Amlodipine Sandoz, pills 5mg, 30pcs

Composition

1 tablet contains:

Active ingredient:

amlodipine bezylate (which corresponds to the content of amlodipine 5 mg) – 6,934 mg.

Auxiliary substances:

anhydrous lactose,

microcrystalline cellulose,

corn starch (dry),

talc,

colloidal anhydrous silicon dioxide,

magnesium stearate.

Pharmacological action

Slow calcium channel blocker, dihydropyridine derivative. It has antihypertensive and antianginal effects. Binding to dihydropyridine receptors, it blocks calcium channels, reduces the transmembrane transfer of calcium ions into the cell (to a greater extent in vascular smooth muscle cells than in cardiomyocytes).

Antianginal action is caused by the expansion of coronary and peripheral arteries and arterioles: with angina, it reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces the total peripheral vascular resistance, reduces preload on the heart, reduces the need for myocardial oxygen.

Dilating the main coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases oxygen supply to the myocardium (especially in vasospastic angina); prevents the development of coronary artery constriction (including caused by smoking). In patients with angina pectoris, a single daily dose increases exercise time, slows down the development of angina and ST-segment ischemic depression, 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 dose provides a clinically significant reduction in blood pressure for 24 hours (in the patient’s lying and standing positions).

It does not cause a sharp decrease in blood pressure, reduced exercise tolerance, or left ventricular ejection fraction. Reduces the degree of left ventricular myocardial hypertrophy, has anti-atherosclerotic and cardioprotective effects in ischemic heart disease. 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 does not adversely affect the metabolism and blood plasma lipids.

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

Indications

• Arterial hypertension.
• Stable angina pectoris of tension.
• Vasospastic angina (Prinzmetal angina).

Contraindications

• Severe arterial hypotension.
• Collapse.
• Cardiogenic shock.
• Unstable angina (with the exception of Prinzmetal angina).
• Age up to 18 years (efficacy and safety have not been established).
• Hereditary lactose intolerance, galactosemia (the drug contains lactose).
• Hypersensitivity to the components of the drug.
• Hypersensitivity to other dihydropyridine derivatives.

With caution:  hepatic insufficiency, mild or moderate arterial hypotension, acute myocardial infarction and during the first month after it, aortic stenosis, chronic heart failure in the decompensation stage, SSS, hypertrophic obstructive cardiomyopathy, elderly age.

Side effects

Classification of side effects when using the drug by frequency of occurrence:

• Often (more than 1%).
• Rarely (from 0.1% to 1%).
• Very rare (less than 0.01%).

From the central nervous system and peripheral nervous system:  often – headache, dizziness, fatigue, drowsiness, mood lability; rarely-asthenia, fainting spells, seizures, peripheral neuropathy, increased sweating, insomnia, depression; very rarely-apathy, ataxia, migraine.

From the cardiovascular system:  often – palpitations, shortness of breath, “flushes” of blood to the face, peripheral edema; rarely – chest pain, excessive decrease in blood pressure, orthostatic hypotension; very rarely – cardiac arrhythmias (ventricular tachycardia, atrial fibrillation), myocardial infarction, aggravation of heart failure.

From the digestive system:  often – nausea, dry mouth, abdominal pain; rarely-dyspepsia, constipation, diarrhea, gum hyperplasia, pancreatitis; very rarely-gastritis, jaundice, increased activity of hepatic transaminases.

From the urinary system:  rarely-pollakiuria.

From the side of the reproductive system:  rarely-violation of sexual function, gynecomastia.

Musculoskeletal disorders:  often-back pain; rarely-myalgia, arthralgia, muscle cramps.

Allergic reactions:  rarely-pruritus of the skin, rash; very rarely-erythema multiforme, angioedema.

Other services:  rarely-visual impairment, dyspnoea, alopecia; very rarely-hyperglycemia, thrombocytopenia.

Interaction

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.

Unlike other slow calcium channel blockers, there is no clinically significant interaction with NSAIDs, especially Indometacin.

Thiazide and loop diuretics, beta-blockers, verapamil, ACE inhibitors, and nitrates enhance the antianginal or hypotensive effects.

It has no effect on the pharmacokinetic parameters of digoxin and warfarin.

Cimetidine does not affect the pharmacokinetics of amlodipine.

Calcium supplements may reduce the effect of slow calcium channel blockers.

Antiviral agents (ritonavir) increase plasma concentrations of slow calcium channel blockers.

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

How to take, course of use and dosage

Inside, regardless of food intake.

For the treatment of arterial hypertension and prevention of tension angina attacks and vasospastic angina:  The initial daily dose of Amlodipine is 5 mg in 1 dose.

If necessary, the dose can be increased to a maximum of 10 mg/day once.

Patients with low body weight or short stature, as well as with severe hepatic insufficiency:  smaller doses may be required.

Patients with renal insufficiency and elderly patients:  no dose adjustment is required.

No dose adjustment is required when co-administered with thiazide diuretics, beta-blockers, and ACE inhibitors.

Overdose

Symptoms:  excessive peripheral vasodilation with a clinically pronounced decrease in blood pressure with the possible development of reflex tachycardia.

Treatment:  use of activated charcoal (in the first 2 hours after overdose), gastric lavage, elevated position of the extremities, control of the functions of the cardiovascular and respiratory systems, BCC and diuresis, active maintenance of the functions of the cardiovascular system, possible appointment of vasoconstrictor drugs to restore vascular tone and increase blood pressure, to eliminate the consequences of calcium channel blockade – intravenous use of calcium gluconate. Hemodialysis is ineffective.

Special instructions

It is optimal to use the drug every day at the same time.

Although slow calcium channel blockers do not have withdrawal symptoms, a gradual dose reduction is recommended before discontinuing treatment.

Amlodipine can be prescribed in combination with thiazide diuretics, alpha – and beta-blockers, ACE inhibitors, prolonged-acting nitrates, sublingual nitroglycerin, NSAIDs, antibiotics, oral hypoglycemic agents.

Amlodipine does not adversely affect the metabolism and plasma lipids, so the drug can be used in patients with bronchial asthma, diabetes mellitus and gout.

Influence on the ability to drive motor vehicles and manage mechanisms

The use of amlodipine does not affect the ability to drive vehicles or other technical means, however, due to the possible excessive decrease in blood pressure, slowing down the reaction rate due to the development of Dizziness, headache, fatigue, etc. side effects, you should carefully consider the individual effect of the drug at the beginning of the course of treatment and when changing the dosage regimen.

Storage conditions

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

Shelf

life is 2 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