Cardepine

Cardepine Dosage/Direction for Use

nicardipine

Manufacturer:

Great Eastern Drug

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
SR cap: Adults: Oral: Angina pectoris, essential hypertension, and adjunct in the management of congestive heart failure: 1 to 2 capsules daily. If the desired response has not been reached after 2 week of treatment, the dosage may be increased to 3 capsules daily.
Inj: Nicardipine injection is intended for intravenous infusion. Dosage must be individualized depending on the severity of hypertension and patient response during dosing.
Monitor BP and heart rate both during and after the infusion; avoid too rapid or excessive reduction in either systolic or diastolic BP during parenteral treatment.
Preparation of Infusion Solution: Dilution Instructions: Nicardipine Injection must be diluted prior to administration. It is administered by slow continuous IV infusion at a concentration of 0.1 mg/ml. Nicardipine infusion solution is prepared by adding the necessary volume of nicardipine injection to a compatible infusion fluid. (See Table 1.)

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Dosage as a Substitute for Oral Nicardipine: For patients who are maintained on oral nicardipine therapy and are being switched to IV therapy, the infusion rates necessary to produce an average plasma concentration equivalent to steady state oral doses are as follows (see Table 2):

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Dosage for Initiation of Therapy in Patients not Currently Receiving Antihypertensive Therapy: Administer nicardipine injection by slow continuous IV infusion at a concentration of 0.1 mg/mL. With constant infusion in patients not currently receiving antihypertensive therapy. BP beings to decrease within minutes. BP reaches approximately 50% of its ultimate reduction in about 45 minutes and does not reach final steady state for about 50 hours. (See Table 3.)

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Conditions Requiring Infusion Adjustment: Hypotension or Tachycardia: Discontinue infusion in case of hypotension or tachycardia. When BP and heart rate have stabilized, restart nicardipine IV infusion at low doses (e.g., 30 to 50 mL/hour) and adjust to maintain desired BP.
Infusion Site Changes: It is recommended that the infusion site be changed every 12 hours to minimize the risk of peripheral venous irritation.
Impaired Cardiac, Liver or Renal Function: Patients with congestive heart failure or impaired liver or renal function should be closely monitored when titrating nicardipine IV.
Transfer to Oral Antihypertensives: When transferring treatment to an oral antihypertensive other than nicardipine oral capsule or tablet, therapy should be started upon discontinuation of nicardipine IV.
If nicardipine tablets or capsules are to be used, the first dose of a thrice daily oral regimen should be taken 1 hour prior to discontinuation of nicardipine IV infusion.
Stable Angina: The usual starting dosage is 0. 6 mg/ hour infused continuously for 30 to 60 minutes. The dosage may be increased by up to 0.5 mg./hr. every 15 minutes to a maximum of 4.0 mg./hr. depending on the need to suppress angina. If symptoms warrant, titration may proceed more rapidly provided the patient is assessed frequently.
For severe hypertension, hypertensive crisis, urgency and for Pre- Peri- Post Operative Hypertension: necessitating careful monitoring and titration, an IV infusion is used.
For severe hypertension, hypertensive emergencies/ crises: Which requires immediate lowering of blood pressure, an IV bolus is used.
Dilution: Dilute the drug with one of the compatible intravenous fluids, i.e. normal saline. 5% glucose solution for injection or Dextrose (5%) Injection at a concentration of 0.01-0.02% of nicardipine (0.1- 0.2 mg/ml). The initial rate of infusion should be 2-10 μg/kg.BW/minute. After blood pressure falls to the desired level, adjust the rate of infusion while monitoring BP levels.
If there is a need to decrease BP rapidly, inject the drug as IV bolus at 10-30 μg./kg.BW over a period of one to two minutes.
Or as prescribed by the physician.
Example of preparing the dose solutions for intravenous infusion: 0.01- 0.02% (0.1-0.2 mg/ml) nicardipine hydrochloride solutions to be administered by intravenous infusion should be prepared using the following examples as references by adding the required volume of the injection to a compatible intravenous solution. (See Table 4.)

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NICARDIPINE INJECTION SHOULD NOT BE ADMIXED WITH SODIUM BICARBONATE (5%) OR LACTATED RINGER'S INJECTION.
DOSAGE MUST BE INDIVIDUALIZED to the severity of the patient's condition and the response during dosing.
An infusion pump should be used to accurately control the rate of infusion.
Discontinue administration when marked hypotension occurs due to an excessive dose of the drug.
Nicardipine infusion should be continued as long as blood pressure control is needed.
Maximum duration without change in infusion site is 12 hours if administered via peripheral vein or 24 hours if administered via central vein.
Dilution is stable in glass or PVC containers for 24 hours at controlled room temperature.
Transfer to Oral Antihypertensive Agents: Patients with acute hypertension who require prolonged therapy to control blood pressure should be started on oral antihypertensive medication as soon as their clinical condition permits. If indicated, therapy with an oral agent should be initiated upon discontinuation of CARDEPINE IV if oral CARDEPINE is used, it should be administered (40 mg every 8 hours) 1 hour prior to CARDEPINE IV discontinuation. If blood pressure control is not adequate within 24 hours after discontinuation of intravenous, oral nicardipine could be supplemented with antihypertensive of physician's choice.
Children: There is no established evidence regarding safe use in children.
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