Medication info
Roxatidine Sustained-release Tablet (Roxatidine Acetate Hydrochloride)

Roxatidine Sustained-release Tablet (Roxatidine Acetate Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Roxatidine Acetate Hydrochloride›75mg / 1 tablet
Manufacturer / importer
Korea Prime Pharmaceutical Co., Ltd.
Appearance
White round sustained-release film-coated tablet
Packaging
30 tablets/bottle, 250 tablets/bottle
Approval status
Active

MFDS item code 202301664 · Approved 2023.05.24 · Insurance code 663608720

Summary

Main use
Treatment of gastric acid disorders (such as ulcers and reflux esophagitis); improvement of gastric mucosal lesions; prevention of aspiration of gastric contents
Who takes it
Adults
Adult dose
1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer roxatidine acetate hydrochloride 75mg orally twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150mg may also be administered once daily in the evening. Gastric and duodenal ulcers are generally treated within 4 weeks, but symptoms resolve within a few days. If a patient is not cured after 4 weeks of treatment, administer the same dose for an additional 2 weeks. For patients with impaired renal function and a creatinine clearance of approximately 20-50ml/min, administer 75mg once daily in the evening. If creatinine clearance is 20ml/min or less, administer 75mg every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg once daily after the evening meal or at bedtime. 3) Preanesthetic administration: Administer 75mg twice (at bedtime on the day before surgery and 2 hours before induction of anesthesia on the day of surgery). Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Korea Prime Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastric acid disorders (such as ulcers and reflux esophagitis); improvement of gastric mucosal lesions; prevention of aspiration of gastric contents

  • Gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • risk of gastric acid aspiration
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • edema
  • acute gastritis
  • acute exacerbation of chronic gastritis
View approved original text

This drug is effectively used for diseases such as gastric and duodenal ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. Furthermore, it is administered to patients at risk of aspiration of gastric acid, particularly before anesthesia in laboring patients, to ensure safety. It is also helpful in improving gastric mucosal lesions that occur during acute exacerbations of acute and chronic gastritis, such as erosion, bleeding, redness, and edema. Therefore, this drug is widely used for the treatment and symptom relief of various gastric-related disorders.

How to take

Adult dose

1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer roxatidine acetate hydrochloride 75mg orally twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150mg may also be administered once daily in the evening. Gastric and duodenal ulcers are generally treated within 4 weeks, but symptoms resolve within a few days. If a patient is not cured after 4 weeks of treatment, administer the same dose for an additional 2 weeks. For patients with impaired renal function and a creatinine clearance of approximately 20-50ml/min, administer 75mg once daily in the evening. If creatinine clearance is 20ml/min or less, administer 75mg every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg once daily after the evening meal or at bedtime. 3) Preanesthetic administration: Administer 75mg twice (at bedtime on the day before surgery and 2 hours before induction of anesthesia on the day of surgery). Adjust the dose as appropriate according to age and symptoms.

Precautions

This drug should not be used in patients who are allergic to this drug or its components. This drug contains lactose, so patients with genetic diseases that cause intolerance to lactose should not take it. Patients with liver or kidney function issues should exercise caution when using this drug; specifically, those with impaired kidney function may need to reduce the dosage or increase the dosing interval. Elderly patients should also use this drug cautiously due to the likelihood of decreased kidney function. During the use of this drug, allergic reactions or symptoms of shock can occur, so symptoms should be closely monitored, and if any abnormal symptoms appear, the medication should be stopped immediately and medical attention sought. Regular blood tests are necessary, as decreases in platelet counts or anemia may be observed; medication should be discontinued if issues arise. Periodic monitoring of liver function is necessary, as liver function abnormalities or jaundice can manifest. Gastrointestinal symptoms such as constipation, diarrhea, nausea, abdominal bloating, and dry mouth may occur. Rarely, neurological symptoms such as confusion, hallucinations, drowsiness, and headaches may develop, so caution is advised. If severe rashes or blisters on the skin occur, take the drug off immediately and inform medical staff. If muscle-related adverse symptoms, such as myalgia or elevated muscle enzyme levels occur, the medication should be discontinued promptly. This drug may rarely result in side effects such as gynecomastia, galactorrhea, malaise, and elevated blood pressure. Interactions may occur when taken with certain specific medications, so if other medications are being taken, you must inform your healthcare provider. The use of this drug is not recommended for pregnant women or those who may become pregnant; if necessary, consultation with a doctor is required for careful consideration. This drug is also not recommended for nursing women, and breastfeeding should be avoided during treatment. Children under the age of 14 should avoid this drug due to established safety concerns. This drug should be kept out of the reach of children, and it is safer not to transfer it to another container.

Side effects

Shock

Not everyone experiences these, and they can vary from person to person.

Storage

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature, specifically between 1°C and 30°C, to maintain the drug's effectiveness.

Appearance and packaging

Appearance

White round sustained-release film-coated tablet

Package unit

30 tablets/bottle, 250 tablets/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.