Normodipin

Normodipin – drug of anti-anginal and long dozozavisimy hypotensive action; blocker of slow calcium channels.

Form of release and structure

Dosage form of Normodipin – a tablet: oblong and roundish, biconvex, almost white or white color; in a dose of 5 mg – on one of the parties an engraving "5"; in a dose of 10 mg – on one of the parties an engraving "10", on other party – risk (on 10 pieces in blisters, 3 blisters in a cardboard pack).

Contains in 1 tablet:

• Active ingredient: an amlodipina безилат – 6,944 or 13,889 mg (the respectively contents of an amlodipin of 5 or 10 mg);
• Auxiliary components: microcrystallic cellulose, calcium hydrophosphate anhydrous, sodium carboxymethylstarch (type A), magnesium stearate.

Indications to use

Normodipin is shown to use for monotherapy or as a part of the combined treatment of the following diseases / states:

• Stable angina of exertion;
• Arterial hypertension;
• Printsmetal's stenocardia (vasospastic stenocardia).

Contraindications

Absolute:

• The expressed arterial hypotension with a systolic arterial pressure (AP) below 90 mm hg;
• Cardiogenic shock;
• Clinically significant aortal stenosis;
• Collapse;
• Unstable stenocardia (except Printsmetal's stenocardia);
• Period of pregnancy and breastfeeding (lactation);
• Children's and teenage age up to 18 years (there is no clinical experience of use);
• Hypersensitivity to an amlodipin, and also other derivatives of dihydropyridine.

Relative (drug is taken with caution in view of the increased probability of complications):

• Abnormal liver functions;
• The Sick Sinus Syndrome (SSS) with the expressed bradycardia, tachycardia;
• Chronic heart failure of not ischemic etiology on classification of NYHA III-IV of a functional class;
• Arterial hypotension;
• Mitral stenosis;
• Hypertrophic subaortic stenosis;
• Acute myocardial infarction, including the period within 1 month after it;
• Advanced age.

Route of administration and dosage

Pill is taken inside.

For therapy of stenocardia and arterial hypertension Normodipin's reception in an initial dose – 5 mg of 1 times a day is recommended. The maximum dose – 10 mg a day. A maintenance dose at arterial hypertension – 5 mg a day.

In case of co-administration with β-adrenoblockers, thiazide diuretics and inhibitors of an angiotensin-converting enzyme (APF) change of a dose of an amlodipin is not required.

Increase _{in T1/2 (elimination half-life)} in an amlodipin and decrease in clearance of creatinine at patients at advanced age is possible. Correction of doses at the same time is not required, but more careful monitoring of patients is necessary.

At a renal failure change of a dose is not required.

Side effects

• Cardiovascular system: often – peripheral hypostases (especially puffiness of feet and anklebones), rushes of blood to the person, heartbeat; infrequently – an excessive lowering of arterial pressure (ABP); very seldom – a vasculitis, development or an exacerbation of heart failure, disturbance of a cordial rhythm (ventricular tachycardia, bradycardia, atrial fibrillation), breast pain, a myocardial infarction, orthostatic hypotension;
• Central and peripheral nervous system: often – drowsiness, increased fatigue, dizziness, a headache; infrequently – a febricula, an adynamy, a hypesthesia, paresthesias, a tremor, вертиго, a peripheral neuropathy, a syncope, sleeplessness, unusual dreams, lability of mood, a hyperexcitability, alarm, a depression; very seldom – an ataxy, amnesia, agitation, apathy;
• Alimentary system: often – abdominal pains, nausea; sometimes – diarrhea or a lock, a meteorism, vomiting, dyspepsia, anorexia, thirst, dryness of a mucous oral cavity; seldom – increase in appetite, a hyperplasia of gums; very seldom – the gastritis, pancreatitis, jaundice (caused by a cholestasia), increase in activity of hepatic transaminases, a hyperbilirubinemia, hepatitis;
• Bodies of a hemopoiesis: very seldom – a leukopenia, a Werlhof's disease, thrombocytopenia;
• Urinogenital system: seldom – impotence, an urodynia, the speeded-up urination, a nocturia; very seldom – a polyuria, a dysuria;
• Integuments: seldom – dermatitis; very seldom – a xerodermia, a purpura, disturbance of a xanthopathy;
• Allergic reactions: infrequently – rash (including erythematic and makulopapulezny), a skin itch; very seldom – a Quincke's disease, a small tortoiseshell, a mnogoformny erythema;
• Musculoskeletal device: sometimes – a mialgiya (at long use), muscular spasms, an arthralgia, arthrosis, a dorsodynia; seldom – a myasthenia;
• Sense bodys: seldom – a ring in ears, a diplopia, a xerophthalmia, vision disorders, conjunctivitis, eye pain;
• Another: seldom – a gynecomastia, an alopecia, диспноэ, a hyperuricemia, decrease/increase in body weight, nasal bleeding, a hyperhidrosis; very seldom – cough, rhinitis, a cold clammy sweat, a parosmiya, accommodation disturbance, disturbance of flavoring feelings, a hyperglycemia.

The following gradation of frequency of side reactions is used:> 1/10 – very often,> 1/100-<1/10 – it is frequent,> 1/1000 - <1/100 – infrequently,> 1/10 000-<1/1000 – seldom, <1/10 000 – it is very rare, including single messages.

Symptoms of overdose are: tachycardia, the expressed decrease in the ABP, a hypertrophied peripheral vazodilatation with risk of development of the expressed and persistent arterial hypotension, to shock and a lethal outcome inclusive.

Therapy: the patient has to be in a dorsal decubitus with the legs raised higher than the level of the head; reception of absorbent carbon, a gastric lavage, support of function of cardiovascular system, control of volume of the circulating blood, a diuresis, indicators of function of heart and lungs is recommended. For the purpose of recovery of a tone of vessels it is necessary to use vasoconstrictive drugs if there are no contraindications to their use. Elimination of effects of blockade of calcium channels requires intravenous administration of calcium of a gluconate.

The hemodialysis at Normodipin's overdose is inefficient.

Special instructions

In the course of therapy it is necessary to carry out control of body weight and consumption of sodium. Also observance of the corresponding diet, hygiene of an oral cavity, regular sanitation of teeth for the purpose of prevention of bleeding, morbidity and a hyperplasia of gums is recommended.

The reduced dose of drug can be required by patients at the expressed abnormal liver function, the patient of low growth and/or with small body weight.

At patients with abnormal liver functions lengthening _{of T1/2} of an amlodipin therefore they need to take drug with caution is possible.

It is recommended to complete therapy by Normodipin by gradual reduction of a dose of an amlodipin in spite of the fact that the reception termination by development of a withdrawal is not followed.

At hypertensive crisis safety and efficiency of medicine are not established.

To some patients, it is preferential at the beginning of therapy at which owing to administration of drug arise dizziness, drowsiness, other side reactions from a nervous system, it is necessary to observe additional precautionary measures at control of difficult mechanisms and driving of motor transport.

Medicinal interaction

Influence of at the same time accepted substances/drugs on blockers of slow calcium channels of a dihydropyridinic row, including амлодипин:

• Thiazide and "loopback" diuretics, nitrates, verapamil, APF inhibitors, β-adrenoblockers - - - - - - - - - – can strengthen hypotensive and anti-anginal action;
• Neuroleptics, _{α1-адреноблокаторы} – strengthen hypotensive action;
• Antiviral means (including ритонавир) – increase concentration in plasma;
• Izofluran, neuroleptics – strengthen hypotensive action;
• Calcium drugs – can reduce therapeutic effect.

Owing to simultaneous use of drugs of lithium with amlodipiny effects of a neurotoxicity can amplify: ataxy, diarrhea, nausea, vomiting, sonitus, tremor.

Use of an amlodipin for therapy of arterial hypertension together with α-adrenoblockers, β-adrenoblockers, thiazide diuretics or APF inhibitors is safe. At stable stenocardia Normodipin it is possible to accept with other anti-anginal drugs: nitrates of the short or prolonged action, β-adrenoblockers..........

Amlodipin is allowed to use with antibacterial, non-steroidal anti-inflammatory drugs (NPVP), especially indometacin, and hypoglycemic drugs for intake.

Sildenafil in a dose of 100 mg at a single dose at patients with essential hypertensia does not influence pharmacokinetics of an amlodipin.

Repeated reception of an amlodipin (10 mg) with atorvastatiny (80 mg) does not cause clinically significant changes of pharmacokinetic action of an atorvastatin.

Grapefruit juice (240 mg) and Normodipin (10 mg) at a single concomitant use significantly do not change pharmacokinetics of an amlodipin.

Single and repeated use of an amlodipin (10 mg) does not exert impact on ethanol pharmacokinetics (alcoholic beverages).

Amlodipin does not influence cyclosporine pharmacokinetics, renal clearance and concentration in digoxin blood serum, and also on efficiency of warfarin (prothrombin time).

Combined use with Cimetidinum does not exert impact on pharmacokinetics of an amlodipin.

According to the researches in vitro at combined use of digoxin, Phenytoinum, warfarin and indometacin with Normodipin, амлодипин does not exert impact on their linkng with blood proteins.

Terms and storage conditions

To store in the place unavailable to children, at a temperature up to 30 °C.

Period of validity – 3 years.