Drugs TV.amlodipin 5mg TV.Pharm treat hypertension, chronic stable angina (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Amlodipine

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

indications

TV.amlodipin drug indicated in the following cases:

Hypertension

Amlodipine is a calcium ionic blocker (slow channel blockers or calcium ion opposites) and inhibits calcium ions through cell membranes into plain 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 post -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 clinical decrease in the clinical position in both the lying position and standing throughout 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 1mm 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, gout.

used in patients with coronary artery disease

The effects of amlodipine on the rate of disease and death rate due to cardiovascular disease, the development of coronary atherosclerosis and atherosclerotic atherosclerosis are studied in the advanced test, randomly assess the effects of NorvaSC on the circuit system (Prevent research).

Multi -central research, random, double blindness, controlled with this placebo monitoring 825 patients with coronary artery disease (CAD) is determined by coronary angiography within 3 years. The research complex includes patients who have a history of myocardial infarction (45%) (45%), shaped the skin through the skin (percutaneous transluole, angioplasty (PTCA) at the initial examination (42%), or a history of angina (69%). The severity of coronary artery disease (CAD) is in the range of 1 artery branch (45%) to over 3 artery branches (21%). Patients with uncontrolled hypertension (diastolic blood pressure [DBP]> 95 mmHg) are excluded from research.

The main cardiovascular events are evaluated by a council with sealed evaluation criteria. Although there was no clear impact on the progression of coronary artery lesions, Amlodipin has prevented the progression of the membrane in the pulse thickening. Amlodipin treated patients are observed significantly reduced (-31 %) on the combination assessment criteria including death from cardiovascular disease, eyelashes, stroke, PTCA, coronary artery surgery (CABG), hospitalized due to unstable angina and serious congestive heart failure (CHF). Also observed that the rate of re-vascular procedures (PTCA and CABG) significantly decreased (-42%) in patients treated with amlodipine. Cases of hospitalization due to unstable angina (-33%) in patients treated with amlodipine compared to the placebo group.

The effectiveness 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 restraint with a placebo over 1997 patients, comparing amlodipine with enalapril in limiting the appearance of block blood embolism (camelot). Among these patients, 663 people are treated with amlodipine 5 mg to 10 mg and 655 patients treated with placebo, in addition to standard treatments including statin drugs, β-adrenergic receptor inhibitors, diuretics and aspirin, within 2 years.

Dynamic pharmacokinetics

After taking treatment doses, Amlodipine 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 21L/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. Amlodipin's plasma semi -discharged time ranges from 35 to 50 hours and is suitable for the daily dosage daily. The concentration of the constant state in plasma is achieved after 7 to 8 days of continuous medication. Amlodipine is metabolized in liver into liver into non -active metabolites, with 10% of the original substance and 60% of the metabolic substance eliminated through the urine.

used with the elderly

Time to reach the peak concentration of amlodipine plasma 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 evil in the age group.

used in children

In a long -term clinical study, 73 patients with hypertension from 12 months of age to less or 17 years of age are used amlodipine with an average of 0.17 mg/kg daily. The bar in the average weight of 45 kg is 23.7 l/hour 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 70kg. The average distribution integral for a 45kg 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 the variable effect at the top and the bottom. When compared to the existing information about pharmacokinetics in adults, the observed parameters in this study show that the one -time daily dose is appropriate.

Before taking Drugs TV.amlodipin 5mg TV.Pharm treat hypertension, chronic stable angina (3 blisters x 10 tablets)

How to use

TV.amlodipin oral and non -meal.

Dosage

adults:

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

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 at the same time with other anti -angina drugs on patients with angina resistant to nitrate derivatives and/ 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 the elderly and young people is the same when using the same amlodipine dose. The usual dose is recommended for the elderly and should be cautious while increasing the dose (see the warning and caution when used and pharmacokinetic properties).

Patients with impaired liver function

The recommended dose has not been repeated in patients with mild to moderate liver failure: Therefore, the dose should be careful and the treatment starts with the lowest doses effectively (see the warning and cautious section when used and pharmacokinetic properties). Amlodipine pharmacokinetic properties have not been studied in severe liver failure. Should start using amlodipine from the lowest doses and increasing slowly in patients with severe liver failure.

Patients with renal failure

Change amlodipine concentration in plasma is not related to the degree of renal failure: Therefore, the recommendation of the usual dosage. Amlodipin cannot be separated

Children and teenagers

Children and teenagers from 6 to 17 years old with hypertension:

The oral hypertension starting dose is recommended in children from 6 to 17 years old, 2.5 mg once a day, then may be increased to 5mg once a day if the desired blood pressure has not been achieved after four weeks. The doses higher than 5mg once daily have not been studied in children.

It is not possible to divide the amlodipine 2.5 mg dose for this form of preparation, proposing the use of amlodipin 5mg instead. Amlodipin 5mg tablets can be divided in half to provide 2.5mg dose.

Read the instructions carefully before use.

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 do

do when overdose? There is a report on the drop of blood pressure, may be prolonged and including death shock.

Amlodipine absorption is significantly reduced 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. In cases of severe hypotension due to the use of amlodipine overdose, positive cardiovascular support measures should be taken, including regular monitoring of cardiovascular and respiratory functions, high limbs and attention to circulatory volume and urine. A vascular medication can be used to restore blood vessel tone and blood pressure, as long as the patient does not have the contraindication to use the drug. Calcium gluconate intravenous injection can be reversed 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.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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

amlodipine is well tolerated, in clinical studies verified by placebo in patients with hypertension or angina, the most unwanted effect is:

Nervous system disorders: headache, dizziness, sleeping chicken. Often clinical significance on biochemical results related to amlodipine.

Unwanted effects are less commonly recorded after the drug is brought to the market including:

Blood disorders and lymph nodes: leukopenia, thrombocytopenia. Visual disorders: visual impairment. Allergy includes 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.

As with other calcium channel blockers, the following adverse effects are rarely reported and cannot be distinguished from the natural process of diseases: myocardial infarction, arrhythmia (including slow rhythms, ventricular tachycardia and atrial fibrillation) and chest pain.

Children (6 - 17 years old):

Amlodipin tolerates well in children. These unwanted effects are similar to the unwanted effects to see in adults. In a study with 268 children, the most unwanted effects are:

Nervous system disorders: headache, dizziness

vasodilic disorders: vasodilation. Serious unwanted effects (mainly headache) are observed in 7.2% of patients using amlodipine 2.5mg; 4.5% use amlodipine 5mg and 4.6% placebo. The most common reason for stopping participating in research is uncontrolled hypertension. There is no case of stopping participating in any research related to abnormal test results. There is no significant change in heart rate.

Notify the physician the unwanted effects when using the drug.

Warnings

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

Contraindicated

TV.amlodipine drugs contraindicated in the following cases:

Contraindicated using amlodipine in the following patients:

sensitive to dihydropyridine, amlodipine or any ingredients of the drug. Hemodynamic is not stable for acute myocardial infarction.

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 (New York Heart Association-nhya), Amlodipin is reported to be related to the increase in lung edema. However, there is no significant difference in the proportion of patients with more severe heart failure in the amlodipine group than the placebo group (see the pharmacological properties section).

Used for patients with impaired liver function

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

The effect of the drug on driving and operating machinery

amlodipine may have a slight or medium impact on the ability to drive and 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.

Using drugs for women during pregnancy and lactation

Amlodipin's safety in pregnant and lactating women has not been established. Amlodipine is not toxic in animal reproductive studies, except for slowing labor and prolonging the rat time at a dose of 50 times higher than the recommended dose for maximum use in humans. Therefore, it is recommended to use amlodipine during pregnancy when there is no safer replacement measure 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.

Experience used on humans shows that Amlodipin has passed through breast milk. The rate of median concentration of amlodipine in milk/plasma in 31 women who are breastfeeding with high blood pressure due to pregnancy is 0.85 after using amlodipine at the starting dose of 5mg once a day, this dose is adjusted if needed (average daily dose and daily dose in weight are 6mg and 98.7 mcg/kg). The estimated daily dose of Amlodipin that babies receives through breast milk is 4.17 mcg/kg.

Drug interaction

Amlodipin has been shown to be safe to use with thiazid diuretics, α-adrenergic receptor inhibitors, β-adrenergic receptor inhibitors, ACE inhibitors, long-lasting nitrats, nitroglycerin under the tongue, non-steroid anti-inflammatory drugs, antibodies and antibiotics Blood.

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

Use multiple doses of 10mg of Amlodipine simultaneously with 80mg of simvastatin increases 77% of exposure rate with simvastatin compared to only simvastatin. For patients with amlodipine, the dose limit of simvastatin is 20mg/day.

CYP3A4 inhibitors

Simultaneously use 180mg of diltiazem daily doses with 5mg of amlodipine in the elderly (69-87 years old) with hypertension increases 57% of the system exposure rate with amlodipine. Simultaneously used with erythromycin on healthy volunteers (18-43 years old) does not significantly change the system exposure rate with amlodipine (up 22% of the area under the curve of the pathway of blood drug concentration over time [AUC]). Although clinically related to these studies is not sure, the pharmacokinetic change may be more pronounced in the elderly patients.

Strong CYP3A4 inhibitors (such as ketoconazole, iTraconazole, ritonavir) may increase the level of amlodipine in the blood than 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 touch substances.

In the following studies, there is no significant change in pharmacokinetics of amlodipine or of drugs in the study when used in combination.

Special studies: Effect other drugs on amlodipin

cimetidine: simultaneously use amlodipine and cimetidine does not change the pharmacokinetics of amlodipin

Aluminum/Magnesi salt (stomach acid neutralizing drugs): Concomitant use of antacids is aluminum salt and magnesium salt with a single dose of amlodipine does not significantly affect Amlodipin pharmacokinetics.

Sildenafil: Use a single dose of 100mg 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: Concomitance of 10mg of Amlodipin with 80mg atorvastatin does not significantly change the pharmacokinetic parameters of Atorvastatin in a stable concentration state in plasma.

digoxin: simultaneously use 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 10mg of amlodipine does not significantly affect the pharmacokinetics of ethanol.

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

Cyclosporin: There are no studies on drug interaction between cyclosporin and amlodipine in healthy volunteers or other groups of objects 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 concentration in the blood 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 Rapamvcin inhibitors (MTOR)

MTor inhibitors such as syrolimus, temsirolimus and Everolimus are CYP3A. 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: unknown.

Storage

Store in a dry place, the temperature does not exceed 30 ° C, avoiding light.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.