SEVELAMER CARBONATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

SEVELAMER CARBONATE

Composition:

SEVELAMER CARBONATE 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Sevelamer Carbonate Tablets, 800 mg for oral use is supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis.    Unit dose packages of 50 (5 x 10) NDC 60687-328-65    Unit dose packages of 100 (25 x 4) NDC 60687-328-31 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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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 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: 0.8 g ( 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 (