Medication info

Nizatidine Capsule 150mg (Nizatidine)

Prescription medicationOralExpired
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Keps Biopharma Co., Ltd.
Appearance
Capsule filled with white to off-white crystalline contents, upper part yellow, lower part light yellow
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Expired

MFDS item code 201406191 · Approved 2014.12.31

This product's status changed to Expired on 2024.12.31. 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; improvement of gastric lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric or 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 recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; outcomes with longer-term administration are unknown. 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. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 20 ml/min 150mg every 3 days Some elderly patients may have a creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in these patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
Keps Biopharma 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 ulcer
  • duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • 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. It also alleviates symptoms of erosive and ulcerative esophagitis diagnosed by endoscopy, as well as heartburn due to gastroesophageal reflux disease (GERD). It is effective in improving symptoms such as damage, bleeding, redness, and swelling of the gastric mucosa that appear during acute exacerbations of acute gastritis and chronic gastritis. By effectively acting on various gastrointestinal diseases, it helps alleviate symptoms and aid recovery for patients. Therefore, this drug is used to treat various diseases related to the stomach and duodenum.

How to take

Adult dose

1. Treatment of active gastric or 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 recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; outcomes with longer-term administration are unknown. 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. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 20 ml/min 150mg every 3 days Some elderly patients may have a creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in these patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This drug is categorized as an H2 receptor antagonist, which reduces gastric acid secretion and is used for the treatment of gastric ulcers and gastroesophageal reflux disease. Before taking this medication, do not use it if you have had an allergic reaction to this drug or similar medications. Allergic symptoms can include skin rash, itching, shortness of breath, or swelling of the throat; if these symptoms occur, stop taking the medication immediately and consult a physician. Patients with poor liver or kidney function should use this drug cautiously, and especially those with decreased kidney function should reduce the dosage or extend the dosing interval. While taking this medication, rare side effects such as anemia, changes in white blood cell count, gastrointestinal disturbances (constipation, diarrhea, nausea, etc.), liver function abnormalities, confusion, headache, drowsiness, dizziness, arrhythmias, gynecomastia, rash, sweating, and others may occur, so it is important to inform your doctor of any unusual symptoms. Because it may mask symptoms of stomach cancer, it should be used only after confirming that there is no malignant condition. If treatment is ineffective, other treatment options should be considered. Since this drug is mainly excreted through the kidneys, elderly patients or patients with reduced kidney function should undergo kidney function tests and adjust their dosage accordingly. Women who are pregnant or nursing should only take this medication after thorough consultation with a physician, as its safety during pregnancy and lactation has not been established. Safety and efficacy in pediatric patients have not been sufficiently confirmed; therefore, it should be used cautiously in children. In the case of overdose, symptoms such as vomiting, diarrhea, and miosis may occur; in such instances, seek immediate medical attention for appropriate treatment. This drug has fewer interactions with other medications, but caution is advised when taken with high-dose aspirin, as it may increase the serum salicylate concentration. During treatment, regular blood tests and monitoring of liver and kidney function should be conducted to observe any abnormalities.

Side effects

  • rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver injury
  • hepatocellular liver injury
  • 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 medication is sensitive to light; therefore, it should be stored in a container that does not allow light to enter. Additionally, it is recommended to store the medication at room temperature between 1 to 30 degrees Celsius, in a place that is neither too hot nor too cold.

Appearance and packaging

Appearance

Capsule filled with white to off-white crystalline contents, upper part yellow, lower part light yellow

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.