Execard

Execard

nicardipine

Manufacturer:

Makcur Laboratories

Distributor:

HLM Pharma
Concise Prescribing Info
Contents
Nicardipine HCl
Indications/Uses
Acute life-threatening HTN particularly in the event of malignant arterial HTN/hypertensive encephalopathy; aortic dissection, when short acting β-blocker therapy is not suitable, or in combination w/ β-blocker when β-blockade alone is not effective; severe pre-eclampsia, when other IV antihypertensive agents are not recommended or are contraindicated. Treatment of post-op HTN.
Dosage/Direction for Use
Administer by continuous IV infusion only. Adult Initial dose: Start w/ continuous administration at a rate of 3-5 mg/hr for 15 min, may be increased by 0.5 or 1 mg-increments every 15 min. Max infusion rate: 15 mg/hr. Maintenance: Reduce dose progressively between 2 & 4 mg/hr when target pressure is reached. Elderly ≥65 yr, patient w/ hepatic or renal impairment Start at 1-5 mg/hr, depending on BP & clinical situation. After 30 min, rate should be increased or decreased by increments of 0.5 mg/hr depending on effect observed. Max infusion rate: 15 mg/hr. Pregnant women Start at 1-5 mg/hr, depending on BP & clinical situation. After 30 min, rate can be increased or decreased by increments of 0.5 mg/hr depending on effect observed. Treatment of pre-eclampsia Max infusion rate: 15 mg/hr. Paed Initial dose: 0.5-5 mcg/kg/min in case of emergency. Maintenance dose: 1-4 mcg/kg/min.
Contraindications
Hypersensitivity. Severe aortic stenosis. Compensatory HTN ie, in case of arteriovenous shunt or aortic coarctation. Unstable angina. W/in 8 days after MI. Patients w/ rare hereditary problems of fructose intolerance.
Special Precautions
Consider decreasing dose by ½ or stopping the infusion if systemic hypotension or reflex tachycardia occurs. Infusion site reactions may occur particularly w/ prolonged duration of administration & in peripheral veins. Change infusion site in case of any suspicion of infusion site irritation. Bolus or IV administration not controlled by use of electronic syringe driver or volumetric pump is not recommended & can increase risk of serious hypotension, particularly in elderly, childn, patients w/ renal or hepatic impairment & in pregnancy. Worsening of cardiac insufficiency may occur in patients w/ CHF or pulmonary oedema, particularly when receiving concomitant β-blockers. Occasionally, patients have developed an increased frequency, duration or severity of angina upon starting or increasing dose or during course of treatment. Reports of worsened portal vein HTN & portal-systemic collateral blood flow index in cirrhotic patients at high doses. Not recommended in ischemic stroke patients unless acute HTN precludes administration of adequate treatment (eg, thrombolysis) or there is other end-organ damage (which is life-threatening in short term). Monitor ICP in patients w/ pre-existing elevated ICP to allow calculation of cerebral perfusion pressure. Patients w/ suspected coronary ischemia; acute cerebral infarction; decreased cardiac function & concomitantly taking β-blocker; history of hepatic dysfunction or impaired hepatic function; renal impairment. Decrease in BP should be progressive & closely monitored during pregnancy. Caution w/ concomitant Mg sulfate during pregnancy. Use for severe pre-eclampsia during 3rd trimester of pregnancy could potentially produce an undesirable tocolytic effect which could potentially interfere w/ spontaneous induction of labour. Not to be used in multiple pregnancies or in pregnant women w/ compromised CV condition except if there is no other acceptable alternative. Not to be used during breast-feeding. Should only be used for life-threatening HTN in ped intensive care settings or post-op contexts. Paed population, especially w/ renal impairment. Elderly.
Adverse Reactions
Headache. Dizziness; lower limb edema, palpitations, hypotension, tachycardia; orthostatic hypotension; nausea, vomiting; flushing.
Drug Interactions
May enhance -ve inotropic effect of β-blockers & cause heart failure in patient w/ latent or uncontrolled heart failure. May cause fatal ventricular fibrillation w/ IV dantrolene. Possible risk of pulmonary edema or excessive decrease in BP w/ Mg sulphate. Plasma conc may be decreased w/ CYP3A4 enzyme-inducing agents (eg, carbamazepine, phenobarb, phenytoin, fosphenytoin, primidone & rifampicin). Plasma conc may be increased w/ CYP3A4 enzyme-inhibiting agents (eg, cimetidine, itraconazole & grapefruit juice). Increased risk of adverse events, particularly oedema, w/ itraconazole. Elevated plasma levels of cyclosporine, tacrolimus or sirolimus; digoxin. Potentiated antihypertensive effect w/ baclofen, α-blockers, TCAs, neuroleptics, opioids & amifostine. Antihypertensive effects may be decreased w/ IV corticosteroids & tetracosactide (except for hydrocortisone). Potential additive or synergistic hypotensive effect w/ inhalational anesth, as well as inhibition of baroreflex heart rate increase associated w/ peripheral vasodilators. Possible enhanced neuromuscular block w/ vecuronium.
MIMS Class
Calcium Antagonists
ATC Classification
C08CA04 - nicardipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Execard soln for inj 1 mg/mL
Packing/Price
10 mL x 5 × 1's