Medication info
Zanitin 150 mg (Nizatidine)

Zanitin 150 mg (Nizatidine)

Prescription medicationTabletOral
Ingredient · strength
Nizatidine›150mg / 1 tablet
Manufacturer / importer
Kyungdong Pharmaceutical Co., Ltd.
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200201865 · Notified 2002.01.09 · Insurance code 648101730

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers, treatment of reflux esophagitis and heartburn, and improvement of gastritis
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 needed. 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 for longer-term administration 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 Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg per day; < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 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 in these patients according to the degree of renal impairment.

Ingredients

Manufacturer
Kyungdong Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute 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 improves heartburn symptoms associated with erosive and ulcerative esophagitis confirmed by endoscopy, and is effective in alleviating gastric mucosal lesions during acute exacerbations of acute and chronic gastritis. It acts comprehensively on various gastrointestinal diseases to enhance gastric mucosal health and alleviate symptoms. Therefore, this drug is used to treat and improve the symptoms of a variety of gastrointestinal diseases.

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 needed. 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 for longer-term administration 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 Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg per day; < 20 ml/min: 150mg every other day Maintenance therapy: Creatinine clearance 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 in these patients according to the degree of renal impairment.

Precautions

This medication should not be used in patients with hypersensitivity to H2-receptor antagonists. Patients with a history of allergic reactions to the drug or with liver and kidney function issues should use this medication cautiously. Particularly, patients with impaired kidney function may experience increased drug concentration, so dosages should be adjusted or intervals between doses increased. Rarely, when using this medication, allergic symptoms such as skin rashes, itching, and bronchial asthma may occur; if such symptoms appear, use should be discontinued immediately. Blood abnormalities, such as anemia or changes in white blood cell counts, may appear, so if any unusual symptoms arise, consult a doctor. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, or nausea may occur. Liver function tests may show increased values or symptoms of liver damage such as hepatitis or jaundice, hence caution regarding liver health is advised. Rarely reported neurological symptoms include confusion, headache, drowsiness, and dizziness; seizures may potentially occur, requiring caution. Irregular rapid heartbeat may also occur. In women, breast enlargement may rarely occur, and in men, erectile dysfunction or decreased libido has been reported. Skin changes such as sweating, urticaria, rash, dermatitis, etc., should be monitored carefully. Moreover, hyperuricemia may develop, unrelated to gout or kidney stones, but caution is needed. It may mask symptoms of stomach cancer, so it should only be used after confirming the absence of malignant conditions. Because this drug is primarily excreted through the kidneys, dosage should be reduced for patients with decreased kidney function, and treatment effects and side effects should be closely monitored. Pregnant or breastfeeding women should use this medication only under a doctor's judgment, as safety has not been established; women who may become pregnant should also be cautious when administering. Safety in pediatric patients has not been sufficiently established, so its use is not recommended. Elderly patients are at higher risk of kidney dysfunction and should have their kidney function tested before administration, and renal status should be carefully monitored during treatment. This medication may affect certain clinical test results, so this should be disclosed prior to testing. In cases of overdose, vomiting, diarrhea, and pupil constriction may occur; inducing vomiting or gastric lavage may be necessary if required. This medication is not effectively removed by dialysis, so caution is warranted in cases of overdose. Long-term high-dose administration has shown no clear evidence of carcinogenicity or reproductive toxicity in animal studies; however, side effects such as liver damage have been reported with high-dose administration. The effects on the fetus during pregnancy are not clearly understood, thus it should be used only when the benefits outweigh the risks. Breastfeeding women should use this medication only when absolutely necessary, as it may be excreted into breast milk. This drug has relatively little interaction with other medications, but caution should be exercised as blood levels may change when used with certain drugs.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylaxis 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 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 sealed container as it may be sensitive to air or moisture. It is advisable to maintain the storage temperature between 15 to 30 degrees Celsius. This will help preserve the efficacy of the drug for an extended period.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

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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.