Sevelamer Carbonate

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Overview

What is Sevelamer Carbonate?

The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.

Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.

Figure 1. Chemical Structure of Sevelamer Carbonate

a, b = number of primary amine groups a + b = 9

c = number of crosslinking groups c = 1

m = large number to indicate extended polymer network

Sevelamer carbonate tablets:

What does Sevelamer Carbonate look like?

What are the available doses of Sevelamer Carbonate?

Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted “AN058” with black ink on one side and plain on the other side.

What should I talk to my health care provider before I take Sevelamer Carbonate?

How should I use Sevelamer Carbonate?

Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.

Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information.

Starting dose of sevelamer carbonate tablets is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients ()

Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. ()

What interacts with Sevelamer Carbonate?

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What are the warnings of Sevelamer Carbonate?

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What are the precautions of Sevelamer Carbonate?

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What are the side effects of Sevelamer Carbonate?

Sorry No records found

What should I look out for while using Sevelamer Carbonate?

Sevelamer carbonate is contraindicated in patients with bowel obstruction.

Sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

What might happen if I take too much Sevelamer Carbonate?

In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

How should I store and handle Sevelamer Carbonate?

Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:Sevelamer carbonate tablets, , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows:Bottle of 90 Tablets: NDC 65162-058-09 Bottle of 270 Tablets: NDC 65162-058-27Bottle of 500 Tablets: NDC 65162-058-50Bottle of 1000 Tablets: NDC 65162-058-11Storage:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sevelamer carbonate tablet contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

Non-Clinical Toxicology

Sevelamer carbonate is contraindicated in patients with bowel obstruction.

Sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

Nimodipine is metabolized via the cytochrome P450 3A4 system located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nimodipine.

In addition, the blood pressure lowering effects of antihypertensives could be enhanced when taken concomitantly with nimodipine.

Inducers of CYP3A4

Nimodipine plasma concentration and efficacy may be significantly reduced when concomitantly administered with strong CYP3A4 inducers. Therefore strong CYP3A4 inducers (e.g. rifampin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) should generally not be administered concomitantly with nimodipine (See ).

Other moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine, although the magnitude of decrease in nimodipine plasma concentrations is not known. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required. Moderate and weak CYP3A4 inducers include: amprenavir, aprepitant, armodafinil, bosentan, efavirenz, etravirine, Echinacea, modafinil, nafcillin, pioglitazone, prednisone and rufinamide.

Inhibitors of CYP3A4

Nimodipine plasma concentration can be significantly increased when concomitantly administered with strong inhibitors of the CYP3A4 system. As a consequence, the blood pressure lowering effect may be increased. Therefore strong CYP3A4 inhibitors should not be coadministered with nimodipine (See ). Strong CYP3A4 inhibitors include some members of the following classes:

Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4. If nimodipine is concomitantly administered with these drugs, blood pressure should be monitored, and a reduction of the nimodipine dose may be necessary. Moderate and weak CYP3A4 inhibitors include amprenavir, aprepitant, atazanavir, amiodarone, alprozalam, cyclosporine, cimetidine, erythromycin, fluconazole, fluoxetine, isoniazid, oral contraceptives, quinuprestin/dalforpristin, and valproic acid.

Blood pressure lowering drugs

Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives, such as:

Blood pressure should be carefully monitored, and dose adjustment of the blood pressure lowering drug(s) may be necessary.

Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.

Cases of bowel obstruction and perforation have also been reported with sevelamer use.

Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery were not included in the sevelamer carbonate clinical studies.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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