Medication info

Anitidine Capsule 150mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Huons Meditech Co., Ltd., HuonsLifeSciences
Appearance
A hard capsule with a yellow upper part and a light yellow lower part containing a white powder.
Packaging
30 capsules/bottle, 200 capsules/bottle
Approval status
Active

MFDS item code 200404751 · Notified 2004.02.16 · Insurance code 052700090

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric mucosal lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Take nizatidine 300 mg orally once daily at bedtime, or 150 mg 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 necessary. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, take 150 mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results for longer-term use are not known. 3. Gastroesophageal reflux disease Adults: Take 150 mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Take 150 mg 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: 150 mg daily Creatinine clearance < 20 ml/min: 150 mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150 mg every other day Creatinine clearance < 20 ml/min: 150 mg 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 in these patients according to the degree of renal impairment.

Ingredients

Manufacturer
Huons Meditech Co., Ltd.
Manufacturer
HuonsLifeSciences

Efficacy & effects

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

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbation of chronic gastritis.
View approved original text

This medication is used to treat active gastric ulcers and duodenal ulcers, as well as to prevent the recurrence of duodenal ulcers. It is also effective in treating erosive and ulcerative esophagitis diagnosed via endoscopy and symptoms of heartburn due to gastroesophageal reflux disease. Additionally, it helps improve lesions such as erosion, bleeding, redness, and swelling of the gastric mucosa seen during acute exacerbation of acute gastritis and chronic gastritis. It acts effectively on various gastrointestinal disorders and enhances gastrointestinal health.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Take nizatidine 300 mg orally once daily at bedtime, or 150 mg 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 necessary. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, take 150 mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results for longer-term use are not known. 3. Gastroesophageal reflux disease Adults: Take 150 mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Take 150 mg 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: 150 mg daily Creatinine clearance < 20 ml/min: 150 mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150 mg every other day Creatinine clearance < 20 ml/min: 150 mg 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 in these patients according to the degree of renal impairment.

Precautions

This medication should not be used in certain patients. Patients who have had allergic reactions to this medication or similar types of drugs should not take this medication. Patients with a history of allergies, poor liver function, and reduced kidney function should use this medication cautiously. In particular, patients with weak kidney function may have increased drug concentrations in the body, so the dose should be reduced or the dosing interval should be extended. Rarely, when taking this medication, skin rash, itching, breathing difficulties, or severe allergic reactions may occur; if these symptoms appear, immediately stop taking the medication and consult a physician. Blood-related issues such as anemia or changes in blood cell counts may occur, so any abnormal symptoms should be reported to a physician. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea can occur. Liver function abnormalities have also been reported occasionally, so liver function tests may be necessary. Rarely, mental confusion, headaches, drowsiness, dizziness, and tachycardia may occur. In women, gynecomastia may develop, and changes in sexual function have been reported. Skin-related side effects may include sweating, urticaria, and dermatitis. This drug is primarily excreted through the kidneys, so elderly patients or those with impaired kidney function should undergo kidney function tests and adjust the dosage accordingly. Women who are pregnant or breastfeeding should only use this medication under a physician's judgment as its safety is not well established. Safety in children has not been sufficiently confirmed, so use in children is not recommended. This medication has relatively few significant drug interactions, but caution is advised when taken with high doses of aspirin. In cases of overdose, symptoms such as vomiting, diarrhea, and excessive salivation may occur, and immediate medical attention should be sought. This medication can mask symptoms of gastric cancer, so it should only be used after confirming malignancy, and if no therapeutic effect is observed, alternative treatments should be considered. Regular blood tests along with liver and kidney function tests are important to monitor for any signs of 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 should be stored in an airtight container and kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A hard capsule with a yellow upper part and a light yellow lower part containing a white powder.

Package unit

30 capsules/bottle, 200 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.