Drugs List

Therapeutic Indications

Uses

Hypertension
Hypertension - in pregnancy

Nicardipine is indicated for the treatment of acute life threatening hypertension, particularly in the event of:
Malignant arterial hypertension/hypertensive encephalopathy.
Aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade is not effective.
Severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contraindicated.

Nicardipine is also indicated for the treatment of post-operative hypertension.

Administration

For continuous intravenous infusion.

Unless given by a central venous line, dilute to a concentration of 0.1 to 0.2 mg/ml before use.

The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump. Blood pressure and heart rate must be monitored at least every 5 minutes during the infusion, and then until vital signs are stable, but at least for 12 hours after the end of the administration of nicardipine.

Contraindications

Compensatory hypertension
Severe aortic stenosis
Unstable angina
Within 8 days of a myocardial infarction

Precautions and Warnings

Children under 18 years
Suspected ischaemic heart disease
Acute phase of cerebral infarction
Breastfeeding
Congestive cardiac failure
Hepatic impairment
History of hepatic disorder
Portal hypertension
Pulmonary oedema
Raised intracranial pressure
Renal impairment

Treatment should be initiated in hospital
Treatment to be initiated and supervised by a specialist
If local infusion site reaction develops, use alternative infusion site
Monitor blood pressure and heart rate during & for 12 hours after infusion
Monitor for intracranial hypertension
Halve infusion rate or discontinue if hypotension or tachycardia occur
Pregnancy: This medication may inhibit labour
Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability

Nicardipine should be used with caution in patients with suspected coronary ischaemia. Occasionally, patients have developed an increased frequency, duration, or severity of angina upon starting or increasing nicardipine dosage, or during the course of treatment.

Due to the risk of severe maternal hypotension and potentially fatal foetal hypoxia, the decrease in blood pressure should be progressive and always closely monitored. Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulfate is used concomitantly.

A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy. The use of antihypertensive drugs is not recommended in ischaemic stroke patients unless acute hypertension precludes the administration of an adequate treatment (e.g. thrombolysis) or there is other end-organ damage which is life-threatening in the short term.

Pregnancy and Lactation

Pregnancy

Nicardipine is considered safe for use in pregnancy in certain circumstances.

Limited pharmacokinetic data have shown that intravenous nicardipine does not accumulate and has a low placental transfer.

In clinical practice, the use of nicardipine during the first two trimesters in a limited number of pregnancies has not revealed any malformative or particular foetotoxic effect to date.

The use of nicardipine for severe pre-eclampsia during the third trimester of pregnancy could potentially produce an undesirable tocolytic effect which could potentially interfere with the spontaneous induction of labour.

Acute pulmonary oedema has been observed when nicardipine has been used as tocolytic during pregnancy, especially in cases of multiple pregnancy (twins or more), with the intravenous route and /or concomitant use of beta-2 agonists. Nicardipine should not be used in multiple pregnancies or in pregnant women with compromised cardio-vascular condition, except if there is no acceptable alternative.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use nicardipine with caution in breastfeeding.

The manufacturer state that nicardipine should not be administered to nursing mothers. However, other organisations considers nicardipine usually compatible with breastfeeding. Information on LactMed states the because of the low levels of nicardipine in breast milk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precaution are required.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angina pectoris
Atrioventricular block
Dizziness
Erythema
Flushing
Headache
Hepatic disorders
Hypotension
Increases in hepatic enzymes
Lower limb oedema
Nausea
Orthostatic hypotension
Palpitations
Paralytic ileus
Phlebitis
Pulmonary oedema
Reflex tachycardia
Tachycardia
Thrombocytopenia
Vomiting

Presentation

Injections of nicardipine

Drugs List

Therapeutic Indications

Uses

Hypertension
Hypertension - in pregnancy

Nicardipine is indicated for the treatment of acute life threatening hypertension, particularly in the event of:
Malignant arterial hypertension/hypertensive encephalopathy.
Aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade is not effective.
Severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contraindicated.

Nicardipine is also indicated for the treatment of post-operative hypertension.

Dosage

The antihypertensive effect will depend on the administered dose. The dosage regimen to achieve the desired blood pressure can vary depending on the targeted blood pressure, the response of the patient, and the age or status of the patient.

Adults

Elderly

Children

Neonates

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For continuous intravenous infusion.

Unless given by a central venous line, dilute to a concentration of 0.1 to 0.2 mg/ml before use.

The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump. Blood pressure and heart rate must be monitored at least every 5 minutes during the infusion, and then until vital signs are stable, but at least for 12 hours after the end of the administration of nicardipine.

Contraindications

Compensatory hypertension
Severe aortic stenosis
Unstable angina
Within 8 days of a myocardial infarction

Precautions and Warnings

Children under 18 years
Suspected ischaemic heart disease
Acute phase of cerebral infarction
Breastfeeding
Congestive cardiac failure
Hepatic impairment
History of hepatic disorder
Portal hypertension
Pulmonary oedema
Raised intracranial pressure
Renal impairment

Treatment should be initiated in hospital
Treatment to be initiated and supervised by a specialist
If local infusion site reaction develops, use alternative infusion site
Monitor blood pressure and heart rate during & for 12 hours after infusion
Monitor for intracranial hypertension
Halve infusion rate or discontinue if hypotension or tachycardia occur
Pregnancy: This medication may inhibit labour
Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability

Nicardipine should be used with caution in patients with suspected coronary ischaemia. Occasionally, patients have developed an increased frequency, duration, or severity of angina upon starting or increasing nicardipine dosage, or during the course of treatment.

Due to the risk of severe maternal hypotension and potentially fatal foetal hypoxia, the decrease in blood pressure should be progressive and always closely monitored. Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulfate is used concomitantly.

A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy. The use of antihypertensive drugs is not recommended in ischaemic stroke patients unless acute hypertension precludes the administration of an adequate treatment (e.g. thrombolysis) or there is other end-organ damage which is life-threatening in the short term.

Pregnancy and Lactation

Pregnancy

Nicardipine is considered safe for use in pregnancy in certain circumstances.

Limited pharmacokinetic data have shown that intravenous nicardipine does not accumulate and has a low placental transfer.

In clinical practice, the use of nicardipine during the first two trimesters in a limited number of pregnancies has not revealed any malformative or particular foetotoxic effect to date.

The use of nicardipine for severe pre-eclampsia during the third trimester of pregnancy could potentially produce an undesirable tocolytic effect which could potentially interfere with the spontaneous induction of labour.

Acute pulmonary oedema has been observed when nicardipine has been used as tocolytic during pregnancy, especially in cases of multiple pregnancy (twins or more), with the intravenous route and /or concomitant use of beta-2 agonists. Nicardipine should not be used in multiple pregnancies or in pregnant women with compromised cardio-vascular condition, except if there is no acceptable alternative.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use nicardipine with caution in breastfeeding.

The manufacturer state that nicardipine should not be administered to nursing mothers. However, other organisations considers nicardipine usually compatible with breastfeeding. Information on LactMed states the because of the low levels of nicardipine in breast milk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precaution are required.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angina pectoris
Atrioventricular block
Dizziness
Erythema
Flushing
Headache
Hepatic disorders
Hypotension
Increases in hepatic enzymes
Lower limb oedema
Nausea
Orthostatic hypotension
Palpitations
Paralytic ileus
Phlebitis
Pulmonary oedema
Reflex tachycardia
Tachycardia
Thrombocytopenia
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 15 October, 2014.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 15 October, 2014.

Summary of Product Characteristics: Nicardipine 10mg/10ml solution for injection. Amdipharm Mercury Company Ltd. Revised April 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Nicardipine Last revised: 16 January, 2014
Last accessed: 15 October, 2014