Normodipine - instructions for use, reviews, analogs and forms of release (5 mg and 10 mg tablets) drugs for the treatment of hypertension and blood pressure, angina in adults, children and pregnancy

In this article, you can read the instructions for using the drug Normodipine. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Normodipin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Normodipina in the presence of existing structural analogues. Use to treat hypertension and reduce blood pressure, angina in adults, children, as well as during pregnancy and lactation.

Normodipine - a slow calcium channel blocker, a dihydropyridine derivative, has an antianginal and hypotensive effect. Linking with segments S6 3 and 4 domains of the alpha-subunit of the calcium channel L-type, blocks calcium channels, reduces the transmembrane transition of calcium ions into the cell (mostly in the smooth muscle cells of the vessels than in the cardiomyocytes). Antianginal effect is due to the expansion of coronary and peripheral arteries and arterioles: with angina decreases the severity of myocardial ischemia; expanding peripheral arterioles, reduces OPSS, reduces preload on the heart, reduces the need for myocardium in oxygen. Expands coronary arteries and arterioles in unchanged and ischemic zones of the myocardium, increases the flow of oxygen into the myocardium (especially with vasospastic angina); prevents the development of spasm of the coronary arteries (including those caused by smoking). In patients with stable angina, a single daily dose increases exercise tolerance, slows the development of angina pectoris and "ischemic" depression of the ST segment, reduces the incidence of angina attacks and the consumption of Nitroglycerin and other nitrates.

Has a long-term dose-dependent hypotensive effect. The hypotensive effect is due to a direct vasodilating effect on smooth muscle vessels. With arterial hypertension, a single dose provides a clinically significant decrease in blood pressure over a period of 24 hours (in the patient's position "lying" and "standing").

Orthostatic hypotension in the appointment of Amlodipine (the active substance of the drug Normodipine) is rare. Does not cause a decrease in exercise tolerance, a fraction of the ejection of the left ventricle. Reduces the degree of myocardial hypertrophy of the left ventricle. Does not affect the contractility and conductance of the myocardium, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases the rate of glomerular filtration, has a weak natriuretic effect. When diabetic nephropathy does not increase the severity of microalbuminuria. 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 and gout.

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

Composition

Amlodipine besylate + auxiliary substances.

Pharmacokinetics

When ingested slowly and almost completely absorbed from the digestive tract. Eating does not affect absorption. The average absolute bioavailability is 64%. It penetrates the blood-brain barrier (GEB) and into breast milk. Binding to plasma proteins - 97%. About 90% of amlodipine is biotransformed in the liver with the formation of inactive metabolites. Amlodipine is excreted from the body with urine (10% of the dose in unchanged form and 60% in the form of inactive metabolites) and with feces (20-25% in the form of metabolites). The derivation is two-phase. When hemodialysis, amlodipine is not removed.

Indications

• arterial hypertension (in the form of monotherapy or in combination with other antihypertensive agents);
• stable angina pectoris (in the form of monotherapy or in combination with other antianginal agents);
• vasospastic angina (Prinzmetal angina) (in the form of monotherapy or in combination with other antianginal agents).

Forms of release

Tablets 5 mg and 10 mg.

Instructions for use and dosing regimen

Inside, the initial dose for the treatment of hypertension and angina is 5 mg 1 timeper day. The maximum daily dose is 10 mg. With arterial hypertension, the maintenance dose is 5 mg per day.

Do not require dose changes with simultaneous administration with thiazide diuretics, beta-blockers and ACE inhibitors.

In elderly patients, the half-life of amlodipine may increase and creatinine clearance may decrease. Dose changes are not required, but more careful monitoring of patients is necessary.

Patients with renal insufficiency do not require dose changes.

Side effect

• palpitation;
• peripheral edema (swelling of the ankles and feet);
• flushes of blood to the skin of the face;
• excessive decrease in blood pressure;
• development or aggravation of the course of heart failure;
• rhythm disturbances (bradycardia, ventricular tachycardia, atrial fibrillation);
• myocardial infarction;
• pain in the chest;
• orthostatic hypotension;
• vasculitis;
• headache;
• dizziness;
• increased fatigue;
• drowsiness;
• asthenia;
• general malaise;
• paresthesia;
• peripheral neuropathy;
• tremor;
• fainting;
• insomnia;
• mood lability;
• unusual dreams;
• increased excitability;
• depression;
• anxiety;
• apathy;
• ataxia;
• amnesia;
• nausea, vomiting;
• stomach ache;
• constipation or diarrhea;
• flatulence;
• dyspepsia;
• anorexia;
• dryness of the oral mucosa;
• thirst;
• increased appetite;
• pancreatitis;
• gastritis;
• jaundice (caused by cholestasis);
• hepatitis;
• thrombocytopenic purpura, leukopenia, thrombocytopenia;
• frequent urination;
• painful urination;
• nocturia;
• impotence;
• dysuria;
• polyuria;
• dermatitis;
• purpura;
• xeroderma;
• violation of skin pigmentation;
• itching;
• rash (including erythematous, maculopapular rash);
• hives;
• angioedema;
• erythema multiforme;
• muscle cramps;
• myalgia (with prolonged use);
• arthralgia;
• backache;
• arthrosis;
• visual impairment;
• conjunctivitis;
• Pain in the eyes;
• xerophthalmia;
• tinnitus;
• alopecia;
• gynecomastia;
• increase / decrease in body weight;
• nose bleed;
• increased sweating;
• cold sticky sweat;
• cough;
• rhinitis;
• a violation of taste sensations;
• hyperglycemia.

Contraindications

• severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
• collapse;
• cardiogenic shock;
• clinically significant aortic stenosis;
• unstable angina (with the exception of Prinzmetal's stenocardia);
• pregnancy;
• lactation period;
• age under 18 years (due to lack of clinical experience in the application);
• hypersensitivity to amlodipine and other dihydropyridine derivatives.

Application in pregnancy and lactation

In animal studies, teratogenic effects of amlodipine have not been identified, but there is no clinical experience with its use in pregnancy and lactation. Therefore, amlodipine should not be given to pregnant and lactating women, nor to women of childbearing age unless they use reliable contraceptive methods.

Use in children

Contraindicated in children and adolescents under the age of 18 (lack of clinical experience in this age group).

special instructions

During the period of treatment with Normodipine, it is necessary to control body weight and sodium intake, and the purpose of the appropriate diet is indicated. It is necessary to maintain dental hygiene and supervision at the dentist (to prevent soreness, bleeding and gingival hyperplasia).

Patients with low body weight, low growth patients and patients with severe liver function impairment may need a smaller dose.

If the liver function is impaired, the half-life of the drug may also be prolonged. Therefore, such patients Normodipine should be administered with caution.

Despite the fact that the discontinuation of taking Normodipine is not accompanied by the development of withdrawal syndrome, it is advisable to discontinue treatment, gradually reducing the dose of the drug.

The efficacy and safety of the drug for hypertensive crisis is not established.

Influence on the ability to drive vehicles and control mechanisms

There have been no reports of the effects of Normodipine on vehicle management or work with machinery. However, some patients, mainly at the beginning of treatment, may experience drowsiness, dizziness and other side effects from the nervous system. When they occur, the patient must observe special precautions when driving and working with complex mechanisms.

Drug Interactions

Normodipine can safely be used to treat arterial hypertension along with thiazide diuretics, alpha-blockers, beta-blockers, or ACE inhibitors.In patients with stable angina, the drug can be combined with other antianginal agents, for example, with long-acting nitrates, beta-blockers or short-acting nitrates.

Amlodipine can be used simultaneously with non-steroidal anti-inflammatory drugs (NSAIDs) (especially indomethacin), antibacterial agents and hypoglycemic agents for oral administration.

It is possible to intensify the antianginal and hypotensive action of slow calcium channel blockers dihydropyridine series when combined with thiazide and loop diuretics, verapamil, ACE inhibitors, beta-adrenoblockers and nitrates, as well as enhance their hypotensive effect when combined with alpha1-adrenergic blockers, antipsychotics .

Although no negative inotropic effects were usually observed in the study of amlodipine, nevertheless some slow calcium channel blockers may increase the negative inotropic effect of antiarrhythmic agents that cause prolongation of the QT interval (for example, Amiodarone and quinidine).

A single admission of Sildenafil in a dose of 100 mg in patients with essential hypertension does not affect the pharmacokinetics parameters of amlodipine.

The repeated use of Normodipine 10 mg and Atorvastatin 80 mg is not accompanied by significant changes in the pharmacokinetics of atorvastatin.

Amlodipine with a single and repeated application in a dose of 10 mg does not affect the pharmacokinetics of ethanol (drinks containing alcohol).

Antiviral agents (ritonavir) increases plasma concentrations of blockers of slow calcium channels, incl. amlodipine.

Neuroleptics and isoflurane increase the hypotensive effect of dihydropyridine derivatives.

Calcium preparations can reduce the effect of blockers of slow calcium channels.

When amlodipine is used together with lithium preparations, it is possible to intensify manifestations of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

Normodipine does not alter the pharmacokinetics of cyclosporine.

Does not affect the concentration of serum Digoxin and its renal clearance.

Has no significant effect on the effect of Warfarin (prothrombin time).

Cimetidine does not affect the pharmacokinetics of amlodipine.

In studies, amlodipine does not affect the binding to blood proteins of digoxin, phenytoin, warfarin, and indomethacin.

Simultaneous single intake of 240 mg of grapefruit juice and 10 mg of amlodipine by mouth is not accompanied by a significant change in the pharmacokinetics of amlodipine.

Analogues of the drug Normodipine

Structural analogs for the active substance:

• Agen;
• Acridipine;
• Amlovas;
• Amlodak;
• Amlodigamma;
• Amlodipine;
• Amlodipharm;
• Amlong;
• Ammonorm;
• Amrorus;
• Amlotop;
• Kalchek;
• Cardilopin;
• Karmagip;
• Corvadil;
• Cordy Cor;
• Norvasc;
• Omerar Cardio;
• Stamlo;
• Tenox.

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