Amlodipine-Teva, pills 5mg 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

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).

Use during pregnancy and lactation

CATEGORY OF ACTION ON THE FETUS. C (Studies of animal reproduction have shown an adverse effect on the fetus, and adequate and strictly controlled studies in pregnant women have not been conducted, but the potential benefits associated with the use of drugs in pregnant women may justify its use, despite the possible risk. )

Contraindications

Hypersensitivity (including to other dihydropyridines), severe arterial hypotension (SBP less than 90 mm Hg), pregnancy, lactation.

With caution. Arterial hypotension, aortic stenosis, CHF of non-ischemic etiology (NYHA class III-IV), liver failure, acute myocardial infarction (and within 1 month after), HOCMP, SSR, age up to 18 years, elderly.

Side effects

of asthma: frequent-more than 1%, infrequently-less than 1%, rarely-less than 0.1%, very rarely-less than 0.01%.

From the cardiovascular system: often-peripheral edema (ankles and feet), palpitations; infrequently-excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely-development or aggravation of HF; very rarely-rhythm disorders (bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction, chest pain, migraine.

From the nervous system: often-headache, dizziness, increased fatigue, drowsiness; infrequently-malaise, fainting, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, depression, anxiety; rarely – convulsions, apathy, agitation; very rarely – ataxia, amnesia.

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 – gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of “liver” transaminases, hepatitis.

Hematopoietic disorders: very rare – thrombocytopenic purpura, leukopenia, thrombocytopenia.

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

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

From the respiratory system: infrequently – shortness of breath, rhinitis; very rarely-cough.

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

Other: 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 plasma, increasing the risk of side effects, and inducers of microsomal liver enzymes can reduce.

Unlike other BMCC, 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.

Ca2+ preparations can reduce the effect of BMCC.

Antiviral agents (ritonavir) increase the plasma concentrations of BMCC, including amlodipine. Neuroleptics and isoflurane-increase the hypotensive effect of dihydropyridine derivatives.

How to take, course of use and dosage

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 smaller doses.

Overdose

Symptoms: a marked decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent hypotension, including shock and death). Treatment: gastric lavage, use of activated charcoal (especially in the first 2 hours after overdose), maintenance of CVS functions, monitoring of heart and lung function, elevated position of the limbs, control of BCC and diuresis, symptomatic and supportive therapy, intravenous use of calcium gluconate and dopamine. Hemodialysis is ineffective.

Special instructions

During treatment, it is necessary to monitor body weight and see 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 treatment.

During treatment, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

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

Angina, Hypertension