Amlodipine: instructions for use. Amlodipine: description, principle of action and distribution of the active components of the drug in the body Amlodipine 5 ml instructions for use

Content

Due to vascular problems, malnutrition, stress and certain diseases, many people suffer from high blood pressure. To help maintain a normal state, you need to use effective medications. A popular remedy is the pressure drug Amlodipine, which effectively reduces high blood pressure.

What is Amlodipine

According to the classification, amlodipine tablets are included in the group of antihypertensive drugs that reduce pressure by relaxing the smooth muscles of the vessels. They are produced by Russian and foreign pharmaceutical companies. The drug acts due to the active substance of the same name. The antianginal effect of the drug lasts more than a day, which helps to keep pressure indicators under control.

pharmachologic effect

Amlodipine pressure tablets are second-generation slow calcium channel blockers. Their active substance belongs to dihydropyridine derivatives, has hypotensive and antianginal effects. The component binds to dihydropyridine receptors, reduces the transmembrane transition of calcium ions into the cell.

The antianginal effect of the drug is due to the expansion of peripheral and coronary arteries, arterioles With angina pectoris, amlodipine reduces the severity of myocardial ischemia, preload on the heart, myocardial oxygen demand, and expands peripheral arterioles. The remedy can prevent the development of spasm of the coronary arteries, reduce the frequency of angina attacks and the need for nitroglycerin.

The drug has a long-term hypotensive effect, which is associated with a vasodilating effect on the smooth muscle tissue of the vessels. With the development arterial hypertension the pressure decreases. The advantages of the drug include the fact that it does not provoke a sharp decrease in pressure, a decrease in exercise tolerance. The tool helps to stop the symptoms of left ventricular myocardial hypertrophy.

The drug does not provoke a reflex increase in the frequency of heart contractions, increases the glomerular filtration rate, and prevents platelet aggregation. In the presence of diabetic nephropathy, the drug Amlodipine does not lead to an increase in signs of microalbuminuria. The drug is not able to have a negative impact on metabolic processes, plasma lipids.

At arterial hypertension a single daily dose of the drug reduces pressure per day, reduces the degree of hypertrophy of the left ventricular myocardium, has anti-atherosclerotic and cardioprotective effects in ischemia. The drug does not affect the contractility and conductivity of the myocardium, inhibits platelet aggregation, and has a weak natriuretic effect. His therapeutic effect comes in three hours and lasts 24 hours.

Amlodipine is slowly absorbed without dependence on food, has a 64% bioavailability, reaches a maximum concentration after 7.5 hours. The component binds to plasma proteins by 95%, penetrates the blood-brain barrier, undergoes metabolism in the liver with the formation of inactive metabolites. The remainder of the dose is excreted in 70 hours by the kidneys, intestines, and bile. Not subject to hemodialysis.

Indications for use

The drug Amlodipine is prescribed for the development of pathologies of cardio-vascular system. Indications for use are:

• arterial hypertension (combination with other treatment or as monotherapy);
• stable angina pectoris;
• dilated cardiomyopathy;
• Prinzmetal's angina;
• chronic heart failure;
• vasospastic angina;
• cardiac ischemia;
• bronchial asthma.

Compound

Amlodipine for pressure is available only in tablet format. Their composition, indicating the main and auxiliary substances:

How to take Amlodipine for high blood pressure

The drug is taken orally, regardless of the meal. Tablets should not be chewed or crushed, they must be washed down with water. In the treatment of hypertension, for the prevention of attacks of angina pectoris and vasopathic type, an initial dose of 5 mg once / day is prescribed, if necessary, increased to a maximum of 10 mg. For violations of the liver, the initial dose is 2.5 mg, for antianginal treatment - 5 mg once / day.

With an infrequent increase in blood pressure, you can take a tablet a day, preferably in the morning. If improvement is not observed, the dosage can be increased to two tablets per day, taken at a time. Long-term use requires reducing the dose to half a tablet per day. With arterial hypertension, 0.5 tablets / day are prescribed for a supporting action. In heart disease, 1-2 tablets / day are recommended on an ongoing basis.

In renal insufficiency and in the elderly, dose adjustment is not required, but patients need careful monitoring. special instructions safe use of amlodipine for pressure:

1. The dose of the drug does not change when combined with thiazide diuretics, monoamine oxidase inhibitors, beta-blockers.
2. During drug therapy, the body weight of patients, the amount of sodium chloride they consume should be monitored, if necessary, prescribing a diet with salt restriction.
3. To prevent soreness, hyperplasia and bleeding of the gums, it is necessary to monitor oral hygiene and visit the dentist regularly.
4. Before stopping treatment with tablets, the dose is gradually reduced. Abrupt withdrawal may lead to deterioration (angina pectoris and hypertensive crisis).
5. The drug does not affect the change in the concentration in the blood of potassium ions, triglycerides, uric acid, glucose, cholesterol, creatinine, low-density lipoproteins, urea nitrogen.
6. The drug should not be used in hypertensive crisis. Dose changes may be required for low body weight, short stature of patients.
7. The drug should be used with caution when driving vehicles and operating dangerous machinery, because it can cause drowsiness and dizziness.
8. It is forbidden to combine with ethanol, alcohol and grapefruit juice.

High blood pressure in type 2 diabetes

In patients with diabetes the second type is often observed hypertension. It is difficult to choose a drug for them that would not affect the deterioration of metabolism. Amlodipine refers to medicines that are allowed to drink from high blood pressure with diabetes. It can be combined with other drugs in the composition complex therapy. The dosage is 5-10 mg per day. In diabetics, tablets reduce the risk of heart attacks, do not reduce glucose, cholesterol and triglycerides, do not worsen cell sensitivity to insulin and do not increase its plasma concentration.

Hypertension in the elderly

Compared to eprosartan, the blood pressure drug amlodipine is better at lowering blood pressure in the elderly. Doctors recommend combining it with Indapamide, a diuretic drug that differs from other diuretics in safety and lack of side effects. In older people, there is a risk of a sharp drop in blood pressure when getting up from a sitting or lying position (orthostatic hypotension). The pressure medicine Amlodipine eliminates this problem, acting smoothly and evenly. The dosage is 2.5-5 mg / day.

Overdose

If you take an increased dose of the drug, it can cause an overdose. Its symptoms are a sharp decrease in pressure, the development of reflex tachycardia and peripheral vasodilation with the risk of shock, death. Treatment consists of gastric lavage, activated carbon, transferring the patient to the Trendelenburg position (lying on his back with the pelvis raised by 45 degrees). May be appointed vasoconstrictor drugs or intravenous calcium gluconate.

Side effects

During therapy with Amlodipine, side effects from various body systems may occur. These include:

• palpitations, peripheral edema, orthostatic hypotension, vasculitis, bradycardia, tachycardia, atrial fibrillation, myocardial infarction, migraine, chest pain;
• headache, dizziness, fatigue, malaise, fainting, asthenia, paresthesia, hypesthesia, neuropathy, tremor, convulsions, apathy, amnesia, ataxia, agitation, depression;
• blurred vision, diplopia, spasm of accommodation, conjunctivitis;
• thrombocytopenia, purpura, leukopenia;
• shortness of breath, rhinitis, cough;
• nausea, abdominal pain, vomiting, flatulence, constipation, diarrhea, dyspepsia, anorexia, thirst, taste disturbances, dry mouth, gum hyperplasia, increased appetite, pancreatitis, gastritis, jaundice, hepatitis;
• pollakiuria, painful urination, dysuria, nocturia, polyuria;
• gynecomastia, impotence;
• myasthenia gravis, back pain, arthralgia, myalgia, arthrosis, convulsions;
• increased sweating, cold sweat, alopecia, xeroderma, impaired skin pigmentation, dermatitis;
• allergy, rash, itching, urticaria, erythema, angioedema;
• tinnitus;
• chills;
• weight gain;
• nose bleed;
• parosmia;
• hyperglycemia.

Contraindications

Amlodipine at high pressure is prescribed with caution to patients with impaired liver function, severe bradycardia or tachycardia, chronic non-ischemic heart failure, aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction. Contraindications for the use of tablets are:

• severe arterial hypotension;
• collapse, cardiogenic shock;
• unstable angina;
• severe arterial stenosis;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
• pregnancy, lactation (breastfeeding);
• age up to 18 years;
• hypersensitivity to the composition, derivatives of dihydropyridine.

drug interaction

Together with the drug, diuretics may be prescribed, ACE inhibitors(angiotensin-converting enzyme), beta-blockers, angiotensin receptor blockers. Other drug interactions:

1. Inhibitors of microsomal oxidation with simultaneous use increase the concentration of amlodipine in the blood plasma, leading to an increase in side effects, and inducers of microsomal liver enzymes reduce its pharmacokinetic properties.
2. Thiazide and loop diuretics, Verapamil, nitrates, Amiodarone, quinidine, alpha-blockers, antipsychotics, isoflurane, antiviral drugs (ritonavir) increase the antiangial and hypotensive effects of the drug.
3. Calcium preparations reduce the effect of the drug
4. Lithium preparations increase neurotoxicity.
5. No interaction was found with Digoxin, Warfarin, Cimetidine.

During pregnancy and lactation

According to animal studies, there was no teratogenic or inotropic effect of the active component of the tablet composition on the fetus. There is no experience of using the drug during pregnancy and lactation, therefore the drug is not prescribed to pregnant and lactating women. Also, you should not take pills for women of childbearing age who do not use reliable methods of contraception.

Amlodipine analogues with the least side effects

Drugs with minimal side effects, according to reviews, that do not cause swelling of the legs and do not impair metabolism, can replace the remedy. These include:

• Duactin- capsules help with hypertension, chronic heart palpitations, have a minimum number of contraindications.
• Tenox- the drug is prescribed for severe hypertension and chronic angina pectoris, but is not suitable for acute heart failure.
• Stamlo- capsules and tablets for arterial hypertension are contraindicated in severe cases of the disease.
• Normodipin- maybe for a short time normalize blood pressure, improve the functioning of the heart and blood vessels, is contraindicated in recent acute myocardial infarction.
• Emlodin- an inexpensive analogue in the form of tablets, is prohibited in case of severe hypotension, impaired functioning of the left ventricle.

Price

The drug can only be bought with a prescription. The product is stored in a dry, dark place at temperatures up to 25 degrees for three years from the date of manufacture. The drug can be bought in the online store or ordered through the pharmacy catalog. The approximate cost of tablets in Moscow will be:

Video

Attention! The information provided in the article is for informational purposes only. The materials of the article do not call for self-treatment. Only a qualified doctor can make a diagnosis and make recommendations for treatment, based on individual features specific patient.

Compound

Contains in its composition amlodipine besylate , in the equivalent of pure amlodipine 5 and 10 mg.

Additional substances are: crospovidone, lactose monohydrate, calcium stearate, povidone.

Release form

Available in the form of tablets of 10, 20, 30, 40, 50 or 100 pieces. Active ingredient 5 or 10 mg per tablet.

pharmachologic effect

Antihypertensive drug with antianginal effect.

Pharmacodynamics and pharmacokinetics

INN: Amlodipine.

The active ingredient is a derivative of dihydropyridine. The principle of action is aimed at blocking slow calcium channels. The drug has antihypertensive, antianginal effect . The main substance binds to dihydropyridine receptors, has a blocking effect on calcium channels, slows down the transmembrane transition of calcium ions into the cell (there are slightly more vessels in the smooth muscle tissue than in karliomyocytes).

The antianginal effect of amlodipine is achieved by the expansion of arterioles, peripheral arteries, coronary arteries, which in angina can reduce the severity of myocardial ischemia. Under the action of the active component, the lumen of the arterioles expands, coronary arteries in ischemic and unaffected areas of the myocardium, the formation of constriction of the coronary arteries is prevented (when smoking).

Hypotensive effect medicinal product is dose dependent. A single dose of a drug for arterial hypertension allows you to achieve a clinically significant drop blood pressure during the day. The drug does not affect ejection fractions in left ventricle , does not cause a decrease in exercise tolerance, does not cause a sharp drop in blood pressure.

The drug is cardioprotective, antiatherosclerotic effects with IBS. Amlodipine increases the rate glomerular filtration , inhibits platelet aggregation, does not cause a reflex increase in heart rate, has a mild natriuretic effect. The severity of microalbuminuria does not increase in patients with diabetic nephropathy . The drug does not affect plasma lipids, metabolic processes. The effect of taking a single dose of amlodipine is observed after 2 hours, lasts a day.

Indications for use of Amlodipine

What are the tablets used for?

The drug is used for , at vasospastic angina , angina pectoris, decompensated form of CHF, painless variant of myocardial ischemia.

Indications for the use of Amlodipine Biocom are the same, since the active ingredients of these drugs are the same.

Contraindications

Contraindications to the use of the drug are: intolerance to dihydropyridines, severe arterial hypotension,. With aortic stenosis, arterial hypotension, acute myocardial infarction, kidney pathology, children under the age of majority, with CHF, mitral stenosis , elderly patients with SSSU, GOKMP Amlodipine is prescribed with caution.

Side effects of Amlodipine

Digestive tract: dry mouth, jaundice skin nausea, elevated liver enzymes, vomiting, dyspeptic disorders , flatulence, diarrhea, gingival hyperplasia, pain in the epigastric region, appetite disorders.

Nervous system: convulsions , mood changes, drowsiness, headache, depression, nervousness, insomnia, malaise, fatigue, asthenia, tremor, paresthesia, hyperesthesia, agitation, ataxia.

The cardiovascular system: ventricular , puffiness, rhythm disturbances, flushing of blood to the face, palpitations, retrosternal pain, drop in blood pressure, migraine, extrasystole, atrial flutter , aggravation of heart failure, orthostatic hypotension, rise in blood pressure.

Urogenital system: polyuria, pollakiuria, nocturia , pain during urination, sexual dysfunction, potency disorders, dysuria.

Musculoskeletal system: myasthenia gravis, arthrosis, arthralgia , myalgia.

Skin covers:, xeroderma, purpura, dermatitis. It is also possible to develop conjunctivitis, rash, pruritus, diplopia , visual disturbances, gynecomastia, tinnitus, chills, xerophthalmia, accommodation disorders , parosmia, rhinitis, cough, sticky sweat, epistaxis, hyperglycemia, increased sweating, perversion of taste perception.

Reviews of the side effects of Amlodipine are quite common.

Amlodipine tablets, instructions for use (Method and dosage)

The drug is taken orally, the initial dosage is 5 mg. The amount of the drug is gradually increased over two weeks to a maximum of 10 mg per day once. Maintenance, daily dosage for arterial hypertension is 2.5-5 mg. With vasospastic angina, exertional angina, a single dose of 5-10 mg per day is prescribed. In order to prevent angina attacks, a daily intake of 10 mg is indicated. Patients with kidney pathology, with low body weight, short stature are prescribed 2.5 mg per day, to achieve an antianginal effect - 5 mg. The initial dosage for CHF is 2.5 mg per day, the dosage is gradually increased to 10 mg per day with good tolerability of the drug.

Instructions for use Amlodipine Teva, Amlodipine Farmak and Biocom are similar.

Overdose

Accompanied by tachycardia, excessive fall, peripheral vasodilation . Requires gastric lavage, control of diuresis and BCC, the appointment of enterosorbents, intravenous administration, supportive and symptomatic therapy. found to be ineffective.

Interaction

(blockade of prostaglandin synthesis by the renal system, retention of sodium ions), sympathomimetics, estrogens , alpha-agonists, NSAIDs weaken the severity of the hypotensive effect. Microsomal oxidation inhibitors increase the risk of side effects due to an increase in the concentration of the drug in the blood, the opposite effect is observed when taken inducers of microsomal enzymes . Nitrates, "loop" diuretics, , beta blockers , thiazide diuretics , ACE inhibitors enhance the severity of hypotensive and antianginal effects. Antipsychotics, alpha1-blockers, quinidine, amiodarone, BMKK increase the hypotensive effect of amlodipine. , cimetidine and digoxin do not affect pharmacokinetic parameters. When taking lithium preparations, an increase in neurotoxicity (tinnitus, ataxia, diarrhea, nausea, tremor, vomiting) is recorded. Calcium preparations reduce the effectiveness of BMCC. quinidine, procainamide enhance the negative inotropic effect.

Terms of sale

Requires a prescription.

Storage conditions

In a dark place inaccessible to children at a temperature not exceeding 25 degrees Celsius.

Best before date

Not more than 3 years.

special instructions

There is no reliable information about the safety of amlodipine for lactating and pregnant women. Therapy requires supervision by a dentist for prevention and timely diagnosis gum hyperplasia , their bleeding and soreness. The drug has no effect on plasma concentrations, triglycerides , glucose, uric acid , urea, nitrogen, LDL. The drug is not characterized by a “withdrawal” syndrome, however, patients are advised to gradually reduce the dosage of the drug before canceling it.

The drug is often used in combination with various active substances: Valsartan, Perindopril, Lisinopril, Bisoprolol.

Recipe in Latin: Rep: Tab. Amlodipini (Amlori=Norvasci)0.01
D.S. 1 tab. 1 r / d

Amlodipine's analogs

What can replace the medicine? Of course, any synonymous drug that contains the word "amlodipine". Medicines are also analogues of the drug: Agen , aladin , Amlo , Amlovas , Amlovel , Amlodak , Amlodex , Amlodin , Amlocor , Amlong , Amlopril , Vasodipine , Vasotal , Vaskopin , norvadin , Semlopin , Stamlo , Tensigal , Emlodin .

Reviews about Amlodipine

Reviews of doctors

The drug is effective tool with heart disease. Often used to prevent heart attack and angina pectoris. The medicine and its dosage must be prescribed by a doctor.

Reviews about Amlodipine Teva characterize the remedy as good drug to reduce pressure. Also a plus is the low price of the drug. However, there are often side effects.

Amlodipine price, where to buy

The price of Amlodipine is highly dependent on the manufacturer and has a wide range.

You can buy Amlodipine Teva 5 mg for 130 rubles for 30 pieces.

The price of Amlodipine Prana is 50 rubles for the same package.

• Internet pharmacies in Russia Russia
• Internet pharmacies in Ukraine Ukraine
• Internet pharmacies in Kazakhstan Kazakhstan

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Published on this page detailed instructions by application Amlodipine. The available dosage forms of the drug (tablets 5 mg and 10 mg), as well as its analogues, are listed. Information is provided on the side effects that Amlodipine can cause, on interactions with other drugs. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (lowering high blood pressure, treatment of angina pectoris), the algorithms for admission, possible dosages for adults and children are described in detail, the possibility of using during pregnancy and lactation is specified. The annotation to Amlodipine is supplemented by reviews of patients and doctors.

Instructions for use and dosing regimen

Inside, the initial dose for the treatment of arterial hypertension and angina pectoris is 5 mg of the drug 1 time per day. The maximum daily dose is 10 mg once.

With arterial hypertension, the maintenance dose may be 2.5-5 mg (1/2 tablet of 5 mg - 1 tablet of 5 mg) per day

With exertional angina and vasospastic angina - 5-10 mg per day, once. In order to prevent angina attacks - 10 mg per day.

In patients with impaired liver function, Amlodipine is prescribed with caution as an antihypertensive agent, at an initial dose of 2.5 mg (1/2 tablet of 5 mg), as an antianginal agent - 5 mg.

Dose changes are not required when administered simultaneously with thiazide diuretics, beta-blockers and ACE inhibitors.

No dose adjustment required in patients with kidney failure.

Release form

Tablets 5 mg and 10 mg. Can be produced in combination with other dosage forms(combined drugs).

Amlodipine- a derivative of dihydropyridine - a blocker of slow calcium channels (BCCC) of the 2nd generation, has an antianginal and hypotensive effect. By binding to dihydropyridine receptors, it blocks calcium channels, reduces the transmembrane transition of calcium ions into the cell (to a greater extent into vascular smooth muscle cells than into cardiomyocytes).

The antianginal effect is due to the expansion of the coronary and peripheral arteries and arterioles: in angina pectoris, it reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces peripheral vascular resistance, reduces the preload on the heart, reduces myocardial oxygen demand. Expands the main coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases the supply of oxygen to the myocardium (especially with vasospastic angina); prevents the development of spasm of the coronary arteries (including those caused by smoking). In patients with stable angina pectoris, a single daily dose increases exercise tolerance, slows down the development of angina pectoris and "ischemic" depression of the ST segment, reduces the frequency of angina attacks and the consumption of nitroglycerin and other nitrates.

It has a long-term dose-dependent hypotensive effect. The hypotensive effect is due to a direct vasodilating effect on vascular smooth muscle. With arterial hypertension, a single dose provides a clinically significant decrease in blood pressure for 24 hours (with the patient lying and standing). Orthostatic hypotension with the appointment of amlodipine is quite rare.

Does not cause a decrease in exercise tolerance, left ventricular ejection fraction. Reduces the degree of hypertrophy of the myocardium of the left ventricle, has anti-atherosclerotic and cardioprotective effects in IHD. It does not affect myocardial contractility and conduction, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases glomerular filtration rate, and has a weak natriuretic effect.

In diabetic nephropathy does not increase the severity of microalbuminuria. Does not have any adverse effect on metabolism and plasma lipid concentration and can be used in the treatment of patients bronchial asthma, diabetes and gout.

A significant decrease in blood pressure is observed after 6-10 hours, the duration of the effect is 24 hours. With long-term therapy maximum reduction AD occurs 6-12 hours after taking amlodipine orally. If, after prolonged treatment, amlodipine is discontinued, the effective reduction in blood pressure persists for 48 hours after the last dose. Then the blood pressure indicators gradually return to the initial level within 5-6 days.

Pharmacokinetics

After oral administration, amlodipine is slowly absorbed from the gastrointestinal tract. Eating does not affect the absorption of amlodipine. Most of the drug in the blood (95%) binds to plasma proteins. Amlodipine undergoes slow but active hepatic metabolism with no significant first pass effect. Metabolites do not have significant pharmacological activity. About 60% of the dose taken orally is excreted by the kidneys mainly in the form of metabolites, 10% - unchanged, and 20-25% - through the intestines, as well as with breast milk.

The drug penetrates the blood-brain barrier. It is not removed by hemodialysis.

In elderly patients (over 65 years of age), the elimination of amlodipine is slower than in younger patients, but this difference is not of clinical significance.

Indications

• arterial hypertension (in monotherapy or in combination with other drugs);
• angina pectoris;
• vasospastic angina (Prinzmetal's angina).

Contraindications

• severe arterial hypotension (systolic blood pressure less than 90 mmHg);
• collapse, cardiogenic shock;
• unstable angina (with the exception of Prinzmetal's angina);
• clinically significant aortic stenosis;
• pregnancy and lactation;
• age up to 18 years (efficacy and safety have not been studied);
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• hypersensitivity to amlodipine, dihydropyridine derivatives and other components of the drug.

special instructions

During the period of treatment with Amlodipine, it is necessary to control body weight and sodium intake, the appointment of an appropriate diet. Maintaining dental hygiene and monitoring by a dentist (to prevent soreness, bleeding and gum hyperplasia) is necessary.

Patients with low body weight, patients of short stature and patients with severe liver dysfunction may require a lower dose.

Despite the fact that discontinuation of Amlodipine is not accompanied by the development of a "withdrawal" syndrome, it is advisable to stop treatment by gradually reducing the dose of the drug.

The efficacy and safety of the drug in hypertensive crisis has not been established.

Influence on the ability to drive vehicles and control mechanisms

There were no reports of the effect of Amlodipine on driving or operating machinery. However, in some patients, mainly at the beginning of treatment, drowsiness and dizziness may occur. When they occur, the patient must take special precautions when driving and working with complex mechanisms.

Side effect

• heartbeat;
• peripheral edema (swelling of the ankles and feet);
• "tides" of blood to the skin of the face;
• excessive decrease in blood pressure;
• dyspnea;
• vasculitis;
• orthostatic hypotension;
• development or worsening of heart failure;
• cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation)
• myocardial infarction;
• pain in the chest;
• headache;
• dizziness;
• increased fatigue;
• drowsiness;
• asthenia;
• paresthesia;
• insomnia;
• mood lability;
• unusual dreams;
• nervousness;
• depression;
• anxiety;
• migraine;
• increased sweating;
• nausea;
• stomach ache;
• vomit;
• constipation or diarrhea;
• flatulence;
• dyspepsia;
• anorexia;
• dry mouth;
• thirst;
• increased appetite;
• gastritis;
• thrombocytopenic purpura, leukopenia, thrombocytopenia;
• frequent urination;
• painful urination;
• impotence;
• gynecomastia;
• dyspnea;
• rhinitis;
• cough;
• dermatitis;
• violation of skin pigmentation;
• skin itching;
• rash (including erythematous, maculopapular rash, urticaria);
• angioedema;
• muscle cramps;
• backache;
• tinnitus;
• Pain in the eyes;
• chills;
• nose bleed.

drug interaction

Amlodipine can be safely used to treat hypertension with thiazide diuretics, alpha-blockers, beta-blockers, or ACE inhibitors. In patients with stable angina, the drug can be combined with other antianginal agents, such as long-acting nitrates, beta-blockers, or short-acting nitrates.

Amlodipine can be used simultaneously with non-steroidal anti-inflammatory drugs (especially indomethacin), antibacterial agents and oral hypoglycemic agents.

It is possible to enhance the antianginal and hypotensive action of BMCC when used together with thiazide and "loop" diuretics, verapamil, ACE inhibitors, beta-blockers and nitrates, as well as to enhance their hypotensive action when used together with alpha-blockers, antipsychotics.

Although a negative inotropic effect has not generally been observed in studies with amlodipine, however, some BMCs may increase the negative inotropic effect of antiarrhythmic agents that cause QT interval prolongation (eg, amiodarone and quinidine).

A single dose of 100 mg of sildenafil (Viagra) in patients with essential hypertension does not affect the pharmacokinetic parameters of amlodipine.

Repeated use of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg is not accompanied by significant changes in the pharmacokinetics of atorvastatin.

Ethanol (drinks containing alcohol): Amlodipine, with a single and repeated use at a dose of 10 mg, does not affect the pharmacokinetics of ethanol (alcohol).

Antiviral agents (ritonavir) increase plasma concentrations of BMCC, incl. amlodipine.

Antipsychotics and isoflurane - increased hypotensive effect of dihydropyridine derivatives.

Calcium preparations can reduce the effect of BMCC.

With the combined use of amlodipine with lithium preparations, it is possible to increase the manifestation of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

Amlodipine does not change the pharmacokinetics of cyclosporine.

Does not affect the serum concentration of digoxin and its renal clearance.

It does not significantly affect the action of warfarin (prothrombin time).

Cimetidine does not affect the pharmacokinetics of amlodipine.

Grapefruit Juice: Co-administration of 240 mg of grapefruit juice and 10 mg of amlodipine orally was not accompanied by a significant change in the pharmacokinetics of amlodipine.

Analogues of the drug Amlodipine

Structural analogues for the active substance:

• Acridipine;
• Amlovas;
• Amlodac;
• Amlodigamma;
• Amlodipine Zentiva;
• Amlodipine Cardio;
• Amlodipine Sandoz;
• Amlodipine Teva;
• Amlodipharm;
• Amlocard-Sanovel;
• Amlong;
• Amlonorm;
• Amlorus;
• Amlotop;
• Vero-Amlodipine;
• Kalchek;
• Cardilopin;
• Corvadil;
• Cordy Core;
• Norvask;
• Normodipin;
• Omelar Cardio;
• Stamlo;
• Tenox.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety have not been studied).

Use during pregnancy and lactation

Amlodipine has not been shown to be teratogenic in animal studies, but there is no clinical experience with its use during pregnancy and lactation. Therefore, amlodipine should not be given to pregnant and lactating women, as well as women of childbearing age, unless they use reliable methods of contraception.

Blockers of "slow" calcium channels. Selective calcium channel blockers. dihydropyridine derivatives. Amlodipine.

ATX code C08CA01

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Pharmacological properties

Pharmacokinetics

When taken orally, the absorption of amlodipine is slow, does not depend on food intake, is about 90%, bioavailability is 60-65%. The maximum plasma concentration when taken orally is reached within 6-12 hours. With constant intake, the equilibrium concentration of Css is created after 7-8 days. Distribution volume - 21 l/kg. Communication with plasma proteins - 90-97%. Crosses the blood-brain barrier and is secreted into breast milk. It is intensively (90%) metabolized in the liver with the formation of inactive metabolites, has the effect of "first pass" through the liver, on average - 35 hours. The total clearance is 500 ml / min. T1 / 2 in patients with arterial hypertension - 48 hours, in elderly patients it increases to 65 hours, with liver failure - up to 60 hours, similar parameters for increasing T1 / 2 are also observed in severe CHF, with impaired renal function - does not change. It is not removed by hemodialysis. Excreted by the kidneys - 60% as metabolites, 10% unchanged; with bile and through the intestines - 20-25% in the form of metabolites, as well as with breast milk.

Pharmacodynamics

A derivative of dihydropyridine is a second-generation slow calcium channel blocker that has antianginal and hypotensive effects. By binding to the S6 segment of the III and IV domains of the alpha1 subunit of the L-type calcium channel, it blocks calcium channels, reduces the transmembrane transition of Ca2+ into the cell (to a greater extent into vascular smooth muscle cells than into cardiomyocytes). The mechanism of hypotensive action is due to a direct relaxing effect on vascular smooth muscles.

The exact mechanism of action of amlodipine in angina is not fully established, but amlodipine reduces ischemia as follows:

1. Amlodipine dilates the peripheral arterioles and thus reduces the total peripheral resistance (afterload), which requires the work of the heart to overcome. Since the heart rate does not change, reducing the load on the heart leads to a decrease in energy consumption and oxygen demand.

2. The mechanism of action of amlodipine probably also includes the expansion of the main coronary arteries and coronary arterioles in both unchanged and ischemic areas of the myocardium. This dilatation increases the supply of oxygen to the myocardium in patients with vasospastic angina (Prinzmetal's angina or variant angina).

In patients with arterial hypertension, a single daily dose of amlodipine provides a clinically significant decrease in blood pressure for 24 hours, both in the supine and standing positions. Due to the slow onset of action, amlodipine does not cause acute hypotension. In patients with angina pectoris, a single daily dose of amlodipine increases the execution time physical activity, delays the development of an angina attack and ST segment depression (by 1 mm) during its execution, reduces the frequency of angina attacks and the consumption of nitroglycerin tablets.

The drug does not cause any adverse metabolic disorders or changes in plasma lipids and can be used in patients with diabetes mellitus and gout, as well as in patients with bronchial asthma.

Use in patients with ischemic disease heart (IHD)

The use of amlodipine 5-10 mg reduces the number of hospitalizations for angina and revascularization procedures in patients with coronary artery disease, and also reduces the number of cases of thrombosis.

Use in patients with heart failure

Results of hemodynamic studies and controlled clinical trials using exercise patients with NYHA class II-IV heart failure have shown that amlodipine does not lead to clinical deterioration, as evidenced by the results of measuring the degree of exercise tolerance, left ventricular ejection function, as well as the analysis of clinical symptoms. The results of a placebo-controlled study to evaluate the effects of amlodipine on the body of patients with NYHA class III-IV heart failure treated with digoxin, diuretics and ACE inhibitors showed that amlodipine does not increase the risk of mortality or mortality and morbidity of heart failure.

The results of a long-term, placebo-controlled study of the effects of amlodipine on the body of patients with clinical insufficiency class III-IV according to the NYHA classification without clinical symptoms or objective evidence suggestive of an underlying ischemic disease receiving stable doses of ACE inhibitors, digitalis, and diuretics indicate that amlodipine does not affect overall mortality due to cardiovascular disease. In this population, according to the indications of patients, the use of amlodipine was more associated with an increase in the incidence of pulmonary edema.

The time of onset of the effect is 2-4 hours; duration of action - 24 hours.

Indications for use

Arterial hypertension

Stable angina and vasospastic angina (Prinzmetal's angina)

Dosage and administration

Inside, once. The initial dose for arterial hypertension and angina pectoris is 5 mg / day, which, if necessary, is increased to a maximum of 10 mg / day. Patients with low body weight or short stature, as well as with severe hepatic insufficiency, may require lower doses.

In patients with hypertension, amlodipine may be used in combination with thiazide diuretics, alpha-blockers, beta-blockers, or angiotensin-converting enzyme inhibitors. With angina pectoris, amlodipine may be used as monotherapy or in combination with other antianginal drugs.

Dose adjustment of amlodipine with simultaneous use of thiazide diuretics, beta-blockers or angiotensin-converting enzyme inhibitors is not required.

Liver failure. Doses have not been established for patients with mild to moderate hepatic insufficiency, so dose selection should be done with caution and start at a low dose. The pharmacokinetics of amlodipine has not been studied in patients with severe hepatic impairment. Amlodipine should be started at low doses and increased gradually in patients with severe hepatic impairment.

Renal failure. Changes in the concentration of amlodipine in blood plasma do not correlate with the degree of renal failure, it is recommended to use the usual doses of the drug. Amlodipine is not removed during dialysis.

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Side effects

The most common side effects of amlodipine are: drowsiness, dizziness, headache, palpitation, flushing, abdominal pain, nausea, swelling of the ankles, fatigue.

From the side of the cardiovascular system: palpitations, swelling of the feet, shortness of breath, rarely - rhythm disturbances (bradycardia, ventricular tachycardia, atrial flutter, atrial fibrillation), chest pain, decreased blood pressure, orthostatic hypotension, fainting; very rarely - the development or aggravation of heart failure, extrasystole, migraine, myocardial infarction, vasculitis.

From the side nervous system: headache, dizziness, excessive fatigue, drowsiness, mood changes, convulsions; rarely - loss of consciousness, hypesthesia, paresthesia, tremor, asthenia, malaise, insomnia, nervousness, depression, extraordinary dreams, anxiety; very rarely - ataxia, apathy, agitation, amnesia, peripheral neuropathy, hypertonicity.

From the side digestive system: nausea, abdominal pain; hyperbilirubinemia, jaundice, increased activity of "liver" transaminases, mostly observed phenomena characteristic of cholestasis; rarely - dry mouth, anorexia, vomiting, constipation or diarrhea, dyspepsia, flatulence, gum hyperplasia; very rarely - gastritis, increased appetite, pancreatitis.

From the genitourinary system: rarely - pollakiuria, painful urge to urinate, nocturia, sexual dysfunction (including decreased potency); very rarely - dysuria, polyuria.

From the musculoskeletal system: rarely - arthralgia, arthrosis, myalgia (with prolonged use), muscle cramps; very rarely - myasthenia gravis.

On the part of the skin: very rarely - xeroderma, alopecia, dermatitis, purpura, discoloration of the skin, hyperhidrosis, Stevens-Johnson syndrome, photosensitivity, erythema multiforme.

Allergic reactions: pruritus, rash (including erythematous, maculopapular rash, urticaria), Quincke's edema, exanthema, exfoliative dermatitis.

From the blood and lymphatic system: leukocytopenia, thrombocytopenia.

Other: rarely - blurred vision, conjunctivitis, diplopia, eye pain, disturbance of accommodation, xerophthalmia, tinnitus, gynecomastia, back pain, feeling hot, chills, weight gain / decrease, dyspnea, epistaxis, increased sweating, thirst ; very rarely - hepatitis, cold sticky sweat, cough, rhinitis, parosmia, taste perversion, hyperglycemia, swelling, pain, malaise. Isolated cases of extrapyramidal syndrome have been reported.

Contraindications

Hypersensitivity (including to other dihydropyridines, amlodipine or any other components)

Severe arterial hypotension (SBP less than 90 mm Hg)

Shock (including cardiogenic)

Left ventricular outflow tract obstruction (eg, severe aortic stenosis)

Hemodynamically unstable heart failure after acute myocardial infarction

Pregnancy, lactation

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption

Drug Interactions"type="checkbox">

Drug Interactions

Inhibitors of microsomal oxidation can increase the concentration of amlodipine in plasma, increasing the risk of side effects, and inducers of microsomal liver enzymes can reduce it.

CYP3A4 inhibitors. Simultaneous administration of diltiazem at a dose of 180 mg and amlodipine at a dose of 5 mg in elderly patients (69-87 years) led to an increase in the systemic exposure of amlodipine by 57%. Simultaneous administration with erythromycin in healthy volunteers (aged 18 to 43 years) did not lead to meaningful change systemic exposure to amlodipine (22% increase in AUC). Although the clinical significance of these data is unclear, pharmacokinetic changes can be clearly expressed in the elderly.

Strong inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir) may increase amlodipine concentrations to a greater extent than diltiazem. Amlodipine should be used with caution in combination with CYP3A4 inhibitors.

CYP3A4 inducers. There are no data on the effect of CYP3A4 inducers on amlodipine. Simultaneous administration of CYP3A4 inducers (for example, rifampicin, St. John's wort) can lead to a decrease in the concentration of amlodipine in the blood plasma. Almodipine should be used with caution in combination with CYP3A4 stimulants.

Unlike other slow calcium channel blockers, there is no clinically significant interaction with NSAIDs, especially indomethacin. Thiazide and "loop" diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates enhance antianginal or hypotensive effects. Does not affect the pharmacokinetic parameters of digoxin, warfarin, atorvastatin and cyclosporine. Cimetidine does not affect the pharmacokinetics of amlodipine. Ca2+ preparations can reduce the effect of slow calcium channel blockers. Antiviral agents (ritonavir) increase plasma concentrations of slow calcium channel blockers, incl. amlodipine. Antipsychotics and isoflurane - increased hypotensive effect of dihydropyridine derivatives.

Taking amlodipine with grapefruit or grapefruit juice is not recommended, since the bioavailability and, accordingly, the hypotensive effect of amlodipine may increase.

Dantrolene (infusion): in animals, after administration of verapamil and intravenous administration dantrolene, developed ventricular fibrillation and fatal cardiovascular failure, accompanied by hyperkalemia. Due to the risk of hyperkalemia, it is recommended to avoid joint reception calcium channel blockers such as amlodipine in patients at risk of developing malignant hyperthermia or for the treatment of malignant hyperthermia.

The blood pressure-lowering effect of amlodipine is enhanced by other medications with antihypertensive properties.

Simvastatin: Co-administration of multiple doses of amlodipine 10 mg with 80 mg simvastatin resulted in a 77% increase in simvastatin exposure compared to simvastatin alone. It is recommended to limit the dose of simvastatin in patients taking amlodipine to 20 mg per day.

special instructions

Care must be taken when used in patients with arterial hypotension, mitral stenosis, hypertrophic obstructive cardiomyopathy, sick sinus syndrome.

During treatment, it is necessary to control body weight and be observed by a dentist (to prevent soreness, bleeding and gum hyperplasia). Amlodipine does not affect plasma concentrations of K+, glucose, TG, total cholesterol, LDL, uric acid, creatinine and urea nitrogen. Abrupt discontinuation of the drug should be avoided due to the risk of worsening angina pectoris. Amlodipine tablets are not recommended for hypertensive crisis. Women of childbearing age should use reliable methods of contraception during the treatment period.

Patients with heart failure. The drug should be used with caution in patients with heart failure. In a long-term placebo-controlled study in patients with severe heart failure (NYHA functional class III-IV), the incidence of pulmonary edema was higher in the amlodipine-treated group compared to the placebo group. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure as they may increase the risk of future cardiovascular events and mortality.

Patients with impaired liver function. In patients with impaired liver function, the half-life of amlodipine is prolonged and the AUC values ​​are higher. Recommendations for dosage in this category of patients have not been developed, so it is necessary to start taking amlodipine with the lowest doses of the permissible range, being careful both at the very beginning of treatment and when increasing the dose of the drug. Patients with severe hepatic impairment require slow dose titration and close monitoring.

Elderly. In the elderly, increasing the dose of the drug should be carried out with caution.

Patients with renal insufficiency. Patients with renal insufficiency do not require dose adjustment. Changes in the concentration of amlodipine in plasma do not correlate with the degree of impaired renal function. Amlodipine is not removed during dialysis.

Use during pregnancy and lactation.

Pregnancy. The safety of use during pregnancy has not been established. In an animal study, reproductive toxicity has been observed with high doses of amlodipine.

Lactation. The safety of use during lactation has not been established. It is not known whether amlodipine is excreted in breast milk. Decision to continue/terminate breastfeeding or continuation/discontinuation of amlodipine therapy should be taken taking into account the benefits of breastfeeding for the child and the benefits of amlodipine treatment for the mother. At the time of treatment should stop breastfeeding.

Fertility. There are insufficient clinical data regarding the potential effect of amlodipine on fertility. In a study on rats, a negative effect on male fertility was found.

Children. There is no experience with the use of amlodipine in children and adolescents under 18 years of age.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

Patients taking amlodipine may develop dizziness, headache, symptoms of fatigue or nausea, so care should be taken when administering amlodipine vehicles and potentially dangerous species activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: excessive peripheral vasodilation, reflex tachycardia. Significant and possibly prolonged systemic hypotension, including fatal shock, has been reported.

Treatment: gastric lavage, administration of activated charcoal, giving an elevated position to the limbs, maintaining the functions of the cardiovascular system, frequent monitoring of heart and respiratory function, control of BCC and diuresis, symptomatic and supportive therapy, intravenous administration of calcium gluconate. Hemodialysis is ineffective. To restore vascular tone and blood pressure, if there are no contraindications, it may be useful application vasoconstrictor drugs.

Terms of dispensing from pharmacies

On prescription

Manufacturer

RUE "Belmedpreparaty", Republic of Belarus

Legal address and address for accepting claims:

220007, Minsk, st. Fabricius, 30,

Name:

Amlodipine (Amlodipine)

Pharmacological
action:

Selective calcium channel blocker class II. The antihypertensive effect is due to a direct relaxing effect on vascular smooth muscle. It is assumed that the antianginal effect of amlodipine is associated with its ability to expand peripheral arterioles; this leads to a decrease in OPSS, while reflex tachycardia does not occur. As a result, there is a decrease in myocardial oxygen demand and energy consumption by the heart muscle. On the other hand, amlodipine appears to dilate large coronary arteries and coronary arterioles in both intact and ischemic areas of the myocardium. This ensures the supply of oxygen to the myocardium during spasms of the coronary arteries.

Pharmacokinetics: When taken orally, it is absorbed from the gastrointestinal tract slowly and almost completely, Cmax in blood plasma is reached within 6-9 hours. Protein binding is 95-98%. It undergoes minimal metabolism during the first passage through the liver and slow but significant hepatic metabolism with the formation of metabolites with little pharmacological activity.
T1 / 2 averages 35 hours and with arterial hypertension can increase to an average of 48 hours, in elderly patients - up to 65 hours and with impaired liver function - up to 60 hours. Excreted mainly as metabolites: 59-62% - by the kidneys , 20-25% - through the intestines.

Indications for
application:

The drug is used for treatment of arterial hypertension in adults (both monotherapy with Amlodipine and its combination with other antihypertensive drugs are allowed).
For the treatment of exertional angina, Prinzmetal's angina (vasospastic angina), including therapy is indicated in cases where nitrates and B-blockers do not have the expected effect.
Treatment of coronary heart disease, including chronic.
The drug can be used in patients with chronic heart failure and bronchial asthma.

Mode of application:

In the treatment of uncomplicated hypertension take 2.5 mg of the drug 1 time per day.
With hypertension complicated by coronary heart disease and angina, take 5 mg of the drug 1 time per day.
If necessary, the dose of the drug can be increased to 10 mg.
The maximum daily dose is 10 mg.
In complex therapy with other antihypertensive drugs, amlodipine does not require dose adjustment.
In patients with renal insufficiency and elderly patients, dose adjustment is not required.

Side effects:

from the cardiovascular system: often - peripheral edema (ankles and feet), tachycardia; sometimes - arterial hypotension, vasculitis; very rarely - cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, syncope;
from the CNS and sensory organs: often - a feeling of heat and hot flashes, increased fatigue, dizziness, headache, drowsiness; sometimes - malaise, increased sweating, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood changes, visual disturbances, tinnitus, changes in taste sensations;
from the genitourinary system: sometimes - increased frequency and urination disorders, nocturia, impotence, gynecomastia;
from the gastrointestinal tract: often - abdominal pain, nausea; sometimes - vomiting, constipation, dyspepsia, diarrhea, dry mouth, intestinal dysfunction; rarely - gingival hyperplasia; very rarely - gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of hepatic transaminases, hepatitis;
from the musculoskeletal system: sometimes - arthralgia, muscle cramps, muscle hypertonicity, myalgia, back pain;
from the hematopoietic system: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia;
from the side of metabolism: very rarely - hyperglycemia;
from the side respiratory system : sometimes - shortness of breath, rhinitis; very rarely - cough;
allergic reactions: sometimes - itching, rash, alopecia; very rarely - angioedema, erythema multiforme, exfoliative dermatitis;
others: sometimes - increase / decrease in body weight; very rarely - a violation of skin pigmentation.

Contraindications:

Increased individual sensitivity to the components of the drug, arterial hypotension, cardiogenic shock, collapse, pregnancy and lactation.
Carefully the drug is prescribed in patients with chronic heart failure, diabetes mellitus, lipid metabolism disorders, liver dysfunction, elderly patients and persons under 18 years of age.
It is also prescribed with caution to patients who have had a myocardial infarction (especially the first month after an acute myocardial infarction).

Interaction
other medicinal
by other means:

With the simultaneous use amlodipine and blockers calcium channels may increase the hypotensive effect.
With the simultaneous use sympathomimetics, estrogens may reduce the antihypertensive effect due to sodium retention in the body.
With the simultaneous use means for inhalation anesthesia may increase the hypotensive effect.
With the simultaneous use amiodarone
With the simultaneous use lithium carbonate possible manifestations of neurotoxicity (including nausea, vomiting, diarrhea, ataxia, trembling and / or tinnitus).
With the simultaneous use orlistat reduces the antihypertensive effect of amlodipine, which can lead to a significant increase in blood pressure, the development of a hypertensive crisis.
With the simultaneous use indomethacin and other NSAIDs, it is possible to reduce the antihypertensive effect of amlodipine due to inhibition of prostaglandin synthesis in the kidneys and fluid retention under the influence of NSAIDs.
With the simultaneous use quinidine may increase the antihypertensive effect.

Pregnancy:

Safety of Amlodipine during pregnancy and lactation not installed. Therefore, the use of Amlodipine during pregnancy is possible only in cases where there is no safer alternative, and the risk associated with the disease itself outweighs the potential risk of treatment for the mother and fetus. At the time of treatment with Amlodipine, breastfeeding should be discontinued.

Children. There is no experience with the use of Amlodipine for the treatment of children, so the drug is not used in pediatric practice.

Overdose:

Symptoms: excessive peripheral vasodilation, pronounced and prolonged decrease in blood pressure, tachycardia.

Treatment: gastric lavage, administration of activated charcoal, giving the patient a horizontal position with raised legs, monitoring of heart and lung function, control of BCC and diuresis; symptomatic and supportive therapy, intravenous fluids, calcium gluconate, dopamine, phenylephrine. Hemodialysis is not effective.

Release form:

Tablets 2.5 each; 5 or 10 mg active ingredient 10 pcs. in a blister, 1 or 3 blisters in a carton.
5 or 10 mg of the active substance, 100 pcs. in a bank of polymeric materials, in a cardboard box.

Storage conditions:

Store in a dry place away from direct sunlight, at a temperature not exceeding 25 degrees Celsius.
Best before date- 2 years.

Tablets
Amlodipine besylate(in terms of amlodipine) - 2.5; 5 or 10 mg;
Other Ingredients: lactose monohydrate, potato starch, povidone, calcium stearate.