Medication info
Renvela Tablets (Sevelamer Carbonate)

Renvela Tablets (Sevelamer Carbonate)

Prescription medicationTabletOral
Ingredient · strength
Sevelamer Carbonate›800mg / 1 tablet
Manufacturer / importer
SANOFI-AVENTIS KOREA CO., LTD.
Appearance
White to off-white oval film-coated tablet
Packaging
180 tablets/bottle
Approval status
Active

MFDS item code 201108203 · Approved 2011.10.10 · Insurance code 652001270

Summary

Main use
Suppression of elevated serum phosphorus in patients with chronic kidney disease on or off dialysis
Who takes it
Adults
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 as follows, according to the serum phosphorus level. 5.5 - 7.5 ㎎/dL: 1 tablet per dose, 3 times daily with meals 7.5 ㎎/dL or higher: 2 tablets per dose, 3 times daily with meals 2) Replacing sevelamer hydrochloride tablets with this medicine When replacing sevelamer hydrochloride tablets with 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 undergoing dialysis was 14g. 3) Replacing calcium acetate preparations with this medicine 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) 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 with meals 3 times daily, at 2-week intervals until the target serum phosphorus level is achieved.

Ingredients

Importer
SANOFI-AVENTIS KOREA CO., LTD.

Efficacy & effects

Suppression of elevated serum phosphorus in patients with chronic kidney disease on or off dialysis

View approved original text

This medication is used for effectively controlling serum phosphorus levels in patients with chronic kidney disease who are undergoing dialysis as well as those who are not receiving dialysis if their serum phosphorus concentration is above 5.5 mg/dL.

How to take

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 as follows, according to the serum phosphorus level. 5.5 - 7.5 ㎎/dL: 1 tablet per dose, 3 times daily with meals 7.5 ㎎/dL or higher: 2 tablets per dose, 3 times daily with meals 2) Replacing sevelamer hydrochloride tablets with this medicine When replacing sevelamer hydrochloride tablets with 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 undergoing dialysis was 14g. 3) Replacing calcium acetate preparations with this medicine 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) 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 with meals 3 times daily, at 2-week intervals until the target serum phosphorus level is achieved.

Precautions

This medicine should not be used in patients who are allergic to the active ingredient or excipients. It should also not be used in patients with very low phosphate levels in the blood or in patients with bowel obstruction or blockage. In patients with narrowed intestines or severe constipation, careful use is required as the medication may swell in the intestine leading to serious complications such as bowel obstruction or perforation. Patients taking this medication may experience gastrointestinal side effects such as vomiting, nausea, diarrhea, abdominal pain, or constipation. If symptoms are severe, consult a doctor. Especially, patients undergoing peritoneal dialysis need to be cautious of the risk of peritonitis and should monitor for symptoms and receive appropriate treatment. This medication does not contain calcium, so patients should regularly test their serum calcium levels and take calcium supplements if necessary. Additionally, long-term use may lead to vitamin A, D, E, K, and folate deficiencies, so it is advisable to periodically check serum vitamin levels and take vitamin supplements if needed. This medication may affect the absorption of other oral medications, so it is safe to take other medicines one hour before or three hours after taking this drug. In particular, it should not be taken with ciprofloxacin, and caution should be exercised when taking it with warfarin, digoxin, enalapril, metoprolol, and iron. Pregnant women or women who may become pregnant should consult a doctor before using this medication due to potential effects on the fetus. Breastfeeding women should consult a doctor regarding breastfeeding and medication intake, as it is unclear whether this drug is excreted in breast milk. It is recommended not to use this medication in children under 18 years of age since its safety and efficacy have not been established. The elderly should generally start with a lower dose and be monitored closely. There are no specific reports of overdose, but prescribed doses should be adhered to according to a doctor's indication. This medication should be taken with meals and should not be crushed or chewed, but swallowed whole. If symptoms such as constipation, severe abdominal pain, or vomiting occur during use, the medication should be discontinued immediately and medical advice should be sought. Additionally, patients with swallowing difficulties or gastrointestinal motility disorders may consider a powdered form instead of this tablet. Patients taking this medication for a long time may develop serious gastrointestinal problems such as inflammation or ulcers, so any unusual symptoms should prompt a reevaluation of treatment. Finally, caution is needed when driving or operating machinery while taking this medication; however, specific research on this matter is still lacking.

Side effects

  • vomiting
  • nausea
  • diarrhea
  • dyspepsia
  • abdominal pain
  • bloating
  • constipation
  • peritonitis
  • hypersensitivity
  • itching
Show 17 more
  • rash
  • fecal impaction
  • intestinal obstruction
  • bowel obstruction
  • intestinal perforation
  • hyperkalemia
  • acidosis
  • dizziness
  • headache
  • hypertension
  • hypotension
  • dyspepsia
  • skin disorders
  • dysphagia
  • esophageal impaction
  • hypothyroidism
  • increased phosphorus levels

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also advisable to store it at room temperature between 1°C and 30°C, not in extremely hot or cold places.

Appearance and packaging

Appearance

White to off-white oval film-coated tablet

Package unit

180 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.