DESCRIPTION
DynaCirc CR? contains isradipine, a calcium antagonist. It is available for once-daily oral administration as a controlled release 5 mg and 10 mg tablet for DynaCirc CR? (isradipine). DynaCirc CR? is a registered trademark for isradipine GITS (Gastrointestinal Therapeutic System) tablets.
Active Ingredient: isradipine
Inactive Ingredients: butylated hydroxytoluene cellulose acetate hydroxypropyl methylcellulose magnesium stearate polyethylene glycol polyethylene oxide polysorbate 80 propylene glycol red ferric oxide silicon dioxide sodium chloride titanium dioxide yellow ferric oxide.
System Components and Performance
Isradipine is delivered from the DynaCirc CR? (isradipine) Controlled Release Tablet as follows: a semipermeable membrane surrounds an osmotically active drug core.The core is composed of two layers: an activelayer 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 exerts pressure against the activedrug layer, releasing isradipine as a fine suspension through the laser-drilled tablet orifice which has been positioned on the active drug layer side. Drug delivery is essentially constant as long as the osmotic gradient remains constant and, after either 5 mg or 10 mg of isradipine is released, gradually falls to a negligible amount.The controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. The delivery of isradipine in DynaCirc CR? (isradipine) Controlled Release Tablets depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the GI tract.The biologically inert core of the tablet remains intact and,unless it becomes trapped, is eliminated in the feces.
INDICATIONS
Hypertension
DynaCirc CR? (isradipine) is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
SIDE EFFECTS
In a controlled clinical trial with DynaCirc CR? (isradipine), dose-related edema occurred at an incidence of approximately 9% at 5 mg 13% at 10 mg 16% at 15 mg and 36% at the highest dose studied (20 mg), was mild to moderate in severity,and was not related to age or gender.
The incidences of elicited or volunteered adverse reactions (excluding non-drug related) in the following tables are based on 6-week multicenter, placebo-controlled, double-blind hypertension studies. Less than 1% of DynaCirc CR? (isradipine) or placebo-treated patients discontinued from these studies due to adverse reactions.