Amlor 5mg tablets viatris treat hypertension, angina (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Amlodipine
Ingredient Coronary artery disease, high blood pressure, angina

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

Indications

Amlor 5 drugs are indicated in the following cases:

Hypertension treatment

Amlodipin is indicated for the first treatment in hypertension and can be used alone to control blood pressure in most patients. Patients who do not have a good response to another former hypertension (apart from amlodipine) may have a better response when adding amlodipine, used in combination with thiazid diuretics, α receptor inhibitors, β receptor inhibitors or angiotensin transferring enzymes.

Hypotension helps reduce the risk of death or non -fatal cardiovascular events, mainly stroke and myocardial infarction. These benefits have been observed in the control tests of drugs for hypertension in various pharmacological subgroups including Amlodipine Besilat tablets.

Treatment of coronary artery disease

Amlodipine is indicated to reduce the risk of coronary artery recurrence and the need for hospitalization due to angina in patients with coronary artery disease.

Treatment of chronic stable angina

Amlodipin is indicated for the first treatment in myocardial ischemia, or due to a fixed obstruction (stable angina) and/or or due to the spasm of coronary artery (Prinzmetal angina or a variable angina). Amlodipine can be used even when only clinical symptoms suggest the possibility of vasodilation, although it has not been able to confirm whether or not there is a circuit spasm. Amlodipine can be used alone as single therapy, or coordinated with other anti -angina drugs in patients with angina that has been resistant to nitrate and/or with receptor inhibitors that have sufficient doses.

Pharmacokological

amlodipine is a calcium ionic blocker (slow channel blockers or calcium ion opposites) and inhibit calcium ionic flow through cell membranes into myocardial cells and vascular smooth muscles.

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 consumption and oxygen needs of the heart muscle. This vasodilation increases the supply of oxygen to the heart muscle in patients with coronary artery spasms (Prinzmetal angina or turbulent angina) and reduces smoking coronary spasms. Due to the slow starting characteristic, Amlodipine avoids the drop in blood pressure when used.

In patients with angina, one day/day amlodipine increases the overall exertion time, the starting time of angina and the ST segment time to 1 mm, reducing the frequency of angina and reducing the amount of nitroglycerin to be used.

Amlodipine is not related to any adverse effects on metabolism or changes in blood lipids and is suitable for use in patients with asthma, diabetes and gut (gout).

Used in patients with coronary artery disease (CAD)

The effect of amlodipine on the incidence and mortality due to cardiovascular disease, the progression of coronary atherosclerosis and carotid arteries have been studied in the advanced assessment test, random impact on the blood vessels of Norvasc (PFIZER AMLOR® - USA) (Prevent research).

Multi -central research, random, double blindness, with this placebo, including 825 CAD patients are determined by coronary angiography in 3 years:

The group of researchers includes patients who have a history of myocardial infarction (Mi, 45%), patients who have given coronary artery through the skin (PTCA) at the first examination (42%), or patients who have a history of angina (69%). The severity of coronary artery disease is classified from 1 affected blood vessel (45%) to 3 or more blood vessels affected (21%). Cardiovascular events are assessed by a council with sealed evaluation criteria. Although there is no clear impact on the progression of coronary lesions, Amlodipin restrains the progression of the middle of the media. Coronary sphere surgery, hospitalized due to unstable angina and congestive heart failure (CHF). Cases of hospitalization due to unstable angina (-32%) in patients treated with amlodipine compared to the placebo group.

The effectiveness of amlodipine in preventing clinical events in patients with coronary artery disease (CAD) has been assessed in an independent, multi -central, random, double -blind study in 1997 patients:

This study compares amlodipine and enalapril in limiting the camelot (Camelot). The main results of the effectiveness of the drug are presented in Table 1.

Table 1: The proportion of clinical results is significant in Camelot test.

Camelot

Clinical results n (%) Amlodipin (n = 663) placebo (n = 655) Reducing risks (value P)

Criteria for assessment of cardiovascular evaluation*

151 (23,1) 31% (0.003)

84 (128)

42% (0.002)

103 (15,7)
27% (0.033) What is the peripular disassus (PVD) in patients who have never been diagnosed with peripheral vascular disease or any treatment for peripheral vascular disease.

2) Cardiovascular assessment criteria (Cardiovascular, CV) are the main evaluation criteria in Camelot research.

Treatment to Prevent Heart Attack Trial (Allhat)

A random study, double the incidence of the disease - The mortality rate called the test of hypertension treatment and hypadoculation of blood lipids to prevent heart attack (Allhat) has been done to compare newer drug use therapies:

Amlodipine 2.5 mg/day to 10 mg/day (Calcium channel blockers) or Lisinopril 10 mg/day to 40 mg/day (Move inhibitors) are used as their first therapy compared to thiazid diuretics, chlorthalidone 12.5 mg/day to 25 mg/day in medium and mild hypertension patients.

A total of 33357 patients with hypertension aged 55 and older are randomly selected and monitored for an average time of 4.9 years. HDL-C

The main evaluation criterion is the combination of coronary artery disease (CHD) death and myocardial infarction (MI) without death. 95% CI (0.90-1.07]; P = 0.65.

Hemodynamic studies and controlled clinical trials, based on exertion activity in patients with heart failure from degree IV to level IV as classified by NYHA (New York Heart Association), has shown that Amlodipine does not cause clinical decline, measured by the ability to tolerate exertion activities, left blood loss and clinical symptoms.

A place of placebo-controlled control (Praise research) is designed to evaluate patients with heart failure III-IV according to NYHA's classification, being treated/ with Digoxin, diuretics, and volume inhibitors, showing that amlodipine does not increase the risk of death or the rate of combined death and disease in heart failure patients.

In a long-term study with the subsequent place to control the placebo (research Praise-2) using amlodipine in patients with heart failure III and IV as classified by NYHA:

These patients do not have clinical symptoms or have objective test results that suggest potential ischemia and are taking stable doses of enzyme inhibitors, Digitalis heart and diuretics, the results show that amlodipine does not affect the total mortality or the mortality rate due to cardiovascular diseases Amlodipin's effectiveness in hypertension patients aged 6 to 17 has been shown in a random study, double blind, 8 weeks, with a place of placebo on 268 patients with hypertension:

All patients are randomly indicated in the 2.5 mg or 5 mg treatment group and monitored for 4 weeks, and then randomly selected to continue using 2.5 mg or 5 mg amlodipine or placebo for the next 4 weeks. In case of placebo, the average decrease in the sitting posture is 5.0 mmHg with amlodipine dose of 5 mg and 3.3 mmHg with the dose of 2.5 mg amlodipine. Learning

absorption

After taking the doses of cavalry, Amlodipin is well absorbed with the peak concentration in plasma reaching about 6 to 12 hours after drinking. Absolute bioavailability is estimated at 64 - 80%. The distribution volume is approximately 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/excretion

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

Amlodipine is metabolized mostly in the liver into non -active metabolites with 10% of the original substance and 60% of metabolites are excreted in the urine.

Used in 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 also increases in patients with congestion heart failure (CHF).

Use in children

In a regular approach clinical study:

73 Pediatric patients from 12 months of age until younger or 17 years old with hypertension using average amlodipine per day is 0.17 mg/kg. This clearance is also within the same limit as the assessment announced in the 70 kg adult adults is 24.8 l/hour. When compared to pharmacokinetics in adults, the parameters in this study show that the one -time daily dose is appropriate.

Before taking Amlor 5mg tablets viatris treat hypertension, angina (3 blisters x 10 tablets)

How to use

Oral drugs.

Dosage

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

For patients with coronary artery disease, the recommended dose is 5 mg to 10 mg once a day. Clinical studies show that most patients need a dose of 10 mg (see pharmacokinetic section - used in patients with coronary artery disease).

There is no need to adjust the amlodipine dose in case of simultaneous use with thiazid diuretics, beta inhibitors or angiotensin transferring enzymes inhibitors.

Used in the elderly

Should be used in normal dose. When the dose of amlodipin is the same for both elderly and young patients, observing the drug has the same ability to tolerate the same in both age groups.

Use in children

Dosage to treat oral hypertension in patients from 6 to 17 years old is 2.5 mg to 5 mg once a day. The dose exceeds 5 mg daily has not been studied in pediatric patients (see the pharmacokinetic section and pharmacokinetics section).

It is unknown the effect of amlodipine on blood pressure on patients under 6 years old.

Used in patients with impaired liver function

Please see the warning and prudent section especially when used.

Used in patients with renal failure

Can use amlodipine with normal doses for patients with renal failure. The change of amlodipine concentration in plasma is not related to the level of renal failure. Amlodipin cannot be separated.

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

Amlodipine absorption decreases significantly when indicating activated carbon at that time 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 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 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, dialysis does not bring results in this case.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

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

Amlodipin is well tolerated, in clinical studies verified by placebo -hypertension patients or angina.

The most unwanted effect is:

Nervous system disorders: headache, dizziness, sleeping chicken.

Pleetal disorders: flushed face.

Dehydration of the digestive system: abdominal pain, nausea.

Systemic and local disorders: edema, fatigue.

In these clinical studies, there is no clinical abnormalities on Amlodipin -related biochemical test results.

Blood disorders and lymphatic systems: leukopenia, thrombocytopenia.

Metabolic and nutrient disorders: Hyperglycemia In: Tinnitus.

Vascular disorders: Hypotenosis, vascular inflammation.

Respiratory disorders, chest and mediastinum: cough, shortness of breath, rhinitis

Disorders of musculoskeletal and connective tissue: joint pain, back pain, muscle contraction, muscle pain.

Kidney and urinary disorders: urinating, urinating disorders, urinating at night.

Reproductive and breast disorders: Big breasts in men, erectile dysfunction.

Testing/measurement index: weight loss/weight loss.

hepatitis, jaundice and increased liver enzymes have also been reported at a very small rate (mainly accompanied by biliary obstruction). 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.

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

Pediatric patients (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. Serious unwanted effects (mainly headache) are observed in 7.2% of patients using amlodipine 2.5 mg, 4.5% use amlodipine 5 mg and 4.6% placebo. The most common reason for stopping the study is uncontrolled hypertension. There is no case of stopping participating in the research due to an abnormal test. There is no significant change in heart rate.

Instructions on how to handle ADR

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

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

Contraindicated

Amlor 5 contraindications in the case:

For patients with a history of hypersensitivity to dihydropyridine, or any ingredients of the drug.

Precautions for use

Use in patients with heart failure

In a long -term research with placebo (Praise - 2) 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 severe heart failure in the amlodipine group compared to the placebo group (see the pharmacological 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 carefully in these patients.

The ability to drive and operate machinery

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

Pregnancy

Amlodipin's safety in pregnant 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 dose for 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 impact on the fertility of rats treated with amlodipine.

Breastfeeding period

The safety of amlodipin in breastfeeding women has not been set.

Drug interaction

amlodipin has been shown to be safe to use with thiazid diuretics, alpha receptor inhibitors, beta receptor inhibitors, angiotensin (ACE) transferring enzymes (ACE), long -lasting nitrats, nitroglycerin lingers under the tongue, anti -inflammatory drugs, antibiotics Drink.

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

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 Amlodipin's pharmacokinetics. This research does not allow the test of the effects of genetic diversity of CYP3A4, the main enzyme is responsible for transforming amlodipine; Therefore, it should not be used amlodipine with grapefruit or grapefruit juice because bioavailability can increase in some patients leading to increased hypotension.

CYP3A4 inhibitors

Simultaneously use 180 mg daily dose of diltiazem with 5 mg of amlodipine for 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 exposure rate of system infection with amlodipine (up 22% under the curve under the curve of blood concentration of blood drugs over time [AUC]). Although clinically related to these studies is not sure, pharmacokinetic changes can be notified more in 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 the concentration of amlodipine in the blood. Should be cautious when using amlodipine along with CYP3A4 induction substances.

In the following studies, there are no significant changes in pharmacokinetics of amlodipine or other drugs in the study when used in combination.

Special studies: The effect of other drugs on amlodipin

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

Aluminum/Magnesi salt (antacids): Concomitance of antacids is aluminum and magnesium salt with a single dose of amlodipine does not significantly affect the pharmacokinetics of amlodipine.

Sidenafil: Use a single dose of 100 mg of Sildenafl in objects with idiopathic hypertension without affecting amlodipine pharmacy parameters. When using Amlodipin and Sildenafl combination, each drug has its own antihypertensive effect.

Special studies: The effect of amlodipine on other drugs

Atorvastatin: simultaneously using 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: 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 10 mg 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 for patients being treated with tacrolimus, the blood concentration should be monitored in the blood and adjust the tacrolimus dose when appropriate.

Interactions between drugs and biochemical tests: unknown.

Storage

Store less than 30 ° C, avoid moisture.

Expiry date: 24 months from the date of production.

Do not use overdue drugs indicated on the packaging.

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