Amzaar

In patients with reduced blood volume (for example, those receiving treatment with large doses of diuretics) or with severe aortic stenosis, symptomatic arterial hypotension may occur. Correction of such conditions must be carried out before prescription or treatment must begin with a lower dose of the drug. Acute arterial hypotension is unlikely due to the gradual onset of action of the drug.

Based on pharmacokinetic data that showed a significant increase in plasma concentrations of losartan in patients with cirrhosis, patients with a history of impaired liver function should be prescribed lower doses of losartan.

Since amlodipine is primarily metabolized in the liver and has a half-life of 56 hours in patients with hepatic impairment, dosage titration should be gradual when administering amlodipine to patients with severe hepatic impairment.

Losartan

In patients with a history of angioedema (swelling of the face, lips, pharynx/larynx and/or tongue), monitoring of the use of the drug is necessary.

Embryotoxicity: Use of drugs that affect the RAAS during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and mortality. The development of oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformities. Possible adverse events in neonates include calvarial hypoplasia, anuria, hypotension, renal failure and death. If pregnancy is diagnosed, the drug should be discontinued immediately.

Fluid and electrolyte imbalance is common in patients with impaired renal function with or without diabetes mellitus, so careful monitoring of these patients is necessary. In clinical trials in patients with type 2 diabetes mellitus with proteinuria, the incidence of hyperkalemia was greater in the losartan group than in the placebo group. Several patients discontinued therapy due to hyperkalemia.

While taking losartan, patients should not take potassium supplements or potassium-containing salt substitutes without prior consultation with their doctor.

Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.

Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with coronary heart disease or cerebrovascular diseases, since an excessive decrease in blood pressure in patients in this group can lead to the development of myocardial infarction or stroke.

As with the use of other drugs that act on the RAAS, in patients with CHF and with or without impaired renal function, there is a risk of developing severe arterial hypotension or acute renal failure.

Since there is insufficient experience with the use of losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA functional class IV), as well as in patients with heart failure and symptomatic life-threatening arrhythmias, losartan should be prescribed with caution in patients of these groups.

Since patients with primary hyperaldosteronism, as a rule, do not respond well to therapy with antihypertensive drugs that act by inhibiting the RAAS, the use of losartan is not recommended in patients in this group.

Data from pharmacokinetic studies indicate that the plasma concentration of losartan in patients with cirrhosis is significantly increased, therefore patients with a history of liver disease should be prescribed losartan at a lower dose. There is no experience with the use of losartan in patients with severe liver dysfunction, so the drug should not be used in patients in this group.

Due to inhibition of the RAAS, changes in renal function, including the development of renal failure, have been observed in some susceptible patients. These changes may subside after treatment is stopped.

Some drugs that affect the RAAS may increase blood urea and serum creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney. Similar effects have been reported with losartan. Such renal dysfunction may be reversible after discontinuation of therapy.

Amlodipine

Unstable angina and acute myocardial infarction may occur after initiation of therapy or an increase in the dose of amlodipine, especially in patients with severe hypertrophic obstructive cardiomyopathy.

If oliguria or arterial hypotension develops in newborns whose mothers took Amzaar during pregnancy, symptomatic therapy aimed at maintaining blood pressure and renal perfusion is necessary. Blood transfusions or dialysis may be required to prevent hypotension and/or maintain renal function.

Clinical studies have not revealed any particularities regarding the safety and effectiveness of losartan in elderly patients (over 65 years of age). In elderly patients, due to reduced clearance, amlodipine therapy is usually recommended to begin with a dose of 2.5 mg once daily. Since Amzaar does not have a dosage containing amlodipine 2.5 mg, this dose should be prescribed in monotherapy with amlodipine.

No studies have been conducted to assess the effect on the ability to drive and operate machines, however, some of the undesirable effects observed with Amzaar may affect the ability to drive and operate machines.

Release form and composition

Dosage form - film-coated tablets: oblong biconvex shape, engraved on one side: on almost white or white tablets - “AT1”, on pink or light pink tablets - “AT2” (10 pcs. per blister, 1 or 3 blisters in a cardboard pack; 300 pcs. in a polyethylene bottle, 1 bottle in a cardboard pack).

Content of active ingredients of Amzaar in 1 tablet:

Losartan potassium: 50 mg (AT1) or 100 mg (AT2);
Amlodipine camsylate: 7.84 mg, equivalent to 5 mg amlodipine.

Auxiliary components: microcrystalline cellulose, crospovidone, mannitol, povidone K30, sodium carboxymethyl starch, butylated hydroxytoluene, magnesium stearate.

Shell composition: hyprolose, hypromellose 2910, titanium dioxide, talc.

Additionally, the shell of tablets engraved with “AT2” contains: red iron oxide dye, yellow iron oxide dye.

Side effects

Cardiovascular system: uncommon – flushing of the face, palpitations, orthostatic hypotension;
Nervous system: often – headache, dizziness; infrequently - drowsiness;
Dermatological reactions: infrequently - urticaria, skin itching;
Respiratory systems: infrequently - shortness of breath;
Digestive system: uncommon - abdominal discomfort, dyspepsia, esophageal reflux, vomiting, constipation;
Urinary system: infrequently – frequent urination;
Labyrinthine disorders and the organ of hearing: infrequently - systemic dizziness;
General disorders: uncommon - peripheral edema, pain or discomfort in the chest, asthenia, feeling of fullness in the abdomen.

Side effects that occur during monotherapy with losartan:

Cardiovascular system: uncommon - cardiac arrhythmias (sinus bradycardia, atrial fibrillation, ventricular tachycardia, tachycardia, ventricular fibrillation), myocardial infarction, palpitations, angina pectoris, vasculitis, orthostatic hypotension, arterial hypotension, fainting;
Nervous system: often – headache, fatigue, dizziness, insomnia, asthenia, increased weakness; uncommon – sleep disturbances, paresthesia, cerebrovascular accident, peripheral neuropathy, drowsiness, memory disorder, ataxia, hyperesthesia, tremor, memory impairment, systemic dizziness, nervousness, migraine;
Lymphatic system and blood system: uncommon – anemia; rarely – thrombocytopenia;
Digestive system: often – abdominal pain, dyspepsia, nausea, diarrhea; uncommon – dry mouth, taste disturbance, anorexia, constipation, flatulence, toothache, gastritis, hepatitis, pancreatitis, functional liver disorder;
Mental disorders: uncommon – depression, anxiety, confusion, anxiety, panic disorder, unusual dreams;
Dermatological reactions: uncommon - dry skin, itching, redness of the skin, alopecia, skin rash, Henoch-Schönlein purpura, increased sweating, photosensitivity;
Metabolism and nutrition: infrequently – gout;
Respiratory system: often - dry cough, shortness of breath, bronchitis, chest pain, throat discomfort, rhinitis, nosebleeds, laryngitis;
Urinary system: uncommon – nocturia, urinary tract infection, urinary frequency disturbance; very rarely - renal failure;
Labyrinthine disorders and the organ of hearing: infrequently – ringing in the ears;
Organ of vision: uncommon – decreased visual acuity, burning sensation in the eye, blurred vision, conjunctivitis;
Genital organs and mammary gland: infrequently – impotence, decreased libido;
Allergic reactions: infrequently - angioedema, urticaria;
Musculoskeletal system: often - swelling of the joints, cramps, joint stiffness, pain; uncommon – arthralgia, fibromyalgia, arthritis; rarely - rhabdomyolysis;
General disorders: fever, facial swelling, increased weakness, asthenia.

Side effects observed with amlodipine monotherapy:

Cardiovascular system: often – palpitations; infrequently – severe decrease in blood pressure; very rarely - shortness of breath, orthostatic hypotension, vasculitis, worsening or development of chronic heart failure, cardiac arrhythmias (including ventricular tachycardia, bradycardia, atrial fibrillation), fainting, myocardial infarction, pulmonary edema, chest pain, edema of the lower extremities;
Nervous system: often - drowsiness, headache (usually at the beginning of use), increased fatigue, dizziness; uncommon – increased excitability, general malaise, paresthesia, hyperesthesia, anxiety, peripheral neuropathy, insomnia, tremor, unusual dreams; very rarely - increased sweating, apathy, agitation, asthenia, migraine, ataxia, amnesia;
Digestive system: often – abdominal pain, nausea; uncommon – thirst, dry mouth, dyspepsia, vomiting, constipation, flatulence, diarrhea, anorexia; rarely – increased appetite, gum hyperplasia; very rarely - gastritis, pancreatitis, jaundice, hyperbilirubinemia, hepatitis, increased activity of liver enzymes;
Hematopoietic system: very rarely - leukopenia, thrombocytopenia, thrombocytopenic purpura;
Mental disorders: infrequently – depression, mood lability;
Urinary system: uncommon – nocturia, painful urination, frequent urination; very rarely - polyuria, dysuria;
Genital organs and mammary gland: uncommon – impotence, gynecomastia;
Respiratory system: infrequently – rhinitis, shortness of breath; very rarely – cough;
Musculoskeletal system: uncommon – myalgia, muscle cramps, arthralgia, arthrosis, back pain; rarely - myasthenia gravis;
Sense organs: infrequently - pain in the eyes, ringing in the ears, impaired accommodation, diplopia, conjunctivitis, xerophthalmia; very rarely - parosmia;
Dermatological reactions: often - flushes of blood to the skin of the face; rarely – Stevens-Johnson syndrome, exfoliative dermatitis; very rarely - cold sweat, alopecia, skin pigmentation disorder, xeroderma;
Allergic reactions: very rarely - skin itching, rash (including maculopapular, erythematous, urticaria), erythema multiforme, Quincke's edema, photosensitivity;
Metabolism: very rarely – hyperglycemia;
Other: infrequently - nosebleeds, loss or increase in body weight.