SEVELAMER HYDROCHLORIDE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

SEVELAMER HYDROCHLORIDE (UNII: GLS2PGI8QG) (SEVELAMER - UNII:941N5DUU5C)

Disponibil de la:

Macleods Pharmaceuticals Limited

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. Sevelamer hydrochloride tablets are contraindicated in patients with bowel obstruction. Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. Risk Summary Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)]. Consider supplementing with these vitamins. 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

Rezumat produs:

Sevelamer hydrochloride tablets are available as follows: 800 mg: White to off white colored, oval shaped, film-coated tablets imprinted with "L 26" on one side and plain on other side. Bottle of 30: NDC 33342-242-07 Bottle of 180: NDC 33342-242-57 400 mg: White to off white colored, oval shaped, film-coated tablets imprinted with "L 25" on one side and plain on other side. Bottle of 360: NDC 33342-241-65 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Do not use sevelamer hydrochloride tablets after the expiration date on the bottle. [See USP controlled room temperature]. Protect from moisture.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

SEVELAMER HYDROCHLORIDE - SEVELAMER HYDROCHLORIDE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVELAMER
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SEVELAMER HYDROCHLORIDE TABLETS.
SEVELAMER HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 04/2020
INDICATIONS AND USAGE
• Sevelamer hydrochloride tablets are a phosphate binder indicated
for the control of serum phosphorus
in patients with chronic kidney disease on dialysis. (1)
DOSAGE AND ADMINISTRATION
• Starting dose is one or two 800 mg or two to four 400 mg tablets
three times per day with meals. (2)
• Adjust by one tablet per meal in two-week intervals as needed to
obtain serum phosphorus target (3.5
to 5.5 mg/dL). (2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 800 mg and 400 mg (3)
CONTRAINDICATIONS
• Bowel obstruction. (4)
• Known hypersensitivity to 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
• The most common reasons for discontinuing treatment were
gastrointestinal adverse reactions. (6.1)
• In a parallel design study of 12 weeks duration,
treatment-emergent adverse reactions to sevelamer
hydrochloride tablets in peritoneal dialysis patients included
dyspepsia (12%), peritonitis (8%), diarrhea
(5%), nausea (5%), constipation (4%), pruritus (4%), abdominal
distension (3%), vomiting (3%), fatigue
(3%), anorexia (3%), and arthralgia (3%). (6.1)
• Cases of fecal impaction and, less commonly, ileus, bowel
obstruction, and bowel perforation have been
reported. (6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MACLEODS PHARMA USA,
INC. AT 1-888-
9