Medication info
Nizatidine Capsule 150mg (Nizatidine)

Nizatidine Capsule 150mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
IYON Pharmaceutical Co., Ltd.
Appearance
A yellowish hard capsule containing a powder that is grayish-white to light yellow.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 199900151 · Notified 1999.10.02 · Insurance code 658600060

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of reflux disease; improvement of gastric mucosal lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg orally 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 recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results for 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. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance 20~50 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 150mg daily Creatinine clearance < 20 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 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 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 such patients according to the degree of renal impairment. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Ingredients

Manufacturer
IYON Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of reflux disease; improvement of gastric mucosal lesions

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

This medication is effective for the treatment of active gastric and duodenal ulcers and for the prevention of recurrence of duodenal ulcers. It also alleviates heartburn symptoms caused by erosive and ulcerative esophagitis diagnosed via endoscopy and gastroesophageal reflux disease. Additionally, it helps improve gastric mucosal lesions such as erosion, bleeding, redness, and swelling that occur during acute exacerbations of acute and chronic gastritis. Thus, this drug is used to alleviate symptoms and improve mucosal condition across a variety of gastrointestinal diseases.

How to take

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg orally 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 recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results for 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. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance 20~50 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 150mg daily Creatinine clearance < 20 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 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 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 such patients according to the degree of renal impairment. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Precautions

This drug is used as an H2-receptor antagonist to suppress gastric acid secretion. Patients who have had allergic reactions to similar types of drugs should avoid using this medication. Patients with a history of drug allergies or those with liver or kidney function problems should use this medication with extra caution. In particular, patients with impaired kidney function may need to reduce the dosage or increase the dosing interval since the drug may remain in the body longer. If allergic symptoms such as skin rash, itching, difficulty breathing, or swelling of the face or neck occur while using this medication, it is important to stop use immediately and consult a healthcare professional. Additionally, symptoms such as anemia, abnormalities in blood cell counts, constipation, diarrhea, dry mouth, and nausea may occur, so any unusual symptoms should be reported. Liver function test values may rise, and symptoms of hepatitis or jaundice may occur, so those with liver health issues need to be particularly cautious. Neurological symptoms such as confusion, headaches, drowsiness, and dizziness may rarely occur, so care should be taken when driving or operating machinery. Symptoms such as arrhythmias, gynecomastia in women, skin rashes, sweating, and vasculitis have also been reported, so you should inform your healthcare provider if such symptoms occur. This medication is primarily excreted through the kidneys, so elderly patients or those with reduced kidney function should have kidney function tests to determine an appropriate dosage and regularly monitor their kidney status during treatment. Women who are pregnant or may become pregnant should only use this medication when it is judged that the benefits of treatment outweigh the risks, and breastfeeding women should only be administered the drug when absolutely necessary. Safety in children has not been established, so caution should be exercised when administering it to children. This drug generally has fewer interactions with other medications, but caution is advised when used concurrently in high doses with aspirin as it may increase the concentration of certain components in the blood. In the case of overdose, symptoms may include vomiting, diarrhea, and pupillary constriction; in such cases, visit a medical facility immediately for appropriate treatment. This medication may mask symptoms of stomach cancer, so it is safer to use it only after confirming that the condition is not malignant. If there are no treatment effects or if adverse reactions are severe, switching to another therapy is recommended.

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 damage
  • hepatocellular liver damage
  • confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • 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 tightly closed container to prevent air or moisture from entering. It should also be stored at room temperature, ideally between 1 to 30 degrees Celsius, avoiding extreme temperatures.

Appearance and packaging

Appearance

A yellowish hard capsule containing a powder that is grayish-white to light yellow.

Package unit

30 capsules/bottle, 100 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.