Lozap Plus , 50 mg + 12.5 mg, 60 pcs.

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Product Description

Composition

1 film-coated tablet contains active ingredients: 

Losartan potassium 50 mg and hydrochlorothiazide 12.5 mg

Excipients 

Mannitol,

microcrystalline cellulose,

croscarmellose sodium,

povidone,

magnesium stearate,

hypromellose 2910/5,

macrogol 6000,

talc,

simethicone emulsion,

Opaspray yellow M-1-22801 (Opaspray yellow M-1-22801) (which includes: purified water, titanium dioxide, denatured ethanol (methylated alcohol BP) (99% ethanol: 1% methanol), hypromellose, dye Quinolin Yellow (E 104), dye Pounceau 4R (E 124)).

DESCRIPTION 

Oblong tablets of light yellow color, film-coated, with a dividing line on both sides.

pharmachologic effect

PHARMACOTHERAPEUTIC GROUP
 
HYPOTENSIVE COMBINED DRUG 
(angiotensin II receptor blocker + diuretic)

ATC code: C09DA01

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
 
The combined drug has a hypotensive effect. Contains losartan potassium - an angiotensin II receptor antagonist (AT1 subtype) and hydrochlorothiazide - a diuretic.
 
Losartan is a specific angiotensin II receptor antagonist (AT1 subtype). Does not inhibit kinase II, an enzyme that degrades bradykinin. Reduces total peripheral vascular resistance (OPSS), blood concentration of adrenaline and aldosterone, blood pressure (BP), pressure in the pulmonary circulation; reduces afterload, has a diuretic effect. Prevents the development of myocardial hypertrophy, increases exercise tolerance in patients with chronic heart failure. 
Hydrochlorothiazide is a thiazide diuretic. Reduces reabsorption of Na +, enhances urinary excretion of K +, bicarbonate and phosphates. Lowers blood pressure by reducing the volume of circulating blood (BCC), changing the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictor substances and increasing the depressor effect on the ganglia.

Pharmacokinetics
 
Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. Has a "first pass" effect through the liver, metabolized by carboxylation to form an active metabolite. Communication with blood plasma proteins - 99%. The time to reach the maximum concentration of losartan is 1 hour, the active metabolite is 3-4 hours after oral administration. The half-life is 1.5 - 2 hours, and its main metabolite is 3 - 4 hours, respectively. About 35% of the dose is excreted in the urine, about 60% through the intestines.
 
Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract. The half-life is 5.8 - 14.8 hours. It is not metabolized by the liver. About 61% is excreted by the kidneys unchanged.

Indications

- Arterial hypertension (in patients for whom combination therapy is optimal); 
- Reducing the risk of cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy.

Contraindications

- hypersensitivity to drug components; 
- anuria; 
- severe arterial hypotension; 
- Severe liver and kidney dysfunction (creatinine clearance? 30 ml / s); 
- hypovolemia (including against the background of high doses of diuretics); 
- pregnancy and lactation; 
- age up to 18 years (efficacy and safety have not been established). The drug is prescribed with caution in patients with diabetes mellitus, hypercalcemia, hyperuricemia and / or gout, as well as in patients with a history of allergy and bronchial asthma, as well as in systemic connective tissue diseases (including systemic lupus erythematosus).

Use with caution in patients with bilateral renal stenosis or stenosis of a solitary kidney artery. 


Side effects

Adverse reactions are limited to those previously observed with the use of losartan potassium and / or hydrochlorothiazide. The most common side effects of essential hypertension include dizziness.
 
Allergic reactions: angioedema, including swelling of the larynx and / or tongue, leading to airway obstruction, and / or swelling of the face, lips, pharynx and / or tongue, occasionally noted with losartan. Some of these patients have previously experienced angioedema with other drugs, including ACE inhibitors. It is extremely rare when taking losartan there were manifestations of vasculitis, including Shenlein-Henoch disease.
 
From the side of the cardiovascular system: lowering blood pressure.
 
On the part of the digestive tract: while taking losartan, rare (<1%) cases of hepatitis and diarrhea were recorded.
 
From the respiratory system: when taking losartan - cough.
 
On the part of the skin: urticaria.
 
Laboratory indicators: rarely (<1%) hyperkalemia (serum potassium more than 5.5 mmol / l), increased activity of "hepatic" transaminases.

Interaction

Losartan enhances the effect of other antihypertensive drugs. There was no clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketokenazole, erythromycin. Like other drugs that block angiotensin II or its action, the simultaneous administration of potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium preparations or salt substitutes containing potassium can lead to hyperkalemia.
 
Hydrochlorothiazide
 
The following drugs can interact with thiazide diuretics when given concomitantly: 
Barbiturates, narcotic analgesics, ethanol - potentiation of orthostatic hypotension may occur.
 
Hypoglycemic agents (oral agents and insulin) - dose adjustment of hypoglycemic agents may be required. 
Other antihypertensive drugs - an additive effect is possible.
 
Colistiramine reduces the absorption of hydrochlorothiazide.
 
Corticosteroids, ACTH - increased loss of electrolytes, especially potassium.
 
Pressor amines - a slight decrease in the effect of pressor amines is possible without interfering with their use.
 
Non-depolarizing muscle relaxants (for example, tubocurarine) - it is possible to enhance the action of muscle relaxants.
 
Lithium preparations - diuretics reduce the renal clearance of Li + and increase the risk of lithium intoxication, therefore, simultaneous use is not recommended.
 
Non-steroidal anti-inflammatory drugs (NSAIDs) - in some patients, the use of NSAIDs can reduce the diuretic, natriuretic and hypotensive effects of diuretics.

Impact on laboratory results
 
Due to their effect on calcium excretion, thiazides can influence the results of the analysis of the function of the parathyroid glands.

How to take, course of administration and dosage

Inside, regardless of food intake.

Arterial hypertension
 
The usual starting and maintenance dose of LOZAP PLUS is 1 tablet per day. For those patients who cannot achieve adequate blood pressure control at this dosage, the dose of LOZAP PLUS can be increased to 2 tablets 1 time per day. 
The maximum dose is 2 tablets once a day. In general, the maximum hypo-tension effect is achieved within 3 weeks after starting treatment. There is no need for a special selection of the initial dose for elderly patients.

Reducing the risk of cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy 
The standard starting dose of LOZAP (losartan) is 50 mg once a day.
 
Patients who failed to reach target blood pressure levels while taking LOZAP (losartan) 50 mg / day need to select therapy by combining losartan with low doses of hydrochlorothiazide (12.5 mg) - LOZAP PLUS, and, if necessary, the dose should be increased to 2 tablets of LOZAP PLUS (only 100 mg of losartan and 25 mg of hydrochlorothiazide per day, once).

Overdose

Symptoms: losartan - a marked decrease in blood pressure, tachycardia, bradycardia (as a result of vagal stimulation). Hydrochlorothiazide - loss of electrolytes (hypokalemia, hyperchloremia, hyponatremia), as well as dehydration resulting from excessive diuresis.
 
Treatment: symptomatic and supportive therapy. If the drug has been taken recently, the stomach should be flushed; if necessary, correction of water-electrolyte disturbances is carried out.
 
Losartan and its active metabolites are not removed by hemodialysis.

Special instructions

LOZAP PLUS can be prescribed together with other antihypertensive drugs.
 
There is no need for a special selection of the initial dose for elderly patients.
 
The drug can increase the concentration of urea and creatinine in the blood plasma in patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney.
 
Hydrochlorothiazide can increase arterial hypotension and disturbances in water-electrolyte balance (decrease in circulating blood volume, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce the excretion of Ca2 + in the urine and cause a transient slight increase in Ca2 + concentration in the plasma blood, increase the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and / or gout.
 
Taking drugs that directly act on the renin-angiotensin system during the II and III trimesters of pregnancy can lead to fetal death. When pregnancy occurs, drug withdrawal is indicated.
 
The use of diuretics is usually not recommended for pregnant women due to the risk of jaundice in the fetus and newborn, maternal thrombocytopenia. Diuretic therapy does not prevent the development of pregnancy toxicosis.
 
There is no information on the effect on the ability to drive a car and other mechanisms.

Release form

Film-coated tablets 50 mg / 12.5 mg. 14 tablets in a blister made of Al / PVC foil. 2 blisters, together with instructions for use, are placed in a cardboard box.
 
10 tablets in a blister of Al / PVC foil, 1, 3 or 9 blisters (10, 30 or 90 tablets) together with instructions for use are placed in a cardboard box.

Storage conditions

List B.
 
In a dry place out of the reach of children at temperatures up to 30 C.

Shelf life

3 years.