Medication info
Sema tablet (Sevelamer Carbonate)

Sema tablet (Sevelamer Carbonate)

Prescription medicationTabletOral
Ingredient · strength
Sevelamer Carbonate›800mg / 1 tablet
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
Oval film-coated tablet in white or pale yellow color
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 180 tablets/bottle
Approval status
Active

MFDS item code 202201762 · Approved 2022.04.29 · Insurance code 671807490

Summary

Main use
Reduction of elevated serum phosphorus levels 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 according to the serum phosphorus level, as follows. 5.5 - 7.5 ㎎/dL: Take 1 tablet 3 times daily with meals 7.5 ㎎/dL or higher: Take 2 tablets 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 1 tablet 3 times daily 1 tablet 3 times daily 2 tablets 3 times daily 2 tablets 3 times daily 3 tablets 3 times daily 3 tablets 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 at 2-week intervals, taken 3 times daily with meals, until the target serum phosphorus level is achieved.

Ingredients

Manufacturer
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

Reduction of elevated serum phosphorus levels in patients with chronic kidney disease, on or off dialysis

View approved original text

This medication is used to control serum phosphate levels in patients with chronic kidney disease. It is particularly effective in patients undergoing dialysis and those not on dialysis but have elevated serum phosphate levels. By doing so, it helps maintain serum phosphate levels within the normal range to prevent the deterioration of kidney function. This control improves overall kidney health and reduces the risk of complications. Therefore, it is used for controlling serum phosphate in patients with chronic kidney disease.

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 according to the serum phosphorus level, as follows. 5.5 - 7.5 ㎎/dL: Take 1 tablet 3 times daily with meals 7.5 ㎎/dL or higher: Take 2 tablets 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 1 tablet 3 times daily 1 tablet 3 times daily 2 tablets 3 times daily 2 tablets 3 times daily 3 tablets 3 times daily 3 tablets 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 at 2-week intervals, taken 3 times daily with meals, until the target serum phosphorus level is achieved.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or excipients, those with hypophosphatemia, and those with bowel obstruction. Patients with gastrointestinal stricture or constipation should use this medication with caution as it may expand in the intestine and cause obstruction or perforation. During use, gastrointestinal symptoms such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, bloating, and constipation may occur, which can lead to discontinuation of treatment. Patients undergoing peritoneal dialysis are at risk for peritonitis, so they must immediately inform healthcare personnel upon symptom occurrence and receive appropriate aseptic therapy and care. This medication may cause serious side effects such as inflammatory bowel disorders or intestinal perforation due to drug aggregation in the gastrointestinal tract, hence if severe constipation, persistent abdominal pain, or vomiting occurs, treatment should be stopped, and immediate medical attention is required. For patients who have difficulty swallowing, it is recommended to consider a powder form instead of tablets, and caution is needed for patients with severe gastrointestinal motility disorders or inflammatory bowel diseases. This medication does not contain calcium or alkaline components, so serum calcium levels should be monitored regularly, and calcium supplements taken if necessary. Long-term use may result in deficiencies of fat-soluble vitamins and folic acid; therefore, it is advisable to periodically check blood vitamin levels and take supplements if needed. This medication may affect the absorption of other oral medications, so it should be taken at least one hour before or three hours after other medications, and blood drug levels should be monitored according to the physician's instructions. It should not be taken concurrently with ciprofloxacin, while no special interactions with warfarin, digoxin, enalapril, metoprolol, or iron have been reported, caution is still advised. Pregnant women should only use this medication if deemed necessary by a physician as it may affect the fetus. It is not known whether this drug is excreted in breast milk, but the possibility is low, so the decision should be made considering breastfeeding status and treatment benefits. This medication is not recommended for children under 18 years since safety and efficacy have not been established. In elderly patients, special precautions are not needed, but it is usually advised to start at lower doses and administer cautiously. Although overdose reports are not available, care should be taken not to exceed the maximum daily dose. This medication must be taken with meals, and the tablets should not be chewed or crushed, but swallowed whole. If unusual symptoms occur during use, consult a doctor immediately, and store it in its original container, avoiding moisture.

Side effects

  • Vomiting
  • nausea
  • diarrhea
  • indigestion
  • abdominal pain
  • bloating
  • constipation
  • hypersensitivity reactions
  • itching
  • rash
Show 17 more
  • fecal impaction
  • intestinal obstruction
  • intestinal occlusion
  • bowel perforation
  • peritonitis
  • hypercalcemia
  • hyperkalemia
  • acidosis
  • dizziness
  • headache
  • hypertension
  • hypotension
  • skin disorders
  • dysphagia
  • esophageal tablet retention
  • 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 avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Oval film-coated tablet in white or pale yellow color

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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.