SEVELAMER HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lupin Pharmaceuticals, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. Sevelamer hydrochloride is contraindicated in patients with bowel obstruction. Sevelamer hydrochloride tablets are 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 irregula

Ürün özeti:

Sevelamer hydrochloride 800 mg tablets are supplied as white to off white, oval shaped biconvex film coated tablets imprinted with 'L025' in black ink on one side and plain on other side.  Sevelamer hydrochloride  800 mg Tablets are packaged in bottles of 180 tablets. Sevelamer hydrochloride  400 mg tablets are supplied as white to off white, oval shaped biconvex film coated tablets imprinted with 'L024' in black ink on one side and plain on other side.  Sevelamer hydrochloride  400 mg Tablets are packaged in bottles of 360 tablets. Bottle of 180 count 800 mg Tablets (NDC 70748-173-26)    Bottle of 360 count 400 mg Tablets (NDC 70748-172-27)    Storage: Store at 20° to 25°C (68° to 77°F):  excursions permitted to 15° to 30°C (59° to 86°F).    Do not use sevelamer hydrochloride tablets after the expiration date on the bottle.    [See USP controlled room temperature]    Protect from moisture. 

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SEVELAMER HYDROCHLORIDE - SEVELAMER HYDROCHLORIDE TABLET
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVELAMER
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SEVELAMER HYDROCHLORIDE TABLETS. <BR><BR>SEVELAMER
HYDROCHLORIDE TABLETS, FOR ORAL USE <BR>INITIAL U.S. APPROVAL:
2000<BR>
INDICATIONS AND USAGE
Sevelamer hydrochloride tablets are 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 or two to four 400 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 and 400 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 LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTE