Amlor 5mg medicine viatris 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
Amlor drugs contain amlodipine active ingredients, which belong to a group of drugs called calcium antagonists.
Amlodipin is used to treat high blood pressure (hypertension) or a chest pain called angina, a rare form of this type of condition is Prinzmetal angina or angina.
In patients with high blood pressure, this drug works by relaxing blood vessels, making it easier to pass through. In patients with angina, amlodipine works by improving blood supply to the heart muscle, so that the heart muscle will receive more oxygen and resulting in avoiding chest pain. This drug does not help relieve chest pain immediately due to angina.
Pharmacokology
amlodipine is a calcium ionic blocker (slow channel blockers or calcium ion opposites) and inhibiting calcium ionic current through cell membranes 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 post -burden). Because the heart rate does not change, this burden reduces the heart to reduce energy 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 clinical pressure in both lying and standing throughout the dose of 24 hours. 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 asthma, diabetes and gout .
Used in patients with coronary artery disease
The effects of amlodipine on the rate of disease and mortality due to cardiovascular disease, the development of coronary atherosclerosis and atherosclerotic atherosclerosis are studied in salvage tests, randomly assessing the effects of Norvasc on the circuit system (Prevent research). Multi -central research, random, double blindness, control 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 (Mi) (45%), shaping the skin through the skin (percutaneous Transluminal Coronary 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 the criteria kept tight. Despite the clear impact on the progression of coronary artery damage, Amlodipin has prevented the progression of the membrane in the circuit that is thickened. 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 carrying out the vascular re-procedure (PTCA and CABG) decreased significantly, (-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, control, fuel study with 1997 patients, comparing Amlodipine with Enalapril in limiting the appearance of block blood embolism (Camelot). Among these patients, 663 people are treated with amlodipin 5mg to 10mg and 655 patients treated with placebo, in addition to standard treatments including statin drugs, β-adrenergic receptor inhibitors, diuretics and aspirin, within 2 years. The main results of the effectiveness of the drug are presented in Table 1. The results show that amlodipine treatment is associated with reducing cases of hospitalization due to angina and a trick to re -vasoconstrictor in patients with coronary artery disease.
Table 1. The clinical results are significant of Camelot study
51 (7,7)
78 (11,8)
(n = 655)
151 (23,1)
84 (12,8)
103 (15,7)
(P)
31% (0.003)
42% (0.002)
27%)
27%) (0.033) A transient local (ray), any diagnosis of peripheral vascular diseases (PVD) in patients who have never been diagnosed with PVD or any cases of hospitalization for PVD treatment.
Cardiovascular assessment criteria (CV) is the main evaluation criterion for the effectiveness of Camelot research.
A random study, double the rate of disease and death rate called testing for hypertension and reducing blood lipids to prevent myocardial infarction (Allhat) has been done to compare newer drugs: amlodipine 2.5mg/day, up to 10mg/day (Calcium channel blockers) or Lisinopril 10mg/day to 40mg/day to be used as a ACE) Thiazid chlorthalidon diuretics 12.5mg/day to 25mg/day in mild to moderate hypertension cases.
A total of 33357 patients with hypertension aged 55 and above are randomly distributed and monitored for an average time of 4.9 years. Patients with at least an additional risk factor for coronary disease (CHD), including eyelashes or stroke in> 6 months or have recorded records of atherosclerotic diseases (CVD) (total 51.5%), diabetes type 2 (36.1%), Lipoprotein - C high density (HDL -C)
The main evaluation criterion is the combination criteria including coronary artery disease (CHD) that is fatal or lashes without death. There is no significant difference on the main target between amlodipine therapy and chlorthalidon -containing therapy: RR, 0.98; 95% CI [0.90 - 1.07], P = 0.65. In addition, there is no significant difference in the mortality rate due to all causes between Amlodipine and chlorthalidon -containing therapy: RR 0.96; 95% CI [0.89 - 1.02], P = 0.20.
Used in patients with heart failure
Hemodynamic studies and controlled clinical trials based on exertion tests in patients with heart failure II-IV according to Nhya show that amlodipine does not lead to clinical decline, based on the ability to withstand exertion activities, blood emulsion of left ventricular ventricular and clinical symptoms. A place for a place to control the use of a praise (praise) designed to evaluate patients with heart failure III-IV according to NYHA using digoxin, diuretics and ACE inhibitors show that amlodipine does not lead to an increase in 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 long-term monitoring (praise-2) on amlodipine in patients with heart failure III and IV according to NYHA without clinical symptoms or without objective results suggesting potential ischemic anemia, with stable dose of ACE inhibitors, heart failure, and diuretic, non-death rate or death rates. On the top of this research complex, Amlodipine is related to the increase in 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.
pharmacokinetic
absorption
After taking treatment doses, Amlodipin is well absorbed with peak concentration in plasma reaching about 6 to 12 hours after drinking. Absolute bioavailability, 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/excretion
Amlodipin's plasma semi -discharged time is from 35 to 50 hours and 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 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 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, the area under the curve (AUC) and the selling time in elderly patients. Area under the curve and time, semi -discharged in patients with congested heart failure (CHF) also increased as expected in the age group.
Before taking Amlor 5mg medicine viatris treats hypertension, angina (3 blisters x 10 tablets)
How to use
Take the tablet with a glass of water. Regardless of meals.
Dosage
For hypertension and angina, the normal starting dose is 5mg of amlodipine once a day, which can increase to a maximum dose of 10mg once a day depending on the response of each patient.
For patients with coronary artery disease, the recommended dose is 5mg to 10mg once a day. Clinical studies show that most patients need a dose of 10mg (see the pharmacokinetic properties - used in patients with coronary artery disease).
There is no need to adjust the amlodipine dose in case of simultaneous use with thiazid diuretics, receptor inhibitors β-adrenergic or ACE inhibitors.
Used in the elderly
Should be used in normal dose. Using amlodipin is the same risk for both elderly and young patients, showing that the drug has good tolerance in both age groups.
Used in patients kidney 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 right after or within 2 hours after taking Amlodipin 10mg 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.
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, the appraisal does not bring results in this case.
What to do when forgetting 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 Amlor 5, you may experience unwanted effects (ADR).
amlodipine is well tolerated, in clinical studies verified by placebo in patients with hypertension or angina, the most unwanted effect is:
circuit disorders
hearing and internal hearing disorders
hepatitis, jaundice and liver enzyme has also been reported at a very small rate (mainly accompanied by biliary obstruction). There are several severe 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.
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:
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
This drug is only used by a doctor. Before using the drug, you need to read the user manual carefully and refer to the information below.
Contraindicated
Amlor 5 contraindications in the following cases:
Precautions for use
Use 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 (NYHA), amlodipine is reported 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 than the placebo group (see the pharmacological characteristics).
Used in patients 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.
The ability to drive and operate machinery
Amlodipin can be slightly or moderate to 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.
Pregnancy and nursing mothers
Amlodipin 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.
Pre -clinical safety data
The ability to cause cancer, mutations and decline in reproductive function
There is no sign of cancer in rats and mice treatment with amlodipine in a 2 -year diet, with a computing concentration so that the daily dose level is 0.5; 1.25 and 2.5 mg/kg/day. The highest dose (in mice and similar to mice is double* clinical dose of a maximum of 10mg on a unit of mg/m2) close to the total dose tolerated with mice but not for mice.
Studies on mutant possibilities show that the drug does not affect the genome or chromosomes.
There is no effect on the reproductive function of mice using amlodipin (64 -day male mice and female mice use 14 days before mating) at a dose of up to 10 mg/kg/day (8 times* Maximum dose indicated for humans, 10mg on a unit of mg/m2).
*Based on the body weight 50kg.
Drug interaction
Amlodipin has been shown to be safe for thiazide diuretics, α -adrenergic receptor inhibitors, receptor inhibitors β - adrenergic, ACE inhibitors, long -lasting nitrats, nitroglycerin under the tongue, antibiotics hypoglycemia.
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 20 mg/day.
Grapefruit juice
Simultaneous use 240ml of grapefruit juice with a single dose of 10mg of amlodipine in 20 healthy volunteers does not significantly affect Amlodipin's pharmacokinetics. This study did not allow the test of the influence of the genetic form of CYP3A4, the main enzyme responsible for transforming amlodipine, so it should not be used amlodipine along with grapefruit or grapefruit juice because bioavailability may increase in some patients leading to increased hypotension.
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. Simultaneous use with Erythromycin on healthy volunteers (18 - 43 years old) does not significantly change the system exposure rate with amlodipine (up 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 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 CYP34.
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 100mg 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.
The effect of amlodipine on other drugs
atorvastatin
Simultaneously use 10mg of amlodipine with 80mg of 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 10mg 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.
Interactions between drugs and biochemical tests
Not known.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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