Amlodac 5 cadila medicine for hypertension, angina (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Amlodipine
Ingredient Coronary artery disease, angina, high blood pressure

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

indications

amlodac 5 1x10 is indicated in the following cases:

Treatment of hypertension

Treatment of chronic stable angina

Kieu Prinzmetal angina pain

Pharmacy

Amlodipin is a derivative of dihydropyridine that has the effect of inserting calcium through cell membranes. Amlodipine blocks calcium type L -type calcium depends on the voltage, acting on the blood vessels in the heart and muscle.

Amlodipine has anti -hypertension effects by directly relaxing smooth muscles around the peripheral artery and has less effect on the heart muscle calcium channel. Therefore, the drug does not conduct the atrial transmission in the heart and does not adversely affect the muscle 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 is 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, which are first selected for treatment. However, Amlodipin can be used in combination with beta blockers along with thiazid or diuretics and along with an angiotensin conversion
enzyme.

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 the entire resistance in the peripheral circuit (after the burden of the burden). Because the heart frequency is not affected, the post -burden of the heart reduces the heart, 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 the area is provided with normal blood. This vasodilation increases the supply of oxygen for patients with cramped angina (Prinzmetal angina). This reduces nitroglycerin demand and in this way, the risk of nitroglycerin resistance may decrease. The 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

After taking the treatment dose, Amlodipin is well absorbed with peak concentration in plasma reaching about 6 to 12 hours after drinking. Absolute bioavailability is estimated at 64% - 80%.

The distribution volume is 21 kg.

Amlodipine's absorption is not affected by food.

Metabolism/excretion

Amlodipin's plasma semi -discharged time is about 35 to 50 hours and is suitable for the dosage once a day. The concentration in the state of plasma is achieved after 7 to 8 days
using continuous drugs.

amlodipine is metabolized largely in the liver into non -active metabolites. 10% of the initial substance and 60% of metabolic substances are eliminated in the urine.

Before taking Amlodac 5 cadila medicine for hypertension, angina (1 blister x 10 tablets)

How to use

oral medication. Use as directed by the treating doctor.

Amlodipin Besylat can drink not to mention meals.

Dosage

Dosage for hypertension treatment:

The usual oral dose of amlodipine is 5 mg, used 1 time/day, the maximum dose is 10 mg, used 1 time/day.

Patients with thin, small or elderly patients or patients with liver failure can start at a dose of 2.5 mg, 1 time/day.

Dosage to treat angina:

To control angina due to coronary artery spasm or chronic stable angina, the common dose in adults is 5 - 10 mg, used 1 time/day.

No need to adjust the amlodipine dose in case of use in conjunction with thiazid diuretics, beta receptor inhibitors or angiotensin transferring enzymes inhibitors.

Special groups

Elderly: Amlodipin used at the same dose for the elderly and young people are equally tolerated. Therefore, the usual dosage can also be used for the elderly, but need special care if the dose increases.

Patients with hepatic impairment: There is no recommendation for patients with mild to moderate liver failure, so they should be carefully used and should start with the lowest dose. Amlodipine pharmacokinetics have not been studied in patients with severe liver failure. Amlodipine should be started at the lowest dose and increase the dose slowly for patients with severe liver failure.

Patients with renal failure: Amlodipine plasma changes are not correlated with the level of renal failure, so the usual dosage is recommended. Can not appraise amlodipine.

Children: Children and teenagers with hypertension from 6 years old to 17 years old: The dose to lower blood pressure in children from 6-17 years old is 2.5 mg once a day as a dose of start, an increase of dose up to 5 mg once a day if the target blood pressure is not achieved after 4 weeks. The dose exceeds 5 mg daily has not been studied in children.

Children under 6 years old: No data available.

What to do when overdose?

Amlodipine poisoning is very rare.

Use 30mg of amlodipine for children 1 and a half years only causing "average" poisoning.

In case of an overdose with calcium blockers, the general treatment is as follows:

Monitor cardiovascular disease with electrocardiograms and treat symptoms of effects on cardiovascular effects along with gastric lavage and active carbon drinking. If necessary, electrolytes must be adjusted. In case of bradycardia and heart heart, atropine must be injected with an intravenous target for adults (for children, intravenously 20 - 50kg/1kg of weight). If necessary, repeat injection. Intravenous injection of 20ml of calcium gluconate solution (9 mg/ml) for 5 minutes for adults, add isoprenalin 0.05 -0.1 mg/min/minute or adrenalin 0.05 -0.3 Ug/kg/minute or dopamine 4-5 ng/kg/min.

For patients with reduced circulatory volume, 0.9%sodium chloride solution is required. When needed, pacemaker must be placed.

In case of serious hypotension, intravenously, 0.9% adrenalin sodium chloride solution. If not effective, use isoprenalin in combination with amrinone. Symptomatic treatment.

What to do when forgetting the dose?

If you forget a dose, use it as soon as possible. However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Amlodipin's most common side effects are ankle edema, from light to medium, related to the dose. In clinical trials, there is a control of Placebo, this effect is about 3% of the
treatment for a dose of 5 mg/day and about 11% when taking 10 mg/day.

Common, ADR> 1/100

Systemic body: Ankle edema, headache, dizziness, blushing and feeling hot, fatigue, weakness.

circulating: excessive hypotension, tachycardia, chest pain.

circulating: extra mind. Translation: Diverse roses.

Warnings

Contraindicated

amlodipine is contraindicated in patients with a history of hypersensitivity to dihydropyridine, amlodipine, or any ingredients of this drug.

Heart failure, shock (including cardiac shock), unstable angina, hypotension, congestion of left ventricle (such as severe aortic valve stenosis), unstable hemodynamic heart failure after acute myocardial infarction.

breastfeeding women. Children under 6 years old.

Precautions when using

Safety and effectiveness of amlodipine on an unpaid hypertension.

Use in patients with heart failure.

Patients with heart failure should be treated carefully. In a long -term study of a placebo, amlodipine in patients with heart failure due to anemia (NYHA level III
and micro), Amlodipine is reported to be related to an increase in pulmonary edema.

Calcium channel blockers, including amlodipine, should be used cautiously in patients with congestive heart failure, because they can increase the risk of future cardiovascular events and death rates.
Used in patients with liver function impairment. Amlodipine therefore should be started at the most low -dose
and need to be used cautiously, both in the initial treatment and when increasing the dose. Slowly and carefully monitoring can be required in patients with severe hepatic failure

Use drugs for patients with renal failure:

Amlodipine plasma changes are not related to renal failure. Amlodipin can be used for these patients in normal doses. Amlodipin cannot be appraised.

Used for the elderly:

Amlodipin used in the same dose for the elderly and young people are equally tolerated. Therefore, the usual dosage can also be used for the elderly, but need special care if the dose increases.

Use for children:

Not known the effectiveness of amlodipine on blood pressure in patients under 6 years old.

The ability to drive and transport machinery

Amlodipin can cause unwanted effects such as headache, dizziness, fatigue ... Caution should be used for drivers or operating machinery.

Pregnant and lactating women

Pregnant women

Amlodipin's safety when used for pregnant women has not been established.

In animal studies, reproductive toxicity has been observed in high doses.

Use during pregnancy is only recommended when there is no safer alternative and when the disease is a greater risk for the mother and the fetus.

breastfeeding women

Do not know if Amlodipin is excreted through breast milk. A decision on whether or not to continue breastfeeding or continuing/stopping treatment with amlodipine should be performed based on the risk of breastfeeding and the benefits of treatment for the mother.

Drug interaction

The effect of other drug products on amlodipin

CYP3A4 inhibitors

Simultaneous use of amlodipine with strong or medium CYP3A4 inhibitors (protease inhibitors, antifungal drugs azol, macrolid such as erythromycin or clarithromycin, verapamil or diltiazem) can lead to significant increase in contact with amlodipine leading to an increase in risk of lowering blood pressure. Mobile changes may be more pronounced in the elderly. Clinical monitoring and dose adjustment may be required.

CYP3A4 induction drugs

There is no available data related to the effects of CYP3A4 induction drugs on Amlodipin. The simultaneous use of CYP3A4 induction drugs (for example, rifampicin, plants) can reduce the
level of amlodipine. Amlodipin should be cautious when used with drugs causing CYP3A4.

Take amlodipine with grapefruit or grapefruit juice is not recommended by bioavailability may increase in some patients leading to increased hypotension effect.

dantrolen (infusion)

In animals, death vibration and cardiovascular collapse are observed with hyperkalemia after taking Verapamil and Dantrolene intravenously. Due to the risk of hyperkalemia, it is recommended that not using the same calcium channel blockers such as amlodipine can avoid patients who are prone to malignant body temperature and in managing malignant body temperature.

The effect of amlodipine on other drugs

Amlodipin co -acting effects on similarly used with other anti -blood pressure drugs.

tacrolimus

There is a risk of increasing blood concentration of tacrolimus when treated in combination with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. To avoid Tarolimus poisoning, when using the
period of Amlodipin for patients treated with tacrolimus, they should require monitoring of tacrolimus concentration in the blood and adjust the tacrolimus dose when appropriate.

cyclosporin

There is no drug interaction studies have been conducted with cyclosporin and amlodipine in healthy volunteers or other patients except for kidney transplant patients, where the base concentration
of cyclosporin can increase increased (average 0% - 40%) has been observed. It is necessary to consider monitoring cyclosporin levels in kidney transplant patients when taking amlodipine and reducing cyclosporin dose should be done when necessary.

Simvastatin

10 mg of Amlodipin, 80mg Simvastatin leads to an increase in 77% of the effect of simvastatin compared to using simvastatin alone. This is the recommendation to limit the dosage of Simvastatin 20 mg daily in diseases
The use of amlodipine.

In clinical interactive studies, Amlodipin does not affect the pharmacokinetics of Atorvastatin, Digoxin or Warfarin.

Storage

Store under 30 ° C. Avoid light.

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