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:

Zydus Pharmaceuticals USA Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is 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 supplementation. 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 in mid and

Produkt oppsummering:

Sevelamer carbonate tablets are off-white to pale yellow colored, modified capsule shaped, biconvex, film-coated tablets imprinted with "824" on one side and plain on other side and are supplied as follows: NDC 68382-824-27 in bottle of 270 tablets with child-resistant closure. NDC 68382-824-10 in bottle of 1,000 tablets NDC 68382-824-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)04/2020
INDICATIONS AND USAGE
Sevelamer carbonate is a phosphate binder indicated for the control of
serum phosphorus in adults and
children 6 years of age and older 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 and based on
body surface area (BSA)
category for pediatric 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)
Titrate based on BSA category for pediatric patients in two week
intervals for 6 weeks and then every 4
weeks as needed to obtain serum phosphorus target. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg (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, bleeding
gastrointestinal ulcers, colitis, ulceration,
necrosis 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 carbonate 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 SUSPECTE