Medication info
Itidine Capsule 150mg (Nizatidine)

Itidine Capsule 150mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Intro Bio Pharma Co., Ltd.
Appearance
A hard capsule with upper yellow and lower pale yellow filled with white to almost white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201907278 · Approved 2019.10.16

Summary

Main use
Treatment of ulcers and prevention of duodenal ulcer recurrence; treatment of esophagitis and heartburn; improvement of gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, orally. 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, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results for longer-term administration are not known. 3. Gastroesophageal reflux disease 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 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 and adjusted as follows. Creatinine clearance / 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 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. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Ingredients

Manufacturer
Intro Bio Pharma Co., Ltd.

Efficacy & effects

Treatment of ulcers and prevention of duodenal ulcer recurrence; 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 is used to treat active gastric and duodenal ulcers and to prevent the recurrence of duodenal ulcers. It also alleviates symptoms of erosive and ulcerative esophagitis diagnosed by endoscopy and heartburn caused by gastroesophageal reflux disease. It is also effective in ameliorating symptoms like erosion, bleeding, redness, and swelling in gastric mucosal lesions that occur during acute exacerbation of acute gastritis or chronic gastritis. Thanks to these effects, it helps in the treatment of various diseases related to the digestive system.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, orally. 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, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results for longer-term administration are not known. 3. Gastroesophageal reflux disease 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 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 and adjusted as follows. Creatinine clearance / 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 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. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

Precautions

This medication should not be used in certain patients. People with allergies to this medication or similar drugs should not take it. Patients with hereditary diseases affecting lactose breakdown should also avoid this medication. Caution is needed when using this medication. Patients with a history of drug allergies, poor liver function, or decreased kidney function should use this drug cautiously. In particular, patients with weakened kidney function may have increased drug concentration, so the dosage should be reduced or the dosing interval increased. While taking this medication, severe allergic reactions such as rash, itching, breathing difficulties, and anaphylaxis may rarely occur. If such symptoms appear, discontinue the medication immediately and consult with healthcare professionals. Additionally, side effects such as anemia, decreased white blood cell count, gastrointestinal problems (constipation, diarrhea, nausea, etc.), liver dysfunction, mental confusion, headache, drowsiness, dizziness, weakness, ventricular tachycardia, gynecomastia in women, impotence, decreased libido, sweating, rash, exfoliative dermatitis, vasculitis, hyperuricemia, fever, chest pain, muscle pain, rhinitis, pharyngitis, cough may occur. Abnormal heart rhythms or rare reports of breast enlargement in women, skin rash, sweating, and vasculitis have also been recorded. This medication can mask symptoms of stomach cancer, so it should be used only after confirming that there is no malignant disease. Since it is mainly excreted through the kidneys, dosage adjustment is necessary for patients with decreased kidney function. During treatment, regular blood tests and liver and kidney function tests should be conducted to check for abnormalities. Pregnant or breastfeeding women should only use this medication when deemed absolutely necessary, as safety has not been established. During breastfeeding, there may be some secretion of the drug into breast milk, so caution is required. Safety for children has not been sufficiently confirmed, and elderly patients may have a high likelihood of kidney function deterioration, so kidney function tests are needed before administration. In case of overdose, symptoms such as vomiting, diarrhea, increased salivation, and pupil constriction may appear, and clinical examination, supportive therapy, and measures for drug removal should be considered if excessive dosage occurs. This drug has minimal potential for interactions with other medications, but caution is warranted when used with high-dose aspirin. Long-term high-dose use of this drug has not shown any evidence of carcinogenicity, and its effects on genetic toxicity and reproductive ability are limited. Regular check-ups should be conducted during treatment to monitor for adverse reactions, and if any abnormal symptoms arise, immediate consultation with healthcare personnel is required.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • increased neutrophils
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • increased GOT
  • increased GPT
  • increased AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynecomastia in females
  • 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 tightly sealed container to prevent air and moisture from entering. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. Storing it this way will help retain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

A hard capsule with upper yellow and lower pale yellow filled with white to almost 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.