SULAR- nisoldipine tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NISOLDIPINE (UNII: 4I8HAB65SZ) (NISOLDIPINE - UNII:4I8HAB65SZ)

Available from:

Covis Pharma US, Inc

INN (International Name):

NISOLDIPINE

Composition:

NISOLDIPINE 8.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. SULAR is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.

Product summary:

SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows: Strength Color Markings 8.5 mg Oyster SCI 500 17 mg Yellow Cream SCI 501 34 mg Burnt Orange SCI 503 SULAR Tablets are supplied in bottles of 100: NDC Code Strength 70515-500-10 8.5 mg 70515-501-10 17 mg 70515-503-10 34 mg Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx only Sular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis Pharma Zug, 6300 Switzerland Made in Germany Rev 07/17

Authorization status:

New Drug Application

Summary of Product characteristics

SULAR- NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE
COVIS PHARMA US, INC
----------
SULAR (NISOLDIPINE)
EXTENDED RELEASE TABLETS
FOR ORAL USE
DESCRIPTION
SULAR (nisoldipine) is an extended release tablet dosage form of the
dihydropyridine
calcium channel blocker nisoldipine. Nisoldipine is
3,5-pyridinedicarboxylic acid, 1,4-
dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester,
C
H
N O , and
has the structural formula:
Nisoldipine is a yellow crystalline substance, practically insoluble
in water but soluble in
ethanol. It has a molecular weight of 388.4. SULAR tablets comprise
three layers: a top
barrier layer, a middle layer containing nisoldipine, and a bottom
barrier layer. The
erodible barrier layers and the hydrogel middle layer provide for the
controlled release of
the drug. SULAR tablets contain either 8.5, 17, or 34 mg of
nisoldipine for once-a-day
oral administration.
Inactive ingredients in the formulation include: Hypromellose,
hypromellose phthalate,
lactose, glyceryl behenate, povidone, magnesium stearate, silicon
dioxide, methacrylic
acid copolymer, and sodium lauryl sulfate. Inactive ingredients in the
film coating include:
polydextrose, titanium dioxide, hypromellose, polyethylene glycol,
iron oxide, and
carnauba wax. Additionally, the 17 mg formulation contains FD&C Yellow
#5.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Nisoldipine is a member of the dihydropyridine class of calcium
channel antagonists
(calcium ion antagonists or slow channel blockers) that inhibit the
transmembrane influx
®
®
20
24
2
6
of calcium into vascular smooth muscle and cardiac muscle. It
reversibly competes with
other dihydropyridines for binding to the calcium channel. Because the
contractile
process of vascular smooth muscle is dependent upon the movement of
extracellular
calcium into the muscle through specific ion channels, inhibition of
the calcium channel
results in dilation of the arterioles. _In vitro_ studies show that
the effects of nisoldipine on
contractile processes are selective, with