CINACALCET tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CINACALCET HYDROCHLORIDE (UNII: 1K860WSG25) (CINACALCET - UNII:UAZ6V7728S)

Disponible desde:

Cipla USA Inc.

Designación común internacional (DCI):

CINACALCET HYDROCHLORIDE

Composición:

CINACALCET 30 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)]. Limitations of Use: Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)]. Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)] . Cinacalcet hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. [see Clinical Studies (14.3)] . Cinacalcet hydrochloride tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)]. Risk Summary L

Resumen del producto:

Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02). Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02). Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02). Storage Store at 25 °C (77 °F), excursions permitted from 15 °C to 30 °C (59°F to 86°F). [See USP controlled room temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CINACALCET - CINACALCET TABLET
CIPLA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CINACALCET
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CINACALCET HYDROCHLORIDE TABLETS.
CINACALCET HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Cinacalcet hydrochloride is a positive modulator of the calcium
sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic
kidney disease (CKD) on dialysis.
(1.1)
Limitations of Use: Cinacalcet hydrochloride tablets are not indicated
for use in patients with CKD who are
not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Hypercalcemia in adult patients with primary HPT for whom
parathyroidectomy would be indicated on
the basis of serum calcium levels, but who are unable to undergo
parathyroidectomy. (1.3)
DOSAGE AND ADMINISTRATION
Cinacalcet hydrochloride tablets should be taken with food or shortly
after a meal (2.1).
Tablets should always be taken whole and not divided (2.1)
Secondary HPT in patients with CKD on dialysis (2.2):
Starting dose is 30 mg once daily.
Titrate dose no more frequently than every 2 to 4 weeks through
sequential doses of 30, 60, 90,
120, and 180 mg once daily as necessary to achieve targeted intact
parathyroid hormone (iPTH)
levels.
iPTH levels should be measured no earlier than 12 hours after most
recent dose.
Hypercalcemia in patients with PC or hypercalcemia in patients with
primary HPT (2.3):
Starting dose is 30 mg twice daily.
Titrate dose every 2 to 4 weeks through sequential doses of 30 mg
twice daily, 60 mg twice daily, 90
mg twice daily, and 90 mg three or four times daily as necessary to
normalize serum calcium levels.
Once the maintenance dose has been established, monitor serum calcium
approximately monthly for
patients with secondary HPT and every 2 months for patients with PC or
primary HPT (2.4)
DOSAGE FORMS AND STRENGTH