Roxagen Sustained Release Tablet 75mg (Roxatidine Acetate Hydrochloride)

Adult dose

Adults 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 generally heal within 4 weeks, but symptoms resolve within a few days. If healing has not occurred after 4 weeks of treatment, administer the same dose for an additional 2 weeks. For patients with impaired renal function and creatinine clearance of approximately 20-50ml/min, administer 75mg once daily in the evening. For patients with creatinine clearance of 20ml/min or less, administer 75mg every other day in the evening. 2) Acute gastritis or 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.

This medication should not be used by individuals who are allergic to this drug or its ingredients. Additionally, this drug contains lactose, so individuals with a genetic condition that prevents them from digesting lactose should not take it. Patients with liver or kidney function problems should be cautious when using this medication. Especially in cases of reduced kidney function, the drug dosage should be reduced or the dosing interval should be increased. Elderly patients may also have decreased kidney function, thus the drug should be administered cautiously. Patients who have previously experienced hypersensitivity reactions to medications should also be careful. If shock symptoms, rashes, or itching occur during treatment, discontinue the medication immediately and consult a healthcare professional. If abnormalities are found in blood tests, treatment should be stopped and appropriate care should be taken. Liver function abnormalities or symptoms of digestive disorders should also be closely monitored. Neurological symptoms such as confusion, hallucination, drowsiness, and headache may rarely occur, so if these symptoms appear, inform your healthcare provider. If severe skin reactions occur, discontinue use immediately, and also be cautious about muscle-related adverse symptoms. This medication may interact with other drugs, so inform your healthcare provider if you are taking medications such as ketoconazole or midazolam. Women who are pregnant or may become pregnant should consult a doctor before taking this drug, and nursing mothers should avoid breastfeeding while on this medication. Safety has not been established for children under 14 years of age, so it should not be used in this population. This medication should be kept out of reach of children and transferring it to other containers should be avoided.

• Shock
• discomfort
• facial pallor
• hypotension
• rash
• itching
• thrombocytopenia
• pancytopenia
• agranulocytosis
• aplastic anemia

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

White round sustained-release film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 250 tablets/bottle