Cardilopin 5mg Egis Pharma treat hypertension, angina (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Amlodipine
Ingredient High blood pressure, angina

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

indications

Cardilopin 5 drugs are indicated in the following cases:

Hypertension; Simple use, if necessary, coordinate with other antihypertensive drugs.

Stable angina and angina due to vasodilators (Prinzmetal angina), simple or combined with other anti -angina drugs.

Pharmacology

Medication group: Selective calcium channel blockers with the main effect of vasodilation, Dihydropyridine derivatives.

Mechanism of action

Amlodipine inhibits calcium ions that pass through the cell membrane into the heart muscle and smooth muscle of the blood vessel wall (slow calcium channel blockers or calcium ions).

The mechanism of anti -hypertension effect is due to the effect of directly relaxing blood vessel muscle and resulting in decreasing barrier.

The mechanism of anti -angina effects has not been fully known, but it is likely to be related to the following two effects:

The relaxation of peripheral arteries reduces the entire resistance on the peripheral, meaning the post -load. Because Amlodipine does not cause reflex tachycardia, the demand for energy of the heart muscle and oxygen needs also decrease.

The main arteries and coronary arteries increases the supply of oxygen for the heart muscle both in normal areas and anemia. Due to these effects, the oxygen supply to the heart muscle is improved even when coronary spasms (Prinzmetal angina).

Pharmacy In patients with hypertension, the medication once a day significantly reduces blood pressure both in a lying or standing position for about 24 hours. Due to the effect of the drug slowly, it is less likely to have sudden hypotension.

In patients with angina, taking medication once a day will increase the time of physical activity, the time of angina and the staining St wave time are low and reduce the frequency of angina appearance and the need for nitroglycerin to hold under the tongue.

There are no harmful effects on metabolism related to amlodipine; The drug has no effect on lipid concentration in plasma, blood sugar and uric acid levels in serum and the drug can also be used safely for patients with bronchial asthma.

Pharmacokinetics

absorption

Amlodipine is well absorbed after drinking. The maximum concentration in plasma is achieved within 6-12 hours. Drinking while eating does not affect the absorption of amlodipine. Absolutely vary between 64 and 80%.

Distribution

Expression distribution volume is 21 l/kg. Plasma concentrations in a stable state (5 - 15 ng/ml) achieved after 7-8 days after treatment. According to In vitro survey results, about 93 - 98% amlodipine in the circulation are attached to protein in plasma.

Metabolism and elimination

Amlodipine is strongly metabolized in the liver. About 90% of the oral dose is transformed into non -active pyridine derivatives. About 10% of the dose is eliminated in the form of unchanged urine. About 60% of non -active derivatives are eliminated in urine and 20-25% in feces. The line of concentration - time in plasma has two phases. The selling time cancel 35 - 50 hours allows medication once a day. The body clearance is 7 ml/min/kg (25 l/hour in people weighing 60 kg). In the elderly, the whole body is about 19 l/hour.

Amlodipine pharmacokinetics does not change when there is kidney damage or in the elderly.

Give a lower starting dose if the patient has liver lesions due to decrease in clearance.

Before taking Cardilopin 5mg Egis Pharma treat hypertension, angina (3 blisters x 10 tablets)

How to use

oral medication.

Dosage

In both hypertension and angina, the starting dose is usually 5 mg once a day, if possible, always drink at the same time of the day. Depending on the response of the patient, the starting dose may increase up to 10 mg once a day. It is not necessary to adjust the dose if used simultaneously with thiazide diuretics, beta blockers and angiotensin conversion inhibitors.

Can take the usual dose for patients with kidney disease. Elderly people may use lower starting dose.

Must reduce the dose (to 2.5 mg a day) in patients with impaired liver function because of the prolonged half -life of amlodipine in these cases.

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?

Animal tests

The single dose of 40 mg/kg causes death in mice and 100 mg/kg for mice.

The only dose of 4 mg/kg or higher causes strong peripheral vessels and hypotension in dogs.

Human data

Experience in overdose amlodipine intentionally in people is limited.

In a report, a patient taking a dose of 250 mg is still asymptomatic and is not necessary to be hospitalized.

In another case, after taking a dose of 120 mg, the patient was hospitalized, gastric and blood pressure were normal.

In the third case, a patient who takes 105 mg has hypotension and returns to normal after increasing the volume of plasma.

A patient taking 70 mg of amlodipine is accompanied by an unknown amount of benzodiazepine with the intention of suicide that has been stunned and unable to cure. The next day the patient died with high levels of benzodiazepine abnormally in plasma.

In a case of a child, a 19 -month -old child takes 30 mg of Amlodipine (about 2 mg/kg). In the emergency room, there is no hypotension, but the heart rate is 180 times/minute. Three hours and a half after taking the medicine, the child is given ipecac and has no sequelae to be seen during the later monitoring process.

Overdose

Because amlodipine is slowly absorbed, the stomach may be helpful. Serious overdose can cause strong peripheral vessels with severe hypotension and may have a tachycardia due to reflexes. If clinically, there is severe hypotension, it is necessary to support the heart actively, monitor the heart and respiration, enhance limbs, monitor the amount of circulating blood and urine and positive symptom treatment. The vasoconstrictor may be helpful to restore blood vessel tone and blood pressure if there is no contraindications. For intravenous calcium gluconate can help reverse the effect of preventing the entry of calcium.

amlodipine is attached to the protein of plasma, so the hemolysis is not beneficial.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

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

Frequency of common side effects (> 1 %) depends on the drug (percentage)

Side effects 2.5 mg

(n = 275)

5 mg

(n = 296)

10 mg

(n = 268)

Parent

(n = 520)

1.8 3.0 10.8 0.6 Face 0.7 1.4 2.6 Currently common side effects (> 1 %) without depending on the dose (calculated by %)

Side effects

amlodipine

(n = 1730)

Parent

(n = 1250)

Abdominal

1.6 0.3 Floating skin rash, gum hyperplasia, indigestion, weakness, joint pain, muscle pain, cramps, sexual disorders (in both male and female patients), shortness of breath, itching, urination many times.

Very rare side effects

Experienced abnormal liver function, jaundice, diverse erythema, large breasts in men.

Other side effects

Like other calcium channel blockers, the following side effects are rarely seen in patients with severe coronary coronary artery, but these side effects cannot be distinguished from the natural progression of the original disease such as: progressive angina, myocardial infarction, ventricular fast and atrial fibrillation.

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Cardilopin 5 contraindicated drug in the following cases:

Too hypersensitivity to amlodipine, dihydropyridine and/or with any other ingredient of the drug.

Children (due to less clinical experience).

Unstable angina.

Aortic stenosis has clinical manifestations.

breastfeeding.

Caution when used

Survey on hemodynamics and clinical trials in patients with heart failure II/III according to NYHA classification does not show that Amlodipine exacerbates the tolerance of the movement, the blood pumping function of the left ventricular as well as the clinical symptoms.

According to the results obtained in patients with heart failure III - IV according to NYHA classification, Amlodipine does not increase the occurrence or death in the cardiovascular system when the drug is used with ACEI inhibitors, diuretics and digoxin.

Amlodipine vasodilation effects occur slowly, so it is very rarely causing blood pressure after medication.

The ability to drive and operate machines

Patients need to know for a few people, although very rare, the drug can cause drowsiness, affecting the ability to drive and operate machinery.

During pregnancy and lactation

Clinical data

When accumulated doses (up to 10 mg/kg/day = 8 times more than the maximum dose to be proposed in humans, calculated on mg/m2) Amlodipine has no effect on the conception of the rat.

The results of amlodipine on rabbits and mice do not show evidence of teratogenic effects.

Human data

Because clinical experience with amlodipine is used when pregnant and breastfeeding is small, not only indicated amlodipine for pregnant women and women of the childbearing age and no effective contraception, unless this indication is justified and beneficial than harmful. Do not use amlodipine when pregnant unless absolutely necessary and more beneficial than harmful.

If there is no other treatment, nursing women must use amlodipine, they should stop breastfeeding.

Medicinal interaction

Amlodipine may increase the hypotension of other anti -hypertension drugs such as beta blockers, although the combination of drugs in general is well tolerated. It is also possible to see increased hypotension if used with drugs such as nitrate, guanidin, aldesleukin, sleeping pills, antidepressants and psychotropic drugs that cause hypotension.

lithium

Amlodipine can significantly increase the clearance of lithium.

Non -steroid anti -inflammatory drugs (NSAID)

When used with nonsteroidal anti -inflammatory drugs and calcium channel blockers may increase the risk of gastrointestinal bleeding and/or may occur against hypotension.

High -linked drugs with protein (such as Coumarine, Hytantoin)

There may be an increase in plasma concentrations of Coumarine and Hytantoin derivatives.

digoxin

Digoxin concentration in serum can increase temporarily.

Storage

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

To be out of reach of children.

Other drugs

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