Medication info
Nizatidine Tablet 150mg (Nizatidine)

Nizatidine Tablet 150mg (Nizatidine)

Prescription medicationTabletOral
Ingredient · strength
Nizatidine›150mg / 1 tablet
Manufacturer / importer
Ixu Pharmaceutical Co., Ltd.
Appearance
Yellow circular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201602656 · Approved 2016.05.13

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. In cases of active gastric ulcer, 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 be continued 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 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. Dosage adjustment for patients with severe renal impairment The dosage for patients with renal impairment should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min — 150mg/day 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 older adults may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced in these patients according to the degree of renal impairment. The clinical impact of this dosage reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
Ixu Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; 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 exacerbations of chronic gastritis.
View approved original text

This medication is effective in treating active gastric and duodenal ulcers and preventing recurrence of duodenal ulcers. It also alleviates symptoms of erosive and ulcerative esophagitis diagnosed by endoscopy and symptoms of heartburn due to gastroesophageal reflux disease (GERD). It is also used to improve gastric mucosal lesions (erosions, bleeding, redness, swelling) that occur during acute exacerbations of acute and chronic gastritis. Overall, this medication helps improve and treat symptoms related to various gastrointestinal diseases.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. In cases of active gastric ulcer, 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 be continued 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 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. Dosage adjustment for patients with severe renal impairment The dosage for patients with renal impairment should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min — 150mg/day 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 older adults may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced in these patients according to the degree of renal impairment. The clinical impact of this dosage reduction in patients with renal impairment has not been evaluated.

Precautions

This medication should not be used in certain patients. Patients who have had allergic reactions to this medication or other H2-receptor antagonists should not take this medication. Allergic reactions may manifest as skin rashes, itching, or difficulty breathing. Additionally, patients with hypersensitivity to the drug, impaired liver function, or reduced kidney function should use this medication with caution. In particular, patients with poor kidney function may need to reduce the dosage or increase the dosing interval, as the drug concentration may remain in the body longer. While taking this medication, various side effects may occur, such as skin rashes, itching, difficulty breathing, various blood abnormalities, gastrointestinal disturbances, liver function abnormalities, mental confusion, headaches, dizziness, irregular heartbeat, symptoms of gynecomastia, and skin rashes. If any of these symptoms occur, discontinue use immediately and consult a healthcare professional. This medication may mask symptoms of stomach cancer, so it should only be used after confirming that it is not cancer. Since it is primarily excreted through the kidneys, patients with reduced kidney function may need dosage adjustments, and careful monitoring of therapeutic effects and side effects is required. Women who are pregnant or may become pregnant should only use this medication if the benefits outweigh the risks. Breastfeeding women should also only use it when necessary, and safety in pediatric patients has not been established. Elderly patients may have impaired kidney function, so it is advisable to have kidney function tests before taking the medication and to closely monitor renal condition during use. In cases of overdose, symptoms such as vomiting, diarrhea, and pupil constriction may occur, and treatment such as activated charcoal administration or gastric lavage may be necessary. This medication is not effectively removed by hemodialysis, so caution is required. This medication has relatively few interactions with other drugs; however, care should be taken when taken with high doses of aspirin as salicylate levels may increase. Finally, this medication is reported to have a low risk of carcinogenicity or genotoxicity even with long-term high-dose administration, but the effects on the fetus during pregnancy have not been thoroughly studied, requiring careful use.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • symptoms of anaphylaxis
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
Show 29 more
  • diarrhea
  • thirst
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • convulsions
  • 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 protect it from air and moisture. It is best to maintain the storage temperature between 15 degrees and 30 degrees.

Appearance and packaging

Appearance

Yellow circular 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.