Roxagen Capsule (Roxatidine Acetate Hydrochloride)

Adult dose

Adults: 1) Gastric and duodenal ulcers, reflux esophagitis, 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 generally treated within 4 weeks, but symptoms subside within several days. For patients who have not healed after 4 weeks of treatment, the same dose should be administered 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. For patients with a creatinine clearance of 20mL/min or less, administer 75mg every other day 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.

This medication should not be used by individuals who are allergic to this medication or its components. Caution is required when administering this medication to individuals with poor liver function or weak kidney function, and in cases of weak kidney function, the dosage should be reduced or the dosing interval extended. Elderly individuals should also be administered this medication with caution. While taking this medication, serious allergic reactions such as shock may occur, so careful observation of physical condition is necessary; if abnormal symptoms appear, the medication should be stopped immediately, and medical attention sought. Allergic symptoms such as skin rash or itching may occur rarely, so if such symptoms appear, medication should be discontinued. Regular blood tests are important as thrombocytopenia or anemia may be detected; if abnormal findings are noted, medication should be stopped. Liver function tests may show elevated levels or symptoms of liver dysfunction, so liver status should be carefully monitored; if problems arise, medication should be stopped immediately. Gastrointestinal symptoms such as constipation, diarrhea, nausea, abdominal bloating, and dry mouth may occur. The central nervous system may be affected, and symptoms such as confusion, hallucinations, drowsiness, dizziness, and headaches may occur rarely. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if any skin abnormalities arise, medication should be stopped immediately. Rhabdomyolysis, a muscle-related disease, may occur, so if muscle pain or changes in urine color are noted, it is important to inform a healthcare provider. Various side effects such as gynecomastia, excessive milk secretion, fatigue, and elevated blood pressure may occur rarely. There may be interactions with other medications, so caution is needed especially when taking ketoconazole or midazolam. Women who are pregnant or may become pregnant should carefully weigh the benefits and risks of using this medication, and breastfeeding mothers are advised to avoid breastfeeding as the drug may be excreted in breast milk. The use of this medication in children under 14 years of age is not recommended as safety has not been established. Elderly patients may experience increased concentrations of this medication in the body due to decreased kidney function, so dosage adjustments are required. This medication should be kept out of the reach of children, and transferring to other containers should be avoided to prevent accidents or degradation of quality.

Shock

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

Appearance

A hard capsule with a greenish upper part and a white lower part containing white sustained-release granules.

Package unit

30 capsules/bottle, 120 capsules/bottle, 300 capsules/bottle