Medication info
Zastidin Capsule 150 mg (Nizatidine)

Zastidin Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Celix Co., Ltd.
Appearance
A hard capsule with a yellow upper part and a light yellow lower part filled with white to grayish-white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 199801649 · Notified 1998.10.22 · Insurance code 646201560

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; improvement of gastritis lesions; treatment of esophagitis and heartburn
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Take 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by mouth. 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, take 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: Take 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: Take 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dosage 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 older adults 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. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
Celix Co., Ltd.

Efficacy & effects

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

  • 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 and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It also alleviates heartburn symptoms associated with erosive and ulcerative esophagitis and gastroesophageal reflux disease (GERD) diagnosed through endoscopy. Additionally, it is effective in improving mucosal lesions such as erosion, bleeding, redness, and edema that occur during acute exacerbations of acute and chronic gastritis. This drug helps protect the gastrointestinal mucosa and relieve symptoms, thereby improving the quality of life of patients. Thus, it is effectively used to treat various inflammatory and ulcerative symptoms related to the stomach and esophagus.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Take 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by mouth. 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, take 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: Take 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: Take 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dosage 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 older adults 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. 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. Those who are allergic to this medication or similar drugs should avoid taking it. In addition, this medication contains lactose, so individuals with genetic conditions that impair lactose digestion should not take it. Some patients need to be cautious when taking this medication. Patients with a history of drug allergies or those with liver or kidney function issues must consult with a physician and take it carefully. Particularly, if kidney function is impaired, the drug concentration may increase, requiring dose adjustments or extended intervals between doses. While taking this medication, rare allergic reactions such as skin rashes, itching, and difficulty breathing may occur, so if such symptoms appear, discontinue the medication immediately and consult with medical personnel. Additionally, gastrointestinal symptoms such as anemia, changes in blood cell counts, constipation or diarrhea, dry mouth, and nausea may occur. Increased liver function test levels or rare occurrences of hepatitis and jaundice have been reported, requiring attention to liver health. Psychological confusion, headaches, drowsiness, dizziness, and muscle weakness may also occur rarely, and cases of rapid heartbeat have been noted. In women, rare breast enlargement symptoms may occur, and in men, erectile dysfunction or decreased libido has been reported, but the difference from normal levels is not significant. Skin reactions such as rashes, increased sweating, hives, and, rarely, vasculitis may also occur. This drug is primarily excreted through the kidneys, so elderly patients or patients with impaired renal function should undergo kidney function tests before administration, and kidney conditions should be checked regularly during treatment. Women who are pregnant or may become pregnant should carefully consider the effects on the fetus and the benefits of treatment when taking this drug, and breastfeeding women should only take it when absolutely necessary. This medication has relatively low drug interactions; however, care is needed when taken together with high-dose aspirin, as it may increase the concentration of specific components in the blood. Symptoms such as vomiting, diarrhea, and pupillary constriction may appear in case of overdose, and appropriate medical treatment is required. This drug is not effectively removed by dialysis; hence, special treatment is necessary in case of overdose. This medication may mask the symptoms of gastric cancer, so it is essential to confirm that there are no malignant diseases before taking it. If treatment effects are absent, transitioning to alternative treatments is recommended.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylaxis symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • thirst
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynecomastia
  • sweating
  • urticaria
  • exfoliative dermatitis
  • vasculitis
  • hyperuricemia
  • fever
  • chest pain
  • muscle pain
  • 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 that is well-ventilated and at room temperature between 1°C and 30°C. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

A hard capsule with a yellow upper part and a light yellow lower part filled with white to grayish-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.