SEVELAMER CARBONATE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 . 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

Produkt oppsummering:

Sevelamer carbonate tablets, for oral administration, are available as: 800 mg:  off white, modified oval tablet core, imprinted "T186" on one side and plain on the reverse side, film coated white,and supplied as: Bottles of 270 tablets (NDC 71205-966-67) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
PROFICIENT RX LP
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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, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Indications and Usage (1)
Dosage and Administration (2)
Contraindications (4)
11/2016
11/2016
03/2016
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 TWI PHARMACEUTICALS,
INC. AT 1-844-518-
2989 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Sevelamer carbonate tablets are a phosphate binder indicated for the
control of serum phosphorus in
adults with chronic kidney disease on dialysis. (1)
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)
Tablets: 0.8 g (3)
Bowel obstruction. (4)
Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride
or to any of the excipients.
(4)
Serious cases of dysphagia, bowel obstruction, and perforation have
been associated with sevelamer
use, some requiring hospitalization and surgery. (5.1)
For oral medication where a reduction in the bioavailability of that
medication would have