Senuvera Tablet 400 mg (Sevelamer Carbonate)

Adult dose

This medicine should be taken 3 times daily with meals. 1) Administration to patients who are not taking phosphate binders The recommended initial dose of this medicine is 0.8g to 1.6g. Take 2~4 tablets with each meal according to the serum phosphorus level, as follows. Table 1 shows the recommended initial dose of this medicine for patients who are not taking phosphate binders. Table 1. Initial dose in patients with chronic kidney disease who are not taking phosphate binders Serum phosphorus 5.5 - 7.5 ㎎/dL: Take 2 tablets per dose, 3 times daily with meals Serum phosphorus 7.5 ㎎/dL or higher: Take 4 tablets per dose, 3 times daily with meals 2) Switching patients taking sevelamer hydrochloride tablets to this medicine When switching patients taking sevelamer hydrochloride tablets to this medicine, administer the same dose. Appropriate dose adjustment may be necessary to achieve the target serum phosphorus level. The maximum daily dose of sevelamer carbonate studied in patients with chronic kidney disease receiving dialysis was 14g. 3) Switching patients taking calcium acetate preparations to this medicine Table 2 shows the recommended initial dose of this medicine based on the current dose of calcium acetate. Table 2. Initial dose in patients with chronic kidney disease when switching from calcium acetate preparations to this medicine Calcium acetate preparation (containing 667mg calcium acetate per tablet) 1 tablet per dose, 3 times daily: Dose of this medicine 2 tablets per dose, 3 times daily Calcium acetate preparation (containing 667mg calcium acetate per tablet) 2 tablets per dose, 3 times daily: Dose of this medicine 4 tablets per dose, 3 times daily Calcium acetate preparation (containing 667mg calcium acetate per tablet) 3 tablets per dose, 3 times daily: Dose of this medicine 6 tablets per dose, 3 times daily 4) Switching from sevelamer carbonate tablets to powder or from powder to tablets When switching between sevelamer carbonate tablets and powder, administer the same dose. Appropriate dose adjustment may be necessary to achieve the target serum phosphorus level. 5) Dose adjustment in all patients taking this medicine If necessary, increase or decrease the dose of this medicine by 0.8g, taken 3 times daily with meals, at intervals of 2 weeks until the target serum phosphorus level is achieved.

This medication should not be used in patients with allergies to the active ingredient or excipients, or in patients with hypophosphatemia or bowel obstruction. Patients with gastrointestinal strictures or constipation should use this medication cautiously, as there is a risk of swelling in the gastrointestinal tract that may lead to bowel obstruction or perforation. Gastrointestinal side effects such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, bloating, and constipation may occur during treatment, and if symptoms worsen, immediate consultation with a healthcare professional is advised. Patients undergoing peritoneal dialysis may experience serious adverse reactions such as peritonitis, requiring prompt diagnosis and treatment, along with strict aseptic techniques. This medication does not contain calcium or alkaline components, so serum calcium levels should be monitored regularly, and calcium supplements may be required if necessary. Prolonged use may reduce levels of fat-soluble vitamins A, D, E, K, and folate, thus regular blood tests to check vitamin status and supplementation is advisable. This medication should be swallowed whole without crushing or chewing, and it is preferable to take it with meals. When taken with other oral medications, it may affect drug absorption; therefore, other medications should be taken at least 1 hour before or after this medication, and blood concentrations should be monitored as necessary. Pregnant women should consider the risks to the fetus and must consult a doctor prior to use; breastfeeding women should consult an expert prior to use, as it is unknown whether this medication is excreted in breast milk. Safety and efficacy in children under 18 years have not been established, so caution is advised in this population. Elderly patients should generally start with lower doses and be administered cautiously. If severe constipation, persistent abdominal pain, or vomiting occurs during treatment, the medication should be discontinued immediately and appropriate medical intervention should be sought. There are no studies on the effects of this medication on driving or operating machinery, so caution is advised.

• Vomiting
• nausea
• diarrhea
• indigestion
• abdominal pain
• flatulence
• constipation
• hypersensitivity reactions
• itching
• rash

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. This will help maintain the effectiveness of the medication for a long time.

Appearance

White or grayish-white oval film-coated tablets

Package unit

30 tablets/bottle, 360 tablets/bottle