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► Alortia (amlodipine + losartan) - Practical Medicine

Alortia (amlodipine + losartan) - coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Alortia coated tablets; 10 mg + 100 mg (1 tablet contains: 100 mg losartan, 10 mg amlodipine); 30 tabl. Krka 30.64 0.00
12.34
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Alortia coated tablets; 10 mg + 50 mg (1 tablet contains: 50 mg losartan, 10 mg amlodipine); 30 tabl. Krka 16.11 0.00
6.96
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Alortia coated tablets; 10 mg + 50 mg (1 tablet contains: 50 mg losartan, 10 mg amlodipine); 60 tables Krka 30.64 0.00
12.34
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Alortia coated tablets; 10 mg + 50 mg (1 tablet contains: 50 mg losartan, 10 mg amlodipine); 90 tabl. Krka 44.71 0.00
17.26
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Alortia coated tablets; 5 mg + 100 mg (1 tablet contains: 100 mg losartan, 5 mg amlodipine); 30 tabl. Krka 30.64 0.00
12.34
Check
Alortia coated tablets; 5 mg + 50 mg (1 tablet contains: 50 mg losartan, 5 mg amlodipine); 30 tabl. Krka 16.11 0.00
6.96
Check
Alortia coated tablets; 5 mg + 50 mg (1 tablet contains: 50 mg losartan, 5 mg amlodipine); 60 tables Krka 30.64 0.00
12.34
Check
Alortia coated tablets; 5 mg + 50 mg (1 tabletcontains: 50 mg of losartan, 5 mg of amlodipine); 90 tabl. Krka 44.71 0.00
17.26
Check

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:amlodipine + losartan

The drug is available on prescription

What is Alortia?

Combined preparation containing an angiotensin II receptor antagonist (losartan) and a calcium antagonist from the group of dihydropyridine derivatives (amlodipine).

What does Alortia contain and how does it work?

It is a combined preparation containing 2 active substances: losartan and amlodipine. Losartan belongs to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is the blocking of angiotensin II receptors which prevents them from binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which comes from the English nameAngiotensin II Receptor Blockers). Angiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The action of losartan, like other sartans, effectively counteracts the effects of angiotensin II and leads to a decrease in blood pressure. Unlike drugs from the angiotensin-converting enzyme inhibitors, sartans do not exacerbate the effects of bradykinin-dependent, for example, cough. Sartans are used as medicines to lower blood pressure and to treat and prevent diseases of the cardiovascular system.
The second active substance is amlodipine, a dihydropyridine derivative belonging to a group of medicines called calcium channel blockers (or calcium channel blockers). Calcium antagonists act by blocking calcium channels, structures that allow the passage of calcium ions across the cell membrane. Amlodipine blocks the inflow of calcium ions from the extracellular space into the smooth muscle cells of the walls of the blood vessels and to a lesser extent into the cells of the heart muscle. Increasing the intracellular calcium concentration is necessary for the contraction of muscle cells. Amlodipine works mainly on peripheral blood vessels. Blockage of calcium channels reduces the tension of the vessel walls and vasodilation. The immediate effect of this action of amlodipine is lowering blood pressure. Enlargement of peripheral arterioles reduces peripheral vascular resistance, which relieves the heart (it reduces energy consumption by the myocardium and its oxygen demand). Coronary arteries are also likely to expand, which increases oxygen transport to the myocardium. As a result, in patients with angina pectoris, exercise tolerance increases (the time to angina pain increases during exercise) and the incidence and severity of angina pains decreases. The clinical condition of patients with angina pectoris improves and nitroglycerin consumption decreases. In hypertensive patients, taking once daily with amlodipine provides a clinically significant reduction in blood pressure over 24 hours.
Thanks to the use of complementary mechanisms of action of both active substances, the antihypertensive effect of the preparation is stronger than in the case of the use of each of the components in monotherapy.

When to use Alortia?

It is indicated for the treatment of essential hypertension in adults who have received adequate control of blood pressure during combination therapy with amlodipine and losartan in the same doses as in the combined preparation as a replacement therapy for the intake of these active substances in separate formulations.

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients of the preparation or to another drug from the group of dihydropyridine calcium antagonists.
You can not use the preparation if you are present:
· Severe liver problems
· Severe hypotension
· Shock, including cardiogenic shock
· Narrowing of the outflow path from the left ventricle (eg severe stenosis of the aortic valve)
Hemodynamically unstable heart failure after myocardial infarction
Do not use in parallel with aliskiren in patients with diabetes or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2).
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.

Take special care with Alortia?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The preparation may cause angioneurotic edema (swelling of the lips, tongue, throat, larynx that may impede breathing and may be life-threatening). In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. People who have ever had angioneurotic edema should remain under close medical supervision.
Caution should be exercised because symptomatic hypotension may occur, especially in patients with circulating, dehydrated or sodium deficient circulating blood (eg, people who have previously received high doses of diuretics, low salt diets, diarrhea or vomiting). Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured. It may be necessary to reduce the initial dose and adjust the dosage by your doctor.
Water-electrolyte imbalance, which should be compensated before treatment, often occurs in patients with impaired renal function and in patients with diabetes with co-existing renal dysfunction. Regular monitoring of creatinine and potassium in the blood is recommended, especially in patients with heart failure and in patients with impaired renal function.
The use of a preparation and medicines that increase the level of potassium in the blood (including potassium sparing diuretics, potassium supplements, potassium salt substitutes) is not recommended. The preparation may cause hyperkalaemia (increase in potassium in the blood). Hyperkalaemia may cause serious arrhythmias. Your doctor will monitor the level of potassium in your blood, especially if you are at increased risk for hyperkalemia.
There are no data on the safety of losartan in patients after recent kidney transplantation.
It is not recommended to use the preparation in patients with primary hyperaldosteronism, because the effect of the preparation in this group of patients is not effective.
Caution should be exercised in people with ischemic heart disease or cerebrovascular disease (people with coronary artery stenosis or cerebrovascular narrowing) because, in this group of patients, a significant reduction in blood pressure may result in a heart attack or stroke.
In people with heart failure whose vascular tone and renal function depends on the activity of the renin-angiotensin-aldosterone system, the use of the preparation may be associated with the risk of severe hypotension and renal dysfunctions, including acute renal failure.
Due to the lack of sufficient clinical experience, caution should be exercised when using the preparation in patients:
· With heart failure co-existing with severe kidney problems
· With severe heart failure (NYHA grade IV)
· With heart failure and symptomatic arrhythmias.
Caution should be exercised if beta-blockers are used in parallel with losartan.
Caution should be exercised in patients with heart failure, especially severe (NYHA grade III and IV); in this group of patients, during the period of application (due to the content of amlodipine in the preparation), there is an increased risk of pulmonary edema.
In patients with congestive heart failure, calcium antagonists, including amlodipine, may increase the risk of cardiovascular events and death.
People with hepatic impairment should be treated with caution as the effect of amlodipine may be exacerbated. If necessary, the doctor will adjust the dosage. In people with liver problems, your doctor will consider reducing the dose of losartan. Severe hepatic impairment is a contraindication to the use of the preparation.
In patients at higher risk of renal dysfunction, in which renal function depends on the activity of the renin-angiotensin-aldosterone system (eg in patients with severe heart failure, bilateral renal artery stenosis or renal artery stenosis of the sole active kidney) use of drugs acting on the renin-angiotensin-aldosterone system may be associated with the risk of oliguria, increased urea and creatinine in the blood. These disorders usually disappear spontaneously after discontinuation of the preparation. Caution should be exercised and treatment should be under special medical supervision. Blood creatinine must be checked regularly.
There is no need to adjust the dose of amlodipine in patients with impaired renal function. Amlodipine is not removed during dialysis.
Elderly patients should be cautious when increasing the dose of amlodipine.
Caution should be exercised if the preparation is used in patients with impaired left ventricular outflow (aortic or mitral stenosis, hypertrophic cardiomyopathy).
In black people, sartan medicines, including losartan, may be less effective in lowering blood pressure.
The parallel use of sartans (including losartan) and other agents acting on the renin-angiotensin-aldosterone system (RAA) is not recommended. Due to the risk of hypotension, hyperkalemia and / or renal dysfunction, including acute renal failure, parallel administration of ACE inhibitors or aliskiren is not recommended. This combination treatment results in increased inhibition of the renin-angiotensin-aldosterone system and can only be used if absolutely necessary under close medical supervision. Blood pressure, renal function and electrolyte concentration should be monitored. In patients with diabetic nephropathy, ACE inhibitors and sartans should not be used in parallel.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
Do not use the preparation in children and adolescents up to 18 years of age because there is insufficient data on the safety and efficacy of the preparation in this age group.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.

Does this preparation affect the ability to drive vehicles?
No studies on the effects on the ability to drive and use machines / machines have been performed. However, it should be taken into account that the preparation may cause dizziness, headache, fatigue, drowsiness or other symptoms that may impair psychophysical fitness and the ability to drive vehicles and operate machinery and equipment, especially at the beginning of treatment and during dose escalation. .
In people who develop the above-mentioned symptoms, the ability to concentrate and react may be impaired. Caution is advised, especially in the initial period of application.

Dosage of Alortia

The preparation is in the form of coated tablets for oral use. The preparation should be taken once a day with water. Can be taken regardless of meals. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Adults: 1 tablet once a day.
The preparation is not suitable for starting treatment. Before starting to use a fixed combination with a fixed content of active substances, your doctor will adjust the dose of amlodipine and losartan individually in the form of separate preparations.
Elderly, caution should be advised when increasing the dose. In people over 75, the doctor will consider the starting dose of losartan 25 mg once daily.
In people with reduced intravascular volume (eg when taking high doses of diuretics) your doctor will consider the starting dose of losartan 25 mg once daily.
There is no need to adjust the dose in adults with impaired renal function.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
The preparation is contraindicated in the case of severe liver dysfunction. People with mild or moderate hepatic impairment should be cautious; the doctor will adjust the dosage.
Children and youth:
There are insufficient data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age. For this reason, the preparation should not be used in this age group.

Can I use Alortia during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Medicines from the sartane group can have a detrimental effect on pregnancy, fetus and newborn development. The preparation should not be used during the first trimester of pregnancy. The use of the preparation in the second and third trimester of pregnancy is contraindicated. If a woman is planning a pregnancy, it is recommended to change the way of antihypertensive treatment. If you suspect pregnancy during the period of taking the preparation, stop taking it immediately and consult a physician. Your doctor may prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Caution should be exercised because the antihypertensive effect may be exacerbated if other antihypertensive agents, vasodilators, diuretics or other drugs that lower blood pressure (eg some antidepressants, antipsychotics, hypnotics, sedatives, barbiturates, opioids) are used in combination with the preparation , nitrates, baclofen, amifostine, alpha-blockers used in the treatment of prostatic hyperplasia and others). Intensification of hypotension and hypotension may occur.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
The parallel use of sartans (including losartan) and other drugs acting on the renin-angiotensin-aldosterone system (including angiotensin converting enzyme or aliskiren inhibitors) is not recommended. This combination treatment results in increased inhibition of the renin-angiotensin-aldosterone system and can only be used if absolutely necessary under close medical supervision. Blood pressure, renal function and electrolyte concentration should be monitored.
Due to the content of losartan in the preparation, it is not recommended to use the preparation in parallel with:
· Lithium, due to the risk of increased neurotoxic effects of lithium; if necessary, the combination of lithium in the blood should be monitored
· With drugs that increase the level of potassium in the blood (potassium salts, potassium-sparing diuretics eg spironolactone, triamteren, amiloride, some antihypertensives, potassium supplements, trimethoprim, tacrolimus, cyclosporine, heparin) and with potassium-containing salt substitutes; these preparations increase the risk of hyperkalemia.
Due to the content of losartan in the preparation, caution should be exercised if the preparation is used with any of the following drugs:
· Non-steroidal anti-inflammatory drugs (eg acetylsalicylic acid, ibuprofen, ketoprofen, selective COX-2 inhibitors) may reduce the antihypertensive effect of the preparation and lead to renal dysfunction, including acute renal failure and increase in potassium in the blood; caution is required, especially in the elderly and monitoring of renal function and ensuring adequate hydration of the patient
· Fluconazole and rifampicin reduce the active concentration of the losartan metabolite, although it is not known if this is clinically relevant.
Due to the content of amlodipine in the preparation, it is not recommended to use the preparation in parallel with:
· Dantrolene (infusion); Avoid calcium antagonists such as amlodipine in parallel with dantrolene (including those susceptible to malignant hyperthermia and the treatment of malignant hyperthermia), because of the risk of fatal arrhythmia
· Grapefruit or grapefruit juice; Grapefruit juice in some people may cause an increase in the antihypertensive effect contained in the preparation of amlodipine.
Due to the content of amlodipine in the preparation, particular caution is required if the preparation is used with any of the following drugs:
· Preparations that increase the activity of the cytochrome P450 3A4 isoenzyme (such as, for example, rifampicin, St. John's wort, phenobarbital, primidone, fosfentyin, phenytoin and carbamazepine) can reduce amlodipine levels in the blood and reduce its effect; Caution should be exercised because the dosage of amlodipine may need to be adjusted by the doctor
· Preparations that reduce the activity of cytochrome P450 3A4 isoenzyme (such as diltiazem, verapamil, ketoconazole, itraconazol and other azole antifungals, ritonavir and other protease inhibitors, erythromycin and other macrolide antibiotics) can inhibit the metabolism of amlodipine and increase its concentration in the blood and significant intensification of its operation; be careful and be under the supervision of a doctor; it may be necessary to adjust the dosage by your doctor
· Simvastatin - in parallel, the use of amlodipine and simvastatin may increase systemic exposure to statins and increase the risk of myopathy and rhabdomyolysis; the necessary dose reduction of simvastatin (as prescribed by your doctor).

What side effects can occur?

Like all medicines, Alortia can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The use of the preparation may be associated with the occurrence of adverse reactions previously reported for each of the active substances (amlodipine and losartan) used independently.
Frequently or rarely occurring side effects associated with the use of amlodipine include: headache and dizziness, fatigue, fainting, tingling or numbness (paresthesia), tremors, mood changes (including anxiety), sleep disorders / drowsiness / insomnia, depression, taste disorders, blurred vision (including double vision), tinnitus, hot flushes (sudden redness of the face), palpitations, hypotension, chest pain, weakness, edema (especially around the ankles), shortness of breath, rhinitis , dry mouth, nausea, abdominal pain, indigestion, vomiting, diarrhea, constipation, alopecia, profuse sweating, rash, pruritus, skin discoloration, purpura, muscle aches and cramps, joint pain, impaired voiding frequency, impotence , gynaecomastia, increase / decrease body weight. Rare or very rare: confusion / confusion, increased muscle tone, peripheral neuropathy, myocardial infarction, arrhythmias, increased liver enzymes, jaundice, hepatitis, increased bilirubin in the blood, gastritis, pancreatitis, gingival hyperplasia, inflammation vascular thrombocytopenia, thrombocytopenia, reduced white blood cell count (leukopenia), increased blood glucose (hyperglycaemia), cough, urticaria, photosensitivity, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in occasional cases that may cause narrowing of the airways) , impede breathing and threaten life), severe skin reactions (Stevens and Johnson syndrome, erythema multiforme, exfoliative dermatitis).
Frequent or not very common side effects associated with the use of losartan include: dizziness and headaches, drowsiness / sleep disorders, heart palpitations, angina pectoris, hypotension, including orthostatic, abdominal pain, constipation, fatigue, fatigue, swelling, increased levels of potassium in the blood (hyperkalemia), rash.Rare: angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and life-threatening), hypersensitivity reactions, anaphylactic reactions, vasculitis, hepatitis, increased liver enzymes. In addition, possible other side effects for which the incidence of anemia has not been determined: anemia, thrombocytopenia, depression, migraine, disturbed taste, tinnitus, cough, diarrhea, pancreatitis, liver dysfunction, kidney problems (including renal failure), urinary tract infections, flu-like symptoms, muscle and joint pains, rhabdomyolysis, sexual dysfunction (impotence), malaise, low blood sodium (hyponatraemia), pruritus, urticaria, hypersensitivity to light.