Medication info
Zinadine Capsule 150 mg (Nizatidine)

Zinadine Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Os Korea Pharmaceutical Co., Ltd.
Appearance
A light yellow to yellow powder-filled capsule with a yellow upper and white lower part.
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 201504732 · Approved 2015.07.09 · Insurance code 629700700

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg per dose once daily at bedtime, or 150mg per dose 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. 2. Prevention of duodenal ulcer recurrence After healing of a duodenal ulcer, adults 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 per dose 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 per dose 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 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 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
Os Korea Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of 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 exacerbation of chronic gastritis
View approved original text

This medication helps treat active gastric and duodenal ulcers and prevents the recurrence of duodenal ulcers. It also alleviates heartburn symptoms caused by erosive and ulcerative esophagitis diagnosed by endoscopy, as well as gastroesophageal reflux disease (GERD). It also has efficacy in improving gastric mucosal lesions (erosions, bleeding, redness, swelling) that occur during acute exacerbations of acute and chronic gastritis. It is used effectively to manage various symptoms related to gastric and esophageal diseases.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg per dose once daily at bedtime, or 150mg per dose 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. 2. Prevention of duodenal ulcer recurrence After healing of a duodenal ulcer, adults 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 per dose 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 per dose 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 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 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 administered to certain patients. For example, those who have had allergic reactions to this drug or other H2-receptor antagonists should not use it. Additionally, it contains lactose, so patients with lactose intolerance or specific genetic digestive disorders should avoid taking it. Caution is needed when administering this drug. Patients with a history of drug allergies, poor liver function, or decreased kidney function may require dosage adjustments or interval modifications when using this drug. Rarely, this medication may cause symptoms such as skin rash, itching, bronchial asthma, or severe allergic reactions, and if such symptoms occur, it should be discontinued immediately. Various side effects, including anemia, changes in blood cell count, digestive disturbances (constipation, diarrhea, nausea), liver dysfunction, mental confusion, headaches, drowsiness, dizziness, irregular heartbeats, breast enlargement in women, skin rashes, etc., have been reported. This drug can mask the symptoms of gastric cancer, so it should only be used after confirming that it is not a malignant disease. It is mainly excreted through the kidneys; therefore, patients with impaired kidney function should have their dosage reduced. If there is no therapeutic effect, it is advisable to switch to another medication, and it is safe to periodically monitor liver and kidney function while using this drug. While this drug has a low interaction potential with other specific medications, caution is required when taken in conjunction with high-dose aspirin, as it can increase serum salicylate levels. Women who are pregnant or nursing should only use this drug if its safety has been sufficiently confirmed and it is deemed necessary under physician guidance. The safety in pediatric patients has not been established, and elderly patients may be at higher risk for decreased kidney function, requiring kidney function tests prior to administration and careful observation during treatment. This drug may affect certain clinical test results, so it is advisable to inform medical personnel during testing. In cases of overdose, symptoms such as vomiting, diarrhea, and miosis may occur, and there are no specific antidotes, so treatment and supportive care based on symptoms are necessary. Additionally, this drug is not well removed by hemodialysis, so caution is required. Long-term high-dose administration has shown low carcinogenic potential in animal studies but has observed side effects such as liver damage and weight loss. Therefore, it is very important to use this medication according to the recommended doses and duration.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic 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 injury
  • hepatocellular liver injury
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • ventricular tachycardia
  • gynecomastia
  • sweating
  • hives
  • 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 prevent air ingress and ideally kept at a temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

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

Package unit

30 capsules/bottle, 500 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.