Nicardipine Aguettant 10mg/10ml Laboratoire Aguettantal treatment solution (10 tubes)

Dosage form Box of 10 tubes x 10ml
Specifications Nicardipine

Ingredient

Thành phần cho 10ml

Composition information	Content
Nicardipine	10mg

Uses

Indications

Nicardipine Aguettant 10 mg/10 ml is indicated in the following cases:

Treatment of malignant hypertension is life -threatening:

Malignant arterial hypertension/brain disease due to hypertension.

Aortic dissection, when treated with a short -acting beta blocker, or used in combination with a beta blockers when the beta receptor inhibitor is simple.

Severe pre -eclampsia, when other venous hypotension drugs are not recommended or contraindicated.

Treatment of hypertension after surgery.

Pharmacokic of

Nicardipine is the second -generation slow -generation channel inhibitor of Phenyl - Dihydropyridine group. Nicardipine has high selective properties for Calci Type L of blood vessel smooth muscles than for myocardial cells. In very low concentrations, the drug inhibits calcium penetration into the cell. This impact is outstanding in the artery smooth muscle. This is reflected by the relatively important and rapid changes of blood pressure, with negligible changes of myocardial contraction (the effect of pressure receptor reflection). Heart frequency increases fleeting, the heart level increases and prolonged because of the post -load reduction. Renal blood vessel resistance decreases.

Nicardipine is associated with plasma proteins with high proportions, on a wide range of concentrations.

Metabolism

Nicardipine is metabolized by Cytochrome P450 CYP3A4. Human studies at a single dose or repeated dose 3 times/day for 3 days shows that less than 0.03% nicardipine in unchanged form is found in urine after oral or intravenous. The main metabolites in the urine are a glucuronide of hydroxy form, formed by the N-methylbenzyl group oxidation reaction and pyridine oxidation.

Elimination

In 96 hours after simultaneously, a nicardipine vein is marked with radioactive isotope and a 30 mg oral dose every 8 hours, 49% of radioactive activity found in urine and 43% in feces. No used products in urine in the form of nicardipine have not changed. After a venous dose, the drug was eliminated through three phases, with the sale time of alpha, 6.4 minutes, beta 1.5 hours, gamma 7.9 hours.

Before taking Nicardipine Aguettant 10mg/10ml Laboratoire Aguettantal treatment solution (10 tubes)

How to use

nicardipine is only used by continuous intravenous infusion.

Nicardipine is only used by specialists in the medical environment, such as hospitals and active care units, continuous blood pressure monitoring with monitor. The speed of drug transmission must be accurately controlled by using an electric syringe or automatic syringe. Heart pressure and heart frequency must be monitored at least every 5 minutes during the transmission until the signs of survival are stable, and at least 12 hours after using Nicardipine.

Dosage

Anti -hypertension effect depends on the dose. The dosage to achieve the desired blood pressure may vary depending on the target blood pressure, the patient's response, the age and total condition of the patient.

Unless being infected via central venous catheter, it is necessary to dilute the drug to a concentration of 0.1 - 0.2 mg/ml before use.

Adults

Initial dose: Start treatment by continuous nicardipine transmission at 3–5 mg/hour at 15 minutes. Can increase the speed of each step 0.5 or 1 mg every 15 minutes. Intravenous speed must not exceed 15 mg/hour.

Maintenance dose: When the target blood pressure has been achieved, the dose must be gradually reduced, usually about 2–4 mg/hour, to maintain the effectiveness of treatment.

switch to oral hypotension: stop using nicardipine or reduce the dose when starting to use simultaneously with an appropriate oral medication. When starting to use oral hypotension, it is important to pay attention to the drug that is delayed. Continue monitoring blood pressure with monitor until you have the desired effect. It is possible to switch to oral treatment with nicardipine tablets 20 mg at the dose of 60 mg/day divided into 3 times, or Nicardipine 50 mg of release tablets lasting at 100 mg/day divided into 2 times.

Elderly patients

Elderly people may be more sensitive to the effects of nicardipine because of the impaired renal and/or liver function. Nicardipine should be used continuously at a dose of 1–5 mg/hour, depending on blood pressure and clinical condition. After 30 minutes, depending on the observation effect, may increase or decrease the speed of each step of 0.5 mg/hour. Intravenous speed must not exceed 15 mg/hour.

Pregnant women

Should use nicardipine intravenously at an initial speed of 1 - 5 mg/hour, depending on blood pressure and clinical condition. After 30 minutes, depending on the observation effect, may increase or decrease the speed of each step of 0.5 mg/hour. In the treatment of pre -eclampsia, the dose usually does not exceed 4 mg/hour. The maximum speed must not exceed 15 mg/hour.

Patients with liver failure

Be cautious when using nicardipine in these patients. Nicardipine is metabolized in the liver, which should be used according to the recommended regimen for elderly patients with liver failure or reduced blood flow through the liver.

Patients with renal failure

Be cautious when using nicardipine in these patients. In some patients with medium renal impairment, the body clearance has been observed lower and the area under the curve (AUC) is more significant. Therefore, the dose should be used according to the recommended regimen for elderly patients with renal failure.

Children

Safety and effectiveness on baby giving birth, babies, breastfeeding and children have not been proven. Only use nicardipine in case of life -threatening hypertension in the Pediatric Care Department or in the postoperative room.

Initial doses: In an emergency, the initial dose is recommended to be 0.5 - 5 mcg/kg/minute.

Maintenance dose: The maintenance dose is recommended to be 1 - 4 mcg/kg/min.

Be cautious when using nicardipine in children with renal failure. In this case, only the lowest dose is effective.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In addition to the measures to support the whole body, calcium solutions using intravenous tract and vasodilic drugs are clinically indicated for patients with signs of the calcium -blocking effect on the cell. Hypoglycemic hypotension can be treated by intravenous transmission of a solution to compensate for the volume of circulation and a high -legged position.

Cannot exclude nicardipine by hemolysis.

What to do when forgetting a dose?

Side Effects

When using Nicardipine Aguettant 10 mg/10 ml, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, dizziness.

Heart: Legend of the lower chest, hypotension, tachycardia.

Vascular blood pressure: Hypotenary pressure vertical.

digestive: nausea, vomiting.

Skin: Red attacks.

Not determined frequency

Blood: platelets.

heart: Atrial block, angina.

Respiratory: pulmonary edema.

digestive: intestinal paralysis. liver: Liver enzyme. skin: Red skin. Systemic: Venous inflammation.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when taking the drug, consecutely the unwanted effects have not been listed in this application.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Nicardipine aguettant 10 mg/10 ml contraindicated in the following cases:

History of hypersensitivity to nicardipine or one of the drug ingredients.

Heavy aortic valve stenosis.

Defined hypertension, such as dynamic shunt - veins or aortic stenosis.

Unstable angina.

within 8 days after myocardial infarction.

Caution when using

Reducing blood pressure quickly under the effect of the drug can lead to body hypertension and reflex tachycardia. If one of these two cases appears when using nicardipine, considering half of the dose or stopping.

Direct intravenous injection (Bolus dose) or an untreated venous tract using an electric syringe or automatic syringe is not recommended and may increase the risk of severe blood pressure, especially in the elderly, children, kidney or liver failure patients and pregnant women.

Heart failure: Be cautious when using nicardipine in patients with congestive or pulmonary heart failure, especially patients treated simultaneously with beta blockers because of the risk of worse heart failure.

Ischemic cardiovascular disease: Nicardipine is contraindicated in unstable angina and during the period right after myocardial infarction. Caution must be used when using nicardipine in patients suspected of being ischemic due to coronary artery causes. Sometimes, the patient has an increase in frequency, prolonged time or increases the severity of angina at the beginning of treatment or when increasing the dose, or while using nicardipine.

Pregnant women: Because of the risk of maternal severe hypotension and the risk of oxygen deficiency in the fetus, the lower pressure takes place slowly and is always closely monitored by monitor. Because there may be an excessive risk of pulmonary edema or lower pressure, be careful when used simultaneously with Magnesium sulfate.

Patients with a history of liver dysfunction or liver failure: There is a report on a rare number of abnormal cases of liver function may be associated with the use of nicardipine. High -risk groups are patients with a history of liver dysfunction or patients with liver failure when they start treatment with nicardipine.

Patients with door venous hypertension: There are reports showing that high -dose nicardipine uses intravenous tract can aggravate the increase in the portal vein pressure and the index of the door system - the person in the cirrhosis patient.

Patients with increased intracranial pressure: Must monitor intracranial pressure to calculate the pressure of brain perfusion.

Patients with stroke: Be cautious when using nicardipine in patients with acute cerebral infarction. Hypertension attacks are often accompanied by a stroke that is not an indication for emergency anti -turbocharger treatment. The use of antihypertensive drugs is not recommended in the event of an anemia stroke, unless hypertension hinder the use of a satisfactory treatment (for example, blood soluble drugs) or in the event of other target organs that are at risk of death.

Coordinate with beta blockers: Be careful when using Nicardipine in combination with beta blockers in patients with heart function impairment. In that case, the beta blocker must be adjusted depending on the clinical condition of each patient.

Initial reactions: There may be local transmission reactions, especially when using the drug extended and using peripheral intravenous lines. Should change the infusion position in case of suspected irritation at the injection site. Using central veins or a more dilute solution may reduce the risk of the response at the injection site.

Children: The safety and effectiveness of nicardipine intravenous sugar has not been studied in clinical trials that are controlled in breastfeeding or children. Therefore, it is necessary to be careful especially in these objects.

Because of the presence of sorbitol, this drug is contraindicated in case of fructose intolerance (a genetic metabolic disorder).

The ability to drive and operate machinery

Not applicable.

Pregnancy

Restricted dynamic data shows that nicardipine intravenous tract is not accumulated. The drug is less through the placenta fence.

In clinical practice, using nicardipine in the first 6 months of pregnancy in a few cases of pregnancy so far does not show any special effects on the birth of the biometric or toxicity for the fetus.

Using nicardipine to treat severe pre -eclampsia in the last 3 months of pregnancy can cause uterine contraction effect, hindering natural labor.The acute pulmonary edema has been recorded when taking nicardipine as a uterine medication during pregnancy, especially in the case of multi-pregnancy (twins or more), with intravenous tract and/or when used simultaneously with Beta-2 vehicles. Do not use nicardipine in the case of multi -pregnancy as well as pregnant women with cardiovascular problems, unless there is no other replacement drug can be raged.

breastfeeding period

nicardipine and its metabolites are excreted in breast milk at very low concentrations. There is not enough information about the influence of nicardipine on infants/breastfeeding. Do not use nicardipine during breastfeeding.

Drug interaction

Increases the effect of reducing myocardial contraction

Nicardipine can increase the effect of reducing the heart muscle contraction of beta blockers and leading to heart failure in patients with hidden or uncontrolled heart failure.

dantrolene

In animal studies, using Verapamil and Dantrolene intravenously leads to death. Therefore, the combination of calcium and dantrolene inhibitors is dangerous.

Magnesi

Due to the high risk of pulmonary edema and excessive reduction of blood pressure, caution must be used simultaneously with Magnesi Sulfate.

Touch and Cytochrome CYP3A4 inhibitors

Nicardipine is metabolized by Cytochrome P450 CYP3A4. The simultaneous use of CYP3A4 induction (carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone and rifampicin) can reduce nicardipine levels in plasma.

Simultaneously used with CYP3A4 enzyme inhibitors (Cimetidine, Itraconazole and grapefruit juice) may increase nicardipine levels in plasma. Simultaneous use of calcium and iTraconazole inhibitors shows increased risk of adverse effects, especially edema due to reducing the metabolism of calcium channel inhibitors in the liver.

Simultaneous use of nicardipine with cyclosporin, tacrolimus or syrolimus leads to increased cyclosporin/tacrolimus levels in plasma. Must monitor the concentration of medications in the blood, if it is necessary to reduce the dose of immunosuppressive drugs and/or nicardipine.

digoxin

Pharmacokinetic studies prove that nicardipine increases the concentration of digoxin in plasma. Digoxin concentration must be monitored at the beginning of treatment simultaneously with nicardipin.

The risk of antihypertensive forces

The drugs that enhance nicardipine's anti -pressure anti -pressure effect when used simultaneously include Baclofene, alpha blockers, three -round antidepressants, nervous drugs, opium and amifostine.

Reducing anti -pressure effects

Nicardipine is used in combination with intravenous corticosteroids and tetracosactide (except hydrocortisone used as an alternative treatment in Addison disease) can lead to a decrease in anti -turbocharger.

Inhalation anesthetics

Nicardipine simultaneous use with inhaled anesthetics can cause antihypertensive effects of force or force, anesthetic also inhibits the increase in heart frequency due to pressure receptor reflexes associated with peripheral vasodilators. Restricted clinical data suggests that the effects of inhaled anesthetics (for example, isofluran, sevofluran and enfluran) on Nicardipine seem to be only average.

Neurological inhibitors - Competitive muscle

Restricted data suggests that Nicardipine, like other calcium inhibitors, increases neurotransmitter block - muscles, perhaps through an impact on the posterior region. Nicardipine simultaneous use may reduce the dosage of vecuronium. Neostigmine's antagonistic antagonistic effects seem to be not affected by nicardipine infusion. No need for additional monitoring.

Storage

At temperatures below 25 ° C.

Store the pipe in the packaging of the manufacturer, avoiding light.

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