skin rash
  • angioedema
  • fever
  • bronchospasm
  • hypotension
  • chest pain
  • granulocytopenia
  • leukopenia
  • thrombocytopenia
  • elevated serum enzyme levels
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  • nausea
  • vomiting
  • constipation
  • diarrhea
  • abdominal fullness
  • abdominal pain
  • loss of appetite
  • dizziness
  • drowsiness
  • confusion
  • excitement
  • insomnia
  • headache
  • heaviness
  • malaise
  • anxiety
  • mental confusion
  • depression
  • hallucinations
  • blurred vision
  • involuntary movement disorders
  • gynecomastia
  • excessive lactation
  • erectile dysfunction
  • decreased libido

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

Storage

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

Appearance and packaging

Appearance

Green round film-coated tablets

Package unit

30 tablets/bottle, 500 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.