SEVELAMER HYDROCHLORIDE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

SEVELAMER HYDROCHLORIDE (UNII: GLS2PGI8QG) (SEVELAMER - UNII:941N5DUU5C)

Tersedia dari:

Winthrop U.S, a business of sanofi-aventis U.S. LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Sevelamer hydrochloride is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride in CKD patients who are not on dialysis have not been studied. Sevelamer hydrochloride is contraindicated in patients with bowel obstruction. Sevelamer hydrochloride is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. Risk Summary Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer hydrochloride may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementing with these vitamins. Data Animal data In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bon

Ringkasan produk:

Sevelamer hydrochloride tablets are supplied as white, oval, film-coated, compressed tablets, imprinted with RENAGEL 800 containing 800 mg of sevelamer hydrochloride. Sevelamer hydrochloride 800 mg Tablets are packaged in bottles of 180 tablets. 1 Bottle of 180 ct 800 mg Tablets (NDC 0955-1048-18) Storage: Store at 25°C (77°F): excursions permitted to 15°C–30°C (59°F–86°F). Do not use Sevelamer hydrochloride tablets after the expiration date on the bottle. [See USP controlled room temperature] Protect from moisture.

Status otorisasi:

New Drug Application Authorized Generic

Karakteristik produk

SEVELAMER HYDROCHLORIDE- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED
WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVELAMER
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SEVELAMER
HYDROCHLORIDE.
SEVELAMER HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Sevelamer hydrochloride is a phosphate binder indicated for the
control of serum phosphorus in
patients with chronic kidney disease on dialysis. (1)
DOSAGE AND ADMINISTRATION
Starting dose is one or two 800 mg tablets three times per day with
meals. (2)
Adjust by one tablet per meal in two-week intervals as needed to
obtain serum phosphorus target (3.5
to 5.5 mg/dL). (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg (3)
CONTRAINDICATIONS
Bowel obstruction. (4)
Known hypersensitivity to sevelamer hydrochloride or to any of the
excipients. (4)
WARNINGS AND PRECAUTIONS
Serious cases of dysphagia, bowel obstruction, bleeding
gastrointestinal ulcers, colitis, ulceration,
necrosis, and perforation have been associated with sevelamer use,
some requiring hospitalization and
surgery. (5.1)
ADVERSE REACTIONS
The most common reasons for discontinuing treatment were
gastrointestinal adverse reactions. (6.1)
In a parallel design study of 12 weeks duration, treatment-emergent
adverse reactions to sevelamer
hydrochloride tablets in peritoneal dialysis patients included
dyspepsia (12%), peritonitis (8%), diarrhea
(5%), nausea (5%), constipation (4%), pruritus (4%), abdominal
distension (3%), vomiting (3%), fatigue
(3%), anorexia (3%), and arthralgia (3%). (6.1)
Cases of fecal impaction and, less commonly, ileus, bowel obstruction,
and bowel perforation have been
reported. (6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GENZYME CORPORATION AT
1-800-847-
0069 AND OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
When clinically significant drug interactions are expected, separa