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CARDENE SR

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Overview

What is CARDENE SR?

CARDENE SR is a sustained release formulation of CARDENE. CARDENE SR capsules for oral administration each contain 30 mg, 45 mg or 60 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium entry blocker).

Nicardipine hydrochloride is a dihydropyridine derivative with the IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure:

Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169°C. It is freely soluble in chloroform, methanol and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether and hexane. It has a molecular weight of 515.99.

CARDENE SR is available in hard gelatin capsules containing 30 mg, 45 mg or 60 mg nicardipine hydrochloride. All strengths contain a two component capsule fill. A powder component containing 25% of total nicardipine hydrochloride dose contains pregelatinized starch and magnesium stearate as inactive ingredients. A spherical granule component containing 75% of total nicardipine hydrochloride dose also contains microcrystalline cellulose, starch, lactose and methacrylic acid copolymer Type C as inactive ingredients.

The colorants used in the 30-mg capsules are titanium dioxide, FD&C Red No. 40 and red iron oxide, and the colorants used in the 45-mg and 60-mg capsules are titanium dioxide and FD&C Blue No. 2.



What does CARDENE SR look like?



What are the available doses of CARDENE SR?

Sorry No records found.

What should I talk to my health care provider before I take CARDENE SR?

Sorry No records found

How should I use CARDENE SR?

Sorry No records found


What interacts with CARDENE SR?

Sorry No Records found


What are the warnings of CARDENE SR?

Sorry No Records found


What are the precautions of CARDENE SR?

Sorry No Records found


What are the side effects of CARDENE SR?

Sorry No records found


What should I look out for while using CARDENE SR?

CARDENE is contraindicated in patients with hypersensitivity to the drug.

Because part of the effect of CARDENE is secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance.


What might happen if I take too much CARDENE SR?

Three overdosages with CARDENE or CARDENE SR have been reported. Two occurred in adults, 1 of whom ingested 600 mg of CARDENE and the other 2160 mg of CARDENE SR. Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion, and slurred speech. All symptoms resolved without sequelae. The third overdosage occurred in a 1-year-old child who ingested half of the powder in a 30-mg CARDENE capsule. The child remained asymptomatic.

Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine.

For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.


How should I store and handle CARDENE SR?

Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayCARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USACARDENE SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.CARDENE SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.For questions of a medical nature or to report an adverse event, call 1-866-437-7742.U.S. Patent No.s 4,940,556 and 5,198,226Cardene is a registered trademark of PDL BioPharma, Inc.Marketed by:PDL Biopharma, Inc.Redwood City, CA 94063Revised: September 2007151102Printed in USA


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Nicardipine is a calcium entry blocker (slow channel blocker or calcium ion antagonist) that inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal models, nicardipine produces relaxation of coronary vascular smooth muscle at drug levels that cause little or no negative inotropic effect.

Non-Clinical Toxicology
CARDENE is contraindicated in patients with hypersensitivity to the drug.

Because part of the effect of CARDENE is secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance.

In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR. In these studies adverse events were elicited by nondirected and in some cases directed questioning; adverse events were generally not serious and about 9% of patients withdrew prematurely from the studies because of them.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).