Medication info
Nizicid Capsule 150mg (Nizatidine)

Nizicid Capsule 150mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
Daewoo Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a yellow upper part and a light yellow lower part containing a whitish powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201402024 · Approved 2014.04.25

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers, treatment of esophagitis and heartburn, and improvement of gastric mucosal lesions
Who takes it
Adults
Adult dose
Treatment of active gastric and 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. 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 use are not known. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 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 per day 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 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.

Ingredients

Manufacturer
Daewoo Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • 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 treats active gastric and duodenal ulcers and prevents recurrence of duodenal ulcers. It also helps relieve heartburn symptoms caused by erosive and ulcerative esophagitis and gastroesophageal reflux disease diagnosed by endoscopy. Additionally, it improves lesions such as erosion, bleeding, redness, and edema of the gastric mucosa that occur during acute exacerbations of acute or chronic gastritis. Overall, this medication is used in the treatment and symptom relief of various gastrointestinal and esophageal diseases.

How to take

Adult dose

Treatment of active gastric and 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. 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 use are not known. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 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 per day 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 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.

Precautions

This medication should not be used in certain patients. Particularly, patients who are allergic to this drug or similar drugs or have genetic issues such as lactose intolerance should not take it. Additionally, patients with hypersensitivity to the medication or issues with liver or kidney function should exercise caution when using this drug. For patients with reduced kidney function, the dose should be reduced or dosing intervals increased. Rarely, allergic reactions such as skin rashes, itching, and respiratory distress may occur; if these symptoms develop, the medication should be discontinued immediately. Various side effects such as anemia, changes in white blood cell count, digestive disorders, liver function abnormalities, mental confusion, headaches, dizziness, arrhythmias, gynecomastia in women, skin rashes, and others have been reported and require caution. This medication can mask symptoms of gastric cancer; therefore, it should only be used when it is certain that it is not gastric cancer, and dose adjustment is necessary for patients with impaired kidney function. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus and baby when using this medication. Older adults are at higher risk of decreased kidney function, so it is advisable to conduct kidney function tests first and closely monitor kidney status during use. This drug has a relatively low potential for interactions with other drugs, but taking it with high doses of aspirin may increase serum salicylate concentration. In case of overdose, symptoms such as vomiting or diarrhea may occur, necessitating appropriate treatment and supportive therapy. This drug cannot be effectively removed by hemodialysis. Although long-term high-dose administration is not known to significantly increase the risk of cancer, caution is still advised as it can affect liver function. Some test results may be affected during clinical testing, so it is important to inform the testing facility that this medication has been taken.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • symptoms of anaphylaxis
  • 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 sealed container to prevent air exposure and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

A hard capsule 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.

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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.