Amzaar
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Amzaar is a combined antihypertensive agent.
Release form and composition
Dosage form - tablets, film-coated: oblong biconvex, engraved on one side: on tablets of almost white or white color - "AT1", on tablets of pink or light pink color - "AT2" (10 pcs. In blister, in a cardboard box 1 or 3 blisters; 300 pcs. in a polyethylene bottle, in a cardboard box 1 bottle).
Content of active ingredients of Amzaar in 1 tablet:
- Losartan potassium: 50 mg (AT1) or 100 mg (AT2);
- Amlodipine camsylate: 7.84 mg, which is equivalent to 5 mg of amlodipine.
Auxiliary components: microcrystalline cellulose, crospovidone, mannitol, povidone K30, sodium carboxymethyl starch, butyl hydroxytoluene, magnesium stearate.
Shell composition: hyprolose, hypromellose 2910, titanium dioxide, talc.
Additionally, as part of the tablet shell with "AT2" engraving: iron dye red oxide, iron dye yellow oxide.
Indications for use
Amzaar is used to treat arterial hypertension in patients without contraindications to combination therapy.
Contraindications
- Aortic stenosis with severe hemodynamic disturbances;
- Severe liver failure (above 9 points on the Child-Pugh scale);
- Shock;
- Severe arterial hypotension;
- Age under 18;
- The period of pregnancy and breastfeeding;
- Hypersensitivity to drug components.
It is recommended to prescribe Amzaar with caution: patients on a diet that limits the intake of table salt, with hyperkalemia, renal failure (creatinine clearance (CC) less than 20 ml / min) or hemodialysis, liver failure (below 9 points on the Child-Pugh scale), arterial hypotension, mitral stenosis, aortic stenosis, sick sinus syndrome (SSS) (tachycardia, severe bradycardia), hypertrophic obstructive cardiomyopathy, chronic heart failure of non-ischemic genesis (II-IV functional class according to NYHA classification), acute myocardial infarction (and during 4 weeks after it), with a reduced volume of circulating blood (BCC) associated with high doses of diuretics, severe diarrhea, vomiting and other conditions that cause hypovolemia in old age.
Method of administration and dosage
The tablets are taken orally 1 time per day with a small amount of water, regardless of the meal.
The use of Amzaar must be started after preliminary titration of doses of losartan and amlodipine. If necessary, you can switch to combination therapy with a separate dose of losartan or amlodipine.
When switching from the simultaneous administration of losartan and amlodipine, the dose of the drug is prescribed in accordance with the doses of the previous monotherapy.
The use of tablets is indicated for patients in whom similar doses of losartan (50 mg) or amlodipine (5 mg) drugs do not sufficiently control blood pressure (BP).
In renal failure with a CC of 20-50 ml / min, patients do not need dose adjustment. When CC is less than 20 ml / min and hemodialysis, it is necessary to adjust the doses of the active components of the drug, prescribing Amzaar in this case is not recommended.
In patients taking diuretics in high doses, the drug can be taken if sufficient replenishment of the BCC is ensured, but only if it is not necessary to reduce the dose of losartan to 25 mg.
In liver failure (below 9 points on the Child-Pugh scale), the use of the drug is allowed if, according to the doctor, it is possible to prescribe losartan at a dose of 50 mg.
Over the age of 65, the drug is prescribed to patients with an adequate tolerance of the dose of losartan 50 mg.
Side effects
- Cardiovascular system: infrequently - rush of blood to the skin of the face, palpitations, orthostatic hypotension;
- Nervous system: often - headache, dizziness; infrequently - drowsiness;
- Dermatological reactions: infrequently - urticaria, pruritus;
- Respiratory systems: infrequently - shortness of breath;
- Digestive system: infrequently - abdominal discomfort, dyspepsia, esophageal reflux, vomiting, constipation;
- Urinary system: infrequently - frequent urination;
- Labyrinth disorders and the organ of hearing: infrequently - systemic dizziness;
- General disorders: infrequently - peripheral edema, pain or discomfort in the chest area, asthenia, a feeling of fullness in the abdomen.
Side effects that occur during losartan monotherapy:
- Cardiovascular system: infrequently - 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; infrequently - sleep disorders, paresthesia, cerebrovascular accident, peripheral neuropathy, drowsiness, memory impairment, ataxia, hyperesthesia, tremor, memory impairment, dizziness, nervousness, migraine;
- Lymphatic system and blood system: infrequently - anemia; rarely, thrombocytopenia;
- Digestive system: often - abdominal pain, dyspepsia, nausea, diarrhea; infrequently - dry mouth, taste disturbance, anorexia, constipation, flatulence, toothache, gastritis, hepatitis, pancreatitis, functional liver disorder;
- Mental disorders: infrequently - depression, anxiety, confusion, anxiety, panic disorder, unusual dreams;
- Dermatological reactions: infrequently - dry skin, itching, redness of the skin, alopecia, skin rash, Schönlein-Henoch purpura, increased sweating, photosensitivity;
- Metabolism and nutrition: infrequently - gout;
- Respiratory system: often - dry cough, shortness of breath, bronchitis, chest pain, discomfort in the throat, rhinitis, epistaxis, laryngitis;
- Urinary system: infrequently - nocturia, urinary tract infection, urinary frequency disorder; very rarely - renal failure;
- Labyrinth disorders and the organ of hearing: infrequently - ringing in the ears;
- Organ of vision: infrequently - decreased visual acuity, burning sensation in the eye, blurred vision, conjunctivitis;
- Genitals and mammary gland: infrequently - impotence, decreased libido;
- Allergic reactions: infrequently - angioedema, urticaria;
- Musculoskeletal system: often - joint swelling, cramps, joint stiffness, pain; infrequently - arthralgia, fibromyalgia, arthritis; rarely - rhabdomyolysis;
- General disorders: fever, facial edema, increased weakness, asthenia.
Side effects noted with amlodipine monotherapy:
- Cardiovascular system: often - palpitations; infrequently - a strong decrease in blood pressure; very rarely - shortness of breath, orthostatic hypotension, vasculitis, aggravation 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 (more often at the beginning of use), increased fatigue, dizziness; infrequently - increased excitability, general malaise, paresthesia, hyperesthesia, anxiety, peripheral neuropathy, insomnia, tremors, unusual dreams; very rarely - increased sweating, apathy, agitation, asthenia, migraine, ataxia, amnesia;
- Digestive system: often - abdominal pain, nausea; infrequently - thirst, dryness of the oral mucosa, dyspepsia, vomiting, constipation, flatulence, diarrhea, anorexia; rarely - increased appetite, gingival 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: infrequently - nocturia, painful urination, frequent urination; very rarely - polyuria, dysuria;
- Genitals and mammary gland: infrequently - impotence, gynecomastia;
- Respiratory system: infrequently - rhinitis, shortness of breath; very rarely - cough;
- Musculoskeletal system: infrequently - myalgia, muscle cramps, arthralgia, arthrosis, back pain; rarely - myasthenia gravis;
- Sense organs: infrequently - pain in the eyes, ringing in the ears, violation of accommodation, diplopia, conjunctivitis, xerophthalmia; very rarely - parosmia;
- Dermatological reactions: often - flushing of the skin of the face; rarely - Stevens-Johnson syndrome, exfoliative dermatitis; very rarely - cold sweat, alopecia, skin pigmentation disorders, xeroderma;
- Allergic reactions: very rarely - pruritus, rash (including maculopapular, erythematous, urticaria), erythema multiforme, Quincke's edema, photosensitivity;
- Metabolism: very rarely - hyperglycemia;
- Others: infrequently - nosebleeds, decrease or increase in body weight.
special instructions
Due to the risk of developing symptomatic arterial hypotension during the period of Amzaar use, the BCC deficiency should be eliminated in the patient before starting treatment.
It is not recommended to prescribe a complex drug for patients taking 25 mg of losartan per day.
After the abolition of amlodipine, care should be taken when prescribing another vasodilating agent, individually selecting the dose and dosing interval, it is necessary to monitor the patient's condition.
The use of amlodipine should be accompanied by an appropriate diet, control of body weight and salt intake, and strict dental hygiene. Regular visits to the dentist will help prevent bleeding, soreness and gum hyperplasia.
Regular monitoring of plasma potassium is required when taking losartan, especially in case of impaired renal function in elderly patients.
The drug can cause the development of hyperkalemia, therefore, care should be taken if it is necessary to simultaneously prescribe potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium-containing salt substitutes, potassium preparations, heparin and other drugs that increase the concentration of potassium in the blood plasma.
In patients with unilateral or bilateral stenosis of the renal artery, the use of losartan can cause a reversible increase in the concentration of urea nitrogen and creatinine in plasma.
Since the action of the drug can cause dizziness, it is recommended to be careful when driving vehicles and mechanisms.
Drug interactions
The antihypertensive effect of Amzaar can increase the simultaneous intake of other antihypertensive drugs.
With the simultaneous use of amlodipine:
- Diltiazem, erythromycin, itraconazole, ketoconazole, ritonavir and other CYP3A4 inhibitors - increase the concentration of amlodipine in plasma (it is necessary to closely monitor peripheral edema and symptoms of hypotension);
- Rifampicin, St. John's wort and other inducers of CYP3A4 - require constant monitoring of blood pressure;
- Lithium preparations - can increase the manifestations of neurotoxicity, causing nausea, tinnitus, vomiting, diarrhea, tremors, ataxia;
- Beta-blockers - can exacerbate heart failure;
- Quinidine, amiodarone (slow calcium channel blockers) - increase the severity of the negative inotropic action of the drug;
- Antipsychotics, isoflurane - enhance the hypotensive effect of dihydropyridine derivatives;
- Dantrolene - when administered intravenously, it can cause arrhythmia, collapse, decreased heart rate, hyperkalemia;
- Calcium preparations - it is possible to reduce the effect of amlodipine;
- Digoxin - does not change renal clearance and its concentration in serum.
The pharmacokinetics of amlodipine is not significantly affected by a single intake of magnesium or aluminum-containing antacids, sildenafil (at a dose of 100 mg), grapefruit juice, cimetidine.
The drug has no effect on the pharmacokinetics of cyclosporine, ethanol, atorvastatin.
Taking amlodipine is indicated against the background of concomitant therapy with thiazide diuretics, angiotensin-converting enzyme (ACE) inhibitors or alpha-blockers, non-steroidal anti-inflammatory drugs (NSAIDs).
When combined with digoxin, phenytoin, warfarin and indomethacin, amlodipine does not affect their binding to blood plasma proteins.
With the simultaneous use of losartan:
- Triamterene, spironolactone, amiloride (potassium-sparing diuretics), potassium supplements, potassium-containing salt substitutes - may increase serum potassium levels;
- NSAIDs (including selective COX-2 inhibitors) - reduce the effect of losartan;
- Fluconazole (an inhibitor of the isoenzyme CYP2C9) - increases the concentration of losartan in the blood plasma;
- Rifampin - reduces the concentration and active metabolite of losartan.
Combination therapy with ACE inhibitors and angiotensin receptor antagonists (ARA) requires regular monitoring of renal function.
No significant pharmacokinetic interaction with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital has been established.
Analogs
Amzaar's analogues are: Amozartan, Lortenza, Burana.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life: in blisters - 2 years, in a plastic bottle - 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
