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nicardipine hydrochloride

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Overview

What is Cardene IV?

Cardene (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Cardene I.V. Premixed Injection for intravenous administration contains 40 mg of nicardipine hydrochloride per 200 mL (0.2 mg/mL) in sodium chloride. Nicardipine hydrochloride is a dihydropyridine derivative with 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 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 I.V. Premixed Injection is available as a ready-to-use sterile, non-pyrogenic, clear, colorless to yellow, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 40 mg (0.2 mg/mL) nicardipine hydrochloride in sodium chloride.

Cardene I.V. Premixed Injection in 0.83% Sodium Chloride

40 mg in 200 mL (0.2 mg/mL)

Each mL contains 0.2 mg nicardipine hydrochloride, 8.3 mg sodium chloride, USP, 0.0384 mg citric acid, anhydrous, USP, and 3.84 mg sorbitol, NF. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7.

The GALAXY container is fabricated from multilayered plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.



What does Cardene IV look like?



What are the available doses of Cardene IV?

Cardene I.V. Premixed Injection is supplied as a single-use, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 40 mg (0.2 mg/mL) nicardipine hydrochloride in sodium chloride.

What should I talk to my health care provider before I take Cardene IV?

How should I use Cardene IV?

Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

Initiate therapy at 25 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 mL/hr (3 mg/hr).

Drug Discontinuation and Transition to an Oral Antihypertensive Agent

Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

Special Populations

Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function


What interacts with Cardene IV?

Sorry No Records found


What are the warnings of Cardene IV?

Sorry No Records found


What are the precautions of Cardene IV?

Sorry No Records found


What are the side effects of Cardene IV?

Sorry No records found


What should I look out for while using Cardene IV?

Do not use in patients with advanced aortic stenosis .


What might happen if I take too much Cardene IV?

Several overdosages with orally administered nicardipine have been reported.  One adult patient allegedly ingested 600 mg of immediate-release oral nicardipine, and another patient, 2160 mg of the sustained-release formulation of nicardipine.  Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion and slurred speech.  All symptoms resolved without sequelae.  An overdosage occurred in a one year old child who ingested half of the powder in a 30 mg nicardipine standard capsule.  The child remained asymptomatic.

Based on results obtained in laboratory animals, lethal overdose 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 overdosage, implement standard measures including monitoring of cardiac and respiratory functions.  Position the patient so as to avoid cerebral anoxia.  Use vasopressors for patients exhibiting profound hypotension.


How should I store and handle Cardene IV?

Store at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature.Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use.To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260. CARDENE is a registered trademark of EKR Therapeutics, Inc.Galaxy is a registered trademark of Baxter International Inc.U.S. Patent Numbers 7612102 and 7659291Revised February 2018 CTCI-010-0218-04-SPLStore at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature.Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use.To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260. CARDENE is a registered trademark of EKR Therapeutics, Inc.Galaxy is a registered trademark of Baxter International Inc.U.S. Patent Numbers 7612102 and 7659291Revised February 2018 CTCI-010-0218-04-SPLStore at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature.Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use.To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260. CARDENE is a registered trademark of EKR Therapeutics, Inc.Galaxy is a registered trademark of Baxter International Inc.U.S. Patent Numbers 7612102 and 7659291Revised February 2018 CTCI-010-0218-04-SPLStore at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature.Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use.To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260. CARDENE is a registered trademark of EKR Therapeutics, Inc.Galaxy is a registered trademark of Baxter International Inc.U.S. Patent Numbers 7612102 and 7659291Revised February 2018 CTCI-010-0218-04-SPLTelmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, , are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side. They are available as follows:Bottles of 30: NDC 42291-790-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side. They are available as follows:Bottles of 30: NDC 42291-791-30Telmisartan tablets, USP, , are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side. They are available as follows:Bottles of 30: NDC 42291-792-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Nicardipine 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 produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

Non-Clinical Toxicology
Do not use in patients with advanced aortic stenosis .

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, barbiturates, or narcotics

Antidiabetic drugs

Other antihypertensive drugs

Cholestyramine and colestipol resins

Corticosteroids, ACTH

Pressor amines (e.g., norepinephrine)

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)

Lithium

Non-steroidal Anti-inflammatory Drugs

In administering nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage.

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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).