SEVELAMER CARBONATE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

REMEDYREPACK INC.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information. Sevelamer carbonate is 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 (

Přehled produktů:

Sevelamer carbonate tablets, 800 mg , are supplied as off-white to light yellow colored, oval shaped, biconvex, film-coated tablet, imprinted with “AN058” with black ink on one side and plain on the other side. They are available as follows: Bottle of 90 Tablets:                           NDC 65162-058-09 Bottle of 270 Tablets:                         NDC 65162-058-27 Bottle of 500 Tablets:                         NDC 65162-058-50 Bottle of 1000 Tablets:                       NDC 65162-058-11 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
REMEDYREPACK 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
Indications and Usage ( 1) 11/2016
Dosage and Administration ( 2) 11/2016
Contraindications ( 4) 03/2016
INDICATIONS AND USAGE
Sevelamer carbonate tablets are a phosphate binder indicated for the
control of serum phosphorus in adults 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 ( 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg (3)
CONTRAINDICATIONS
Bowel obstruction. (4)
Known hypersensitivity to sevelamer carbonate, sevelamer
hydrochloride, or any of the excipients. ( 4)
WARNINGS AND PRECAUTIONS
Serious cases of dysphagia, bowel obstruction 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 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 AMNEAL PHARMACEUTICALS
AT 1-877-835-5472 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
For oral medication where a reduction in the bioavailability of that
medication would have a clinically significant effect on
its safe