Medication info
Hyusetan Tablet (Sevelamer Carbonate)

Hyusetan Tablet (Sevelamer Carbonate)

Prescription medicationTabletOral
Ingredient · strength
Sevelamer Carbonate›400mg / 1 tablet
Manufacturer / importer
(Co., Ltd.) Huons
Appearance
White or grayish oval film-coated tablets
Packaging
30 tablets/bottle, 360 tablets/bottle
Approval status
Active

MFDS item code 202402436 · Approved 2024.10.15 · Insurance code 670609410

Summary

Main use
Improvement of hyperphosphatemia in 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 2~4 tablets of this medicine with each meal according to the serum phosphorus level, as follows. 5.5 - 7.5 ㎎/dL: Take 2 tablets per dose with meals 3 times daily 7.5 ㎎/dL or higher: Take 4 tablets per dose with meals 3 times daily 2) Substitution of this medicine for patients taking sevelamer hydrochloride tablets When substituting this medicine for sevelamer hydrochloride tablets, administer the same dose. Appropriate dose adjustment may be required 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 → 2 tablets per dose, 3 times daily 2 tablets per dose, 3 times daily → 4 tablets per dose, 3 times daily 3 tablets per dose, 3 times daily → 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 required 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, with meals 3 times daily until the target serum phosphorus level is achieved.

Ingredients

Manufacturer
(Co., Ltd.) Huons

Efficacy & effects

Improvement of hyperphosphatemia in chronic kidney disease (on or off dialysis)

View approved original text

This medication helps in the control of serum phosphorus in patients with chronic kidney disease who are undergoing dialysis. It is also used to control serum phosphorus levels in patients with chronic kidney disease who are not on dialysis and have serum phosphorus levels 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 2~4 tablets of this medicine with each meal according to the serum phosphorus level, as follows. 5.5 - 7.5 ㎎/dL: Take 2 tablets per dose with meals 3 times daily 7.5 ㎎/dL or higher: Take 4 tablets per dose with meals 3 times daily 2) Substitution of this medicine for patients taking sevelamer hydrochloride tablets When substituting this medicine for sevelamer hydrochloride tablets, administer the same dose. Appropriate dose adjustment may be required 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 → 2 tablets per dose, 3 times daily 2 tablets per dose, 3 times daily → 4 tablets per dose, 3 times daily 3 tablets per dose, 3 times daily → 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 required 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, with meals 3 times daily until the target serum phosphorus level is achieved.

Precautions

This medication should not be used in patients who are hypersensitive to the active ingredient or excipients. It should also not be used in patients with hypophosphatemia or intestinal obstruction. Caution is required for patients with intestinal strictures or severe constipation, as this medication can swell in the gastrointestinal tract and may lead to obstruction or perforation. During treatment, gastrointestinal adverse reactions such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation may occur, and care should be taken. Patients undergoing peritoneal dialysis are at risk for peritonitis, so symptoms of peritonitis should be monitored immediately and appropriate treatment received. This medication does not contain calcium or alkaline components, so calcium and bicarbonate levels in the blood should be checked regularly, and calcium supplements taken if necessary. Long-term use may lead to deficiencies of fat-soluble vitamins (A, D, E, K) and folic acid, thus regular blood tests are necessary, and vitamin supplements should be taken if needed. Patients with dysphagia may find it difficult to swallow this medication, so a powdered form should be considered. When taken with other oral medications, it may affect the absorption of those drugs, so it is advisable to take this medication at least 1 hour before or after other medications. Pregnant women should use this medication cautiously, considering its effects on the fetus, while breastfeeding women should consult a healthcare professional since it is unlikely to be secreted in breast milk. The safety and efficacy of this medication in children under 18 years of age have not been established. There is no specific report of overdose, but the recommended dosage should be followed. This medication must be taken with food and should not be crushed or chewed but swallowed whole, and stored away from moisture. If symptoms of severe constipation, persistent abdominal pain, or vomiting occur during use, the medication should be stopped immediately and a doctor consulted. No studies have been conducted on its effects on driving or operating machinery, so caution is advised.

Side effects

  • Vomiting
  • nausea
  • diarrhea
  • indigestion
  • abdominal pain
  • bloating
  • constipation
  • peritonitis
  • hypersensitivity
  • itching
Show 16 more
  • rash
  • fecal obstruction
  • intestinal obstruction
  • bowel obstruction
  • intestinal perforation
  • hyperkalemia
  • acidosis
  • dizziness
  • headache
  • hypertension
  • hypotension
  • skin disorders
  • dysphagia
  • esophageal obstruction
  • hypothyroidism
  • increased phosphorus levels

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

Storage

This medication can be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to ensure the safety and effectiveness of the medication.

Appearance and packaging

Appearance

White or grayish oval film-coated tablets

Package unit

30 tablets/bottle, 360 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.