SEVELAMER CARBONATE- sevelamer carbonate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C)

Available from:

Impax Generics

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, this drug product is not labeled with that pediatric information. Sevelamer carbonate tablets are 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. Risk Summary Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplemen

Product summary:

Tablets: Sevelamer carbonate tablets 800 mg are supplied as white to off-white, film-coated, oval tablets, debossed with "L3" on one side and plain on the other side, containing 800 mg of sevelamer carbonate on an anhydrous basis, microcrystalline cellulose, colloidal silicon dioxide, stearic acid 50, polyvinyl alcohol, titanium dioxide, macrogol/PEG 3350 and talc. Sevelamer carbonate tablets 800 mg are packaged in bottles of 30, 270 and 700 tablets. 1 Bottle of 30 Tablets (NDC 0115-1309-08) 1 Bottle of 270 Tablets (NDC 0115-1309-27) 1 Bottle of 700 Tablets (NDC 0115-1309-38) Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
IMPAX GENERICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVELAMER CARBONATE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEVELAMER
CARBONATE TABLETS.
SEVELAMER CARBONATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Indications and Usage (1)
11/2016
Dosage and Administration (2)
11/2016
INDICATIONS AND USAGE
Sevelamer carbonate tablet is a phosphate binder indicated for the
control of serum phosphorus in adults with chronic
kidney disease on dialysis. (1)
DOSAGE AND ADMINISTRATION
Starting dose of sevelamer carbonate is 0.8 or 1.6 grams administered
orally three times per day with meals based on
serum phosphorus levels for adult patients. (2.1)
Titrate by 0.8 g per meal in two week intervals for adult patients as
needed to obtain serum phosphorus target. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.8 g (3)
CONTRAINDICATIONS
Bowel obstruction. (4)
Known hypersensitivity to sevelamer carbonate, sevelamer
hydrochloride, or to any of the excipients. (4)
WARNINGS AND PRECAUTIONS
Serious cases of dysphagia, bowel obstruction, and perforation have
been associated with sevelamer use, some
requiring hospitalization and surgery. (5.1)
ADVERSE REACTIONS
Most of the safety experience is with sevelamer tablets and sevelamer
hydrochloride. In long-term studies with
sevelamer hydrochloride, which contains the same active moiety as
sevelamer carbonate, the most common adverse
events included: vomiting (22%), nausea (20%), diarrhea (19%),
dyspepsia (16%), abdominal pain (9%), flatulence
(8%) and constipation (8%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT IMPAX LABORATORIES,
INC. AT 1-800-934-6729 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
For oral medication where a reduction in the bioavailability of that
medication would have a clinically significant effect on
its safety or efficacy, consider separation of the