Generic

Sevelamer Carbonate

Indications

In adult patients receiving haemodialysis or peritoneal dialysis, Sevelamer Carbonate is used to manage hyperphosphataemia. Sevelamer Carbonate is also used to treat hyperphosphatemia in adults with chronic renal disease who are not on dialysis and have a blood phosphorus level of 1.78 mmol/l. To manage the progression of renal bone disease, Sevelamer Carbonate should be administered as part of a multitherapeutic approach that includes calcium supplementation, 1,25-dihydroxy Vitamin D3 or one of its equivalents.

Pharmacology

Sevelamer carbonate is a metal- and calcium-free non-absorbed phosphate binding crosslinked polymer. Multiple amines are separated from the polymer backbone by one carbon. In the intestine, these amines are protonated and bind with phosphate molecules by ionic and hydrogen bonding. Sevelamer carbonate decreases the phosphate content in the serum by binding phosphate in the gastrointestinal tract and limiting absorption (serum phosphorus).

Dosage & Administration

Starting dose: The recommended starting dose of Sevelamer Carbonate is 2.4 g (Three Sevelamer 800 mg tablets or Three Sevelamer 800 mg sachets of powder for oral suspension) or 4.8 g (Six Sevelamer 800 mg tablets or Six Sevelamer 800 mg sachets of powder for oral suspension) per day based on clinical needs and serum phosphorus level. Sevelamer Carbonate tablet or suspension must be taken three times per day with meals.

For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.

Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.

Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.

Interaction

Medicate intuitive: Interaction thinks about have not been conducted in patients on dialysis. In interaction thinks about in solid volunteers, Sevelamer Hydrochloride, which contains the same dynamic moiety as Sevelamer Carbonate, diminished the bioavailability of ciprofloxacin by around 50% when co-administered with Sevelamer Hydrochloride in a single dosage consider. Subsequently, Sevelamer Carbonate ought to not be taken at the same time with ciprofloxacin. Diminished levels of ciclosporin, mycophenolate mofetil and tacrolimus have been detailed in transplant patients when co-administered with Sevelamer Hydrochloride without any clinical results (i.e join dismissal). The plausibility of an interaction cannot be prohibited and a near observing of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus ought to be considered amid the utilize of combination and after its withdrawal. Exceptionally uncommon cases of hypothyroidism have been detailed in patients co-administered Sevelamer Hydrochloride, which contains the same dynamic moiety as Sevelamer Carbonate, and levothyroxine. Closer checking of thyroid fortifying hormone (TSH) levels is subsequently suggested in patients getting Sevelamer Carbonate and levothyroxine. Patients taking anti-arrhythmic restorative items for the control of arrhythmias and anti-seizure therapeutic items for the control of seizure clutters were avoided from clinical trials. Caution ought to be worked out when endorsing Sevelamer Carbonate to patients too taking these restorative items. In interaction considers in sound volunteers, Sevelamer Hydrochloride, which contains the same dynamic moiety as Sevelamer Carbonate, had no impact on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Sevelamer Carbonate isn’t ingested and may influence the bioavailability of other therapeutic items. When regulating any therapeutic item where a diminishment within the bioavailability may have a clinically noteworthy impact on security or viability, the therapeutic item ought to be managed at slightest one hour some time recently or three hours after Sevelamer Carbonate, or the doctor ought to consider observing blood levels.

Contraindications

In patients with intestinal blockage, Sevelamer Carbonate is not recommended. Patients who have a known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or any of the excipients should avoid using Sevelamer Carbonate.

Pregnancy & Lactation

In individuals with intestinal blockage, Sevelamer Carbonate should not be used. Patients who have a known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or any of the excipients should avoid taking Sevelamer Carbonate.

Precautions & Warnings

Sevelamer carbonate is not absorbed systemically after oral treatment, therefore it is unlikely that prenatal exposure to the drug will occur. Considerations in Clinical Practice In pregnant women, sevelamer carbonate may lower serum levels of fat-soluble vitamins and folic acid.

Following oral delivery, Sevelamer carbonate is not absorbed systemically by the mother, and nursing is not expected to expose the child to Sevelamer carbonate. Considerations in Clinical Practice In pregnant women, sevelamer carbonate may lower serum levels of fat-soluble vitamins and folic acid.

Therapeutic Class

Drugs for reduction of serum phosphorus in patients with ESRD

Storage Conditions

Store in a cold, dry, and light-protected location.

Pharmaceutical Name

ACME Laboratories Ltd.