Medication info

Nizatidine Capsule 150mg (Nizatidine)

Prescription medicationApproval withdrawn
Ingredient · strength
Nizatidine›Strength being verified
Manufacturer / importer
COSMAX Pharma Co., Ltd.
Appearance
A hard capsule with a yellow upper and light yellow lower part filled with white to nearly white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201901594 · Approved 2019.03.15

This product's status changed to Approval withdrawn on 2023.07.19. 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 heartburn, and improvement of gastric lesions
Who uses it
Adults
Adult dosage
1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg 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. In cases of active gastric ulcers, malignancy must be ruled out before treatment. 2. Prevention of duodenal ulcer recurrence Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may continue 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. Dosage adjustment for patients with severe renal impairment The dose should be reduced and adjusted as follows for patients with renal impairment. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min, 150mg 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 Creatinine clearance may be reduced to below 50mL/min in some older adults. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced in these patients according to the degree of renal impairment. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
COSMAX Pharma Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers, treatment of esophagitis and heartburn, and improvement of gastric lesions

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute gastritis
View approved original text

This medication is used for the treatment of active gastric and duodenal ulcers and for the prevention of duodenal ulcer recurrence. It is also effective in treating erosive and ulcerative esophagitis diagnosed by endoscopy, as well as symptoms of heartburn due to gastroesophageal reflux disease (GERD). It helps improve gastric mucosal lesions, such as erosion, bleeding, redness, and swelling that appear during acute exacerbations of acute gastritis or chronic gastritis. This drug alleviates discomfort due to gastrointestinal diseases and protects the gastric mucosa to improve symptoms.

Dosage and Administration

Adult dosage

1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg 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. In cases of active gastric ulcers, malignancy must be ruled out before treatment. 2. Prevention of duodenal ulcer recurrence Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may continue 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. Dosage adjustment for patients with severe renal impairment The dose should be reduced and adjusted as follows for patients with renal impairment. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min, 150mg 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 Creatinine clearance may be reduced to below 50mL/min in some older adults. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced in these patients according to the degree of renal impairment. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This medication is an H2-receptor antagonist that is used to treat gastrointestinal diseases by reducing gastric acid secretion. Patients with hypersensitivity to this drug or a history of hypersensitivity to H2-receptor antagonists should not use it. Additionally, this drug contains lactose, so patients with genetic conditions such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid it. Patients with a history of drug hypersensitivity, those with impaired liver or kidney function, should use this drug with caution, and particularly those with poor kidney function may need to reduce the dose or extend the dosing interval. If allergic reactions such as rash, pruritus, difficulty breathing, or anaphylaxis occur while using this drug, it should be discontinued immediately. Blood abnormalities such as anemia, leukopenia, and thrombocytopenia may occur, so if these symptoms appear, the medication should be stopped and the doctor consulted. Gastrointestinal symptoms such as constipation, diarrhea, and nausea may occur, and liver dysfunction has also been reported. Rarely, neurological symptoms such as confusion, headache, drowsiness, and dizziness may occur, necessitating caution when driving or operating machinery. Endocrine abnormalities, such as gynecomastia or decreased libido, could occur in some patients. This drug is primarily excreted through the kidneys, so elderly patients with impaired renal function should undergo kidney function tests before administration and monitor their renal status closely during treatment. The safety of this drug during pregnancy or lactation has not been established, and it should be used only if the benefits are judged to outweigh the risks. The safety of this drug in children is also not established, so it is advisable to avoid use in children. This drug has few significant interactions with other medications; however, caution is advised when taken with high doses of aspirin, as it may increase plasma salicylate levels. In cases of overdose, symptoms such as vomiting, diarrhea, and pupil constriction may appear, and immediate medical treatment should be sought. This drug may mask symptoms of gastric cancer, so it should only be used after confirming malignancy, and if no therapeutic effect is observed, it is recommended to switch to other treatment methods.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylaxis symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
Show 29 more
  • diarrhea
  • dry mouth
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated ALP
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • convulsions
  • 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 medication should be stored in a tightly closed container to prevent exposure to air and kept at a temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness and ensure safe use.

Appearance and packaging

Appearance

A hard capsule with a yellow upper and light yellow lower part filled with white to nearly white powder

Package unit

30 capsules/bottle, 300 capsules/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.