Medication info
Nizatide Tablets 150mg (Nizatidine)

Nizatide Tablets 150mg (Nizatidine)

Prescription medicationTabletOral
Ingredient · strength
Nizatidine›150mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
Light yellow round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201907346 · Approved 2019.10.18

Summary

Main use
Treatment of gastric and duodenal ulcers, esophagitis, and reflux-related heartburn; improvement of gastric lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg orally twice daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if needed. 2. Prevention of duodenal ulcer recurrence Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results with longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose 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; < 20 ml/min: 150mg every other day. Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day; < 20 ml/min: 150mg every 3 days.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

Treatment of gastric and duodenal ulcers, esophagitis, and reflux-related heartburn; improvement of gastric lesions

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • 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 medicine is used to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It also relieves the symptoms of heartburn caused by erosive and ulcerative esophagitis diagnosed by endoscopy, as well as gastric reflux disease. It is effective in improving gastric mucosal lesions (erosions, bleeding, redness, swelling) that occur during acute exacerbation of acute gastritis and chronic gastritis. This medication helps restore gastric health and improve symptoms.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg orally twice daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if needed. 2. Prevention of duodenal ulcer recurrence Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results with longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose 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; < 20 ml/min: 150mg every other day. Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day; < 20 ml/min: 150mg every 3 days.

Precautions

This medicine is an H2-receptor antagonist that is used to treat gastric diseases by reducing gastric acid secretion. Patients who have had allergic reactions to similar medications should not use this drug. Patients with a history of drug hypersensitivity or issues with liver or kidney function should use this drug cautiously. In particular, patients with impaired kidney function may have increased drug concentration, necessitating a reduction in dosage or an increase in dosing intervals. This drug contains the dye Yellow No. 5, so patients allergic to this component should also be cautious. If symptoms of hypersensitivity such as skin rash, itching, or difficulty breathing occur during use, it should be discontinued immediately. Blood abnormalities such as anemia, leukopenia, and thrombocytopenia may occur, so report any unusual symptoms to the hospital. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may occur. Rare cases of elevated liver function tests or liver damage symptoms such as hepatitis and jaundice have been reported, so liver health should be monitored. Occasionally, neurological symptoms such as headache, drowsiness, dizziness, and confusion may occur, so caution is needed when driving or operating machinery. Tachycardia may occur, so patients with heart disease should be cautious. In women, breast enlargement may occur rarely, while men have reported sexual dysfunction. Skin changes such as sweating, hives, and rashes can occur, so monitor for skin changes. This drug is primarily excreted by the kidneys, so elderly patients with reduced kidney function should undergo kidney function testing before administration and keep monitoring kidney status during treatment. Pregnant women or those who may become pregnant should only use this drug when the therapeutic benefits outweigh the risks, and nursing mothers should use it only when necessary. Safety in pediatric patients has not been established, so it should be used with caution in children. This drug has relatively few drug interactions, but caution is advised when used with high doses of aspirin, as it may increase serum salicylate levels. In the case of an overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur, and appropriate medical treatment should be provided if needed. This drug may mask symptoms of gastric cancer, so it must be used only after confirming that it's not gastric cancer. If there is no therapeutic effect, it is advisable to switch to another medication, and liver and kidney function, as well as blood test results, should be regularly monitored during treatment.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • symptoms of anaphylaxis
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • elevation of GOT
  • elevation of GPT
  • elevation of AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • 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 medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius (room temperature) to preserve the drug's efficacy for a longer period.

Appearance and packaging

Appearance

Light yellow 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.