Sevel 400 mg Tablet

The Active Ingredient of Sevel tablet is Sevelamer Carbonate, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer Carbonate is known chemically as poly (allylamine-co-N,N’-diallyl-1,3diamino-2-hydroxypropane) carbonate salt. Sevelamer Carbonate is hygroscopic, but insoluble in water.

Each film-coated tablet contains Sevelamer Carbonate INN 800 mg.

Sevelamer Carbonate is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Patients Not Taking a Phosphate Binder : The recommended starting dose of Sevelamer Carbonate is 800 to 1600 mg, which can be administered as two to four 400 mg

Sevelamer Carbonate Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Sevelamer Carbonate for patients not taking a phosphate binder.

Switching from Sevelamer Hydrochloride tablets: For patients switching from Sevelamer Hydrochloride tablets to

Sevelamer Carbonate tablets use the same dose.

Patients switching From Calcium Acetate : Table 2 gives recommended starting doses of Sevelamer Carbonate based on a patients current calcium acetate dose.

Dose Titration for all Patients taking Sevelamer Carbonate :

Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline. 

Sevelamer Carbonate is contraindicated in patients with hypophosphatemia or bowel obstruction.

Side effects reported include peritonitis, diarrhoea, nausea, constipation, abdominal pain, flatulence, vomiting, fatigue, anorexia,

Serum Phosphorus Sevelamer Carbonate 800 mg > 5.5 and < 7.5 mg/dL 1 tablets three times daily with meals

7.5 and < 9.0 mg/dL 2 tablets three times daily with meals

9.0 mg/dL 2 tablets three times daily with meals

Serum Phosphorus Sevelamer Carbonate > 5.5 mg/dL Increase 1 tablet per meal at 2 week intervals 3.5 - 5.5 mg/dL Maintain current dose < 3.5 mg/dL Decrease 1 tablet per meal arthralgia, dyspepsia, pruritus, rash and uncommon cases of ileus, intestinal obstruction and intestinal perforation may occur. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.

The safety of Sevelamer Carbonate has not been established in patients with dysphagia swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. So, Sevelarner Carbonate should be used with caution in patients with gastrointestinal disorders. Serum bicarbonate and chloride levels should be monitored while using this drug. It may reduce vitamin D, E, K (clotting factors) and Folic acid levels of serum.

So these should be monitored.

Pregnancy category C. Sevelamer Carbonate should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.

There are no data on the excretion of Sevelarner Carbonate in to breast milk. Sevelarner Carbonate should only be given to lactating women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the infant.

There is no evidence for special considerations when Sevelamer

Carbonate is administered for elderly patients. In general, dose selection for an elderly patient should be cautions, usually starting at the low end of the dosing range.

The safety and efficacy of Sevelamer Carbonate has not been established in pediatric patients.

Sevelamer Carbonate has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.

Ciprofloxacin : Sevelamer Carbonate decreased the bioavailability of ciprofloxacin by approximately 50%.

Digoxin: Sevelamer Carbonate did not alter the pharmacokinetics of a single dose of digoxin.

Warfarin: Sevelamer Carbonate did not alter the pharmacokinetics of a single dose of warfarin.

Enalapril : Sevelamer Carbonate did not alter the pharmacokinetics of a single dose of enalapril.

Metoprolol: Sevelamer Carbonate did not alter the pharmacokinetics of a single dose of metoprolol. Iron: Sevelamer Carbonate did not alter the absorption of a single oral dose of iron as 200 mg exsiccated ferrous sulfate tablet.

Each box contains 2 x 6 tablets in Alu-Alu blister strips