Amlodipin 5mg Domesco medicine treats 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

Amlodipine 5 mg drug is indicated in the following cases:

Hypertension.

Chronic stable angina. Smell into smooth muscle cells in the heart and blood vessels.

Amlodipine's blood pressure lowering mechanism is due to the effect of direct relaxation of blood vessel muscles. Amlodipine's exact mechanism reduces angina has not been fully determined, but Amlodipine reduces the overall anemia burden due to the following two effects:

Amlodipin relaxes peripheral arteries and thus reduces the peripheral resistance total of the heart (reducing the burden). Because the heart rate does not change, this burden reduces the heart to reduce energy consumption and oxygen needs of the heart muscle.

The mechanism of action of amlodipine may also include the relaxation of the main coronary arteries and coronary arteries, both in anemia and normal areas. This vasodilation increases the supply of oxygen to the heart muscle in patients with coronary artery spasms (Prinzmetal angina or angina variables) and reduces smoking coronary spasms.

In patients with hypertension, one -time dose/day shows a significant hypotension in both lying and standing in the 24 -hour dose. Due to the slow -on -effect trigger, fasting blood pressure is not one of the effects of amlodipine.

In patients with angina, the use of Amlodipin once a day increases the overall exertion time, the starting time of angina and time until the 1 mm ST segment inhibitors and reduces both the frequency of angina and reduces the use of nitroglycerin tablets.

Not found that amlodipine is related to any adverse effects on metabolism or changes in plasma lipids and amlodipine suitable for use in patients with asthma, diabetes and gout.

Used in patients with coronary artery disease: The effect of amlodipine in preventing clinical events in patients with coronary artery disease has been assessed in an independent, multi -central, random, double -blind study, with a placebo with a placebo over 1997 patients, comparing amlodipine with enalapril in limiting the appearance of thromosomic embolism (Camelot).

The results show that amlodipine treatment is associated with reducing cases of hospitalization caused by angina and a trick to re -vascular in patients with coronary artery disease.

Use on heart failure patients: Hemodynamic studies and control clinical trials based on exertion tests in patients with heart failure II - IV according to NYHA shows that amlodipine does not lead to clinical decline, based on tolerance of exertion activities, blood pressure fraction of left ventricle and clinical symptoms.

A place to control the placebo (praise) is designed to assess patients with heart failure III - IV according to Nyha using digoxin, diuretics and ACE inhibitors show that amlodipine does not lead to increased mortality or a combination of mortality rates and disease condition in patients with heart failure.

In the next study, there is a place to use a placebo-monitoring (praise-2) about amlodipine in patients with heart failure III and IV according to NYHA without clinical symptoms or without objective results suggesting hidden ischemic anemia, with stable dose of ACE inhibitors, heart failure and diuretics, amlodipine, non-death rate circuit.

On the same research complex, Amlodipine is associated with increasing the recognition of cases of lungs, although there is no significant difference in the rate of more severe heart failure between the group using amlodipine compared to the placebo group.

Use on children (6 to 17 years old): Amlodipin's effectiveness in children with hypertension from 6 to 17 years old is proved in a random drug test, regard to placebo, double blindness, for 8 weeks on 268 patients with hypertension.

All patients are randomly divided into the treatment branch of 2.5 mg or 5 mg and are monitored for 4 weeks, then they are randomly selected to continue using 2.5 mg or 5 mg amlodipine or placebo for another 4 weeks.

Compared to the initial time, the treatment once daily with amlodipine 5 mg reduces the systolic and diastolic blood pressure of statistical significance. The average reduction of systolic blood pressure in a placebuilded sitting position is estimated at 5.0 mmHg for amlodipine 5 mg and 3.3 mmHg for 2.5 mg amlodipine. Group analysis shows the effectiveness of younger children from 6 to 13 years old is equivalent to the older children from 14 to 17 years old.

pharmacokinetics

absorption - distribution

After taking treatment doses, 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 about 21 l/kg. Amlodipine absorption is not affected by food. In vitro studies show that about 97.5 % amlodipine in the circulation is attached to plasma proteins.

Metabolism - Elimination

Amlodipin's plasma semi -discharged time ranges from 35 to 50 hours and is suitable for daily dosage daily. The concentration in the state of plasma is achieved after 7 to 8 days of continuous drug use.

amlodipin is metabolized mostly in the liver into non -active metabolites, with 10 % of the initial substance and 60 % of the metabolites are eliminated in the urine.

Used in the elderly: Amlodipin's peak plasma concentration time is the same between the elderly and young people. However, Amlodipine's clearance tends to decrease with an increase in the area under the curve (AUC) and the sale time in elderly patients. The area under the curve and the sale time in patients with congestive heart failure (CHF) also increased as expected in the age group.

Used in children: In a clinical study using long -term drugs, 73 patients with hypertension from 12 months to less or equal to 17 years of age are used amlodipine at an average daily dose of 0.17 mg/kg.

The clearance of objects weighing on average 45 kg is 23.7 l/h and 17.6 l/hour respectively in men and women. This area is similar to the announced estimates of 24.8 l/hour in adults 70 kg. The average distribution volume for a 45 kg patient is 1130 l (25.11 l/kg).

Observing the effect on blood pressure is maintained throughout the 24 -hour dose, with a small difference of variable effects at the top and bottom. When compared to the existing information about pharmacokinetics in adults, these research parameters show that the one -time daily dose is appropriate.

Before taking Amlodipin 5mg Domesco medicine treats hypertension, angina (3 blisters x 10 tablets)

How to use

amlodipine 5 mg oral.

Dosage

Adults

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

In patients with hypertension, amlodipine has been used simultaneously with thiazid diuretics, alpha blockers, beta blockers or angiotensin -shaped enzyme inhibitors.

For angina, amlodipine can be used in monomers or simultaneously with other anti -angina drugs in patients with angina resistant to nitrate derivatives or appropriate beta blockers.

There is no need to adjust the amlodipine dose in case of simultaneous use with thiazid diuretics, alpha blockers, beta blockers or angiotensin -shift enzyme inhibitors.

Special subjects:

Elderly

The ability to tolerate elderly and young patients is the same when using the same amlodipine dose. The usual dose is recommended for the elderly, so it should be cautious when increasing the dose (see the warning and caution when taking drugs and pharmacokinetic properties).

Patients with impaired liver function

recommended dose has not been set in patients with mild to medium liver failure. Therefore, you should choose the dose carefully and the treatment begins with the lowest dose effectively.

Amlodipine pharmacokinetic properties have not been studied in cases of severe liver failure. Should start using amlodipine from the lowest dose and increasing slowly in patients with severe liver failure.

Patients with renal failure

Change amlodipine concentration in plasma is not related to the level of renal failure. Therefore, the usual dosage recommendations. Amlodipin cannot be appraised.

Children and teenagers

Children and teenagers from 6 to 17 years old with hypertension: The initial dose of anti -hypertension is recommended in children from 6 to 17 years old is 2.5 mg once a day, then can be increased to 5 mg once a day if the desired blood pressure has not been achieved after four weeks. Doses higher than 5 mg once daily have not been studied in children. Amlodipine dose is not divided by 2.5 mg for this form of preparation, the proposal to use other cell format has the appropriate content.

Children under 6 years old: No data.

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?

Existing data suggests that large -scale overdose can cause peripheral vessels and may be accompanied by tachycardia. There is a report on strong hypotension, prolonged and including death shock.

How to handle overdose drugs

Amlodipine absorption decreases significantly when indicating activated carbon right after or within 2 hours after taking Amlodipin 10 mg in healthy volunteers. In some cases, the stomach may need.

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

Can use a vasoconstrictor to recover blood vessels and blood pressure, as long as the patient does not have contraindicated use of the drug.

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

What to do when you forget a dose? 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

Unwanted effects (ADR) when using amlodipin 5 mg that you may encounter.

Common

Headache, dizziness, sleeping chicken. Blushing face.

Abdominal pain, nausea. Phu, tired.

less common

leukopenia, thrombocytopenia.

Hyperglycemia. nose. Men, erectile dysfunction. Weakness, discomfort, pain.

Rare

Rare allergic reactions including itching, skin rash, angioedema and diverse roses. There are several serious cases that need to be hospitalized, which have been reported regarding the use of amlodipine. In many cases, the causal relationship between the unwanted effects mentioned above and the use of amlodipine is unclear.

Instructions on how to handle ADR

Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

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

Contraindicated

Contraindicated use of amlodipine in the following patients:

Sensitive to dihydropyridin, amlodipine or any ingredients of the drug.

Caution when using

used in patients with heart failure

In a long-term study of placebo-verified (Praise-2 Research) using amlodipine in patients with heart failure due to anemia, III and IV according to the New York Heart Association's classification (NYHA), Amlodipin is reported to be related to the increase in pulmonary edema ratio.

However, there is no significant difference in the proportion of patients with heart failure more serious in the amlodipine group compared to the placebo group (see the pharmacological properties section).

Used in patients with impaired liver function

Like all other calcium channel blockers, Amlodipine's waste time is prolonged in patients with liver function impairment and recommended doses for these patients have not been set up. Therefore, Amlodipin needs to be used cautiously in these patients.

Pills containing starch, patients allergic to flour (except for coeliac) should not use this drug.

The ability to drive and operate machinery

amlodipine may have a slight or medium impact to the ability to drive, operate machinery. If the patient uses amlodipine dizziness, headache, fatigue or nausea, their reaction ability may be impaired. Patients need to be carefully warned, especially from the beginning of treatment.

Pregnancy

Amlodipine safety in pregnant women has not been set. 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 dose for maximum use in humans.

Therefore, Amlodipine should only be used during pregnancy when there is no safer replacement and when the disease itself contains greater risks for mothers and embryos. There is no effect on the ability to conceive on mice using amlodipine.

Lactation period

The safety of amlodipine in breastfeeding women has not been set. Experience used on humans shows that Amlodipin has passed through breast milk.

Amlodipine median concentration ratio in milk/plasma in 31 women who are breastfeeding with hypertension due to pregnancy is 0.85 after using amlodipine at the starting dose of 5 mg once daily, this dose is adjusted if needed (average daily dose and daily dose in weight 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

Simvastatin

Use multiple doses of 10 mg amlodipine simultaneously with 80 mg of simvastatin increases 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 pharmacokinetics of Amlodipine.

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

CYP3A4 inhibitors

Simultaneously use 180 mg of diliazem daily dose with 5 mg of amlodipine in the elderly (69 - 87 years old) with hypertension increases 57 % of the system exposure rate with amlodipine.

Concentrated with Erythromycin on healthy volunteers (18 - 43 years old) does not significantly change the system exposure rate with amlodipine (an increase of 22 % under the curve under the curve of the blood concentration of blood drugs over time [AUC]).

Although clinically related to these studies is not sure, the pharmacokinetic change may be more pronounced in the elderly patients. Strong inhibitors CYP3A4 (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

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 amlodipine. Simultaneous use with CYP3A4 induction substances (such as rifampicin, hypericum perforatum) can reduce amlodipine levels in plasma.

Should be cautious when using amlodipine along with CYP3A4 induction substances. In the following studies, there is no significant change in pharmacokinetics of amlodipine or other drugs in the study when used in combination.

Special studies: The effect of other drugs on amlodipin

cimetidine

Simultaneous use amlodipine and cimetidine does not change the pharmacokinetics of amlodipine.

Aluminum/Magnesi salt (stomach acid neutralization)

Concentrated use of antacids is aluminum salt and magnesium salt with a single dose of amlodipine does not significantly affect the pharmacokinetics of Amlodipin.

Sildenafil

Use a single dose of 100 mg of Sildenafil in objects with idiopathic hypertension does not affect the pharmacokinetic parameters of Amlodipin. When used in combination with amlodipine and sildenafil, each drug has its own lowering effect.

Special studies: The effect of amlodipine on other drugs

Atorvastatin

Simultaneously use 10 mg of amlodipine with 80 mg Atorvastatin does not significantly change the pharmacokinetic parameters of Atorvastatin in a stable concentration state in plasma.

digoxin

Simultaneous use of amlodipine with digoxin does not change the concentration of digoxin in plasma or the renal clearance of digoxin in healthy volunteers.

Ethanol (alcohol)

Use single -dose or multi -dose 10 mg of amlodipine does not significantly affect the pharmacokinetics of ethanol.

warfarin

Simultaneous use amlodipine with warfarin does not change the time of prothrombin inhibitors of warfarin.

cyclosporin

There is no study of drug interaction between cyclosporin and amlodipine in healthy volunteers or other groups of subjects except for kidney transplant patients. Different studies in kidney transplant patients show that simultaneous use of amlodipine with cyclosporin affects the bottom concentration of cyclosporin from unchanged to an average increase of 40 %. Consider to monitor cyclosporin levels in kidney transplant patients using amlodipine.

tacrolimus

There is a risk of increased blood tacrolimus concentration when used simultaneously with amlodipine. To avoid the toxicity of tacrolimus, when using amlodipine in patients treated with tacrolimus, the blood tacrolimus concentration must be monitored and adjust the dose of Tacrolimus if appropriate.

Mechanical goals of Rapamycin inhibitors (MTOR)

Mtor inhibitors such as syrolimus, temsirolimus, and Everolimus are CYP3A substrate. Amlodipine is a weak CYP3A inhibitor. When used simultaneously with MTor inhibitors, Amlodipine may increase the exposure of MTor inhibitors.

Interactions between drugs and biochemical tests

Not known.

Storage

Store in a dry place, avoid light, temperatures below 30 ° C.

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