Losartan - medication with antihypertensive effect.
release form and composition
Losartan is produced in the form of tablets, film-coated: round, lenticular, is allowed a small surface roughness;on a break - white with a yellowish tint, or white;12.5 and 25 mg - white with a grayish tinge and white, 50 mg - pink, 100 mg - yellow (in blister packs of 10 pieces, 3 blisters in a carton box;. In blisters to 15 pcs, 2.4, 6 blisters in a carton box, in blisters of 10, 30 pieces, on 1-6, 10 packs per carton box;. in blisters of 20 pieces, 1, 3 packs in a carton box;. inblisters on 7 pcs, 1-4 on the packaging in a carton box;. banks (jars) for 10, 20, 30,40, 50, 60, 100 pieces, and 1 bank in a carton box)..
1 Tablets The composition includes:
- Active ingredient: losartan potassium - 12.5 mg, 25 mg, 50 mg or 100 mg;
- Excipients (tablets of 12.5 / 25/50 / 100mg, respectively): lactose monohydrate (milk sugar) - 114.63 / 149.5 / 270.6 / 115 mg, microcrystalline cellulose - 5.72 / 1224 / 26.6 / 40 mg, crosc
armellose sodium (primelloza) - 4.29 / 9.18 / 15.2 / 11.2 mg, colloidal silicon dioxide (aerosil) - 1.43 / 2.04 / 32.8 mg povidone (low molecular weight polyvinylpyrrolidone) - 0/0/0/9 mg magnesium stearate - 1.43 / 2.04 / 3.8 / 2.8 mg.
- 12,5 and 25 mg (respectively): Opadry II White (polyvinyl alcohol (E1203) - 40% titanium dioxide (E171) - 25% polyethylene glycol (macrogol) (E1521) - 20, 2% talc (E553b) - 14.8%) - 2.983 / 3.975 mg, 30% simethicone emulsion (water - 50-69,5% polydimethylsiloxane - 25,5-33%, polyethylene glycol sorbitan tristearate - 3.7% methyl cellulose - 1-5% silica - 5.1%) - 0.017 / 0.025 mg;
- 50 mg: Opadry II pink (polyvinyl alcohol (E1203) - 40% titanium dioxide (E171) - 24.18% talc (E553b) - 14.8% polyethylene glycol (macrogol) (E1521) - 20.2% dye carmine red (E120) - 0.54%, aluminum lake based on the charming red dye (E129) - 0.08%, aluminum lake dye sunset yellow (E110) - 0.15%, aluminum lake onquinoline-based yellow dye (E104) - 0.05%) - 9.923 mg simethicone emulsion 30% (water - 50-69,5%, polyethylene glycol sorbitan tristearate - 3.7%, polydimethylsiloxane - 25,5-33% methylcellulose- 1-5% silica - 1.5%) - 0.077 mg;
- 100 mg (Hypromellose - 4.8 mg Talc - 1.6 mg of titanium dioxide - 0.826 mg polyethylene glycol 4000 (Macrogol 4000) - 0.72 mg yellow ferric oxide (iron oxide) - 0.054 mg) or(dry film coating mixture containing: hypromellose - 60% talc - 20% titanium dioxide - 10.33% macrogol 4000 (polyethylene glycol 4000) - 9%, yellow iron oxide (iron oxide) - 0.67%)- 8 mg.
- Protection kidneys in type 2 diabetes with proteinuria (the action is shown in slowing the progression of renal failure, namely the reduction of the incidence of hypercreatininemia, proteinuria, end-stage renal disease (requiring kidney transplantation or dialysis), mortality rates);
- downside associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy (cumulative effect is a decrease in the incidence of stroke, cardiovascular death and myocardial infarction);
- Chronic heart failure in the case of failure of treatment with ACE inhibitors.
- severe hepatic insufficiency (due to lack of experience of the application);
- Refractory hyperkalemia;
- lactase deficiency, lactose intolerance and a syndrome of glucose-galactose malabsorption;
- simultaneous use of aliskiren in patients with diabetes and / or functional renal impairment (glomerular filtration rate at less than 60 mL per minute);
- Pregnancy and lactation;
- the age of 18;
- hypersensitivity to the drug.
relative (disease / condition in which Losartan should be used with caution):
- Renal failure;
- Disturbances of water and electrolyte balance;
- Liver failure (less than 9 points on the Child-Pugh);
- Coronary heart disease;
- Reduced blood volume;
- artery stenosis sole kidney or bilateral renal artery stenosis;
- condition after kidney transplantation;
- mitral and aortic stenosis;
- Obstructive hypertrophic cardiomyopathy;
- severe heart failure (IV functional class NYHA classification), angioedema in history;
- Heart failure, accompanied by life-threatening arrhythmias;
- Heart failure is accompanied by severe renal insufficiency;
- primary aldosteronism;
- Cerebrovascular disease.
Dosage and Administration
Losartan is taken orally, regardless of meal times.
drug can be used as monotherapy or concomitantly with other antihypertensive drugs.
Unless otherwise purposes, the daily dose received in one reception.
In most cases hypertension standard initial and maintenance daily dose is 50 mg.Typically, the maximum antihypertensive effect is reached after 3-6 weeks after initiation of therapy.In some patients, to achieve a greater effect can be increased up to a maximum dose - 100 mg per day.
By reducing the volume of circulating blood (for example, high doses of diuretics) Losartan starting to take a dose of 25 mg per day.
No need for individual selection of the starting dose in elderly patients and in patients with renal insufficiency, including patients on dialysis.
When liver failure (less than 9 points on a scale Child-Pugh) during hemodialysis, as well as patients from 75 years of drug is recommended to be administered in a lower initial dose - 25 mg.
Standard daily starting dose of Losartan to reduce the risk associated cardiovascular morbidity and mortality in patients with left ventricular hypertrophy and arterial hypertension is 50 mg.Further increase in the dose recommended by 2 times (1 or 2 doses, depending on the degree of blood pressure lowering) or the addition of hydrochlorothiazide.
standard initial daily dose of Losartan to protect the kidney in patients with type 2 diabetes mellitus with proteinuria is 50 mg.Further increase in the dose recommended by 2 times depending on the degree of blood pressure reduction.Losartan can be used simultaneously with other antihypertensive drugs (alpha- and beta-blockers, diuretics, centrally acting antihypertensive drugs, blockers "slow" calcium channels), insulin and other hypoglycemic drugs (inhibitors of glucosidase glitazones and sulfonylureas).
In chronic heart failure the initial daily dose is 12.5 mg Losartan.Usually the dose is titrated at weekly intervals to the usual maintenance dose - 50 mg 1 time per day (depending on individual tolerance).
Losartan is generally well tolerated, side effects are transient and bland character and do not require treatment discontinuation.
In applying the drug may develop disorders of some body systems that appear with varying frequency (& gt; 1% - frequently;
- digestive system: often - abdominal pain, dyspepsia, diarrhea, nausea, rarely - dry mucous membranesmouth, anorexia, flatulence, toothache, gastritis, constipation, abnormal liver function, hepatitis, vomiting;
- Cardiovascular system: frequent - palpitations, tachycardia, rarely - angina, symptomatic hypotension (especially in patients with intravascular dehydration,for example, in severe heart failure, or when taking high doses of diuretics), dose-related orthostatic hypotension, bradycardia, myocardial infarction, arrhythmia, vasculitis;
- central nervous system and sensory organs: often - headache, dizziness, insomnia, rare - anxiety, impairedsleep, memory impairment, somnolence, peripheral neuropathy, gipostezii, paraesthesia, tremor, depression, ataxia, syncope, conjunctivitis, taste disturbance and vision, tinnitus, migraine;
- urinary system: rarely - urinary tract infections, urgent need to urinate, functional disorders of the kidneys;
- Respiratory system: often - cough, swelling of the nasal mucosa, bronchitis, sinusitis, sore throat, infection of the upper respiratory tract;
- hemopoietic system: rarely - anemia, eosinophilia, thrombocytopenia, Henoch-Schönlein purpura;
- reproductive system: rarely - impotence, decreased libido;
- Musculoskeletal System: often - muscle cramps, pain in the legs and back;rarely - arthritis, arthralgia, pain in the knee and shoulder, fibromyalgia;
- Skin: rare - increased sweating, dry skin, erythema, ecchymosis, photosensitivity, alopecia;
- Allergic reactions: seldom - skin rash, urticaria, pruritus, angioedema (including swelling of the vocal cord and larynx, causing airway obstruction and / or swelling of the lips, face, tongue and / or throat);
- General disorders: often - peripheral edema, asthenia, fatigue, weakness, pain in the chest;
- Other: rarely - nosebleeds, exacerbation of gout.
also possible development of violations by the laboratory parameters: & gt; 1% and 0.1% and
In developing or worsening of these side effects, as well as the development of atypical symptoms should see a doctor.
In rare cases, the use of Losartan developing disturbances in the form of anaphylactic reactions, angioedema involving the larynx and pharynx, causing airway obstruction and / or swelling of the face, lips, tongue and / or throat.Therefore, if there is indication of angioedema drug history should be taken with extreme caution.
In patients with decreased volume of circulating blood (for example, receiving high doses of diuretics) may develop symptomatic hypotension.It is necessary to carry out the correction of these states to losartan or to begin receiving therapy with lower doses.
Disturbances of water and electrolyte balance are characteristic of patients with renal insufficiency, diabetes mellitus type 2, or without it.When losartan these patients need to be very careful because of the risk of hyperkalemia.
During therapy need to regularly monitor the content of potassium in the blood, especially in elderly patients and in functional disorders of the kidneys.Without prior approval from a physician should not take potassium supplements or salt substitutes containing potassium.
If there is indication of liver disease, a history of Losartan should be taken in lower doses, it is associated with an increase in plasma concentrations of the drug.
During therapy need to regularly at regular intervals to monitor the concentration of creatinine in the blood serum.
Use caution when driving and performing other potentially hazardous activities that require high concentration and rapid psychomotor reactions, because of the possible development of dizziness, especially in patients taking diuretic medications and switched to losartan.
With simultaneous use of Losartan with some drugs may cause the following effects:
- Rifampicin, fluconazole: a decrease in the level of the active metabolite;
- Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene, eplerenone) or preparations that enhance the potassium content (e.g., heparin), potassium supplements, and a potassium salt: potassium increase in serum;
- lithium preparations: decrease sodium excretion and increased serum concentrations of lithium (necessary to carry out its monitoring of serum concentration);
- Nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors: decrease of antihypertensive effect;in patients with impaired renal function treated with NSAIDs may further deterioration of renal function;
- Other antihypertensives: an increase in the severity of antihypertensive action;
- drugs that reduce blood pressure (eg, tricyclic antidepressants, antipsychotics, baclofen, amifostine): increased risk of hypotension;
- Drugs acting on the renin-angiotensin-aldosterone system: increased risk of hypotension, hyperkalemia, syncope and renal dysfunction (including acute renal failure);necessary to carry out careful monitoring of blood pressure, fluid and electrolyte balance and renal function.
Losartan may be used concomitantly with other antihypertensive drugs.
combined use of aliskiren in patients with diabetes and renal insufficiency (glomerular filtration rate at less than 60 mL per minute) is not recommended.
Terms and conditions of storage
Store protected from light, out of reach of children at a temperature of 25 ° C.
Shelf life - 3 years.