Roxarex Extended Release Tablet 75 mg (Roxatidine Acetate Hydrochloride)

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.

This medication should not be used by individuals allergic to this medication or its components. This medication contains lactose, so individuals with a genetic problem that prevents them from digesting lactose should not take it. Caution is required when using this medication in individuals with impaired liver function. In individuals with compromised kidney function, the blood concentration of this medication may increase, so the dosage should be reduced or the interval between doses increased. Elderly individuals should also be cautious when using this medication, as should those who have had allergic reactions to medications in the past. During the course of this medication, serious allergic reactions like shock may occur, so symptoms should be closely monitored. Rarely, hypersensitivity symptoms such as skin rash or itching may occur, and if these symptoms are observed, the medication should be immediately discontinued. Routine blood tests should be conducted, as thrombocytopenia or anemia may be detected during blood tests, and if abnormalities are found, the medication should be discontinued and treatment should be sought. Liver dysfunction or jaundice symptoms may appear, so liver condition should be carefully monitored. Gastrointestinal symptoms such as constipation, diarrhea, nausea, abdominal bloating, and dry mouth may occur. Rarely, neurological symptoms such as confusion, hallucinations, drowsiness, dizziness, and headaches may occur; in severe cases, seizures may manifest. Serious skin disorders such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if any skin abnormalities are observed, the medication should be discontinued immediately. Muscle-related side effects such as myalgia or rapid increases in enzyme levels in the muscles may occur; if these symptoms are noted, the medication should also be discontinued immediately. Rarely, gynecomastia, excessive milk secretion, fatigue, and elevated blood pressure may occur. Caution is required when used in conjunction with other H2 receptor antagonists due to the risk of serious allergic reactions such as anaphylaxis, nephritis, or cardiac conduction abnormalities. This medication may mask symptoms of gastric cancer, so it should only be used after confirming the absence of malignancy. In cases of mild gastrointestinal disturbances, it should be taken under the guidance of a doctor or pharmacist. During the treatment period, the patient’s condition should be closely monitored, and the minimum effective dose should be used; if there is no effect, switching to another medication is recommended. Periodic checks of liver function, kidney function, and blood condition are necessary. This medication can reduce the absorption of certain antifungal agents and enhance the effects of some sedatives, so caution is required when taken together. Taking it with food or antacids does not significantly affect absorption. Safety during pregnancy has not been fully established, therefore, pregnant women or those who might become pregnant should take it under a doctor's supervision. This medication can be transmitted through breast milk, so breastfeeding should be avoided while taking this medication. It is advised not to use in children under 14 years of age, as safety has not been established. Elderly individuals may have reduced kidney function leading to higher blood concentrations of this medication, so the dosage should be reduced or the interval between doses increased for careful use. Keep this medication in a safe place out of the reach of children, and be careful not to transfer it to another container as the quality may change.

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This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to safely preserve the medication’s effectiveness for a long period.

Appearance

White round extended release film-coated tablet

Package unit

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