Universal reference book for medicines
Name of the drug: VAZOTENZ ®

Active substance: losartan

Type: Angiotensin II receptor antagonist

Manufacturer: ACTAVIS hf.
(Iceland)
Composition, form of production and packaging
The tablets are coated with a
white color, round, biconvex, with risks on both sides and lateral risks, with markings of "3" on the one side of the risks and "L" on the other side of the risks.

1 tab.

Losartan potassium 50 mg

Additives: mannitol - 203.8 mg, microcrystalline cellulose - 81 mg, croscarmellose sodium - 14.38 mg, povidone K-30 - 7.22 mg, magnesium stearate - 3.6 mg, hypromellose 6 - 4.44 mg, titanium dioxide (E171) - 0.92 mg, talcum powder - 0.92 mg, propylene glycol 0.92 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
The tablets covered with a cover of white color, oval, biconcave, with risk from one side and marking "4L" - on the other, with lateral risks.

1 tab.

Losartan Potassium 100 mg

Auxiliary substances: mannitol - 407.6 mg, microcrystalline cellulose - 162 mg, croscarmellose sodium - 28.76 mg, povidone K-30 - 14.44 mg, magnesium stearate 7.2 mg, hypromellose 6-8.88 mg, titanium dioxide (E171) 1.84 mg, talcum powder - 1.84 mg, propylene glycol - 1.84 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
The tablets covered with a cover of white color, round, biconcave, with marking "1L" from one side.

1 tab.

Losartan potassium 12.5 mg

Additives: mannitol - 50.95 mg, microcrystalline cellulose - 20.25 mg, croscarmellose sodium - 3.595 mg, povidone K-30 - 1.805 mg, magnesium stearate - 0.9 mg, hypromellose 6 - 1.11 mg, titanium dioxide (E171) - 0.23 mg, talcum powder - 0.23 mg, propylene glycol 0.23 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
The tablets covered with a cover of white color, round, biconcave, with marking "2L" on the one hand.

1 tab.

Losartan potassium 25 mg

Auxiliary substances: mannitol - 101.9 mg, microcrystalline cellulose - 40.5 mg, croscarmellose sodium - 7.19 mg, povidone K-30 - 3.61 mg, magnesium stearate - 1.8 mg, hypromellose 6 - 2.22 mg, titanium dioxide (E171) - 0.46 mg, talcum powder - 0.46 mg, propylene glycol 0.46 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Specific antagonist of angiotensin II receptors (subtype AT 1 ).
He suppresses kinase II - an enzyme that destroys bradykinin. Reduces OPSS, the concentration in the blood of adrenaline and aldosterone, blood pressure, pressure in the small circle of the circulation. Decreases afterload, has a diuretic effect. It interferes with the development of myocardial hypertrophy, increases tolerance to exercise in patients with heart failure.
After a single dose, the hypotensive effect (decreases systolic and diastolic blood pressure) reaches a maximum after 6 hours, then gradually decreases within 24 hours.

The maximum hypotensive effect is achieved in 3-6 weeks after the start of the drug.

PHARMACOKINETICS

Suction

Losartan is rapidly absorbed from the digestive tract.
Bioavailability is about 33%. T max of losartan is reached after 1 hour.
Metabolism

Subjected to the effect of "first passage" through the liver, it is metabolized by carboxylation with the participation of the CYP2C9 isoenzyme with the formation of an active metabolite.
T max of active metabolite is achieved after 3-4 hours. Binding to plasma proteins is 99%.
Excretion

T 1/2 of losartan is 1.5-2 hours, and its main metabolite is 6-9 hours. About 35% of the dose is excreted in the urine, about 60% - through the intestine.

Pharmacokinetics in special clinical cases

It was found that the concentration of losartan in the blood plasma in patients with cirrhosis of the liver is significantly increased.

INDICATIONS

- arterial hypertension;

- chronic heart failure (as part of combination therapy, with intolerance or inefficiency of therapy with ACE inhibitors).

DOSING MODE

The drug is taken orally, regardless of food intake, the frequency of intake is 1 time / day.

With arterial hypertension, the average daily dose is 50 mg.
In some cases, to achieve a greater effect, the dose is increased to 100 mg in 2 divided doses or 1 time / day.
When appointing the drug to patients receiving diuretics in high doses, the initial dose of Vasotens should be reduced to 25 mg 1 time / day.

The initial dose for patients with heart failure is 12.5 mg 1 time / day.
Typically, the dose increases with a weekly interval (ie 12.5 mg / day, 25 mg / day and 50 mg / day) to an average maintenance dose of 50 mg 1 time / day, depending on the patient's tolerance of the drug.
Patients with impaired hepatic function (including cirrhosis of the liver) should be prescribed lower doses of Vasotenz.

In elderly patients, as well as in patients with impaired renal function, including patients undergoing dialysis, there is no need to adjust the initial dose.

SIDE EFFECT

From the central nervous system and peripheral nervous system :? 1% - dizziness, asthenia, headache, fatigue, insomnia;
<1% - anxiety, sleep disturbance, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hypostases, migraine, tremor, ataxia, depression, syncope.
From the sense organs: ringing vushah, a violation of taste, a change in vision, conjunctivitis.

On the part of the respiratory system: 1% - nasal congestion, cough *, upper respiratory tract infections (high body temperature, sore throat, sinusopathy *, sinusitis, pharyngitis);
<1% - dyspnea, bronchitis, rhinitis.
From the digestive system :? 1% - nausea, diarrhea *, dyspeptic phenomena *, abdominal pain;
<1% - anorexia, dry mouth, toothache, vomiting, flatulence, gastritis, constipation.
From the musculoskeletal system: 1% - convulsions, myalgia *, pain in the back, chest, legs;
<1% - arthralgia, shoulder pain, knee, arthritis, fibromyalgia.
From the cardiovascular system: orthostatic hypotension (dose-dependent), palpitation, tachy- or bradycardia, arrhythmias, angina.

On the part of the genitourinary system: <1% - mandatory urination, urinary tract infections, impaired renal function, weakened libido, impotence.

Dermatological reactions: <1% - dry skin, erythema, hot flushes, photosensitization, increased sweating, alopecia.

Allergic reactions: <1% - urticaria, rash, itching, angioedema (including face, lips, throat and / or tongue).

Other: hyperkalemia (serum potassium more than 5.5 mmol / l), anemia.

* There are side effects, the incidence of which is comparable to placebo.

The association of side effects occurring with a frequency of <1% of cases with the use of losartan has not been proven.

In most cases, Vasotens is well tolerated, side effects are transient and do not require withdrawal of the drug.

CONTRAINDICATIONS

- arterial hypotension;

- Hyperkalemia;

- dehydration;

- Pregnancy;

- the period of lactation (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for liver failure.

PREGNANCY AND LACTATION

There are no data on the use of losartan in pregnancy.
However, it is known that drugs acting directly on the renin-angiotensin system, when used in the II and III trimesters of pregnancy, can cause a developmental defect or even the death of a developing fetus. Therefore, when a pregnancy occurs, the use of Vasotens should be stopped immediately.
When appointing during lactation, a decision should be made whether to stop breastfeeding or stop treatment with Vasotensis.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function, including patients on dialysis, there is no need to adjust the initial dose.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with impaired hepatic function (including cirrhosis of the liver) should be prescribed lower doses of Vasotenz.

APPLICATION FOR CHILDREN

Contraindication: age under 18 years (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

In elderly patients, there is no need to adjust the initial dose.

SPECIAL INSTRUCTIONS

It is necessary to correct the dehydration prior to the appointment of Vasotens or to start treatment with the drug at a lower dose.

Drugs that affect the renin-angiotensin system can increase the concentration of urea in the blood and serum creatinine in patients with bilateral renal stenosis or stenosis of the artery of a single kidney.

During the treatment period, the concentration of potassium in the blood should be monitored regularly, especially in elderly patients, with renal dysfunction.

The drug may be administered with other antihypertensive agents.

Use in Pediatrics

Safety and effectiveness of the drug in children are not established.

OVERDOSE

Symptoms: marked decrease in blood pressure, tachycardia, because of parasympathetic (vagus) stimulation, bradycardia may appear.

Treatment: forced diuresis, symptomatic therapy;
Hemodialysis is ineffective.
DRUG INTERACTION

There was no clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital.

In patients with dehydration (previous treatment with diuretics in high doses), there may be a marked decrease in blood pressure.

Strengthens (mutually) the effect of other antihypertensive drugs (diuretics, beta-adrenoblockers, sympatholytics).

Increases the risk of hyperkalemia when combined with potassium-sparing diuretics and potassium preparations.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 2 years.
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