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:

Glenmark Pharmaceuticals Inc., USA

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred at 7-21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurredin the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight). Risk Summary Sevelamer hydrochloride is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to sevelamer hydrochloride. Clinical Considerations Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in lactating women [see Clinical Pharmacology (12.2)] . Consider supplementing with these vitamins. The safety and efficacy of sevelamer hydrochloride has not been established in pediatric patients. Clinical studies of sevelamer hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Ringkasan produk:

Sevelamer Hydrochloride Tablets, 400 mg are supplied as off-white to pale yellow, oval shaped, biconvex film-coated tablets, imprinted with ‘G446’ on one side and plain on the other side and are supplied as follows: Bottles of 30 tablets with child-resistant closures: NDC 68462-446-30 Bottles of 360 tablets with child-resistant closures: NDC 68462-446-26 Sevelamer Hydrochloride Tablets, 800 mg are supplied as off-white to pale yellow, modified capsule shaped, biconvex film-coated tablets, imprinted with ‘G447’ on one side and plain on the other side and are supplied as follows: Bottles of 30 tablets with child-resistant closures: NDC 68462-447-30 Bottles of 180 tablets with child-resistant closures: NDC 68462-447-18 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not use sevelamer hydrochloride tablets after the expiration date on the bottle. Dispense in a tight container. Protect from moisture and store in a dry place. Keep tablets in original/pharmacy container.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SEVELAMER HYDROCHLORIDE- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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.
SEVELAMER HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 04/2020
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
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2020
Sevelamer hydrochloride tablets are a phosphate binder indicated for
the control of serum
phosphorus in patients with chronic kidney disease on dialysis. (1)
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)
Tablets: 800 mg and 400 mg (3)
Bowel obstruction. (4)
Known hypersensitivity to sevelamer hydrochloride or to any of the
excipients. (4)
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)
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%), ano