Norvask

Norvask – the drug having anti-hypertensive and anti-anginal effect.

Form of release and structure

Norvask is issued in the form of tablets: white or almost white, in the form of an octahedron with the uneven parties, on one party – the Pfizer logo, on another (depending on a dosage) – "AML-5" or "AML-10" (on 10 pieces in blisters, on 1, 3, 4, 9 blisters in a cardboard pack; on 14 pieces in blisters, on 1 blister in a cardboard pack).

Is a part of 1 tablet:

• Active agent: амлодипин – 5 or 10 mg (it is equivalent to the maintenance of a bezilat of an amlodipin – 6,944 and 13,889 mg respectively);
• Additional components (5/10 mg of active agent): magnesium stearate – 2/4 mg, microcrystallic cellulose – 124,056/248,111 mg, sodium carboxymethylstarch – 4/8 mg, calcium hydrophosphate – 63/126 mg.

Indications to use

• Arterial hypertension;
• Vasospastic stenocardia (alternative stenocardia or Printsmetal's stenocardia);
• Stable stenocardia.

Drug can be used independently or in a combination with other hypotensive or anti-anginal drugs.

Contraindications

Absolute:

• The heavy course of arterial hypotension (systolic pressure is less than 90 mm hg);
• Hemodynamically unstable heart failure after a myocardial infarction;
• Obstruction of the taking-out path of a left ventricle, including a heavy aortal stenosis;
• Age up to 18 years (the researches confirming safety and efficiency of use of Norvask for this age category of patients were not conducted);
• Hypersensitivity to drug components, and also to other derivatives of dihydropyridine.

Relative (purpose of Norvask demands care against the background of the following diseases / states):

• Chronic heart failure of not ischemic etiology (on NYHA classification – the III-IV functional class);
• Acute myocardial infarction (in addition – for 30 days after it);
• Liver failure;
• Hypertrophic subaortic stenosis;
• Unstable stenocardia;
• Arterial hypotension;
• Aortal and mitral stenosis;
• Syndrome of weakness of a sinus node, including the expressed tachycardia, bradycardia;
• Simultaneous use with inductors or inhibitors of an isoenzyme CYP3A4.

Due to the lack of data on safety and efficiency of use of Norvask to pregnant women drug is appointed only after assessment of a ratio of advantage and risk for health of mother and a fruit. In the period of a lactation for the period of therapy breastfeeding needs to be interrupted.

Route of administration and dosage

Pill should be taken inside, washing down with water in the sufficient volume (100 ml).

The recommended dosing mode: 5 mg once a day. If necessary increase in a single dose to maximum – 10 mg is possible.

For patients of advanced age, patients with functional disturbances of kidneys or a liver, and also at the combined use with thiazide diuretics, inhibitors of an angiotensin-converting enzyme and β-adrenoblockers correction of the scheme of administration of drug is not required.

Side effects

Possible side effects (more than 1/10 – it is very frequent; more than 1/100 and less than 1/10 – it is frequent; more than 1/1000 and less than 1/100 – infrequently; more than 1/10 000 and less than 1/1000 – it is rare; less than 1/10 000 (taking into account separate messages) – it is very rare):

• Nervous system: often – drowsiness, increased fatigue, dizziness, a headache; infrequently – hypesthesias, an adynamy, a febricula, peripheral neuropathy, paresthesias, a hyperexcitability, a tremor, lability of mood, sleeplessness, unusual dreams, a depression, a ring in ears, a food faddism, uneasiness; very seldom – an ataxy, migraine, amnesia, the increased sweating, agitation, apathy;
• Cardiovascular system: often – rushes of blood to face skin, feeling of heartbeat, peripheral hypostases (preferential feet and anklebones); infrequently – excessive lowering of arterial pressure; very seldom – a vasculitis, a syncope, thorax pains, short wind, orthostatic hypotension, a myocardial infarction, aggravation of a current or developing of chronic heart failure, disturbance of a heart rhythm (including atrial fibrillation, bradycardia and ventricular tachycardia);
• Digestive tract: often – abdominal pains, nausea; infrequently – thirst, vomiting, diarrhea or a lock, dyspepsia, a meteorism, dryness of a mucous membrane of an oral cavity, anorexia; seldom – increase in appetite, a fibromatosis of gums; very seldom – the gastritis, pancreatitis, jaundice (caused by a cholestasia), hepatitis, increase in blood serum of amount of bilirubin, increase in activity of hepatic transaminases;
• Skeletal and muscular system: infrequently – arthrosis, dorsodynias, muscular spasms, an arthralgia, a mialgiya; seldom – a myasthenia;
• Respiratory system: infrequently – rhinitis, диспноэ, nasal bleeding; very seldom – cough;
• Hemopoietic system: very seldom – a leukopenia, Verlgof's disease, thrombocytopenia;
• Urinogenital system: infrequently – a nocturia, the painful and/or speeded-up urination, erectile dysfunction; very seldom – a polyuria, a dysuria;
• Integuments: seldom – dermatitis; very seldom – cold sweat, a pigmental xeroderma, a hair loss, disturbance of skin pigmentation;
• Sense bodys: infrequently – disturbance of accommodation and sight, a diplopia, eye pain, a xerophthalmia, conjunctivitis;
• Metabolism: very seldom – a hyperglycemia; infrequently – change (increase or decrease) of body weight;
• Datas of laboratory: very seldom – increase in content of glucose in blood serum;
• Allergic reactions: infrequently – a skin itch, rash (including urticaria, erythematic, makulopapulezny rash); very seldom – a multiformny erythema, a Quincke's disease;
• Others: infrequently – a gynecomastia, a fever; very seldom – disturbance of sense of smell (parosmiya).

Special instructions

To avoid development of morbidity, the hyperplasia and bleeding of gums need to maintain hygiene of teeth and to be observed at the stomatologist.

Elderly patients need more careful observation of a state.

At hypertensive crisis Norvask is not appointed (there are no data on its safety and efficiency).

At chronic heart failure (a class III and IV on NYHA) not ischemic genesis increase in frequency of edematization of lungs in the absence of signs of deterioration in heart failure is noted.

Because of probability of development of strongly expressed lowering of arterial pressure, emergence of drowsiness, dizziness and other side effects at control of motor transport and performance of other potentially dangerous works as the patient it is necessary to be careful, in particular at the beginning of a course of inclusion of Norvask and at increase in a dosage.

Medicinal interaction

Norvask, depending on indications, can be applied safely in a combination to the following medicines:

• Arterial hypertension: thiazide diuretics, α-adrenoblockers, β-adrenoblockers or inhibitors of an angiotensin-converting enzyme;
• Stable stenocardia: other anti-anginal means, including β-adrenoblockers, nitrates of the short or prolonged action.

At the combined use of Norvask with non-steroidal anti-inflammatory drugs (including indometacin), antibiotic and peroral hypoglycemic medicines of clinically significant interaction it was not revealed.

At the combined use of Norvask with some drugs the following effects can be observed:

• Neuroleptics, _{α1-адреноблокаторы}: strengthening of their anti-hypertensive action;
• Inhibitors of an angiotensin-converting enzyme, diuretics (thiazide and loopback), β-adrenoblockers and nitrates: strengthening of anti-anginal and anti-hypertensive action;
• Simvastatin (a multiple concomitant use of a simvastatin in a dose of 80 mg and an amlodipina in a dose of 10 mg): increase in exposure of a simvastatin (it is necessary to limit its dose to 20 mg);
• The antiarrhytmic drugs causing lengthening of an interval of QT (quinidine, Amiodaronum): strengthening of expressiveness of negative inotropic effect;
• Neuroleptics and изофлуран: strengthening of anti-hypertensive action of Norvask;
• Antiviral drugs (ритонавир): increase in plasma concentration of an amlodipin;
• Lithium drugs: strengthening of manifestation of its neurotoxicity (in the form of a sonitus, an ataxy, nausea, a tremor, vomiting, diarrhea);
• SUR3A4 isoenzyme inhibitors: increase in system exposure of an amlodipin at patients of advanced age against the background of arterial hypertension;
• Powerful inhibitors of an isoenzyme CYP3A4 (итраконазол, кетоконазол): increase in concentration of an amlodipin in a blood plasma (the combined use demands care);
• CYP3A4 isoenzyme inductors: influence on arterial pressure (careful control at a concomitant use with Norvask is necessary);
• Grapefruit juice: increase in bioavailability of an amlodipin and, as a result, strengthening of hypotensive effect (the combination is not recommended).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 4 years.