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DynaCirc CR®
(isradipine) Controlled Release Tablets
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.
The structural formula of isradipine is:
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Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water ( < 10 mg/L at 37°C), but is soluble in ethanol and freely soluble in acetone,chloroform and methylene chloride.
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.
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 "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 exerts pressure against the "active"drug 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.
DynaCirc CR® (isradipine) is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
The dosage of DynaCirc CR® (isradipine) Controlled Release Tablets should be individualized.The recommended initial dose of DynaCirc CR® (isradipine) is 5 mg once-daily as monotherapy or in combination with a thiazide diuretic. An antihypertensive response usually occurs within 2 hours,with the peak antihypertensive response occurring 8-10hours post-dose; blood pressure reduction is maintained for at least 24 hours following drug administration.If necessary,the dose may be adjusted in increments of 5 mg at 2-4 week intervals up to a maximum dose of 20 mg/day. Adverse experiences are increased in frequency above 10 mg/day.
DynaCirc CR® (isradipine) Controlled Release Tablets should be swallowed whole and should not be bitten or divided.
The bioavailability (increased AUC) of immediate-release DynaCirc® (isradipine) is increased in elderly patients (above 65 years of age), patients with hepatic functional impairment, and patients with mild renal impairment. Ordinarily, a starting dose of DynaCirc CR® (isradipine) 5 mg once-daily should be used in these patients.
DynaCirc CR® (isradipine) Controlled Release Tablets:
5 mg: A light pink, round, standard biconvex and film coated tablet. Printing is in red with "DynaCirc CR (isradipine) " in a semicircle with "5"centered below the semicircle.
Bottles of 100 controlled release tablets (NDC 65726-235-25)
Bottles of 30 controlled release tablets (NDC 65726-235-10)
10 mg: A beige, round, standard biconvex and film coated tablet. Printing is in red with "DynaCirc CR (isradipine) " in a semicircle with "10"centered below the semicircle.
Bottles of 100 controlled release tablets (NDC 65726-236-25)
Bottles of 30 controlled release tablets (NDC 65726-236-10)
Below 86°F (30°C) in a tight container,protected from moisture and humidity.
Distributed by: Reliant Pharmaceuticals,Inc. Liberty Corner,NJ 07938. Address Medical Inquiries to: Reliant Medical Inquiries, c/o PPD 2655 Meridian Parkway, Durham,NC 27713-2203. or Call: 877-311-7515. FDA Rev date: 5/18/2005
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.
The most common adverse experiences ( ≥ 1.0%) reported with DynaCirc CR® (isradipine) in a dose-response study are shown in the following table.There were no discontinuations of patients treated with DynaCirc CR® (isradipine) in this study due to these common side effects.
Most Frequently Reported Newly-Occurring Adverse Reactions
in Dose-Response Study
| Adverse Reactions (Excluding Non-Drug Related) | DynaCirc CR® (isradipine) | ||||
| 5 mg (N=79) |
10 mg (N=79) |
15 mg (N=82) |
20 mg (N=78) |
Placebo Group (N=83) |
|
| Headache | 13.9% | 12.7% | 18.3% | 10.3% | 15.7% |
| Edema | 8.9% | 12.7% | 15.9% | 35.9% | 3.6% |
| Dizziness | 5.1% | 6.3% | 3.7% | 6.4% | 2.4% |
| Constipation | 3.8% | 1.3% | 1.2% | 2.6% | 0.0% |
| Fatigue | 2.5% | 7.6% | 3.7% | 3.8% | 2.4% |
| Flushing | 2.5% | 3.8% | 1.2% | 1.3% | 1.2% |
| Abdominal Discomfort | 1.3% | 5.1% | 3.7% | 5.1% | 1.2% |
| Rash | 1.3% | 1.3% | 0.0% | 2.6% | 0.0% |
The table below shows elicited or volunteered adverse experiences for DynaCirc CR® (isradipine) treated patients in two 6-week, placebo-controlled, multicenter studies, at doses from 5-20 mg, and considered by the investigator to be at least possibly drug related.The results for DynaCirc CR® (isradipine) treated patients are presented for all doses pooled together (reported by at least 1.0% of active drug treated patients).The incidence of adverse reactions are listed below:
| Adverse Reactions (Excluding Non-Drug Related) | Treatment Group | |
| DynaCirc CR®(isradipine) (N=422) |
Placebo (N=186) |
|
| Edema | 15.2% | 2.2% |
| Headache | 13.0% | 12.4% |
| Dizziness | 4.7% | 2.7% |
| Fatigue | 4.3% | 2.2% |
| Abdominal Discomfort | 2.8% | 0.5% |
| Flushing | 1.9% | 0.5% |
| Constipation | 1.7% | 0.0% |
| Palpitations | 1.2% | 0.0% |
| Nausea | 1.2% | 1.6% |
| Abdominal Distention | 1.2% | 0.0% |
The following adverse experiences were reported in 0.5%-1.0% or less of DynaCirc CR® (isradipine) or immediate-release DynaCirc® (isradipine) treated patients in hypertensive studies,or were noted in postmarketing experience with immediate-release DynaCirc® (isradipine) Capsules. More serious events are shown in italics. The relationship of these adverse experiences to isradipine administration is uncertain.
SKIN:Pruritus, urticaria, angioedema.
MUSCULOSKELETAL: Backache/pain, joint pain,neck pain/sore/stiff,legs ache/pain,cramps of legs/feet.
RESPIRATORY: Dyspnea, nasal congestion,cough.
CARDIOVASCULAR: Epistaxis,tachycardia,chest pain,shortness of breath,hypotension, syncope,atrial or ventricular fibrillation,myocardial infarction,heart failure.
GASTROINTESTINAL:Diarrhea,vomiting,appetite increased or decreased.
UROGENITAL: Pollakiuria,impotence,dysuria,nocturia.
CENTRAL NERVOUS: Drowsiness, insomnia, lethargy,nervousness, libido decrease/frigidity,impotence, depression, paresthesia (which includes numbness and tingling), transient ischemic attack,stroke.
AUTONOMIC: Dry mouth,hyperhidrosis,visual disturbance.
MISCELLANEOUS: Weight gain, throat discomfort, drug fever, leukopenia, elevated liver function tests.
No gastrointestinal bleeding has been reported in clinical trials with DynaCirc CR® (isradipine) Controlled Release Tablets.
In a long-term (one-year) DynaCirc CR® (isradipine) open-label, hypertension trial, the adverse events reported were generally the same as those seen in the short-term placebo-controlled studies. About 6% of DynaCirc CR® (isradipine) treated patients discontinued the long-term trial due to adverse reactions.
With immediate-release DynaCirc® (isradipine) Capsules, most of the adverse experiences were transient, mild, and related to vasodilatory effects.The following table shows the most common adverse events reported in U.S.clinical tri-als for immediate-release DynaCirc® (isradipine) Capsules, volunteered or elicited, and considered by the investigator to be at least possibly drug related.
| Adverse Experience | DynaCirc® (isradipine) | Placebo (N=297) % |
ActiveControls* (N=414) % |
|||
| All Doses | 2.5 mg b.i.d. | 5 mg b.i.d.† | 10 mg b.i.d.†† | |||
| Headache | 13.7 | 12.6 | 10.7 | 22.0 | 14.1 | 9.4 |
| Dizziness | 7.3 | 8.0 | 5.3 | 3.4 | 4.4 | 8.2 |
| Edema | 7.2 | 3.5 | 8.7 | 8.5 | 3.0 | 2.9 |
| Palpitations | 4.0 | 1.0 | 4.7 | 5.1 | 1.4 | 1.5 |
| Fatigue | 3.9 | 2.5 | 2.0 | 8.5 | 0.3 | 6.3 |
| Flushing | 2.6 | 3.0 | 2.0 | 5.1 | 0.0 | 1.2 |
| Chest Pain | 2.4 | 2.5 | 2.7 | 1.7 | 2.4 | 2.9 |
| Nausea | 1.8 | 1.0 | 2.7 | 5.1 | 1.7 | 3.1 |
| Dyspnea | 1.8 | 0.5 | 2.7 | 3.4 | 1.0 | 2.2 |
| Abdominal Discomfort | 1.7 | 0.0 | 3.3 | 1.7 | 1.7 | 3.9 |
| Tachycardia | 1.5 | 1.0 | 1.3 | 3.4 | 0.3 | 0.5 |
| Rash | 1.5 | 1.5 | 2.0 | 1.7 | 0.3 | 0.7 |
| Pollakiuria | 1.5 | 2.0 | 1.3 | 3.4 | 0.0 | |
