Amlorus

Amlorus – a blocker of slow calcium channels, drug with anti-anginal and anti-hypertensive action.

Form of release and structure

Dosage form – tablets: a ploskotsilindrichesky form, almost white or white color (the mramornost is possible), with a facet (on 10 таб. in blister strip packagings, in a pack cardboard 3 packagings).

Active agent: амлодипин (in the form of a bezilat), in 1 tablet – 2,5, 5 or 10 mg.

Auxiliary components: cellulose microcrystallic, calcium stearate, silicon dioxide colloid (aerosil), кросповидон, lactoses monohydrate, talc.

Indications to use

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

Amlorus is applied as monodrug or as a part of a combination therapy (in a combination with hypotensive (arterial hypertension) or anti-anginal (vasospastic and stable stenocardias) means).

Contraindications

• Age up to 18 years;
• Unstable stenocardia (except for vasospastic stenocardia);
• Cardiogenic shock;
• Heavy arterial hypotension (systolic arterial pressure is less than 90 mm hg);
• Acute myocardial infarction (first 28 days);
• Obstruction of the taking-out path of a left ventricle (including clinically significant stenosis of an aorta);
• Glyukozo-galaktozny malabsorption, deficit of lactase, lactose intolerance;
• Lactation period;
• Hypersensitivity to components of drug or other derivatives of dihydropyridine.

With care:

• Mitral/aortal stenosis;
• Chronic heart failure of not ischemic etiology of the III-IV functional class according to NYHA classification;
• Sick sinus syndrome (tachycardia, the expressed bradycardia);
• Hypertrophic subaortic stenosis;
• Arterial hypotension;
• Abnormal liver function;
• Advanced age;
• Pregnancy (drug is appointed only when the estimated advantage exceeds possible risks).

Route of administration and dosage

Amlorus it is necessary to accept inside, washing down with enough water, 1 time a day.

The initial dose at arterial hypertension and stenocardia makes 5 mg, in need of it increase up to 10 mg.

The supporting daily dose at arterial hypertension – 5 mg, at Printsmetal's stenocardia – 5-10 mg in 1 reception.

Decrease in an initial dose at arterial hypertension to 2,5 mg can be required by elderly people and patients with a liver failure.

Reduction of an initial dose is required to patients with the expressed abnormal liver functions, to patients of low growth and people with small body weight. To such patients as anti-anginal means Amlorus appoint 5 mg, as hypotensive – on 2,5 mg.

At co-administration of inhibitors of the angiotensin-converting enzyme (ACE), beta adrenoblockers or thiazide diuretics Amlorus's dose is not required to be adjusted.

Side effects

• From cardiovascular system: often (≥1/100, <1/10) – feeling of heat and rushes of blood to face skin, peripheral hypostases (anklebones and feet), a cardiopalmus; infrequently (≥1/1000, <1/100) – an excessive lowering of arterial pressure, a vasculitis, orthostatic hypotension; seldom (≥1/10 000, <1/1000) – aggravation of a current or development of chronic heart failure; very seldom (<1/10 000, including separate messages) – thorax pain, disturbances of a heart rhythm (including atrial fibrillation, ventricular tachycardia, bradycardia), a myocardial infarction;
• From the central nervous system: often – a headache, migraine, drowsiness, dizziness, increased fatigue; infrequently – alarm, the increased sweating, a febricula, unusual dreams, a peripheral neuropathy, an adynamy, sleeplessness, nervousness, a tremor, hypesthesias, lability of mood, a syncope, paresthesias, a depression; seldom – agitation, spasms, apathy; very seldom – amnesia, an ataxy;
• From an urinary system: infrequently – a nocturia, speeded up and/or an urodynia, impotence; very seldom – a polyuria, a dysuria;
• From respiratory system: infrequently – nasal bleeding, rhinitis, an asthma; very seldom – cough;
• From integuments: infrequently – a hair loss; seldom – dermatitis; very seldom – a xerodermia, disturbance of a xanthopathy;
• From the alimentary system: often – nausea, an abdominal pain; infrequently – thirst, anorexia, a meteorism, dryness of a mucous membrane of an oral cavity, dyspepsia, a lock or diarrhea, vomiting; seldom – increase in appetite, a hyperplasia of gums; very seldom – increase in activity of hepatic transaminases, gastritis, jaundice (usually cholestatic), a hyperbilirubinemia, hepatitis, pancreatitis;
• From a metabolism: very seldom – a hyperglycemia;
• From bodies of a hemopoiesis: very seldom – a leukopenia, a Werlhof's disease, thrombocytopenia;
• From a musculoskeletal system: infrequently – a dorsodynia, a mialgiya, arthrosis, myotonia, an arthralgia; seldom – a myasthenia;
• From sense bodys: infrequently – a food faddism, vision disorders, conjunctivitis, eye pain, a xerophthalmia, a diplopia, a ring in ears, accommodation disturbance; very seldom – a parosmiya;
• Allergic reactions: infrequently – skin rash, an itch; very seldom – a small tortoiseshell, a Quincke's disease, a mnogoformny erythema;
• Others: infrequently – a fever, decrease or increase in body weight, a gynecomastia; very seldom – cold sweat.

Special instructions

At arterial hypertension Amlorus it is possible to combine with APF inhibitors, alpha and beta adrenoblockers, thiazide diuretics.

At stenocardia Amlorus can be appointed in a combination with other anti-anginal means, for example, beta adrenoblockers, nitrates of the short or prolonged action.

Amlodipin does not exert impact on plasma concentration of creatinine, uric acid, an urea nitrogen, triglycerides, lipoproteids of low density, the general cholesterol, glucose and potassium ions therefore it can be applied to treatment of patients with a diabetes mellitus, gout and bronchial asthma.

Amlorus it is possible to apply to therapy of the patients predisposed to vasoconstriction (a vascular spasm).

During treatment it is necessary to control body weight, to limit sodium consumption, to adhere to the diet appointed by the doctor, to be observed at the stomatologist (for prevention of bleeding, morbidity and a hyperplasia of gums), and also to be careful when driving the car and performing potentially dangerous types of works.

Amlodipin does not cause a withdrawal, nevertheless before its cancellation it is recommended to reduce a dose gradually.

Medicinal interaction

• Calcium drugs: the effect of an amlodipin decreases;
• Inhibitors of a microsomal oxidation: concentration of an amlodipin in a blood plasma increases and the risk of development of side effects amplifies;
• Lithium drugs: manifestations of their neurotoxicity (an ataxy, diarrhea, nausea, vomiting, a sonitus, a tremor) can amplify;
• Inductors of microsomal enzymes of a liver: concentration of an amlodipin in a blood plasma decreases;
• The antiarrhytmic drugs causing lengthening of an interval of QT (quinidine, Amiodaronum, procaineamide): strengthening of expressiveness of their negative inotropic effect is possible;
• APF inhibitors, beta adrenoblockers, loopback and thiazide diuretics, nitrates, verapamil: anti-hypertensive and anti-anginal action of an amlodipin amplifies;
• Neuroleptics, _{alfa1-adrenoblockers}, quinidine, Amiodaronum: anti-hypertensive action can amplify;
• Antiviral drugs (ритонавир): plasma concentration of an amlodipin increases.

At the use of grapefruit juice during treatment by Amlorus decrease in concentration of an amlodipin in a blood plasma is possible, however at a single dose of 240 mg of juice and 10 mg of an amlodipin essential changes of pharmacokinetics of drug are not noted.

Terms and storage conditions

To store in the place protected from light, dry and unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.