Norvask 10 mg tablets 30
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Active substance: amlodipine bezylate 13.889 mg, which corresponds to the content of amlodipine 10 mg.
Excipients: microcrystalline cellulose - 248.111 mg, calcium hydrogen phosphate anhydrous - 126 mg, sodium carboxymethyl starch - 8 mg, magnesium stearate - 4 mg.
Slow calcium channel blocker (BMCC), a derivative of dihydropyridine. It has an antihypertensive and antianginal effect. Blocks slow calcium channels, reduces the transmembrane transition of calcium ions into cells (to a greater extent - into smooth muscle cells of blood vessels than into cardiomyocytes).
Antianginal action is due to the expansion of coronary and peripheral arteries and arterioles.
With angina pectoris, it reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces OPSS, reduces the afterload on the heart, reduces the need for myocardium in oxygen. Expanding the coronary arteries and arterioles in unchanged and ischemic zones of the myocardium, increases the supply of oxygen to the myocardium (especially with vasospastic angina); prevents 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 attacks and ischemic depression of the ST segment, reduces the frequency of angina attacks and consumption of nitroglycerin and other nitrates.
It has a long-term dose-dependent antihypertensive effect, the mechanism of which is due to a direct relaxing effect on the smooth muscles of the vessels. In arterial hypertension, a single dose provides a clinically significant decrease in blood pressure for 24 hours (in the position of the patient lying and standing).
Orthostatic hypotension with the use of amlodipine is quite rare.
Amlodipine does not cause a decrease in exercise tolerance, the left ventricular ejection fraction. Reduces the degree of hypertrophy of the left ventricular myocardium. It does not affect the contractility and conductivity of the myocardium, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases GFR, has a weak natriuretic effect. In diabetic nephropathy, the severity of microalbuminuria does not increase. It does not have any adverse effect on the metabolism and concentration of blood 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 the defeat of one vessels and up to stenosis of 3 or more arteries and atherosclerosis of the carotid arteries), who have undergone myocardial infarction, percutaneous transluminal angioplasty of the coronary arteries (PTCA) or in 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, PTCA, coronary artery bypass grafting, leads to a decrease in the number of hospitalizations for unstable angina pectoris and the progression of chronic cardiac heart disease insufficiency (CHF), reduces the frequency of interventions aimed at restoring coronary blood flow.
Does not increase the rate of mortality or the development of complications and deaths in patients with chronic heart failure (III-IV functional class according to the NYHA classification) against the background of therapy with digoxin, diuretics and ACE inhibitors.
In patients with CHF (III-IV functional class according to the NYHA classification) of non-ischemic etiology with the use of amlodipine there is a possibility of pulmonary edema.
Indications for use
- arterial hypertension (both as monotherapy and in combination with other antihypertensive drugs);
- stable angina and vasospastic angina (Prinzmetal angina) (both as monotherapy and in combination with other antianginal agents).
- severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
- obstruction of the outgoing tract of the left ventricle (including severe aortic stenosis);
- shock (including cardiogenic);
- hemodynamically unstable heart failure after myocardial infarction;
- age up to 18 years (efficacy and safety have not been established);
- hypersensitivity to amlodipine and other derivatives of dihydropyridine, as well as excipients that make up the drug.
With caution, the drug should be used in patients with hepatic insufficiency, chronic heart failure of non-ischemic etiology III-IV functional class according to the NYHA classification, unstable angina, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and within 1 month after it), SSSU (severe tachycardia, bradycardia), arterial hypotension, with simultaneous use with inhibitors or inducers of the isoenzyme CYP3A4.
Use in pregnancy and lactation
Safety of the drug Norvask ® during pregnancy is not established, so the use during pregnancy is possible only when the intended benefit to the mother exceeds the potential risk to the fetus.
There is no evidence of excretion of amlodipine in breast milk. However, it is known that other slow calcium channel blockers (dihydropyridine derivatives) are excreted in breast milk. In this regard, if necessary, the use of the drug Norvask ® during lactation, the issue of stopping breastfeeding should be addressed.
There was no effect of amlodipine on fertility in a study on rats.
Use in case of impaired liver function
With caution, the drug should be used in patients with hepatic insufficiency.
Use in renal dysfunction
In patients with impaired renal function, it is recommended to use Norvask ® at normal doses, however, a possible slight increase in T should be considered 1/2 .
Use in childrenContraindicated appointment of the drug under the age of 18 years, because the effectiveness and safety of its use in this group of patients are not precisely established.
Use in elderly patientsIn elderly patients, the drug is recommended to be used in an average therapeutic dose, a change in the dose of the drug is not required.
During treatment with the drug, it is necessary to maintain oral hygiene and observation by a dentist (to prevent soreness, bleeding and hyperplasia of the gums).
In elderly patients, T may increase 1/2 and reduce the clearance of the drug. Dose changes are not required, but more careful monitoring of patients in this category is necessary.
Efficacy and safety of the drug Norvask ® with hypertensive crisis not established.
Despite the lack of slow calcium channel blockers withdrawal syndrome, discontinuation of treatment with Norvask ® it is desirable to carry out, gradually reducing the dose of the drug.
Against the background of the use of amlodipine in patients with chronic heart failure (class III and IV according to the NYHA classification) of non-ischemic genesis, an increase in the incidence of pulmonary edema was noted, despite the absence of signs of worsening heart failure.
Influence on the ability to drive vehicles and control mechanisms
Although against the background of taking the drug Norvask ® no negative effect on the ability to drive a car or other technical means was observed, however, due to a possible excessive decrease in blood pressure, the development of dizziness, drowsiness and other side effects, one should be attentive to the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.
Dosage and Administration
The drug is taken orally 1 time / day, washed down with the necessary amount of water (100 ml).
With arterial hypertension and angina pectoris, the initial dose is 5 mg, depending on the individual reaction of the patient, it can be increased to a maximum dose of 10 mg.
No dose adjustment of Norvask is required ® with the simultaneous use of thiazide diuretics, beta-blockers or ACE inhibitors.
In elderly patients, the drug is recommended to be used in an average therapeutic dose, a change in the dose of the drug is not required.
Despite the fact that T 1/2 amlodipine, like all calcium channel blockers, increases in patients with impaired liver function, dose adjustment of the drug in this category of patients is usually not required.
In patients with impaired renal function it is recommended to use Norvask ® at normal doses, however, a possible slight increase in T should be considered 1/2 .
Symptoms: a pronounced decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (there is a possibility of pronounced and persistent arterial hypotension, including with the development of shock and death).
Treatment: gastric lavage, the appointment of activated charcoal (especially in the first 2 hours after an overdose), a horizontal position with a low headboard, maintaining the function of the cardiovascular system, monitoring the performance of the heart and lungs, monitoring BCC and diuresis. To restore vascular tone - the use of vasoconstrictor drugs (in the absence of contraindications to their use); to eliminate the effects of calcium channel blockade - intravenous administration of calcium gluconate. Hemodialysis is ineffective.
The frequency of adverse reactions given below has been determined according to the WHO classification: very often (>1/10), often (from >1/100 to <1/10), infrequently (from >1/1000 to <1/100), rarely (from >1/10,000 to <1/1000), very rarely (from <1/10,000), including individual reports, is unknown (it is impossible to estimate the frequency based on available data).
From the cardiovascular system: often - a feeling of palpitations, peripheral edema (ankles and feet), "flushes" of blood to the skin of the face; infrequently - excessive decrease in blood pressure; very rarely - fainting, shortness of breath, vasculitis, orthostatic hypotension, development or aggravation of the course of chronic heart failure, heart rhythm disturbances (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain.
From the musculoskeletal system: infrequently - arthralgia, muscle cramps, myalgia, back pain, arthrosis; rarely - myasthenia gravis.
From the nervous system: often - headaches, dizziness, increased fatigue, drowsiness; infrequently - asthenia, general malaise, hypoesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood lability, unusual dreams, increased excitability, depression, anxiety, ringing in the ears, perversion of taste; very rarely - migraine, increased sweating, apathy, agitation, ataxia, amnesia; unknown - extrapyramidal disorders.
From the digestive system: often - abdominal pain, nausea; infrequently - vomiting, constipation or diarrhea, flatulence, dyspepsia, anorexia, dry mouth, thirst; rarely - hyperplasia of the gums, increased appetite; very rarely - gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of hepatic transaminases, hepatitis.
From the hematopoietic system: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia.
From the respiratory system: infrequently - shortness of breath, rhinitis, nosebleeds; very rarely - cough.
From the side of the organ of vision: infrequently - diplopia, impaired accommodation, xerophthalmia, conjunctivitis, eye pain, visual impairment.
From the urinary system: infrequently - frequent urination, painful urination, nocturia; very rarely - dysuria, polyuria.
From the reproductive system: infrequently - a violation of erectile function, gynecomastia.
From the skin: rarely - dermatitis; very rarely - alopecia, xeroderma, cold sweat, impaired skin pigmentation.
From the side of metabolism: infrequently - an increase / decrease in body weight; very rarely - hyperglycemia.
Allergic reactions: infrequently - skin itching, rash (including erythematous, maculo-papular rash, urticaria); very rarely - angioedema, erythema multiforme.
Other: infrequently - chills, pain of unspecified localization; very rarely - parosmia.
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
Shelf life - 4 years. Do not use after the expiration date.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian
- Russian title