SEVELAMER CARBONATE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Sevelamer Carbonate (UNII: 9YCX42I8IU) (Sevelamer - UNII:941N5DUU5C)

Prieinama:

Cardinal Health 107, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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 supp

Produkto santrauka:

Tablets: Sevelamer carbonate Tablets 800 mg are supplied as white to off-white, oval, film-coated tablets plain on one side and imprinted ‘R789’ on one side, containing 800 mg of sevelamer carbonate on an anhydrous basis, ammonium hydroxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lecithin, mannitol, polyvinyl alcohol, propylene glycol, shellac, talc, xanthan gum and zinc stearate. The tablet imprint contains iron oxide black ink. Overbagged with 10 tablets per bag, NDC 55154-3358-0 Storage:  Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature] Protect from moisture.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
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, FILM COATED 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
2.
DOSAGE AND ADMINISTRATION
3.
4.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
3.
4.
WARNINGS AND PRECAUTIONS
2.
ADVERSE REACTIONS
2.
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S
LABORATORIES, INC. AT 1-888-
375-3784 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 safety or efficacy consider separation of
the timing of administration and/or monitor
clinical responses or blood levels of the concomitant medication. (7)
• Sevelamer did not alter the pharmacokinetics of digoxin,
enalapril, iron, metoprolol and warfarin. (7)
• Sevelamer has demonstrated interaction with ciprofloxacin,
mycophenolate mofetil, and therefore these
drugs should be dosed separately from sevelamer carbonate. (7)
_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._
SEE 17 FOR PATIENT COUNSELING INFORMATION.
Sevelamer carbonate tablet is a phosphate binder indicated for the
control of serum phosphorus in
adults with chronic kidney disease on dialysis. (1)
Starting dose of sevelamer carbonate tablet is 0.8 or 1.6 grams
administered orally three times per
day with meals based on serum phosp