Medication info

Selzatin Tablets (Nizatidine)

Prescription medicationTabletOralExpired
Ingredient · strength
Nizatidine›150mg / 1 tablet
Manufacturer / importer
Telcon R&D Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 201500072 · Approved 2015.01.07

This product's status changed to Expired on 2025.01.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and reflux symptoms; improvement of gastric lesions
Who takes it
Adults
Adult dose
Treatment of active gastric or duodenal ulcers: Adults take 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by mouth. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. For active gastric ulcers, malignancy must be ruled out before treatment. Prevention of duodenal ulcer recurrence: After healing of a duodenal ulcer, adults take 150mg by mouth once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term administration are unknown. Gastroesophageal reflux disease: Adults take 150mg by mouth twice daily, in the morning and evening. Treatment may continue for up to 12 weeks. Improvement of gastric mucosal lesions: Adults take 150mg by mouth twice daily, in the morning and evening, for 2 weeks. Dosage adjustment for patients with severe renal impairment: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg once daily Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance < 20 ml/min: 150mg every 3 days Some elderly patients may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should be reduced in these patients in accordance with their reduced renal function. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Ingredients

Manufacturer
Telcon R&D Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and reflux symptoms; improvement of gastric lesions

  • Active gastric ulcers
  • duodenal ulcers
  • recurrence of duodenal ulcers
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn due to gastroesophageal reflux disease
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbation of chronic gastritis
View approved original text

This medication is used to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. Additionally, it alleviates symptoms of heartburn caused by erosive and ulcerative esophagitis and gastroesophageal reflux disease (GERD). It is also effective in improving gastric mucosal lesions such as erosion, bleeding, redness, and edema that occur during acute exacerbations of acute and chronic gastritis. This drug helps alleviate and treat symptoms associated with various gastrointestinal disorders.

How to take

Adult dose

Treatment of active gastric or duodenal ulcers: Adults take 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by mouth. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. For active gastric ulcers, malignancy must be ruled out before treatment. Prevention of duodenal ulcer recurrence: After healing of a duodenal ulcer, adults take 150mg by mouth once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term administration are unknown. Gastroesophageal reflux disease: Adults take 150mg by mouth twice daily, in the morning and evening. Treatment may continue for up to 12 weeks. Improvement of gastric mucosal lesions: Adults take 150mg by mouth twice daily, in the morning and evening, for 2 weeks. Dosage adjustment for patients with severe renal impairment: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg once daily Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance < 20 ml/min: 150mg every 3 days Some elderly patients may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should be reduced in these patients in accordance with their reduced renal function. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Precautions

This drug should not be used in patients who have had an allergic reaction to this drug or other H2-receptor antagonists. Precautions should be taken when using this drug in patients with a history of allergic reactions to medication, patients with poor liver function, and patients with kidney-related issues. Patients with reduced kidney function may have elevated levels of this drug, and the dosage should be reduced or the interval between doses extended. If allergic symptoms such as rash, itching, or difficulty breathing occur during treatment, the medication should be stopped immediately. Blood abnormalities may manifest as anemia, leukopenia, or thrombocytopenia, so consult a physician if symptoms arise. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may occur. There may be liver function abnormalities, so symptoms of hepatitis or jaundice should be reported to medical personnel immediately. Neurological symptoms such as confusion, headache, drowsiness, and dizziness may rarely occur. Be cautious as asymptomatic ventricular tachycardia may occur. In women, breast enlargement may rarely occur, and erectile dysfunction or decreased libido have also been reported. Skin reactions such as rash, sweating, and urticaria may develop, so report any skin abnormalities. This drug may cause hyperuricemia unrelated to gout or kidney stones. It could conceal symptoms of gastric cancer, so it should be used only after confirming that it is not a malignant condition. Since this drug is primarily excreted through the kidneys, dosage adjustments may be necessary for patients with moderate to severe kidney impairment. If there is no therapeutic effect, it is better to switch to another drug, and liver and kidney function as well as blood conditions should be monitored regularly. Pregnant women or those who may become pregnant should carefully consider the risks and benefits of using this drug. Breastfeeding women should use this drug only when absolutely necessary, and safety in pediatric patients has not been established. Elderly patients are more likely to have reduced kidney function, so kidney function tests should be conducted before administration and monitored closely during treatment. This drug may affect the results of certain clinical tests, so inform the testing personnel of its use. Overdose may result in symptoms such as vomiting, diarrhea, and increased salivation, with no specific antidote but treatment should be given based on symptoms. Long-term high-dose administration has a low risk of carcinogenicity or genotoxicity, although adverse effects such as liver damage have been observed in animal experiments. In animal studies during pregnancy, some fetal malformations have been reported, so caution is warranted when using during pregnancy, and drug excretion into breast milk can also occur, warranting caution during lactation.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylaxis symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • thirst
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynecomastia
  • sweating
  • urticaria
  • exfoliative dermatitis
  • vasculitis
  • hyperuricemia
  • fever
  • chest pain
  • myalgia
  • rhinitis
  • pharyngitis
  • cough

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture. It is best to keep it in a cool place at a temperature between 15 and 30 degrees.

Appearance and packaging

Appearance

Yellow 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.

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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.