SEVELAMER CARBONATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Macleods Pharmaceuticals Limited

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 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-solub

Tóm tắt sản phẩm:

Tablets: Sevelamer Carbonate Tablets 800 mg are supplied as white to off white, oval shaped, biconvex, film-coated tablets imprinted with “L 28” on one side and plain on other side. Bottles of 270: NDC 33342-215-58 Storage: Store at 20° to 25°C (68° to 77°F): excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature] Protect from moisture. Dispense in a tight container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SEVELAMER CARBONATE - SEVELAMER CARBONATE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
----------
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
INDICATIONS AND USAGE
Sevelamer carbonate tablets are 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 tablets 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 SUSPECTED AD