SEVELAMER CARBONATE- sevelamer carbonate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sevelamer carbonate tablet is 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

Product summary:

Sevelamer carbonate tablets, for oral use is supplied as white to off white capsule shaped film coated tablets imprinted with “A800”on one side and plain on the other side. Bottle of 30                                              NDC 42571-378-30 Bottle of 270                                            NDC 42571-378-43 Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVELAMER CARBONATE - SEVELAMER CARBONATE TABLET
MICRO LABS LIMITED
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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
INDICATIONS AND USAGE
Sevelamer carbonate tablet 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 tablet 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 ADVERSE REACTIONS, CONTACT MICRO LABS USA, INC. AT
1-855