Amlodipine pills 10mg, 20pcs

Composition

1 tablet contains:  

Active ingredient:

amlodipine besylate (in terms of amlodipine) – 10 mg.

Auxiliary substances:

Ingredients: calcium stearate,

potato starch,

lactose (milk sugar),

magnesium stearate,

microcrystalline cellulose.

Pharmacological action

A dihydropyridine derivative-BMCC of the second generation, has an antianginal and antihypertensive effect. Binding to the S6 segment of the III and IV domains of the alpha-1 subunit of the L-type calcium channel, it blocks calcium channels and reduces the transmembrane transition of Ca2+ into the cell (to a greater extent into vascular smooth muscle cells than into cardiomyocytes).

It has antihypertensive and antianginal effects. The mechanism of antihypertensive action of amlodipine is due to the direct relaxing effect on vascular smooth muscles. The reduction of myocardial ischemia occurs due to the expansion of coronary and peripheral arteries and arterioles in unchanged and ischemic areas of the myocardium, a decrease in OPSS, a decrease in afterload, and myocardial oxygen demand.

Increases oxygen supply to the myocardium in patients with vasospastic angina (Prinzmetal angina); prevents the development of coronary spasm caused by smoking.

In patients with angina pectoris, a single daily dose increases the time of exercise, delays the development of the next angina attack and depression of the S-T segment (by 1 mm) during exercise, reduces the frequency of angina attacks and nitroglycerin consumption. 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 daily dose provides a clinically significant reduction in blood pressure for 24 hours (in the patient’s “lying” and “standing” positions).

In patients with CCC diseases (including single-vessel coronary atherosclerosis and up to 3 or more arterial stenosis, carotid artery atherosclerosis) who have undergone MI, percutaneous transluminal angioplasty of the coronary arteries, or patients with angina pectoris, the use of amlodipine prevents thickening of the intima-media of the carotid arteries, reduces mortality from MI, stroke, transluminal angioplasty, aorto-coronary artery bypass grafting; reduces the number of hospitalizations for unstable angina and the progression of CHF; reduces the frequency of interventions aimed at restoring coronary blood flow.

It does not increase the risk of death or development of complications and deaths in patients with CHF (NYHA class III-IV) during therapy with digoxin, diuretics and ACE inhibitors. In patients with CHF (NYHA class III-IV) of non-ischemic etiology, amlodipine is likely to cause pulmonary edema. It does not cause a sharp decrease in blood pressure, reduced exercise tolerance, or LV ejection fraction.

Reduces the degree of LV myocardial hypertrophy. It does not affect the contractility and conduction of the myocardium, does not cause a reflex increase in heart rate, 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 has no adverse effects on the metabolism and plasma lipids. Time of onset of the effect – 2-4 hours; duration – 24 hours.

Indications

Arterial hypertension (monotherapy or in combination with other antihypertensive drugs), stable angina pectoris and vasospastic angina pectoris (monotherapy or in combination with other antihypertensive drugs). antianginal drugs).

Contraindications

Hypersensitivity to amlodipine, other dihydropyridine derivatives, and other components of the drug.

Severe arterial hypotension (systolic blood pressure less than 90 mm Hg). Collapse. Cardiogenic shock. Unstable angina (with the exception of Prinzmetal angina). Severe aortic stenosis. Age up to 18 years (efficacy and safety have not been established). Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Pregnancy. Lactation period. Use the drug with caution for: liver function disorders, sinus node weakness syndrome (severe bradycardia, tachycardia ), chronic heart failure of non-ischemic etiology of NYHA functional class III-IV, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and within 1 month after), the elderly.

Side effects

From the cardiovascular system: often-palpitations, peripheral edema (swelling of the ankles and feet); infrequently-excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely-development or aggravation of chronic heart failure; very rarely-rhythm disorders ( bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction, chest pain, migraine. From the central nervous system: often-headache, dizziness, increased fatigue; infrequently-malaise, fainting, neuropsychiatric asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, depression, anxiety; rarely-convulsions, apathy, agitation; very rarely-ataxia, amnesia. Hematopoietic disorders: very rare – thrombocytopenia, leukopenia, thrombocytopenic purpura. From the respiratory system: infrequently – shortness of breath, rhinitis; very rarely-cough. From the digestive tract: 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 – gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of “liver” transaminases, hepatitis. From the genitourinary system: infrequently-pollakiuria, painful urination, nocturia, impotence; very rarely-dysuria, polyuria. From the skin: rarely-increased sweating; very rarely-cold sticky sweat, xeroderma, alopecia, dermatitis, purpura, discoloration of the skin. Allergic reactions: infrequently-pruritus of the skin, rash; very rarely-angioedema, erythema multiforme, urticaria. From the musculoskeletal system: infrequently-arthralgia, muscle cramps, arthrosis, myalgia (with prolonged use), back pain; rarely-myasthenia gravis. Others: infrequently-alopecia, tinnitus, gynecomastia, weight gain/loss, visual impairment, diplopia, accommodation disorders, xerophthalmia, conjunctivitis, eye pain, taste distortion, chills, nosebleeds, increased sweating; rarely – dermatitis; very rarely – cold sticky sweat, parosmia, skin pigmentation disorder, hyperglycemia.

Interaction

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

Unlike other BMCs, amlodipine has no clinically significant interaction with nonsteroidal anti-inflammatory drugs, especially Indometacin. Thiazide and loop diuretics, beta-blockers, verapamil, ACE inhibitors, and nitrates enhance the antianginal or hypotensive effects of amlodipine. Amiodarone, quinidine, alpha-1-blockers, antipsychotics (neuroleptics), and isoflurane may enhance the antihypertensive effect of amlodipine.

Calcium supplements may reduce the effect of BMCC. When amlodipine is co-administered with lithium preparations, it is possible to increase the manifestations of neurotoxicity of the latter ( nausea, vomiting, diarrhea, Ataxia, tremor, tinnitus). Amlodipine does not affect the pharmacokinetic parameters of digoxin and warfarin. Cimetidine does not affect the pharmacokinetics of amlodipine. Antiviral agents (ritonavir ) they contribute to an increase in the concentration of BMCC (including amlodipine) in blood plasma.

How to take, course of use and dosage

Inside, regardless of food intake.

For the treatment of arterial hypertension and prevention of attacks of tension angina and vasospastic angina: the initial dose of Amlodipine is 5 mg once a day.

If necessary, the daily dose can be increased to a maximum of -10 mg (1 time per day).

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 an overdose), maintenance of the cardiovascular system, monitoring of heart and lung function indicators, Trendelenburg pose, monitoring of the volume of circulating blood and diuresis. To restore vascular tone – the use of vasoconstrictor drugs (in the absence of contraindications to their use); to eliminate the consequences of calcium channel blockade – intravenous use of calcium gluconate. Hemodialysis is not effective.

Special instructions

Use in patients with impaired liver function: patients with impaired liver function as a hypotensive agent, Amlodipine is prescribed with caution, at an initial dose of 2.5 mg, as an antiangial agent – 5 mg.

Use in patients with renal insufficiency: no dose adjustment is required in patients with renal insufficiency. In elderly patients: T 1/2 may increase and creatinine clearance (CC) may decrease. No dose changes are required, but patients should be monitored more closely.No dose adjustment is required when co-administered with thiazide diuretics, beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors.

During treatment with Amlodipine, it is necessary to monitor the body weight of patients and the amount of sodium salt they consume ; an appropriate low-salt diet is prescribed. It is necessary to maintain dental hygiene and regularly visit the dentist (to prevent soreness, bleeding and gum hyperplasia).

The dosage regimen of Amlodipine in elderly patients is similar to that in patients of other age groups. When increasing the dose, careful monitoring of elderly patients is necessary. Despite the absence of “withdrawal” syndrome in BMCC, a gradual dose reduction is recommended before discontinuing treatment. Amlodipine does not affect the plasma concentrations of potassium, glucose, triglycerides, total cholesterol, low-density lipoproteins, uric acid, creatinine and urea nitrogen in the blood. Abrupt discontinuation of the drug should be avoided due to the risk of worsening angina pectoris.

Amlodipine tablets are not recommended for hypertensive crisis. Patients with low body weight, short stature, and severe hepatic impairment may require a lower dose. Effects on the ability to drive vehicles and operate mechanisms There have been no reports of the effect of Amlodipine on driving vehicles or working with mechanisms. However, some patients may experience drowsiness and dizziness, especially at the beginning of treatment.

If they occur, you should be careful when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Amlodipine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Angina, Hypertension