Medication info
Nizatidine Capsule 150 Milligrams (Nizatidine)

Nizatidine Capsule 150 Milligrams (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Kips Biopharma Co., Ltd.
Appearance
Hard capsule with an upper yellow and lower pale yellow shell filled with white to almost white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201603493 · Approved 2016.06.15 · Insurance code 674401220,693202670

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and reflux heartburn; improvement of gastric lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric or 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 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 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. 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 Creatinine clearance may be reduced to below 50mL/min in some elderly patients. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced in these patients in accordance with the degree of renal impairment. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
Kips Biopharma Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and reflux 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 medication is used to treat active gastric and duodenal ulcers and prevent the recurrence of duodenal ulcers. It also improves symptoms of erosive and ulcerative esophagitis and gastroesophageal reflux disease (GERD) that cause heartburn. Additionally, it is effective in treating gastric mucosal lesions (erosion, bleeding, redness, swelling) due to acute exacerbations of acute and chronic gastritis. By improving the symptoms and lesions associated with various gastrointestinal disorders, it alleviates the patient's symptoms.

How to take

Adult dose

1. Treatment of active gastric or 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 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 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. 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 Creatinine clearance may be reduced to below 50mL/min in some elderly patients. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced in these patients in accordance with the degree of renal impairment. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This medication should not be used in certain patients. It should not be administered to patients with a history of allergic reactions to this medication or similar medications. Additionally, it contains lactose and should not be used in patients with lactose intolerance or certain genetic metabolic disorders. This medication should be used cautiously in patients with a history of drug allergies or impaired liver or kidney function. In particular, patients with poor kidney function may have prolonged concentrations of this medication in the body, requiring dosage reduction or increased dosing intervals. If allergic symptoms such as skin rash, itching, difficulty breathing, or swelling of the face or neck occur while taking this medication, it should be discontinued immediately. Additionally, be aware that anemia, abnormalities in blood cell counts, dyspeptic symptoms, liver function abnormalities, confusion, headache, dizziness, and weakness may also occur. This medication may mask symptoms of gastric cancer, so its use should be examined to ensure it is not a malignant disease. Patients with diminished kidney function require dose adjustment, and if no therapeutic effect is observed, it is advisable to switch to another medication. Women who are pregnant or breastfeeding should carefully weigh the risks and benefits before using this medication. Precautions are warranted for children and the elderly, as safety and efficacy have not been adequately established for these populations. No significant drug interactions have been reported with this medication, but there may be changes in drug blood concentrations when used with high-dose aspirin. In cases of overdose, symptoms such as vomiting or diarrhea may occur, and since there is no specific antidote, it is important to receive treatment appropriate to the symptoms. Finally, this medication is known to have a low risk of carcinogenicity even with long-term high-dose administration, but elderly patients with impaired kidney function may have a higher risk of side effects and should undergo regular examinations.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • increased neutrophils
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • 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 air and moisture from entering and should be kept at room temperature, between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Hard capsule with an upper yellow and lower pale yellow shell filled with white to almost 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.