Medication info

Kenatin Capsule 150 mg (Nizatidine)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
KMS Pharmaceutical Co., Ltd.
Appearance
Hard capsule with a yellow upper part and a light yellow lower part filled with white to nearly white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Expired

MFDS item code 201902752 · Approved 2019.04.29

This product's status changed to Expired on 2024.04.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence of ulcers, treatment of esophagitis and heartburn, and improvement of gastric mucosal lesions associated with gastritis
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if needed. 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 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 for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: creatinine clearance 20~50 ml/min, 150mg daily Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: creatinine clearance < 20 ml/min, 150mg every other day Maintenance therapy: creatinine clearance 20~50 ml/min, 150mg every other day Maintenance therapy: creatinine clearance < 20 ml/min, 150mg every 3 days Some older adults 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
KMS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of ulcers, treatment of esophagitis and heartburn, and improvement of gastric mucosal lesions associated with gastritis

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn due to gastroesophageal reflux disease
  • 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 heartburn symptoms caused by erosive and ulcerative esophagitis diagnosed by endoscopy and gastroesophageal reflux disease. It is helpful in improving gastric mucosal lesions, such as erosion, bleeding, erythema, and edema, which occur during acute exacerbation of acute gastritis and chronic gastritis. Overall, it is an effective medication for the treatment of gastric and duodenal-related diseases and symptom improvement.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if needed. 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 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 for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: creatinine clearance 20~50 ml/min, 150mg daily Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: creatinine clearance < 20 ml/min, 150mg every other day Maintenance therapy: creatinine clearance 20~50 ml/min, 150mg every other day Maintenance therapy: creatinine clearance < 20 ml/min, 150mg every 3 days Some older adults 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 medication should not be used in certain patients. Those who have had an allergic reaction to this medication or similar drugs should not take it. Additionally, individuals with a genetic disorder that affects lactose digestion should avoid this medication. There are cases when caution is required while taking this medication. Patients with a history of drug allergies should use it with caution. Patients with poor liver function or kidney issues should also take it with care, and in cases of impaired kidney function, the dosage should be reduced or the interval of taking the medication should be increased. Rarely, allergic reactions such as skin rashes, itching, and dyspnea may occur while taking this medication. Conditions such as anemia or abnormalities in blood cell counts may develop, so if any unusual symptoms occur, the medication should be discontinued immediately. Gastrointestinal side effects such as constipation, diarrhea, dry mouth, and nausea may occur. Increased liver enzyme levels, hepatitis, or jaundice have been reported infrequently due to liver function abnormalities. Mental confusion, headaches, drowsiness, and dizziness may occur, and seizures may rarely occur. Tachycardia may also be observed. In women, breast enlargement may rarely occur and reports of erectile dysfunction or decreased libido have been noted in men. Symptoms such as sweating, urticaria, rash, dermatitis, and vasculitis may also appear on the skin. Additionally, increases in uric acid levels not related to gout or kidney stones, fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough have been reported. This medication may mask symptoms of gastric cancer, so it should be confirmed whether or not it is gastric cancer before use. It is primarily excreted through the kidneys, so patients with deteriorated kidney function need dose adjustments. While monitoring treatment effects, periodic blood tests and liver and kidney function assessments should be carried out. Interactions with other drugs are relatively few, but concurrent use with high doses of aspirin may increase serum salicylate levels. Pregnant or nursing women should only take this medication when the doctor determines that the benefits of treatment outweigh the risks, as its safety has not been firmly established. Nursing mothers should only take it if absolutely necessary, as some may be secreted in breast milk. Safety in children has not been established. Elderly patients are likely to have reduced kidney function, and the dosage should be determined after performing kidney function tests and closely monitoring their kidney status. In the event of overdose, symptoms such as vomiting, diarrhea, excessive salivation, and miosis may occur, and if necessary, treatment such as inducing vomiting or gastric lavage may be required. This medication cannot be effectively eliminated through hemodialysis. There is no evidence of carcinogenicity even with prolonged high-dose administration, and no genotoxicity has been observed. However, caution is needed as some liver damage was observed in animal studies. In pregnant animal studies, high-dose administration may affect the fetus, so it should be used cautiously during pregnancy. This medication may rarely lead to erectile dysfunction symptoms in men, so if symptoms occur, consultation with a doctor 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 injury
  • hepatocellular liver injury
  • 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 air and moisture ingress, and it should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

Hard capsule with a yellow upper part and a light yellow lower part filled with white to nearly 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.