Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied CARDENE I.V. is supplied as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) nicardipine hydrochloride in sodium chloride. Pack Size Diluent NDC Number 10 bags, each containing 20 mg in 200 mL (0.1mg/mL) 0.86% Sodium Chloride NDC 43066-009-10 10 bags, each containing 40 mg in 200 mL (0.2mg/mL) 0.83% Sodium Chloride NDC 43066-016-10 16.2 Storage and Handling Store at controlled room temperature 20º to 25ºC (68º to 77ºF), refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use. Discard unused portion.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. 40 mg in 200 mL (0.2 mg/mL) Galaxy Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-016-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 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. DOSAGE : See prescribing information. CAUTIONS : Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE : Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Code 2G3444 Baxter Logo Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-34-00-2344 *BAR CODE 343066016104 Carton Label CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE NDC 43066-016-10 Rx only CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. DOUBLE CONCENTRATION: CHECK INFUSION RATE Code 2G3444 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA 40 mg in 200 mL (0.2 mg/mL) STORE IN CARTON UNTIL READY TO USE 1 Galaxy Single Dose Container Discard unused portion CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) Barcode (01) 00343066016104 Iso-osmotic Sterile, nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 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. DOSAGE: See prescribing information. CAUTIONS: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE: Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-01-00-1677 CARDENE® I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE CARDENE® I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection For Intravenous Infusion Only. 20 mg in 200 mL (0.1 mg/mL) Galaxy Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-009-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.1 mg NICARDIPINE HYDROCHLORIDE in 8.6 mg SODIUM CHLORIDE, USP with 0.0192 mg CITRIC ACID ANHYDROUS, USP and 1.92 mg SORBITOL, NF. HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE : See prescribing information. CAUTIONS : Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE : Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license Code 2G3443 Baxter Logo Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-34-00-2345 *BAR CODE 343066009106 Carton Label CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL NDC 43066-009-10 Rx only CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection For Intravenous Infusion Only. Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA Code 2G3443 20 mg in 200 mL (0.1 mg/ml) STORE IN CARTON UNTIL READY TO USE 1 Galaxy Single Dose Container Discard unused portion CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL (0.1 mg/mL) Barcode (01) 00343066009106 Iso-osmotic Sterile, nonpyrogenic Each mL contains 0.1 mg NICARDIPINE HYDROCHLORIDE in 8.6 mg SODIUM CHLORIDE, USP with 0.0192 mg CITRIC ACID ANHYDROUS, USP and 1.92 mg SORBITOL, NF. HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE: See prescribing information. CAUTIONS: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE: Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-01-00-1734 CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL Cardene Representative Container Label 43066-016-10 1 of 2 Cardene Representative Container Label 43066-016-10 2 of 2 Cardene Representative Carton Label 43066-016-10 1 of 2 Cardene Representative Carton Label 43066-016-10 2 of 2 Cardene Representative 20mg Container Label 1 of 2.jpg Cardene Representative 20mg Container Label 2 of 2.jpg Cardene Representative 20mg Carton Label 1 of 2.jpg Cardene Representative 20mg Carton Label 2 of 2.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied CARDENE I.V. is supplied as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) nicardipine hydrochloride in sodium chloride. Pack Size Diluent NDC Number 10 bags, each containing 20 mg in 200 mL (0.1mg/mL) 0.86% Sodium Chloride NDC 43066-009-10 10 bags, each containing 40 mg in 200 mL (0.2mg/mL) 0.83% Sodium Chloride NDC 43066-016-10 16.2 Storage and Handling Store at controlled room temperature 20º to 25ºC (68º to 77ºF), refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to use. Discard unused portion.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. 40 mg in 200 mL (0.2 mg/mL) Galaxy Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-016-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 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. DOSAGE : See prescribing information. CAUTIONS : Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE : Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Code 2G3444 Baxter Logo Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-34-00-2344 *BAR CODE 343066016104 Carton Label CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE NDC 43066-016-10 Rx only CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection For Intravenous Infusion Only. DOUBLE CONCENTRATION: CHECK INFUSION RATE Code 2G3444 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA 40 mg in 200 mL (0.2 mg/mL) STORE IN CARTON UNTIL READY TO USE 1 Galaxy Single Dose Container Discard unused portion CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) CARDENE I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL (0.2 mg/mL) Barcode (01) 00343066016104 Iso-osmotic Sterile, nonpyrogenic Each mL contains 0.2 mg NICARDIPINE HYDROCHLORIDE in 8.3 mg SODIUM CHLORIDE, USP with 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. DOSAGE: See prescribing information. CAUTIONS: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE: Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-01-00-1677 CARDENE® I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL DOUBLE CONCENTRATION: CHECK INFUSION RATE CARDENE® I.V. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 40 mg in 200 mL Container Label CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection For Intravenous Infusion Only. 20 mg in 200 mL (0.1 mg/mL) Galaxy Single-Dose Container Discard unused portion 200 mL Iso-osmotic NDC 43066-009-10 Rx only Sterile, Nonpyrogenic Each mL contains 0.1 mg NICARDIPINE HYDROCHLORIDE in 8.6 mg SODIUM CHLORIDE, USP with 0.0192 mg CITRIC ACID ANHYDROUS, USP and 1.92 mg SORBITOL, NF. HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE : See prescribing information. CAUTIONS : Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE : Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license Code 2G3443 Baxter Logo Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-34-00-2345 *BAR CODE 343066009106 Carton Label CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL NDC 43066-009-10 Rx only CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection For Intravenous Infusion Only. Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in the USA Code 2G3443 20 mg in 200 mL (0.1 mg/ml) STORE IN CARTON UNTIL READY TO USE 1 Galaxy Single Dose Container Discard unused portion CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL (0.1 mg/mL) Barcode (01) 00343066009106 Iso-osmotic Sterile, nonpyrogenic Each mL contains 0.1 mg NICARDIPINE HYDROCHLORIDE in 8.6 mg SODIUM CHLORIDE, USP with 0.0192 mg CITRIC ACID ANHYDROUS, USP and 1.92 mg SORBITOL, NF. HYDROCHLORIC ACID and/or SODIUM HYDROXIDE may have been added to adjust pH. DOSAGE: See prescribing information. CAUTIONS: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Do not add supplemental medication. Must not be used in series connections. STORAGE: Store at controlled room temperature 20º to 25º C (68º to 77º F); refer to USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. PROTECT FROM LIGHT, STORE IN CARTON UNTIL READY TO USE. U.S. Patent Numbers 7612102 and 7659291 Baxter and Galaxy are registered trademarks of Baxter International Inc. Cardene is a registered trademark of Chiesi USA, Inc. and is used under license. Manufactured and Marketed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA To report suspected adverse reactions, contact Baxter Healthcare Corporation at 1-866-888-2472 07-01-00-1734 CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL CARDENE I.V. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL Cardene Representative Container Label 43066-016-10 1 of 2 Cardene Representative Container Label 43066-016-10 2 of 2 Cardene Representative Carton Label 43066-016-10 1 of 2 Cardene Representative Carton Label 43066-016-10 2 of 2 Cardene Representative 20mg Container Label 1 of 2.jpg Cardene Representative 20mg Container Label 2 of 2.jpg Cardene Representative 20mg Carton Label 1 of 2.jpg Cardene Representative 20mg Carton Label 2 of 2.jpg
Overview
CARDENE I.V. (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). CARDENE I.V. for intravenous administration contains 20 mg (0.1 mg/mL) of nicardipine hydrochloride per 200 mL in either dextrose or sodium chloride or 40 mg (0.2 mg/mL) of nicardipine hydrochloride per 200 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-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169ºC. 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. 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 20 mg (0.1 mg/mL) or 40 mg (0.2 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride. Nicardipine Hydrochloride in 4.8% Dextrose Injection 20 mg in 200 mL (0.1 mg/mL) Each mL contains 0.1 mg nicardipine hydrochloride, 48 mg dextrose hydrous, USP, 0.0192 mg citric acid, anhydrous, USP, and 1.92 mg sorbitol, NF. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7. Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection 20 mg in 200 mL (0.1 mg/mL) Each mL contains 0.1 mg nicardipine hydrochloride, 8.6 mg sodium chloride, USP, 0.0192 mg citric acid, anhydrous, USP, and 1.92 mg sorbitol, NF. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 3.7 to 4.7. Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection 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. 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. Cardene Structural Formula
Indications & Usage
• CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. ( 1.1 ) 1.1 Hypertension CARDENE I.V. (nicardipine hydrochloride) is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1) ] .
Dosage & Administration
• For Intravenous Use. ( 2.1 ) • No further dilution is required. ( 2.3 ) • When substituting for oral nicardipine therapy, use the intravenous infusion rate from the table below ( 2.1 ): Oral CARDENE Dose Equivalent I.V. Infusion Rate (0.1 mg/mL) Equivalent I.V. Infusion Rate (0.2 mg/mL) 20 mg q8h 0.5 mg/hr = 5 mL/hr 0.5 mg/hr = 2.5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 1.2 mg/hr = 6 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr 2.2 mg/hr = 11 mL/hr • In a patient not receiving oral nicardipine, initiate therapy at 5 mg/hr. Increase the infusion rate by 2.5 mg/hr every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 15 mg/hr until desired blood pressure reduction is achieved. ( 2.1 ) Conversion Table (mg/hr) Equivalent I.V. Infusion Rate (0.1 mg/mL) Equivalent I.V. Infusion Rate (0.2 mg/mL) 5 mg/hr 50 mL/hr 25 mL/hr 2.5 mg/hr 25 mL/hr 12.5 mL/hr 15 mg/hr 150 mL/hr 75 mL/hr • If unacceptable hypotension or tachycardia occurs, discontinue the infusion. When blood pressure and heart rate stabilize, restart the infusion at low doses such as 3-5 mg/hr. ( 2.2 ) 2.1 Recommended Dosing 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: Oral CARDENE Dose Equivalent I.V. Infusion Rate 20 mg in 200 mL (0.1 mg/mL) Equivalent I.V. Infusion Rate 40 mg in 200 mL (0.2 mg/mL) 20 mg q8h 0.5 mg/hr = 5 mL/hr 0.5 mg/hr = 2.5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 1.2 mg/hr = 6 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr 2.2 mg/hr = 11 mL/hr Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine CARDENE I.V. 20 mg in 200 mL (0.1 mg/mL): Initiate therapy at 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 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 30 mL/hr (3 mg/hr). CARDENE I.V. 40 mg in 200 mL (0.2 mg/mL): 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. 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. slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.2 , 5.3 and 5.4) ] 2.2 Monitoring The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes. Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of CARDENE I.V. may be restarted at low doses such as 30-50 mL/hr (3 - 5 mg/hr) for 20 mg in 200 mL or 15-25 mL/hr (3 - 5 mg/hr) for 40 mg in 200 mL and adjusted to maintain desired blood pressure. 2.3 Instructions for Administration Administer CARDENE I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Warnings and Precautions (5.5) ] . CARDENE I.V. is available as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required. Inspect CARDENE I.V. visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. CARDENE I.V. is normally a clear, colorless to yellow solution. Do not combine CARDENE I.V. with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete. Preparation for administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.
Warnings & Precautions
• Closely monitor response in patients with angina, heart failure, impaired hepatic function, or renal impairment. ( 5.1 , 5.2 , 5.3 , 5.4 ) • To reduce the possibility of venous thrombosis, phlebitis, and vascular impairment, do not use small veins, such as those on the dorsum of the hand or wrist. Exercise extreme care to avoid intra-arterial administration or extravasation. ( 5.5 ) • To minimize the risk of peripheral venous irritation, change the site of infusion of CARDENE I.V. every 12 hours. ( 5.5 ) 5.1 Exacerbation of Angina Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V. The mechanism of this effect has not been established. 5.2 Exacerbation of Heart Failure Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects. 5.3 Increased effect with Impaired Hepatic Function Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow. 5.4 Prolonged effect with Impaired Renal Function When CARDENE I.V. was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment. 5.5 Local Irritation To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.
Contraindications
• Do not use in patients with advanced aortic stenosis ( 4.1 ). 4.1 Advanced Aortic Stenosis CARDENE I.V. is contraindicated in patients with advanced aortic stenosis because part of the effect of CARDENE I.V. is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.
Adverse Reactions
Most common adverse reactions: are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of CARDENE I.V. Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse experiences occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia. The table below shows percentage of patients with adverse events where the rate is >3% more common on CARDENE I.V. than placebo. Adverse Event Cardene I.V. (N=144) Placebo (N=100) Body as a Whole Headache, n (%) 21 (15) 2 (2) Cardiovascular Hypotension, n (%) 8 (6) 1 (1) Tachycardia, n (%) 5 (4) 0 Digestive Nausea/vomiting, n (%) 7 (5) 1 (1) Other adverse events have been reported in clinical trials or in the literature in association with the use of intravenously administered nicardipine: Body as a Whole: fever, neck pain Cardiovascular: angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis Digestive : dyspepsia Hemic and Lymphatic: thrombocytopenia Metabolic and Nutritional: hypophosphatemia, peripheral edema Nervous: confusion, hypertonia Respiratory: respiratory disorder Special Senses: conjunctivitis, ear disorder, tinnitus Urogenital: urinary frequency Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. The following adverse reaction has been identified during post-approval use of CARDENE I.V.: decreased oxygen saturation (possible pulmonary shunting).
Drug Interactions
• Cimetidine increases oral nicardipine plasma levels. ( 7.2 ) • Oral or intravenous nicardipine may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended when co-administering CARDENE I.V. ( 7.3 , 7.4 ) 7.1 Beta-Blockers In most patients, CARDENE I.V. can safely be used concomitantly with beta blockers. However, titrate slowly when using CARDENE I.V. in combination with a beta-blocker in heart failure patients [see Warnings and Precautions (5.2) ]. 7.2 Cimetidine Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration. Frequently monitor response in patients receiving both drugs. Data with other histamine-2 antagonists are not available. 7.3 Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of cyclosporine during CARDENE I.V. administration, and reduce the dose of cyclosporine accordingly. 7.4 Tacrolimus Concomitant administration of intravenous nicardipine and tacrolimus may result in elevated plasma tacrolimus levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of tacrolimus during CARDENE I.V. administration, and adjust the dose of tacrolimus accordingly. 7.5 In Vitro Interaction The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
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