Medication info

Double One Tablet

Prescription medication경구Approval withdrawn
Ingredient · strength
Ranitidine Hydrochloride›168mg / 1 tabletTripotassium Bismuth Dicitrate›200mg / 1 tabletSucralfate Hydrate›600mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Green oblong film-coated triple tablet
Packaging
30 tablets, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201506749 · Approved 2015.09.24

This product's status changed to Approval withdrawn on 2025.02.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, and gastritis
Who takes it
Adults
Adult dose
Typically taken orally as 1 tablet twice daily, irrespective of meals, once in the morning and once before sleep. 1) Gastric and duodenal ulcers: 1 tablet twice daily or 2 tablets once before sleep daily. Especially for patients with duodenal ulcers, administering 2 tablets twice daily in the morning and before sleep may yield higher treatment rates. For ulcer prevention due to NSAID use or during long-term administration.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

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

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

This medication is used to treat ulcers of the stomach and duodenum, gastritis, Zollinger-Ellison syndrome, and other gastrointestinal diseases. It alleviates the symptoms of gastroesophageal reflux disease and helps to prevent postoperative ulcers. It is also effective in preventing ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). It is used preoperatively to prevent Mendelson's syndrome. Thus, it is used to treat and prevent various gastrointestinal-related symptoms.

How to take

Adult dose

Typically taken orally as 1 tablet twice daily, irrespective of meals, once in the morning and once before sleep. 1) Gastric and duodenal ulcers: 1 tablet twice daily or 2 tablets once before sleep daily. Especially for patients with duodenal ulcers, administering 2 tablets twice daily in the morning and before sleep may yield higher treatment rates. For ulcer prevention due to NSAID use or during long-term administration.

Precautions

This medication should not be used by patients with severely impaired kidney function or those undergoing dialysis. Additionally, patients with a known allergy to this medication or its components should avoid its use. Patients with a history of acute porphyria, a rare blood disorder, should also refrain from using this medication. It is not recommended for patients who have undergone upper gastrointestinal surgery, pregnant women or women who may become pregnant, and premature or newborn infants. Patients on a potassium-restricted diet should also exercise caution. This medication should be used with caution in patients with liver dysfunction, those with a history of drug allergies, elderly patients, and those with a history of kidney problems. When taken in conjunction with NSAIDs, there is a particular risk of gastrointestinal bleeding, so regular monitoring is required. Since it may mask gastric cancer symptoms, patients with gastric ulcers or new dyspepsia symptoms over the age of 40 should confirm there are no malignant conditions before use. Patients with gastric and duodenal ulcers caused by Helicobacter pylori infection should undergo eradication therapy concurrently. Severely ill ICU patients are at risk of fecalith formation and should be monitored closely. Patients with hypophosphatemia should be cautious as the aluminum component of this medication can hinder phosphate absorption. Those with swallowing difficulties should use this medication with caution due to the risk of respiratory complications. This medication can rarely cause severe allergic reactions or anaphylactic shock, so if any abnormal symptoms occur during use, treatment should be stopped immediately and medical assistance sought. Skin rash, hives, angioedema, fever, bronchospasm, and other hypersensitivity reactions may also occur, and it is important to discontinue treatment if these appear. Blood tests may show leukopenia, thrombocytopenia, or liver function abnormalities, so consult a doctor immediately if any unusual symptoms occur. Arrhythmias or abnormal heart rhythms have been reported infrequently, so patients with heart conditions should exercise caution. Gastrointestinal symptoms may include nausea, vomiting, constipation, diarrhea, and abdominal pain, with stool color sometimes turning black, though this is due to the medication's effect and does not require separate treatment. Severe dizziness, drowsiness, confusion, and seizures may rarely occur as neurological side effects, necessitating immediate discontinuation if these symptoms arise. Gynecomastia, increased milk secretion, and erectile dysfunction have also been reported very rarely, though causality is not clear. Myalgia and arthralgia may occur, and rhabdomyolysis, a severe muscle disease, can rarely manifest, necessitating immediate cessation if symptoms present themselves. Skin rashes, hair loss, and other symptoms of itching have also been reported. Long-term use of this medication is not recommended, and it is important to use the minimum effective dose while closely monitoring treatment progress. Elderly patients or those with chronic lung disease, diabetes, and weakened immunity are at increased risk of pneumonia and should be monitored closely. Additionally, if dizziness or drowsiness occurs while taking this medication, avoid driving or operating hazardous machinery. There may be drug interactions, so patients on anticoagulants or certain antibiotics and anticonvulsants should consult their physicians. When taking medications such as sucralfate, it's advisable to take them at different times. Pregnant or nursing women should not use this medication, and safety in children has not been established, so its use is not recommended. In case of overdose, measures such as vomiting or gastric lavage may be necessary, and in severe cases, dialysis may be required to remove the drug. This medication may reduce gastric acid secretion, potentially promoting bacterial growth in the gastrointestinal tract, so ocular examination may be necessary with prolonged use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness (including chest pain), difficulty breathing (including bronchospasm), cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever associated respiratory abnormalities, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headaches, lightning headaches, seizures,

Mild side effects

  • Skin rash
  • hives
  • angioedema
  • fever
  • hypotension
  • chest pain
  • nausea
  • vomiting
  • constipation
  • diarrhea
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  • abdominal distension
  • abdominal pain
  • loss of appetite
  • itching
  • darkening of the tongue
  • dizziness
  • drowsiness
  • confusion
  • agitation
  • insomnia
  • headache
  • heaviness in the head
  • malaise
  • anxiety
  • depression
  • hallucinations
  • blurred vision
  • involuntary movement disorder
  • gynecomastia
  • hypersecretion of milk
  • erectile dysfunction
  • decreased libido
  • arthralgia
  • myalgia
  • glossitis
  • hair loss

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 and moisture. It is advisable to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. Proper storage helps to preserve the potency of the medication for a longer period.

Appearance and packaging

Appearance

Green oblong film-coated triple tablet

Package unit

30 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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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.