Medication info
Seynubella Tablets (Sevelamer Carbonate)

Seynubella Tablets (Sevelamer Carbonate)

Prescription medicationTabletOral
Ingredient · strength
Sevelamer Carbonate›800mg / 1 tablet
Manufacturer / importer
Yuyu Pharmaceutical Co., Ltd.
Appearance
White or grayish oval film-coated tablet
Packaging
180 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202202489 · Approved 2022.06.14 · Insurance code 644503360

Summary

Main use
Improvement of serum phosphorus levels in patients with chronic kidney disease (on or not on 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 of this medicine with each meal as follows, according to the serum phosphorus level. 5.5 - 7.5 ㎎/dL: 1 tablet per dose, taken with meals 3 times daily 7.5 ㎎/dL or higher: 2 tablets per dose, taken with meals 3 times daily 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 Calcium acetate preparation (containing calcium acetate 667mg per tablet): 1 tablet per dose, 3 times daily → Dose of this medicine: 1 tablet per dose, 3 times daily Calcium acetate preparation (containing calcium acetate 667mg per tablet): 2 tablets per dose, 3 times daily → Dose of this medicine: 2 tablets per dose, 3 times daily Calcium acetate preparation (containing calcium acetate 667mg per tablet): 3 tablets per dose, 3 times daily → Dose of this medicine: 3 tablets per dose, 3 times daily 4) Switching between sevelamer carbonate tablets and powder 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 at 2-week intervals, taken with meals 3 times daily, until the target serum phosphorus level is achieved.

Ingredients

Manufacturer
Yuyu Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of serum phosphorus levels in patients with chronic kidney disease (on or not on dialysis)

View approved original text

This medication is used to effectively control serum phosphorus levels in patients with chronic kidney disease who are either on dialysis or not and have high serum phosphorus levels.

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 of this medicine with each meal as follows, according to the serum phosphorus level. 5.5 - 7.5 ㎎/dL: 1 tablet per dose, taken with meals 3 times daily 7.5 ㎎/dL or higher: 2 tablets per dose, taken with meals 3 times daily 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 Calcium acetate preparation (containing calcium acetate 667mg per tablet): 1 tablet per dose, 3 times daily → Dose of this medicine: 1 tablet per dose, 3 times daily Calcium acetate preparation (containing calcium acetate 667mg per tablet): 2 tablets per dose, 3 times daily → Dose of this medicine: 2 tablets per dose, 3 times daily Calcium acetate preparation (containing calcium acetate 667mg per tablet): 3 tablets per dose, 3 times daily → Dose of this medicine: 3 tablets per dose, 3 times daily 4) Switching between sevelamer carbonate tablets and powder 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 at 2-week intervals, taken with meals 3 times daily, until the target serum phosphorus level is achieved.

Precautions

This medication should not be used in patients who have allergic reactions to the active ingredient or excipients. Additionally, it should not be used in patients with low phosphate levels or those with bowel obstruction due to the risk of causing bowel perforation as it expands in the intestinal tract. In patients with intestinal strictures or constipation, this medication should be administered cautiously as it may cause bowel obstruction or perforation. Gastrointestinal adverse reactions such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, bloating, and constipation may occur during the use of this medication. Particularly in patients undergoing peritoneal dialysis, serious adverse reactions such as peritonitis may occur, so symptoms should be monitored closely. Patients with dysphagia or esophageal issues should consider using a powder form instead of the tablet form of this medication. This medication does not contain calcium, so blood calcium levels should be regularly monitored and calcium supplements taken if necessary. Patients with chronic kidney disease are at risk for deficiencies in fat-soluble vitamins and folic acid, so regular monitoring and supplementation of vitamin status is recommended. This medication may interfere with the absorption of other oral medications, so it should be taken at least 1 hour before or 3 hours after taking other medications, and medication concentrations should be monitored in consultation with a physician. Women who are pregnant should only use this medication if the benefits outweigh the risks, as determined by a physician. It is unknown whether this medication is excreted in breast milk, but it is generally considered unlikely, so whether to use it should be decided after consultation with a physician. Safety and efficacy in children under 18 years of age have not been established, thus use is not recommended. Generally, elderly patients should start at a lower dose and be monitored carefully. There are no specific reports of overdose, but if suspected, consult medical personnel immediately. When taking this medication, it must be taken with food, and tablets should not be crushed or chewed. It should be stored in the original container away from moisture. If severe constipation, persistent abdominal pain, or vomiting occurs during treatment, immediately discontinue use and consult medical personnel. Patients undergoing peritoneal dialysis should be closely monitored to promptly identify symptoms of peritonitis and apply appropriate aseptic techniques. Taking this medication concurrently with certain drugs (e.g., Ciprofloxacin) may decrease the effectiveness of the medication, so consult a physician to adjust timing of administration. Hypothyroidism has been rarely reported, so patients taking thyroid hormones require regular tests. The possibility of accumulation in the body cannot be completely ruled out with long-term use, so caution is needed for long-term administration. The effects on driving or machine operation are unknown, hence caution is advised.

Side effects

  • Vomiting
  • nausea
  • diarrhea
  • indigestion
  • abdominal pain
  • bloating
  • constipation
  • hypersensitivity reactions
  • itching
  • rash
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  • bowel obstruction
  • intestinal obstruction
  • bowel perforation
  • peritonitis
  • hyperkalemia
  • acidosis
  • dizziness
  • headache
  • hypertension
  • hypotension
  • skin disease
  • dysphagia
  • esophageal retention
  • hypothyroidism
  • increased phosphorus levels

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It's important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help retain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

White or grayish oval film-coated tablet

Package unit

180 tablets/bottle, 30 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.