Roxatin Sustained Release Capsule 37.5mg (Roxatidine Acetate Hydrochloride)

Adult dose

Adults 1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer 75mg of roxatidine acetate hydrochloride per dose 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 condition has not healed after 4 weeks of treatment, continue treatment at the same dose for an additional 2 weeks. For patients with impaired renal function and creatinine clearance of 20-50ml/min, administer 75mg per dose once daily in the evening. For creatinine clearance of 20ml/min or less, administer 75mg per dose 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) 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). ㆍAdjust the dose appropriately according to age and symptoms.

This medication should not be used by those who have allergic reactions to it or its components. Patients with liver or kidney function issues must exercise caution when using this medication. Particularly in cases of impaired kidney function, the drug concentration may increase, warranting a dose reduction or extension of dosing intervals. Elderly patients are also at risk of increased drug concentration and should be administered cautiously. Patients with a history of drug hypersensitivity should also proceed with caution. Serious allergic reactions like shock may occur while using this medication, so if initial symptoms such as discomfort, facial pallor, or hypotension present themselves, drug use should be immediately discontinued and appropriate treatment sought. Skin reactions such as itching or rash may occur rarely; if these symptoms appear, drug use should be stopped. Blood tests may reveal thrombocytopenia or anemia, and regular testing should occur; if abnormalities are found, administration should cease. Abnormal liver function or jaundice symptoms may occur, thus liver status should be closely monitored and administration should be stopped immediately in the event of abnormalities. Gastrointestinal symptoms such as constipation, diarrhea, nausea, abdominal distension, or dry mouth may arise. Rarely, psychiatric or neurological symptoms such as confusion, hallucinations, drowsiness, dizziness, or headaches may present, warranting caution. Serious skin conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may develop; immediate drug discontinuation is required if skin abnormalities appear. Muscle-related symptoms, including rhabdomyolysis, may occur; if muscle pain or changes in urine color occur, drug administration should be stopped immediately. Other rare side effects may include gynecomastia, increased milk secretion, lethargy, and elevated blood pressure. When combined with similar medications, anaphylaxis, nephritis, or cardiac conduction abnormalities have been reported; if abnormal symptoms arise, drug administration should be stopped immediately. This medication may mask symptoms of stomach cancer, thus it should only be used after confirming that there are no malignant tumors, and it should be used in mild gastrointestinal diseases only under the guidance of a physician or pharmacist. During treatment, the patient's condition should be closely monitored, using the minimum effective dose, and if no effect is observed, a change to a different medication should be considered. This medication may interact with some medications, reducing the absorption of ketoconazole and enhancing the effect of midazolam. It does not affect absorption when taken with food or antacids. Pregnant women or women of childbearing potential should use this medication only when the therapeutic benefits outweigh risks, as its safety is not definitively established. This medication may be secreted in breast milk, so breastfeeding should be avoided while taking it. Safety is not established for children under 14 years, and it is advisable not to use it in this age group. Finally, this medication should be stored out of reach of children, and care should be taken not to transfer it to another container to avoid accidents or loss of quality.

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This medication must be stored in a tightly closed container to protect it from air and moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius. This will ensure the medication's effectiveness is preserved safely.

Appearance

A white hard capsule with white granules inside.

Package unit

30 capsules/bottle, 250 capsules/bottle