Amlodipine-Teva, pills 10mg 30pcs

Composition

1 tablet contains:

Active ingredient:

amlodipine bezylate (in terms of amlodipine 10 mg) – 13,888 mg.

Auxiliary substances:

microcrystalline cellulose,

calcium hydrophosphate (anhydrous),

sodium carboxymethyl starch (type A),

magnesium stearate.

Pharmacological action

Slow calcium channel blocker (BMCC). Dihydropyridine derivative-blocker of” slow ” calcium channels of the second generation.

It has antianginal and antihypertensive effects. Blocks calcium channels, reduces the transmembrane transfer of calcium ions into the cell (more to vascular smooth muscle cells than to cardiomyocytes).

The antianginal effect is caused by the expansion of coronary and peripheral arteries and arterioles: in angina pectoris, it reduces the severity of myocardial ischemia; by expanding peripheral arterioles, it reduces the total peripheral vascular resistance (OPSS), reduces afterload on the heart, and reduces the need for myocardial oxygen.

Dilating the coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases oxygen supply to the myocardium (especially in vasospastic angina); prevents spasm of the coronary arteries (including those caused by smoking).

In patients with stable angina, a single daily dose increases exercise tolerance, increases the time to angina attack and “ischemic” ST-segment depression, reduces the frequency of angina attacks and consumption of nitroglycerin and other nitrates.

It has a long-term dose-dependent hypotensive effect. The hypotensive effect is due to the direct vasodilating effect on vascular smooth muscles. In patients with arterial hypertension, a single dose provides a clinically significant reduction in blood pressure (BP) for 24 hours (in the patient’s “lying” and “standing”positions). Orthostatic hypotension with the appointment of amlodipine is quite rare. It does not cause a decrease in the left ventricular ejection fraction. Reduces the degree of left ventricular myocardial hypertrophy. It does not affect the contractility and conduction of the myocardium, does not cause a reflex increase in the heart rate (HR), inhibits platelet aggregation, increases the glomerular filtration rate, and has a weak natriuretic effect.

In diabetic nephropathy, it does not increase the severity of microalbuminuria. It does not have any adverse effect on the metabolism and concentration of plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes mellitus and gout. A significant decrease in blood pressure is observed after 6-10 hours, the duration of the effect is 24 hours.

In patients with diseases of the cardiovascular system, including coronary atherosclerosis with damage to one vessel and up to stenosis of 3 or more arteries, carotid artery atherosclerosis, myocardial infarction, percutaneous transluminal angioplasty (TLAP) of the coronary arteries or patients with angina pectoris, the use of amlodipine prevents the development of thickening of the intima – media of the carotid arteries, reduces mortality from myocardial infarction, stroke, TLAP, aorto – coronary bypass surgery; reduces the incidence of unstable angina and the progression of chronic heart failure (CHF); reduces the frequency of interventions aimed at restoring coronary blood flow.

It does not increase the risk of death or complications and deaths in patients with CHF (NYHA functional class III – IV) during therapy with digoxin, diuretics, and angiotensin converting enzyme (ACE) inhibitors. In patients with CHF (NYHA functional class III – IV) of non-ischemic etiology, amlodipine is likely to cause pulmonary edema.

Indications

• Arterial hypertension.
• Stable angina pectoris of tension.
• Vasospastic angina pectoris.

Contraindications

• Hypersensitivity to amlodipine, other dihydropyridine derivatives or other components of the drug.
• Severe arterial hypotension (systolic blood pressure less than 90 mm Hg).
• Cardiogenic shock.
• Acute myocardial infarction (within the first 28 days).
• Unstable angina (with the exception of Prinzmetal angina).
• Obstruction of the outflow tract of the left ventricle.
• Clinically significant aortic stenosis.
• Age up to 18 years (efficacy and safety have not been established).

Use with caution:  liver function disorders, sinus node weakness syndrome (severe bradycardia, tachycardia), chronic heart failure of non-ischemic etiology of NYHA functional class III-IV, arterial hypotension, aortic stenosis, mitral stenosis, acute myocardial infarction (after the first 28 days), elderly age, impaired renal function.

Side effects

The frequency of adverse reactions listed below was determined according to the following (World Health Organization classification):

• Very often – at least 10%.
• Often – not less than 1%, but less than 10%.
• Infrequently – not less than 0.1%, but less than 1%.
• Rarely – not less than 0.01%, but less than 0.1%.
• Very rarely – less than 0.01%, including individual messages.

From the central nervous system:  often – headache (especially at the beginning of treatment), dizziness, increased fatigue, drowsiness; infrequently – general malaise, hypesthesia, neuropsychiatric asthenia, paresthesia, acrodystrophic neuropathy, intentional tremor, insomnia, emotional lability, unusual dreams, nervousness, increased excitability, depression, anxiety, increased sweating; rarely-convulsions, apathy, agitation; very rarely – ataxia, amnesia, and migraines.

From the digestive system:  often – nausea, abdominal pain; infrequently-vomiting, changes in bowel movements (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry oral mucosa, thirst; rarely – gum hyperplasia, increased appetite; very rarely – pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, increased activity of “liver” transaminases, hepatitis.

From the cardiovascular system:  often-peripheral edema (ankles and feet), palpitations, “flushes” of blood to the skin of the face; infrequently-excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely-development or aggravation of the course of CHF; very rarely-fainting, shortness of breath, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema.

From the hematopoietic and lymphatic systems:  very rarely – thrombocytopenic purpura, leukopenia, thrombocytopenia.

From the urinary system:  infrequently-pollakiuria, painful urination, nocturia; very rarely-dysuria, polyuria.

From the side of the reproductive system and mammary glands:  infrequently-gynecomastia, impotence.

Respiratory system disorders:  infrequently-shortness of breath, rhinitis; very rarely – cough.

From the musculoskeletal system:  infrequently-muscle cramps, myalgia, arthralgia, back pain, osteoarthritis; rarely-myasthenia gravis.

From the side of the skin:  infrequently-alopecia; rarely-dermatitis; very rarely-xeroderma, cold sticky sweat, skin pigmentation disorder.

Allergic reactions:  rarely-pruritus of the skin, rash (including erythematous, maculopapular rash); very rarely-urticaria, angioedema, erythema multiforme.

From the side of the senses:  infrequently-tinnitus, visual impairment, diplopia, accommodation disorders, xerophthalmia, conjunctivitis, eye pain; very rarely-parosmia.

From the side of metabolism:  very rarely – hyperglycemia.

Other services:  infrequently – weight loss, weight gain, taste distortion, nosebleeds, chills.

Interaction

Interactions of amlodipine with antihypertensive, antianginal and antiarrhythmic drugs

Amlodipine can be safely used for the treatment of hypertension together with thiazide diuretics, alpha-blockers or ACE inhibitors.

In patients with stable angina, amlodipine can be combined with other antianginal agents, such as long-acting or short-acting nitrates.

It is possible to enhance the antianginal and hypotensive effects of BMCC when combined with thiazide and loop diuretics, ACE inhibitors and nitrates, as well as to enhance their hypotensive effect when combined with alpha_-1-blockers.

Beta-blockers, when used concomitantly with amlodipine, can cause an exacerbation of the course of heart failure.

Although no negative inotropic effects have usually been observed in studies of amlodipine, however, some BMCs may increase the severity of the negative inotropic effects of antiarrhythmic agents that cause prolongation of the QT interval (for example, amiodarone and quinidine).

Interactions of amlodipine with NSAIDs

Unlike other BMCs, no clinically significant interaction of amlodipine (second generation BMCs) was found when co-administered with nonsteroidal anti-inflammatory drugs (NSAIDs), including indomethacin.

Interactions that do not alter the pharmacokinetics of amlodipine

Cimetidine does not affect the pharmacokinetics of amlodipine.

Grapefruit juice: concomitant single oral administration of 240 mg grapefruit juice and 10 mg amlodipine is not accompanied by a significant change in the pharmacokinetics of amlodipine.

Aluminum-or magnesium-containing antacids: their single use does not significantly affect the pharmacokinetics of amlodipine.

A single dose of 100 mg of sildenafil in patients with arterial hypertension does not affect the pharmacokinetics of amlodipine.

Interactions that do not involve changes in the pharmacokinetics of other drugs

It does not affect the serum concentration of digoxin and its renal clearance. It does not significantly affect the effect of warfarin (prothrombin time).

In vitro studies, amlodipine did not affect the binding of digoxin, phenytoin, warfarin, and Indometacin to plasma proteins.

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 (beverages containing alcohol): amlodipine with a single and repeated use in a dose of 10 mg does not affect the pharmacokinetics of ethanol.

Amlodipine does not alter the pharmacokinetics of cyclosporine.

Interactions of amlodipine with antibiotics and antiviral drugs

Erythromycin, when co-administered, increases the_cmax of amlodipine in young patients by 22%, and in the elderly-by 50%.

Antiretroviral drugs (ritonavir ) increase the plasma concentrations of BMCC, including amlodipine.

Interactions of amlodipine with lithium preparations and anaesthetics

Neuroleptics and isoflurane-increase the hypotensive effect of dihydropyridine derivatives.

When amlodipine is co-administered with lithium preparations, it is possible to increase the manifestation of neurotoxicity (nausea and vomiting, diarrhea, ataxia, intentional tremor, tinnitus).

How to take, course of use and dosage

Inside, once a day, with the necessary amount of water (100 ml).

With arterial hypertension and angina pectoris: the initial dose is 5 mg once a day. In the absence of a therapeutic effect for 2 to 4 weeks, the dose of the drug can be increased to 10 mg/day. once.

In elderly patients: no dose adjustment is required.

In patients with impaired liver function: Despite the fact that T_1/2 of amlodipine, like all BMCC, increases in patients with impaired liver function, dose adjustment is usually not required.

In patients with renal insufficiency: It is recommended to use Amlodipine-Teva in normal doses.

Overdose

Symptoms: marked decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent arterial hypotension, including shock and death).

Treatment: gastric lavage, use of activated charcoal (especially in the first 2 hours after overdose), maintenance of cardiovascular function, elevated position of the lower extremities, monitoring of heart and lung function, control of circulating blood volume (BCC) and diuresis. To restore vascular tone – the use of vasoconstrictors (in the absence of contraindications to their use). To eliminate the consequences of calcium channel blockade – intravenous use of calcium gluconate. Hemodialysis is ineffective.

Special instructions

During therapy with Amlodipine – Teva, it is necessary to monitor body weight and sodium intake, and the appointment of an appropriate diet is indicated.

It is necessary to maintain oral hygiene and follow up with a dentist (to prevent soreness, bleeding and gum hyperplasia).

Use in cardiovascular diseases: when using Amlodipine – Teva in patients with chronic heart failure of NYHA functional class III and IV, pulmonary edema may develop.

In acute myocardial infarction, Amlodipine-Teva is prescribed after stabilization of hemodynamic parameters.

Use in hepatic insufficiency: patients with hepatic insufficiency should be under the supervision of a doctor if necessary to take Amlodipine – Teva.

Use in the elderly: in elderly patients, T _{1/2 may increase} and drug clearance may decrease. Dose changes are not required, but more careful monitoring of patients in this category is necessary.

Use in patients with impaired renal function: in patients with impaired renal function, monitoring of the condition is necessary. The efficacy and safety of Amlodipine-Teva in hypertensive crisis has not been established.

Influence on the ability to drive vehicles and other complex mechanisms

Although no adverse effects on the ability to drive vehicles or other complex mechanisms were observed while taking Amlodipine – Teva, however, due to the possible excessive decrease in blood pressure, the development of dizziness, drowsiness and other adverse reactions, caution should be exercised in these situations, especially at the beginning of treatment and when increasing the dose. Despite the absence of “withdrawal” syndrome in BMCC, it is advisable to stop treatment with Amlodipine – Teva, gradually reducing the dose of the drug.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Amlodipine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Angina