Medication info

Huzatin Tablet 150mg (Nizatidine)

Prescription medicationTabletOralExpired
Ingredient · strength
Nizatidine›150mg / 1 tablet
Manufacturer / importer
Hyubist Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201403694 · Approved 2014.08.08

This product's status changed to Expired on 2024.08.08. 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 reflux heartburn; improvement of gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric and 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. 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. Dosage adjustment for patients with severe renal impairment Dosage for patients with renal impairment should be adjusted by reducing the dose as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg daily; < 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 creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced according to the degree of renal impairment in these patients.

Ingredients

Manufacturer
Hyubist Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication helps to treat active gastric and duodenal ulcers and prevents the recurrence of duodenal ulcers. It also improves the symptoms of erosive and ulcerative esophagitis and heartburn due to gastroesophageal reflux disease confirmed by endoscopy. It alleviates gastric mucosal lesions (erosion, bleeding, redness, swelling) that occur during acute exacerbations of acute gastritis and chronic gastritis, thus promoting gastric health. It is effective in treating various gastrointestinal disorders and is used for the relief of patients' symptoms and gastric mucosal recovery.

How to take

Adult dose

1. Treatment of active gastric and 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. 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. Dosage adjustment for patients with severe renal impairment Dosage for patients with renal impairment should be adjusted by reducing the dose as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance 20~50 ml/min: 150mg daily; < 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 creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced according to the degree of renal impairment in these patients.

Precautions

This medication should not be administered to patients who have had hypersensitivity reactions to H2-receptor antagonists. Patients with a history of drug allergy reactions should use it cautiously. Patients with poor liver function or kidney issues should adjust the dosage or extend the interval of administration for this medication. If allergic symptoms such as rash, itching, difficulty breathing, or laryngeal edema occur while using this medication, it should be discontinued immediately. Routine blood tests are important as there can be changes in anemia or blood levels of leucocytes and platelets. Digestive symptoms like constipation, diarrhea, dry mouth, and nausea may occur, so caution is advised. Liver function test results may increase, and serious liver problems like hepatitis or jaundice may occur, albeit rarely. Mental confusion, headache, drowsiness, or dizziness may appear, so caution is needed. There can be episodes of tachycardia. In women, gynecomastia may occur rarely, along with reports of erectile dysfunction or decreased libido. Skin reactions like rash, hives, and sweating may appear, so it’s important to report any abnormal symptoms. Though not related to gout or kidney stones, hyperuricemia may occur, along with symptoms like fever or muscle pain. Symptoms of gastric cancer may be masked, necessitating confirmation that it is not a malignant tumor before use. This medication is primarily eliminated through the kidneys, so patients with reduced kidney function should decrease the dosage and closely monitor treatment progress. There is insufficient pharmacokinetic research on patients with liver and kidney problems, necessitating caution. This medication has relatively few interactions with specific drugs, but when used with high-dose aspirin, the serum salicylate concentration may increase. Women who are pregnant or may become pregnant should carefully consider the effects of this medication on the fetus before starting treatment. Lactating women should use it only if necessary, as this medication may be secreted in small amounts in breast milk. Safety and efficacy in children have not been established, so caution is required in their use. Elderly patients are at higher risk of decreased kidney function, so kidney function tests should be conducted before administration, and their kidney condition should be closely monitored during treatment. This medication may cause false-positive results in urobilinogen tests, so this should be noted during testing. Overdose may result in symptoms such as vomiting, diarrhea, and miosis, and necessary measures like inducing vomiting or gastric lavage should be taken if needed. This medication is not removed by hemodialysis; therefore, alternative treatment methods are required in case of overdose. Though no carcinogenicity or genotoxicity have been reported in animal studies with long-term high-dose use, some changes may be noted in the liver, so caution is advised. In pregnant animal studies, high-dose treatment has reported some fetal abnormalities, so pregnant women should be cautious in its use. In lactating animals, growth inhibition has been observed, so nursing mothers should carefully decide on drug administration. Rare side effects related to erectile dysfunction have been reported with this medication, so consult a doctor if there are any changes in sexual function.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • symptoms of anaphylaxis
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • increased GOT
  • increased GPT
  • increased AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynaecomastia
  • 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 sealed container to protect it from air and moisture. Additionally, it is recommended to store the medication at a temperature between 15 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 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.