Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases | Endocrinology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Novartis
Approval Status: Approved February 1997
Treatment Area: hypertension
DynaCirc CR, a once-a-day calcium channel blocker, has been
approved for the treatment of hypertension. Developed by Sandoz
Research in collaboration with ALZA Corporation, DynaCirc CR is
available in 5 mg and 10 mg controlled release tablets. The new
formulation is Novartis’ first launch of a line extension and
offers continuous reduction of blood pressure throughout a 24 hour
period. DynaCirc CR has been demonstrated to be safe in a broad
range of patients, including elderly, really impaired and diabetic
patients, as well as patients with underlying cardiovascular
conditions.
Isradipine, the active ingredient in DynaCirc CR, is a potent
intermediate-acting dihydropyridine calcium antagonist.
DynaCirc CR achieves its once-a-day dosing regimen through the
use of osmotic controlled release technology developed by ALZA
Corporation in Palo Alto, California. Known as OROS, OSMOTIC
THERAPEUTIC SYSTEM, the system is based on a semipermeable membrane
surrounding an osmotically active core. The core is composed of two
layers, an active layer containing the drug and a pharmacologically
inert, but osmotically active, push layer.
After ingestion, the tablet overcoating is quickly dissipated in
the gastrointestinal tract allowing water to enter the tablet
through the semipermeable membrane. The polyethylene oxide polymer
swells in the osmotic push layer and expands against the active
drug layer releasing an essentially constant dose of isradipine as
a fine suspension.
(1) Cohen JD, Carr AA, Blecker D, et al. DYNAMICS trial of
isradipine in hypertension with and without coexisting diseases.
Cline Geriatr. 1994;2:36-52.
(2) Marcus AO, Antihypertensive therapy with the calcium channel
blocker isradipine; an appropriate choice for the diabetic patient
with hypertension, Review. Curr Ther Res, 1993;54:763-778.
(3) Berg KJ, Holdaas H, Endresen L, et al. Effects of isradipine
on renal function in cyclosporin-treated renal transplanted
patients. Nephrol Dial Transplant. 1991;6:725-730.
(4) Francischetti EA, de Silva IB, Fagundes VG. Effects of
long-term administration of isradipine on renal hemodynamics and
sodium metabolism. J Cardiovasc Pharmacol. 1992;19 (supp
3):S90-92.
(5) Persson B, Andersson OK, Wysocki M, et al. Renal and
hemodynamic effects of isradipine in essential hypertension. Am J
Med, 1989;86 (supp 4A):60-64.
(6) Grossman E, Messerli FH, Oren S, et al. Cardiovascular
effects of isradipine in essential hypertension. Am J. Cardiol.
1991;68:65-70 SOURCE Novartis Pharmaceuticals Corporation.