Description
id: d11a7af2-b048-45bd-ae1d-b1dcbfaf0384
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sensipar® (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Its empirical formula is C22H22F3N•HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity.
Cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water.
Sensipar® tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively).
Cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:
Inactive Ingredients: Sensipar® tablets are comprised of the active ingredient, and the following inactive ingredients: pre-gelatinized starch, microcrystalline cellulose, povidone, crospovidone, colloidal silicon dioxide, and magnesium stearate. Tablets are coated with color (Opadry® II green), clear film-coat (Opadry® clear) and carnauba wax.
INDICATIONS AND USAGE
id: 7535fb90-1c5e-430a-af9e-a6b13217c323
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sensipar® is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis.
Sensipar® is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.
CONTRAINDICATIONS
id: 98081bdf-72fd-45aa-96be-3cdb4733f7cd
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Sensipar® is contraindicated in patients with hypersensitivity to any component(s) of this product.
OVERDOSAGE
id: 4aa11060-151c-4bd9-b310-f509711d4460
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Doses titrated up to 300 mg once daily have been safely administered to patients on dialysis. Overdosage of Sensipar® may lead to hypocalcemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcemia and appropriate measures taken to correct serum calcium levels (see PRECAUTIONS).
Since Sensipar® is highly protein bound, hemodialysis is not an effective treatment for overdosage of Sensipar®.
DOSAGE AND ADMINISTRATION
id: b9adf9ab-4652-4734-8a1e-832d0324dafe
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Sensipar® tablets should be taken whole and should not be divided. Sensipar® should be taken with food or shortly after a meal.
Dosage must be individualized.
HOW SUPPLIED
id: fef22d1d-3618-4498-9f00-738025b4304d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sensipar® 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” on the opposite side.
Sensipar® 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “60” on the opposite side.
Sensipar® 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “90” on the opposite side.
They are supplied by State of Florida DOH Central Pharmacy as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 53808-0577-1 |
30 mg |
30 Tablets in a Blister Pack |
light green |
55513-073 |
| 53808-0578-1 |
60 mg |
30 Tablets in a Blister Pack |
light green |
55513-074 |
REFERENCES
id: cd1c13e8-1102-4535-b8ab-ef93e4bff4d8
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
1. National Kidney Foundation: K/DOQI clinical practice guidelines: bone metabolism and disease in chronic kidney disease. American Journal of Kidney Disease 4 2:S1-S201, 2003
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – TABLET, 30 MG
id: e21efdea-ceab-4e39-b84d-36ae68881e26
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amgen®
NDC 53808-0577-1
Sensipar®
(cinacalcet HCI) Tablets
Rx Only
30 tablets
30 mg
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP controlled room temperature.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – TABLET, 60 MG
id: 73df51d1-28dd-4dcd-b08d-c87235fd0b0c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amgen®
NDC 53808-0578-1
Sensipar®
(cinacalcet HCI) Tablets
Rx Only
30 tablets
60 mg
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP controlled room temperature.
