Medication info
Nizatidine Capsule 150 mg (Nizatidine)

Nizatidine Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Pamgen Science Co., Ltd.
Appearance
A hard capsule with a purple upper part and a pale yellow lower part filled with a white to gray-white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201400834 · Approved 2014.02.21 · Insurance code 670103540

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric 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; outcomes with 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 for patients with severe renal impairment The dose should be reduced and adjusted as follows for patients with renal impairment. Creatinine clearance Dosage 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 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 impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
Pamgen Science Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of esophagitis and heartburn; improvement of gastric lesions

  • Active gastric ulcer
  • duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • 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 heartburn caused by erosive and ulcerative esophagitis diagnosed by endoscopy, and is effective in improving gastric mucosal lesions characterized by erosion, bleeding, redness, and swelling during acute exacerbations of acute and chronic gastritis. Therefore, this drug helps in treating various gastrointestinal diseases and alleviating symptoms.

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; outcomes with 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 for patients with severe renal impairment The dose should be reduced and adjusted as follows for patients with renal impairment. Creatinine clearance Dosage 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 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 impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This drug should not be used in patients with known allergic reactions or histories of hypersensitivity to specific medications. Care should be taken when using this drug in patients with liver or kidney function problems. Especially in cases of impaired kidney function, the blood concentration of the drug may increase, so the dosage should be reduced or the dosing interval prolonged. This medication contains a dye called Yellow No. 5, so caution is advised for patients allergic to this ingredient. During use, allergic symptoms such as skin rash, itching, and difficulty in breathing may occur; if these symptoms appear, discontinue use immediately. Adverse effects such as anemia or abnormalities in blood cell counts, digestive disturbances, liver function abnormalities, confusion, headache, dizziness, weakness, ventricular tachycardia, gynecomastia, erectile dysfunction, decreased libido, sweating, exfoliative dermatitis, vasculitis, hyperuricemia, fever, chest pain, myalgia, rhinitis, pharyngitis, coughing may occur; consult a physician if unusual symptoms arise. Also, this drug can mask symptoms of stomach cancer, so it should only be used after confirming it is not a malignant condition. Patients with reduced kidney function or the elderly should determine the appropriate dosage through kidney function tests, and the kidney condition should be closely monitored during treatment. Women who are pregnant or breastfeeding should only use this drug if the benefits of treatment outweigh the risks, as its safety has not been established. Safety in children has not been sufficiently confirmed, so it should be administered cautiously to children. In case of overdose, symptoms such as vomiting or diarrhea may appear, and appropriate treatment should be sought if necessary. This drug generally has few interactions with other medications, but caution is needed when used with high-dose aspirin. Finally, it is important to have regular blood tests and liver and kidney function tests to check for abnormalities during the use of this medication.

Side effects

  • Rash
  • pruritus
  • 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
  • mental 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 tightly sealed container to prevent exposure to air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a long time.

Appearance and packaging

Appearance

A hard capsule with a purple upper part and a pale yellow lower part filled with a white to gray-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.