Renavel Tablets (Sevelamer Carbonate)

Adult dose

This medicine should be taken with meals 3 times daily. 1) Administration to patients not taking phosphate binders The recommended initial dose of this medicine is 0.8g to 1.6g. Take 1~2 tablets with each meal according to the serum phosphorus level as follows. 5.5 - 7.5 ㎎/dL: Take 1 tablet per dose, 3 times daily with meals 7.5 ㎎/dL or higher: Take 2 tablets per dose, 3 times daily with meals 2) Substitution of this medicine for patients taking sevelamer hydrochloride tablets When substituting this medicine for sevelamer hydrochloride tablets, administer the same dose. Appropriate dosage 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 undergoing dialysis was 14g. 3) Substitution of this medicine for patients taking calcium acetate preparations 1 tablet per dose, 3 times daily 1 tablet per dose, 3 times daily 2 tablets per dose, 3 times daily 2 tablets per dose, 3 times daily 3 tablets per dose, 3 times daily 3 tablets per dose, 3 times daily 4) Substitution between sevelamer carbonate tablets and powder When substituting between sevelamer carbonate tablets and powder, administer the same dose. Appropriate dosage adjustment may be necessary to achieve the target serum phosphorus level. 5) Dosage 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 2-week intervals until the target serum phosphorus level is achieved.

This medication should not be used in certain patients. Patients who are allergic to any component or excipient contained in this medication should not take it. Additionally, patients with significantly low phosphate levels in their blood and those with intestinal obstruction should not take this medication due to the risk of serious problems such as intestinal obstruction or perforation, as it may swell in the intestines. Patients with bowel stricture or constipation should use this medication with greater caution. Due to its swelling characteristics in the intestines, there is a possibility of intestinal obstruction or perforation, necessitating caution. This medication commonly shows gastrointestinal side effects such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, bloating, and constipation in various clinical trials. In particular, patients on hemodialysis or peritoneal dialysis may experience severe infections such as peritonitis, and should consult a healthcare professional immediately if symptoms occur. If constipation symptoms occur or existing constipation worsens, appropriate treatment is required to prevent severe complications. This medication may be difficult for patients with dysphagia to swallow; in such cases, consideration should be given to using powdered forms of the medication. In addition, careful administration is required in patients with gastrointestinal motility disorders, inflammatory bowel disease, or a history of major gastrointestinal surgery. This medication does not contain calcium or alkaline components, so regular monitoring of blood calcium levels and bicarbonate and chloride levels is necessary. Especially in cases of hypocalcemia, calcium supplements should be taken concurrently. Patients with chronic kidney disease may have their serum levels of fat-soluble vitamins A, D, E, K, and folic acid affected by this medication, so they should regularly check their vitamin status and take supplements if necessary. This medication can interfere with the absorption of other oral medications, so when taken with other drugs, it should be taken at least 1 hour before or 3 hours after. In particular, it should not be taken concurrently with ciprofloxacin. Pregnant women should only take this medication if the doctor carefully assesses the risks and benefits, as it may affect the fetus. For nursing mothers, it is unclear whether this medication is secreted in breast milk; however, due to its non-absorptive nature, the likelihood of excretion is low, but a decision should be made considering the benefits of nursing and medication therapy. The safety and efficacy of this medication have not been established in children under 18 years of age, so administration is not recommended. Elderly patients require special caution, generally starting at lower doses and gradually adjusting the dosage. This medication must be taken with food, and should not be crushed or chewed but swallowed whole. If severe constipation, persistent abdominal pain, or vomiting occurs during treatment, the medication should be discontinued immediately and medical advice sought. Patients on peritoneal dialysis should carefully monitor for symptoms of peritonitis and strictly adhere to aseptic techniques. When taking this medication with certain drugs (e.g., levothyroxine), regular monitoring of thyroid function is necessary. While no studies have been conducted regarding its effects on driving or operating machinery, caution is advised during use. No cases of overdose have been reported, but the prescribed dosage should be strictly followed, and medical consultation should be sought if any abnormal symptoms occur.

• vomiting
• nausea
• diarrhea
• indigestion
• abdominal pain
• bloating
• constipation
• peritonitis
• hypersensitivity
• itching

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Storing the medication this way can help maintain its effectiveness for a longer period.

Appearance

White or grayish-white oval film-coated tablets

Package unit

30 tablets/bottle, 180 tablets/bottle