Medication info

Nizagreen Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Sears Pharmaceutical Co., Ltd.
Appearance
Hard gelatin capsule with yellow upper and lower parts filled with white to off-white crystalline contents
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Expired

MFDS item code 201905809 · Approved 2019.08.16

This product's status changed to Expired on 2024.08.16. 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 takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine 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. Dose adjustment for patients with severe renal impairment The dose 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 daily Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day Creatinine clearance < 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 renal function in these patients. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Ingredients

Manufacturer
Sears Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • bleeding
  • redness
  • swelling
  • acute gastritis
  • acute exacerbation of chronic gastritis
View approved original text

This medicine is used to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It also alleviates heartburn symptoms caused by erosive and ulcerative esophagitis and gastroesophageal reflux disease (GERD) confirmed by endoscopy. It is effective in improving lesions such as erosion, bleeding, redness, and swelling of the gastric mucosa that occur during acute exacerbations of acute or chronic gastritis. This medication protects the gastric mucosa and improves symptoms, helping to maintain digestive health.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine 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. Dose adjustment for patients with severe renal impairment The dose 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 daily Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min: 150mg every other day Creatinine clearance < 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 renal function in these patients. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Precautions

This medication is an H2 receptor antagonist used to suppress gastric acid secretion. Patients with hypersensitivity to this drug or those who have experienced allergic reactions to H2 receptor antagonists should not use it. Patients with a history of drug allergies should use this drug with caution, especially those with impaired liver or kidney function, who may need dose adjustments or extended dosing intervals. During use, various side effects such as skin rashes, itching, shortness of breath, blood abnormalities, digestive disorders, liver dysfunction, confusion, headaches, dizziness, heart palpitations, gynecomastia, sweating, and skin rashes may occur, and if any of these symptoms appear, immediate discontinuation of the drug and consultation with a healthcare professional is necessary. This drug can mask gastric cancer symptoms, so it should only be used after confirming malignancy, and dose adjustments are needed in patients with decreased kidney function. It is important to regularly conduct blood tests and liver and kidney function tests during treatment to monitor for abnormalities. This drug has a low potential for interactions with several medications; however, caution is advised when used concurrently with high doses of aspirin, as it may increase serum salicylate levels. Women who are pregnant or may become pregnant and breastfeeding should use this drug cautiously only if necessary, and safety in children has not been established. Elderly patients are at a higher risk for decreased kidney function, and kidney function tests should be performed before administration and monitored during use. In case of overdose, symptoms such as vomiting, diarrhea may occur, and activated charcoal administration or gastric lavage may be necessary. This drug has not shown evidence of carcinogenicity even with long-term high-dose use; however, caution is advised as it may affect liver function.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
Show 29 more
  • 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 drug is sensitive to light and should be stored in a container that blocks light. Additionally, the drug should be stored at a temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain its effectiveness and safety.

Appearance and packaging

Appearance

Hard gelatin capsule with yellow upper and lower parts filled with white to off-white crystalline contents

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.

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.