Gastricserbangjeong (Roxatidine Acetate Hydrochloride)

Adult dose

Adults 1) Gastric and duodenal ulcers, gastroesophageal reflux disease, Zollinger-Ellison syndrome: Administer 75mg of roxatidine acetate hydrochloride 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 usually treated within 4 weeks, but symptoms subside within a few days. If the ulcers have not healed after 4 weeks of treatment, continue treatment at the same dose for an additional 2 weeks. For patients with renal impairment and a creatinine clearance of approximately 20-50ml/min, administer 75mg once daily in the evening. For patients with a creatinine clearance of 20ml/min or less, administer 75mg every other day in the evening. 2) Acute gastritis and acute exacerbations of chronic gastritis: Administer 75mg once daily after dinner or at bedtime. 3) Pre-anesthetic 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.

This medication should not be used in patients who are allergic to this medication or its components. Additionally, since it contains lactose, patients with lactose intolerance, galactose intolerance, or certain genetic metabolic disorders should not take it. Patients with liver or kidney function problems should use this medication cautiously, particularly if kidney function is impaired, as the concentration of the drug may increase, necessitating dosage adjustment or prolonging dosing intervals. Elderly patients should also take care due to potential impairment of kidney function. Patients with a history of hypersensitivity reactions to medications should be administered this drug with caution. This medication can cause allergic reactions or severe shock; if symptoms such as discomfort, facial pallor, or hypotension occur, immediately discontinue use and seek medical assistance. If symptoms of hypersensitivity such as skin rash or itching appear, discontinue use. Abnormal blood-related symptoms, such as thrombocytopenia or anemia, can occur, so regular blood tests are important. Liver dysfunction or signs of jaundice may occur, so liver condition should be monitored closely, and if any abnormal signs are observed, discontinue the drug. Gastrointestinal side effects such as constipation, diarrhea, nausea, abdominal distension, or dry mouth may occur. Neurological side effects such as confusion, hallucination, drowsiness, headache, or dizziness may rarely occur and should be observed. There can be severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so discontinue use immediately if skin abnormalities appear. Muscle-related adverse reactions such as myalgia or rhabdomyolysis can occur, so consult a healthcare professional if experiencing muscle pain or changes in urine color. This medication may interact with other drugs; thus, consultation with a physician is required, especially for those taking ketoconazole or midazolam. Women who are pregnant or may become pregnant should have careful consideration before taking this medication, and nursing mothers are advised to avoid it as the drug may be excreted in breast milk. The use of this medication is not recommended for children under 14, as its safety has not been established. Lastly, keep this medication out of reach of children and avoid transferring it to another container.

Shock

This medication should be stored in a tightly closed container to prevent air or moisture entry. Also, it is advisable to store it at room temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance

White, round, sustained-release film-coated tablet

Package unit

30 tablets/bottle, 250 tablets/bottle