Medication info

IZADIN Capsule 150 mg (Nizatidine)

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

MFDS item code 201902499 · Approved 2019.04.23

This product's status changed to Expired on 2024.04.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric and duodenal ulcers (prevention of duodenal ulcer recurrence), esophagitis, and heartburn; improvement of gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers In adults, administer nizatidine 300mg once daily at bedtime or 150mg 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 After healing of a duodenal ulcer in adults, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term treatment are unknown. 3. Gastroesophageal reflux disease In 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 In adults, administer 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 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 Some older adults may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should be reduced according to the degree of renal impairment in these patients as well. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
K.S. Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastric and duodenal ulcers (prevention of duodenal ulcer recurrence), esophagitis, and heartburn; improvement of gastritis

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbations 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 treats heartburn symptoms related to erosive and ulcerative esophagitis diagnosed by endoscopy and GERD. It is effective in improving lesions such as erosion, bleeding, redness, and swelling of the gastric mucosa that occur during acute exacerbations of acute and chronic gastritis. This medicine helps to heal gastric mucosal damage and alleviate uncomfortable symptoms. Overall, it is used to improve issues related to gastric and duodenal diseases and esophagitis.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers In adults, administer nizatidine 300mg once daily at bedtime or 150mg 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 After healing of a duodenal ulcer in adults, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term treatment are unknown. 3. Gastroesophageal reflux disease In 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 In adults, administer 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 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 Some older adults may have creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should be reduced according to the degree of renal impairment in these patients as well. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This medication is not safe for those with hypersensitivity to certain drugs. Those with a history of drug allergies or issues with liver or kidney function should take special care while using this medication. Patients with reduced kidney function may experience prolonged retention of the drug in the body, necessitating reduced dosages or extended intervals between doses. If allergic symptoms such as skin rash, itching, or difficulty breathing occur during treatment, discontinue use immediately and consult a physician. Blood-related side effects may occur, such as anemia or changes in white blood cell counts; report any unusual symptoms to healthcare providers. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. It may affect liver function, and rare occurrences of elevated liver enzymes or symptoms of hepatitis and jaundice necessitate caution. Mental confusion, headaches, drowsiness, and dizziness may occur, although rarely, and seizures have been reported; consult healthcare providers if any unusual symptoms arise. Changes in heart rhythm may occur, so those with heart disease should exercise increased caution. Women may experience rare symptoms of breast enlargement, while men have reported erectile dysfunction or decreased libido. Skin reactions such as sweating, hives, rash, or dermatitis may occur, so monitor skin condition carefully. Uric acid levels may increase unrelated to gout or kidney stones, and symptoms such as fever or muscle pain have been reported. This medication may mask symptoms of gastric cancer, so ensure it is not a malignancy before use. Since the drug is primarily excreted through the kidneys, patients with impaired kidney function may require dosage adjustments, and regular blood tests and liver and kidney function tests are advisable during treatment. Women who are pregnant or may become pregnant, as well as nursing mothers, should carefully consider the benefits and risks before using this medication. The safety for pediatric patients has not been established, and elderly patients may have higher risks of kidney function decline, requiring kidney function tests before and close monitoring during administration. In case of overdose, symptoms such as vomiting, diarrhea, and pinpoint pupils may occur; treatment may include activated charcoal administration or gastric lavage if needed. This drug has a low potential for interactions with other medications, but blood concentrations may change when used with certain drugs, so consult with the prescribing physician.

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
  • myalgia
  • rhinitis
  • pharyngitis
  • cough

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a container that protects it from light and air, maintaining a storage temperature between 1 and 30 degrees Celsius. Proper storage will preserve the medication's effectiveness.

Appearance and packaging

Appearance

A hard capsule with yellow upper and lower parts filled with white to whitish 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.

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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.