Amzaar

Amzaar – the combined anti-hypertensive means.

Form of release and structure

Dosage form – tablets, film coated: an oblong biconvex shape, on one of the parties the engraving is put: on tablets of almost white or white color - "AT1", on tablets of pink or light pink color - "AT2" (on 10 pieces in the blister, in a cardboard pack 1 or 3 blisters; on 300 pieces in a polyethylene bottle, in a cardboard pack 1 bottle).

Content of active ingredients of Amzaar in 1 tablet:

• Lozartan of potassium: 50 mg (AT1) or 100 mg (AT2);
• Amlodipina камзилат: 7,84 mg that is equivalent to 5 mg of an amlodipin.

Auxiliary components: cellulose microcrystallic, кросповидон, Mannitolum, K30 povidone, sodium carboxymethylstarch, butyl hydroxytoluene, magnesium stearate.

Structure of a cover: hypro rod, gipromelloza 2910, titanium dioxide, talc.

In addition as a part of a cover of tablets with an engraving of "AT2": dye ferrous oxide red, dye ferrous oxide yellow.

Indications to use

Amzaar apply to treatment of arterial hypertension at patients without contraindications to a combination therapy.

Contraindications

• Stenosis of the mouth of an aorta with the expressed hemodynamic disturbances;
• The expressed liver failure (it is higher than 9 points on a scale of Chayld-Pyyu);
• Shock;
• Heavy arterial hypotension;
• Age up to 18 years;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

With care Amzaar is recommended to appoint: the patient who is on the diet limiting reception of table salt at a hyperpotassemia, a renal failure (the clearance of creatinine (CC) is less than 20 ml/min.) or a hemodialysis, a liver failure (it is lower than 9 points on a scale of Chayld-Pyyu), arterial hypotension, a mitral stenosis, an aortal stenosis, the sick sinus syndrome (SSS) (tachycardia, the expressed bradycardia), a hypertrophic subaortic stenosis, chronic heart failure of not ischemic genesis (the II-IV functional class on NYHA classification), an acute myocardial infarction (and within 4 weeks after it), at the reduced the volume of the circulating blood (VCB) connected with the reception of high doses of diuretics, severe diarrhea, vomiting and other states causing a hypovolemia at advanced age.

Route of administration and dosage

Pill is taken in 1 times a day, washing down with a small amount of water, irrespective of meal.

Amzaar's use needs to be begun after preliminary titration of doses of a lozartan and an amlodipin. In case of need it is possible to pass to a combination therapy from separate reception of a lozartan or an amlodipin.

Upon transition from a concomitant use of a lozartan and an amlodipin the dose of drug is appointed according to doses of the previous monotherapy.

Use of tablets is shown to patients who have similar doses of drugs of a lozartan (50 mg) or an amlodipina (5 mg) in insufficient degree control the arterial pressure (AP).

At a renal failure with KK of 20-50 ml/min. sick dose adjustment is not required. At KK it is less than 20 ml/min. and a hemodialysis it is necessary to adjust doses of active components of drug, Amzaar in this case is not recommended to appoint.

At the patients accepting diuretics in high doses, administration of drug is possible when ensuring sufficient completion of OTsK, but only if the dose decline of a lozartan to 25 mg is not required.

At a liver failure (it is lower than 9 points on a scale of Chayld-Pyyu) use of drug is allowed if, according to the doctor, purpose of a lozartan in a dose of 50 mg is possible.

65 years drug are aged more senior appoint to patients with adequate portability of a dose of a lozartan of 50 mg.

Side effects

• Cardiovascular system: infrequently – rushes of blood to face skin, a heart consciousness, orthostatic hypotension;
• Nervous system: often – a headache, dizziness; infrequently – drowsiness;
• Dermatological reactions: infrequently – urticaria, a skin itch;
• Respiratory systems: infrequently – an asthma;
• Alimentary system: infrequently – discomfort in a stomach, dyspepsia, an ezofagealny reflux, vomiting, a lock;
• Urinary system: infrequently – a frequent urination;
• Labyrinth disturbances and acoustic organ: infrequently – a rotatory vertigo;
• General frustration: infrequently – peripheral hypostases, pain or discomfort in a breast, an adynamy, feeling of overflow in a stomach.

The side effects arising against the background of monotherapy lozartany:

• Cardiovascular system: infrequently – disturbances of a heart rhythm (a sinus bradycardia, a ciliary arrhythmia, ventricular tachycardia, tachycardia, fibrillation of ventricles), a myocardial infarction, a heart consciousness, stenocardia, a vasculitis, orthostatic hypotension, arterial hypotension, a syncope;
• Nervous system: often – a headache, fatigue, dizziness, sleeplessness, an adynamy, the increased weakness; infrequently – sleep disorders, paresthesias, disturbance of cerebral circulation, a peripheral neuropathy, drowsiness, a dysmnesia, an ataxy, hyperesthesias, a tremor, a memory impairment, a rotatory vertigo, nervousness, migraine;
• Lymphatic system and system of blood: infrequently – anemia; seldom – thrombocytopenia;
• Alimentary system: often – an abdominal pain, dyspepsia, nausea, diarrhea; infrequently – dryness in a mouth, taste disturbance, anorexia, a lock, a meteorism, a dentagra, gastritis, hepatitis, pancreatitis, functional disorder of a liver;
• Disturbances of mentality: infrequently – a depression, concern, confusion of consciousness, uneasiness, panic frustration, unusual dreams;
• Dermatological reactions: infrequently – a xeroderma, an itch, erubescence, an alopecia, skin rash, Shenleyn-Genokh's purpura, the increased sweating, a photosensitization;
• Metabolism and food: infrequently – gout;
• Respiratory system: often – dry cough, an asthma, bronchitis, a stethalgia, discomfort in a drink, rhinitis, nasal bleeding, laryngitis;
• Urinary system: infrequently – a nocturia, an infection of urinary tract, disturbance of frequency of an urination; very seldom – a renal failure;
• Labyrinth disturbances and acoustic organ: infrequently – a ring in ears;
• Organ of sight: infrequently – decrease in visual acuity, burning sensation in an eye, a sight illegibility, conjunctivitis;
• Generative organs and mammary gland: infrequently – impotence, decrease in a libido;
• Allergic reactions: infrequently – a Quincke's disease, a small tortoiseshell;
• Musculoskeletal system: often – a swelling of joints, spasms, rigidity of joints, pain; infrequently – an arthralgia, fibromyalgia, arthritis; seldom – рабдомиолиз;
• General frustration: fever, a face edema, the increased weakness, an adynamy.

The side effects noted at monotherapy amlodipiny:

• Cardiovascular system: often – a heart consciousness; infrequently – strong decrease in the ABP; very seldom – short wind, orthostatic hypotension, a vasculitis, aggravation or development of chronic heart failure, disturbance of a heart rhythm (including ventricular tachycardia, bradycardia, atrial fibrillation), a faint, a myocardial infarction, a fluid lungs, thorax pain, hypostasis of the lower extremities;
• Nervous system: often – drowsiness, a headache (is more often at the beginning of use), increased fatigue, dizziness; infrequently – a hyperexcitability, a febricula, paresthesias, hyperesthesias, uneasiness, a peripheral neuropathy, sleeplessness, a tremor, unusual dreams; very seldom – the increased sweating, apathy, agitation, an adynamy, migraine, an ataxy, amnesia;
• Alimentary system: often – abdominal pains, nausea; infrequently – thirst, a xerostomia, dyspepsia, vomiting, a lock, a meteorism, diarrhea, anorexia; seldom – increase in appetite, a hyperplasia of gums; very seldom – gastritis, pancreatitis, jaundice, a hyperbilirubinemia, hepatitis, increase in activity of liver enzymes;
• System of a hemopoiesis: very seldom – a leukopenia, thrombocytopenia, a Werlhof's disease;
• Mental disturbances: infrequently – a depression, lability of mood;
• Urinary system: infrequently – a nocturia, an urodynia, the speeded-up urination; very seldom – a polyuria, a dysuria;
• Generative organs and mammary gland: infrequently – impotence, a gynecomastia;
• Respiratory system: infrequently – rhinitis, short wind; very seldom – cough;
• Musculoskeletal system: infrequently – a mialgiya, muscular spasms, an arthralgia, arthrosis, a dorsodynia; seldom – a myasthenia;
• Sense bodys: infrequently – eye pain, a ring in ears, accommodation disturbance, a diplopia, conjunctivitis, a xerophthalmia; very seldom – a parosmiya;
• Dermatological reactions: often – rushes of blood to face skin; seldom – Stephens-Johnson's syndrome, exfoliative dermatitis; very seldom – cold sweat, an alopecia, disturbance of a xanthopathy, a xerodermia;
• Allergic reactions: very seldom – a skin itch, rash (including makulopapulezny, erythematic, a small tortoiseshell), a mnogoformny erythema, a Quincke's edema, photosensitivity;
• Metabolism: very seldom – a hyperglycemia;
• Others: infrequently – nasal bleeding, decrease or increase in body weight.

Special instructions

Because of risk of development of symptomatic arterial hypotension during Amzaar's use, prior to treatment at the patient it is necessary to eliminate deficit of OTsK.

The patients accepting 25 mg of a lozartan a day are not recommended to appoint complex drug.

After cancellation of an amlodipin it is necessary to be careful at purpose of other vazodilatiruyushchy means, individually selecting a dose and an interval of dosing it is necessary to control a condition of the patient.

Use of an amlodipin should be accompanied with the corresponding diet, control of body weight and the use of table salt, respect for strict hygiene of teeth. Regular visit of the stomatologist will allow to avoid bleeding, morbidity and a hyperplasia of gums.

Regular control of content of potassium in plasma at reception of a lozartan is required, especially at a renal failure from elderly patients.

Drug can cause development of a hyperpotassemia therefore it is necessary to be careful in need of co-administration of kaliysberegayushchy diuretics (including Spironolactonum, Triamterenum, amiloride), the kaliysoderzhashchy substitutes of salt, drugs of potassium, heparin and other means increasing potassium concentration in a blood plasma.

With a unilateral or bilateral renal artery stenosis use of a lozartan can cause reversible increase in concentration of an urea nitrogen and creatinine in plasma in patients.

As effect of drug can cause dizziness, it is recommended to be careful at control of vehicles and mechanisms.

Medicinal interaction

Hypotensive action of Amzaar can raise a concomitant use of other antihypertensives.

At simultaneous use of an amlodipin:

• Diltiazem, erythromycin, итраконазол, кетоконазол, ритонавир and other CYP3A4 inhibitors – increase concentration of an amlodipin in plasma (it is necessary to conduct careful control of peripheral hypostases and symptoms of hypotension);
• The rifampicin, St. John's Wort which is made a hole and other inductors CYP3A4 – demand constant control of the ABP;
• Lithium drugs – can strengthen manifestations of a neurotoxicity, making sick, a sonitus, vomiting, diarrhea, a tremor, an ataxy;
• Beta adrenoblockers – can cause an exacerbation of heart failure;
• Quinidine, Amiodaronum (blockers of slow calcium channels) – increase expressiveness of negative inotropic effect of drug;
• Neuroleptics, изофлуран – strengthen hypotensive effect of derivatives of dihydropyridine;
• Dantrolen – at intravenous administration can cause arrhythmia, a collapse, decrease in force of cordial reductions, a hyperpotassemia;
• Calcium drugs – decrease in effect of an amlodipin is possible;
• Digoxin – does not change renal clearance and the concentration in blood serum.

On pharmacokinetics of an amlodipin significant effect magnesium - or aluminum-bearing antacids, a sildenafil (in a dose of 100 mg), grapefruit juice, Cimetidinum does not accord a single dose.

Drug does not exert impact on pharmacokinetics of cyclosporine, ethanol, an atorvastatin.

Reception of an amlodipin is shown against the background of the accompanying therapy by thiazide diuretics, inhibitors of an angiotensin-converting enzyme (APF) or alpha adrenoblockers, non-steroidal anti-inflammatory drugs (NPVS).

At a combination to digoxin, Phenytoinum, warfarin and indometacin амлодипин does not influence their linkng with proteins of a blood plasma.

At simultaneous use of a lozartan:

• Triamterenum, Spironolactonum, amiloride (kaliysberegayushchy diuretics), potassium additives, kaliysoderzhashchy substitutes of salt – can promote increase in level of potassium in blood serum;
• NPVS (including the selection TsOG-2 inhibitors) – reduce effect of a lozartan;
• Flukonazol (CYP2C9 isoenzyme inhibitor) – increases the level of concentration of a lozartan in a blood plasma;
• Rifampinum – reduces concentration and an active metabolite of a lozartan.

The combination therapy APF inhibitors and the antagonists of receptors of angiotensin (ARA) demands regular control of function of kidneys.

Significant pharmacokinetic interaction with a hydrochlorothiazide, digoxin, warfarin, Cimetidinum and phenobarbital is not established.

Terms and storage conditions

To store at a temperature up to 30 °C. To protect from children.

Period of validity: in blisters – 2 years, in a polyethylene bottle – 3 years.