Kavasdin 5 Khanh Hoa medicine supports the treatment of hypertension (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Amlodipine

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

indications

Kavasdin 5 drugs are indicated in the following cases:

Hypertension.

Chronic stable angina. Amlodipine blocks calcium type L -type calcium depends on the voltage, acting on the blood vessels in the heart and muscle.

Anti -hypertension effect by directly relaxing smooth muscles around the peripheral artery and has less effect on myocardial calcium channel. Therefore, the drug does not conduct the atrial transmission in the heart and does not adversely affect the muscle contraction force.

Amlodipin also works well, which is to reduce kidney blood vessel resistance, thus increasing blood flow in the kidneys and improving kidney function. Therefore, the drug can also be used to treat people with heart failure.

Amlodipin has no adverse effects on plasma lipid concentrations or glucose metabolism, so it can be used amlodipine to treat hypertension in people with diabetes. However, there are no long -term clinical trials to prove that Amlodipine has the effect of reducing death.

In many countries, the standard treatment to protect patients with hypertension from stroke and death is still beta and diuretics, these drugs are first selected for treatment. However, Amlodipin can be used in combination with beta blockers along with thiazid or diuretics and with angiotensin conversion enzyme inhibitors.

Amlodipin works well when standing, lying as well as sitting and while working. Because amlodipine is slowly acting, there is less risk of acute or reflective hypotension.

Anti -angina effect:

Amlodipin relaxes peripheral arteries, thus reducing all the obstacles in the peripheral circuit (the posterior burden).

Because the heart frequency is not affected, the burden of the heart reduction of the heart decreases, along with reducing the need for oxygen and energy to the heart muscle.

This reduces the risk of angina.

In addition, amlodipine also causes coronary artery dilatation both in ischemic area and a normal blood supply area.

This vasodilation increases oxygen supply to patients with cramped angina (Prinzmetal -type angina).

This reduces nitroglycerin demand and in this way, the risk of nitroglycerin resistance may decrease.

Time for anti -angina effect is 24 hours. People with angina can use amlodipine in combination with beta blockers and always use with nitrate (basic treatment of angina).

Pharmacokinetics

absorption

Amlodipin's bioavailability when drinking about 60 - 80% and not affected by food. The maximum concentration in plasma is achieved after drinking within 6 - 12 hours.

Distribution

Amlodipine has a large distribution and more than 95% in combination with plasma proteins.

Stable plasma concentrations reach 7 to 8 days after taking the drug once a day. The integral distribution is approximately 21 liters/kg body weight and drugs linked to protein - high plasma (over 98%).

Metabolism and elimination

The clearance in plasma is normal at about 7 ml/min/kg body weight due to excretion mainly through metabolism in the liver. The metabolites are inactive and excreted through the urine. Relatively 30 - 40 hours of sale.

In people with liver failure, Amlodipine's exhaust time increases, so it may be necessary to reduce the dose or extend the time between the dose.

Before taking Kavasdin 5 Khanh Hoa medicine supports the treatment of hypertension (10 blisters x 10 tablets)

How to use

take the tablet with a glass of water. Can be taken with food or not.

Dosage

adults

For hypertension and angina, the normal starting dose is 5 mg of amlodipine once a day. It can be increased to the maximum dose of 10 mg once a day depending on the response of each patient.

In patients with hypertension, amlodipin has been used simultaneously with thiazid diuretics, alpha blockers, beta blockers and angiotensin enamel inhibitors.

For angina, amlodipine can be used in the form of single therapy or simultaneously used with other anti -angina drugs in patients with anti -nitrate derivatives and/or appropriate beta blockers.

No need to adjust the dose when using amlodipine simultaneously with thiazid diuretics, alpha blockers, beta blockers or angiotensin transfer enzymes inhibitors.

Special subjects

Elderly

The ability to tolerate the elderly and young patients is the same when using the same amlodipine dose.

Usually recommended for the elderly and need to be cautious when increasing the dose.

Patients with liver failure

recommended dose has not been set for patients with mild to medium liver failure. Therefore, it is necessary to be cautious when choosing the dose and starting treatment with the lowest dose effectively.

Amlodipine pharmacological properties have not been studied in cases of severe liver failure. It is necessary to start using amlodipine at the lowest doses and increasing slowly in patients with severe liver failure.

Patients with renal failure

The change of amlodipine concentration in plasma is not correlated with the level of renal failure. Therefore, the usual dosage recommendation.

Amlodipin cannot be separated.

Children and teenagers

Children and teenagers from 6 to 17 years old with high blood pressure: The recommended starting dose is used for oral treatment to treat hypertension in children from 6 to 17 years old is 2.5 mg once a day, then can increase to 5 mg daily if the desired blood pressure is not achieved after four weeks.

The dose greater than 5 mg per day has not been studied in children.

Children under 6 years old

No data.

There is no special requirement on drug treatment after use.

Note:

The above dose is for reference only.

Existing data suggests that overdose of a large extent can cause peripheral vessels and may be accompanied by tachycardia. There is a report on the drop of blood pressure, may be prolonged and including death shock.

Handling

Amlodipine absorption decreases significantly when indicating activated carbon at that time or within 2 hours after taking Amlodipin 10 mg in volunteers.

In some cases, the stomach may need.

For cases of severe hypotension due to the overdose of amlodipine, positive cardiovascular support measures should be taken, including regular monitoring of cardiovascular and respiratory functions, high limbs and attention to the volume of circulation and urine.

Can use a vasoconstrictor to recover blood vessel tone and lower blood pressure, as long as the patient has no contraindication to use that drug.

can be intravenous with calcium gluconate to reverse the effect of calcium channel blockers. Because amlodipine is heavily connected to plasma proteins, dialysis does not bring results in this case.

What to do when you forget 1 dose?

However, if the time of relaxation with the next dose is too short, skip the forgotten dose and continue the medication calendar.

Do not use double dose to compensate for missed dose.

Side Effects

When using Kavasdin 5 you may experience unwanted effects (ADR).

Common, 1/100 ≤ ADR

Nervous system: headache, dizziness, chicken sleep.

Blood and lymphatic system: leukopenia, thrombocytopenia. sense. Sweating, hemorrhage, tanning, urticaria. Pain

Testing/measurement index: weight gain/weight loss.

Allergic reactions such as itching, skin rash, angiography and diverse roses.

Hepatitis, jaundice and increased liver enzymes have also been reported at a very small rate (mainly accompanied by biliary obstruction). With other calcium channel blockers, the following unexpected effects are rarely reported and cannot be distinguished from the natural process of diseases: myocardial infarction, arrhythmia (including slow rhythm, ventricular tachycardia and atrial fibrillation) and chest pain.

Common: 1/100 ≤ ADR

Nervous system: headache, dizziness.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

This drug is only used by prescription. Before using the drug, you need to read the user manual carefully and refer to the information below.

Contraindicated

Contraindications to use amlodipine in patients:

Sensitive to the derivatives of dihydropyridine, amlodipine or any ingredients of the drug.

Severe hypotension.

SHARE (including cardiac shock).

Conclusion of the output of the left ventricle (for example: severe aorta stenosis).

Unstable hemodynamic heart failure after acute myocardial infarction.

Caution when using

used in patients with heart failure

In a long -term research with placebo, when using amlodipine in patients with heart failure III and IV according to the classification of the New York Cardiovascular Association, Amlodipin is reported related to an increase in pulmonary edema ratio.

However, there is no significant difference in the proportion of patients with severe heart failure in the amlodipine group compared to the placebo group.

Used in patients with impaired liver function

Like all other calcium channel blockers, Amlodipine's waste sale time is prolonged in patients with impaired liver function. The recommended dose for this patient has not been set up.

Therefore, Amlodipin needs to be used cautiously in these patients.

The ability to drive and operate machinery

Clinical experiences with Amlodipin have shown that almost no decline in the ability to drive and operate the patient's machines.

During pregnancy and lactation

pregnancy

The safety of amlodipine in pregnant and lactating women has not been established.

Amlodipine is not toxic in animal reproductive studies, except for slowing labor and prolonging mouse delivery time with a dose of 50 times higher than the recommended doses of maximum use in humans.

Therefore, Amlodipine should only be used during pregnancy when there is no safer replacement measure and when the disease itself contains greater risks for mothers and embryos.

There is no impact on the fertility of rats when treated with amlodipine.

Breastfeeding period

Experience used on humans shows that Amlodipin has passed through breast milk.

The median concentration ratio of amlodipine in milk/plasma in 31 women who are breastfeeding with hypertension due to pregnancy is 0.85, after using amlodipine at the starting dose is 5mg/time/day and is adjusted if needed (average daily dose and daily dose in the body are 6 mg and 98.7 mcg/kg).

Amlodipin's estimated daily dose that babies receives through breast milk is 4.17 mcg/kg.

Drug interaction

Amlodipin has been shown to be safe to use with thiazide diuretics, alpha receptor inhibitors, beta receptor inhibitors, angiotensin (ACE) enzyme inhibitors (ACE), prolonged nitrate, nitroglycerin under the tongue, NSAIDs, antibodies and oral blood sugar drugs.

In vitro data from human plasma studies has shown that amlodipine does not affect the cohesion of plasma proteins of research drugs (digoxin, phenytoin, warfarin or indomethacin).

Simvastatin used multi -dose 10 mg of amlodipine simultaneously with 80 mg of simvastatin increasing 77% of exposure rate with simvastatin compared to only simvastatin. For patients with amlodipine, the dose limit of simvastatin is 20 mg/day.

Grapefruit juice: simultaneously use 240 ml of grapefruit juice with a single dose of 10 mg amlodipine in 20 healthy volunteers does not significantly affect the kinetics of Amlodipine.

This research does not allow testing of the effects of the genetic form of CYP3A4, the main enzyme is responsible for transforming amlodipine. Therefore, amlodipine should not be used with grapefruit or grapefruit juice because bioavailability can increase in some patients leading to increased hypotension effect.

Strong CYP3A4 inhibitors (such as ketoconazole, otraconazole, ritonavir) may increase the concentration of amlodipine in the blood larger than the diltiazem. Should be cautious when using amlodipine along with CYP3A4 inhibitors.

Clarithromycin is a CYP3A4 inhibitor. The risk of increased hypotension in patients using clarithromycin along with amlodipine. Should monitor patients closely when using simultaneously amlodipine with clarithromycin.

CYP3A4 induction substances: There is currently no data on the effects of CYP3A4 induction substances on Amlodipin. Simultaneous use with CYP3A4 induction substances (such as rifampicin, hypericum perforatum) can reduce the concentration of amlodipine in the blood. Should be cautious when using amlodipine along with CYP3A4 touch substances.

The effect of other drugs on amlodipine

cimetidin: simultaneously use Amlodipine and cimetidin does not change the kinetics of amlodipin.

Sidenafil: Using a single dose of 100 mg of Sidenafil in objects with idiopathic hypertension does not affect amlodipine pharmacokinetic parameters. When using a combination of amlodipine and sildenafil, each drug has its own antihypertensive effect.

The effect of amlodipine on other drugs

Atorvastatin: simultaneously use Amlodipin 10 mg and 80 mg Atorvastatin does not significantly change the pharmacokinetics parameters of Atorvastatin in a stable plasma concentration state. Healthy. Between amlodipine and cyclosporin in healthy volunteers or other groups of objects, except for kidney transplant patients. Different studies in kidney transplant patients show that the simultaneous use of amlodipine with cyclosporin affects the bottom concentration of amlodipine from unchanged to an average increase of 40%. It is necessary to consider monitoring cyclosporin levels in kidney transplant patients with amlodipine. To avoid the toxicity of tacrolimus, when using amlodipine for patients being treated with tacrolimus, the blood tacrolimus concentration should be monitored and adjust the tacrolimus dose when appropriate.

Mechanical goals of Rapamycin inhibitors such as syrolimus, temsirolimus, Everolimus are the substrate of CYP3A. Amlodipine is a weak inhibitor CYP3A. When used simultaneously with rapamycin inhibitors, amlodipine can increase exposure of rapamycin inhibitors.

Interactions between drugs and biochemical tests: unknown.

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

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