Medication info

Nizant Capsule (Nizatidine)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Aprogen Biologics Co., Ltd.
Appearance
Hard capsules with a yellow upper part and a light yellow lower part containing a whitish powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Expired

MFDS item code 201405899 · Approved 2014.12.16

This product's status changed to Expired on 2024.12.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of esophagitis and reflux heartburn; treatment and prevention of recurrence of gastric and duodenal ulcers; improvement of gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine orally 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 needed. In patients with active gastric ulcers, malignancy must be ruled out before treatment. 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 in patients with severe renal impairment The dose in patients with renal impairment should be reduced and adjusted 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 Creatinine clearance may be below 50mL/min in some elderly patients. 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
Aprogen Biologics Co., Ltd.

Efficacy & effects

Treatment of esophagitis and reflux heartburn; treatment and prevention of recurrence of gastric and duodenal ulcers; 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 to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It is also effective in relieving the heartburn symptoms caused by erosive and ulcerative esophagitis and gastroesophageal reflux disease diagnosed by endoscopy. It is used to improve lesions (erosion, bleeding, redness, swelling) of the gastric mucosa during acute exacerbations of acute and chronic gastritis. Overall, it helps to relieve symptoms related to diseases of the stomach and duodenum and improve tissue health.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine orally 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 needed. In patients with active gastric ulcers, malignancy must be ruled out before treatment. 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 in patients with severe renal impairment The dose in patients with renal impairment should be reduced and adjusted 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 Creatinine clearance may be below 50mL/min in some elderly patients. 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 patients with hypersensitivity to this medication or other H2-receptor antagonists. Also, since this medication contains lactose, it should not be administered to patients with a genetic disorder that prevents proper digestion of lactose. Care should be taken when administering to patients with a history of drug hypersensitivity, poor liver function, and decreased kidney function. In particular, patients with impaired kidney function may experience increased blood levels of this medication, so it may be necessary to reduce the dosage or extend the dosing interval. If any hypersensitivity symptoms such as skin rash, itching, or difficulty breathing occur while using this medication, it should be discontinued immediately. Abnormal blood symptoms such as anemia or leukopenia may occur, so consult a physician if any abnormal symptoms arise. Gastrointestinal symptoms such as constipation, diarrhea, or nausea may occur infrequently. Elevated liver function test results or liver problems such as hepatitis or jaundice have also been reported, so caution is needed regarding liver health. Rarely, symptoms such as mental confusion, headache, drowsiness, and dizziness may occur, so it is advisable to report any of these symptoms. A temporary increase in heart rate may also occur. In women, breast enlargement may occur rarely, and erectile dysfunction or decreased libido have also been reported. Symptoms such as sweating, urticaria, or rash may occur, so be vigilant regarding skin changes. This medication may mask symptoms of stomach cancer, so it should be used only after confirming there is no stomach cancer. Primarily excreted through the kidneys, dosing adjustments may be necessary for patients with impaired kidney function. During treatment, regular blood tests and liver and kidney function tests should be performed to monitor status. Pregnant women or women who may become pregnant should only use this medication when the benefits outweigh the potential risks to the fetus, as its effects on pregnancy are not clearly established. Breastfeeding women should use this medication only when necessary, as it is partially excreted in breast milk. The safety and efficacy in children have not been adequately established. Older adults may have reduced kidney function, so kidney function should be tested to determine the appropriate dosage while also monitoring kidney status during treatment. In the case of overdose, symptoms such as vomiting, diarrhea, or pupil constriction may occur, and emergency treatment should be sought if necessary. No significant drug interactions have been reported; however, caution is advised when taking it with high-dose aspirin. Finally, while the risk of carcinogenicity with long-term high-dose use of this medication is considered low, side effects such as liver damage or weight loss have been observed in animal studies. Therefore, it's crucial to adhere closely to the recommended dosage and duration per a physician's instructions when using this medication.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • neutrophilia
  • thrombocytopenic purpura
  • constipation
Show 29 more
  • diarrhea
  • thirst
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental 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 to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it in this manner helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Hard capsules with a yellow upper part and a light yellow lower part containing a whitish 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.