Universal reference book for medicines
Product name: LORISTA ® H (LORISTA ® H)

Active substance: hydrochlorothiazide, losartan

Type: Antihypertensive drug

Manufacturer: KRKA (Slovenia) packing and packing KRKA (Slovenia)
Composition, form of production and packaging
The tablets covered with a film membrane
from yellow to yellow with a greenish tinge color, oval, slightly biconcave, with a risk on one side;
type of tablet on a cross-section - the core of a tablet of white color.
1 tab.

Losartan potassium 50 mg

hydrochlorothiazide 12.5 mg

Excipients: pregelatinized starch - 34.92 mg, microcrystalline cellulose - 87.7 mg, lactose monohydrate - 63.13 mg, magnesium stearate - 1.75 mg.

The composition of the film membrane: hypromellose - 5 mg, macrogol 4000 - 0.5 mg, dye quinoline yellow (E104) - 0.11 mg, titanium dioxide (E171) - 1.39 mg, talc - 0.5 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
The tablets covered with a film membrane from yellow to yellow with a greenish tinge color, oval, slightly biconcave, with a risk on one side;
type of tablet on a cross-section - the core of a tablet of white color.
1 tab.

Losartan potassium 50 mg

hydrochlorothiazide 12.5 mg

Excipients: pregelatinized starch - 34.92 mg, microcrystalline cellulose - 87.7 mg, lactose monohydrate - 63.13 mg, magnesium stearate - 1.75 mg.

The composition of the film membrane: hypromellose - 5 mg, macrogol 4000 - 0.5 mg, dye quinoline yellow (E104) - 0.11 mg, titanium dioxide (E171) - 1.39 mg, talc - 0.5 mg.

10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Combined antihypertensive drug.

Losartan is a selective antagonist of angiotensin II receptor type AT 1 non-protein.

In vivo and in vitro, losartan and its biologically active carboxylic metabolite (EXP-3174) block all physiologically significant effects of angiotensin II on AT 1 -receptors regardless of the route of its synthesis: leads to an increase in plasma renin activity, reduces the concentration of aldosterone in the blood plasma.

Losartan indirectly causes the activation of AT 2 -receptors by increasing the level of angiotensin II.
Losartan does not inhibit the activity of kininase II, an enzyme that is involved in the metabolism of bradykinin.
Reduces OPSS, pressure in a small circle of blood circulation;
reduces afterload, has a diuretic effect.
It prevents the development of myocardial hypertrophy, increases tolerance to physical activity in patients with chronic heart failure.

The administration of losartan 1 time / day leads to a statistically significant decrease in systolic and diastolic blood pressure.
During the day, losartan evenly controls BP, while the antihypertensive effect corresponds to a natural circadian rhythm. Decrease in blood pressure at the end of the dose of the drug was approximately 70-80% of the effect at the peak of the drug, 5-6 hours after admission. The withdrawal syndrome is not observed; also losartan does not have a clinically significant effect on heart rate.
Losartan is effective in men and women, as well as in the elderly (? 65 years) and younger patients (? 65 years).

Hydrochlorothiazide is a thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron;
delays the excretion of calcium ions, uric acid. Has antihypertensive properties; the hypotensive effect develops due to the expansion of arterioles.Virtually no effect on normal blood pressure. Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours.
Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

PHARMACOKINETICS

The pharmacokinetics of losartan and hydrochlorothiazide with simultaneous application does not differ from that in their separate application.

Losartan

Suction

Well absorbed from the digestive tract.
The intake of the drug with food does not have a clinically significant effect on its serum concentrations. Bioavailability is about 33%. C max losartan in the blood plasma is achieved 1 h after ingestion, and C max EXP-3174 is reached after 3-4 hours.
Distribution

More than 99% of losartan and EXP-3174 bind to plasma proteins, mainly albumin.
V d of losartan is 34 liters. Very poorly penetrates the BBB.
Metabolism

It is subject to significant metabolism during the "first passage" through the liver, forming the active metabolite EXP-3174 (14%) and a number of inactive metabolites.

Excretion

The plasma clearance of losartan and EXP-3174 is approximately 10 ml / s (600 ml / min) and 0.83 ml / s (50 ml / min), respectively.
The renal clearance of losartan and EXP-3174 is about 1.23 ml / s (74 ml / min) and 0.43 ml / s (26 ml / min), respectively. T 1/2 of losartan and EXP-3174 is 2 hours and 6-9 hours, respectively.About 58% of the drug is excreted with bile, 35% - kidney.
Hydrochlorothiazide

Suction and distribution

After oral administration, the absorption of hydrochlorothiazide is 60-80%.
C max in the blood is achieved 1-5 hours after ingestion. Binding hydrochlorothiazide to blood plasma proteins - 64%.
Metabolism and excretion

Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys.
T 1/2 is 5-15 hours.
INDICATIONS

- arterial hypertension (patients who are shown combined therapy);

- reduced risk of cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy.

DOSING MODE

The drug is taken orally, regardless of food intake.
Lorist H can be combined with other antihypertensive agents.
With arterial hypertension, the initial and maintenance dose is 1 tab.
1 time / day. The maximum antihypertensive effect is achieved within 3 weeks of therapy. To achieve a more pronounced effect, it is possible to increase the dose to 2 tablets. 1 time / day. The maximum daily dose is 2 tablets.
With reduced BCC (for example, with diuretics in high doses), the recommended initial dose of losartan in patients with hypovolemia is 25 mg 1 time / day.
In this regard, treatment with Loristo H is necessary to begin after the abolition of diuretics and correction of hypovolemia.
In elderly patients and patients with moderate renal insufficiency (CK 30-50 ml / min), including patients on dialysis , correction of the initial dose of the drug is not required.

To reduce the risk of cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy, the standard initial dose of losartan is 50 mg 1 time / day.
Patients who failed to achieve the target blood pressure level when taking Losartan 50 mg / day require treatment with a combination of losartan with low doses of hydrochlorothiazide (12.5 mg) and, if necessary, increase the dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg / day, further - to increase the dose of Lorist H to 2 tablets. 1 time / day.
SIDE EFFECT

From the side of the central nervous system: often - headache, systemic and non-systemic dizziness, insomnia, fatigue;
sometimes - a migraine.
From the cardiovascular system: often - orthostatic hypotension (dose-dependent), palpitation, tachycardia;
rarely vasculitides.
On the part of the respiratory system: often - cough, upper respiratory tract infections, pharyngitis, swelling of the nasal mucosa.

From the digestive system: often - diarrhea, dyspepsia, nausea, vomiting, abdominal pain;
rarely - hepatitis, a violation of liver function; very rarely - increased activity of liver enzymes and bilirubin.
From the musculoskeletal system: often - myalgia, back pain;
sometimes - arthralgia.
On the part of the system of hematopoiesis: infrequently - anemia, purple Shenlaine-Genocha.

On the part of laboratory indicators: often - hyperkalemia, increased concentrations of hemoglobin and hematocrit (clinically insignificant);
sometimes - a moderate increase in the level of urea and creatinine in the blood serum.
Allergic reactions: sometimes - hives, itching;
rarely anaphylactic reactions, angioedema (including swelling of the larynx and tongue, causing airway obstruction and / or swelling of the face, lips, pharynx).
Other: often - asthenia, weakness, peripheral edema, chest pain.

CONTRAINDICATIONS

anuria;

- severe renal dysfunction (CK <30 ml / min);

- Hyperkalemia;

- Dehydration (including on the background of taking diuretics in high doses);

- pronounced violations of the liver function;

- refractory hypokalemia;

- arterial hypotension;

- deficiency of lactase;

- galactosemia or glucose / galactose malabsorption syndrome;

- Pregnancy;

- lactation period;

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

- hypersensitivity to losartan and other components of the drug;

- hypersensitivity to derivatives of sulfonamides.

With caution should be used for violations of water-electrolyte balance of blood (hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia), bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, diabetes mellitus, hypercalcemia, hyperuricemia and / or gout, with a burdened allergic anamnesis patients angioedema developed earlier with the intake of other medicinal substances, including ACE inhibitors) and bronchial asthma, systemic blood diseases (including with SLE), about
simultaneously with NSAIDs (including inhibitors of COX-2).
PREGNANCY AND LACTATION

There are no data on the use of losartan in pregnancy.
Renal perfusion of the fetus, which depends on the development of the renin-angiotensin system, begins to function in the third trimester of pregnancy. The risk to the fetus increases with the use of losartan in the II and III trimesters, tk. taking medicines directly acting on the renin-angiotensin system during the II and III trimesters of pregnancy can lead to fetal death.
It is not recommended the appointment of diuretics during pregnancy due to the risk of jaundice in the fetus and newborn, thrombocytopenia in the mother.
Diuretic therapy does not prevent the development of pregnancy toxicity.
When establishing a pregnancy, Lori N should be stopped immediately.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

It is not recommended to prescribe the drug for severe renal dysfunction and patients on hemodialysis.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is not recommended for patients with liver damage.

APPLICATION FOR CHILDREN

The drug is contraindicated for the treatment of children and adolescents under the age of 18 , since there is no experience of using the drug in pediatrics.

APPLICATION IN ELDERLY PATIENTS

Older patients do not need to adjust the initial dose of the drug.

SPECIAL INSTRUCTIONS

Can be prescribed together with other antihypertensive drugs.

There is no need for a special selection of the initial dose in elderly patients.
The drug can increase the concentration of urea and creatinine in the blood plasma in patients with bilateral stenosis of the renal arteries or stenosis of the renal artery of a single kidney.
Hydrochlorothiazide can increase arterial hypotension and disturbances of water-electrolyte balance (decrease in bcc, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce calcium excretion in the urine and cause a transient, insignificant increase in calcium concentration in the blood plasma, increase cholesterol concentration and TG, to provoke the emergence of hyperuricemia and / or gout.

Lorist ® H contains lactose, so the drug is not prescribed for patients with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.

Impact on the ability to drive vehicles and manage mechanisms

Almost all patients during the treatment with Lorist ® H can perform actions requiring increased attention (for example, driving or dangerous technical means).
In individuals at the beginning of therapy, the drug can cause arterial hypotension and dizziness and, thus, indirectly affect their psychophysical state. For safety reasons, before starting activities requiring increased attention, patients should first assess their response to ongoing treatment.
OVERDOSE

Losartan

Symptoms: marked decrease in blood pressure, tachycardia;
bradycardia due to parasympathetic (vagal) stimulation.
Treatment: forced diuresis, symptomatic therapy, hemodialysis is ineffective.

Hydrochlorothiazide

Symptoms: the most common symptoms are a consequence of a deficiency of electrolytes (hypokalemia, hypochloraemia, hyponatremia) and dehydration due to excessive diuresis.
With the simultaneous administration of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.
Treatment: symptomatic therapy.

DRUG INTERACTION

Losartan

Clinical studies have not shown clinically significant pharmacokinetic interaction of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin.

Rifampicin and fluconazole reduce the level of the active metabolite (this interaction has not been clinically studied).

The combination of losartan with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium-containing additives or potassium salts can lead to hyperkalemia.

NSAIDs, incl.
selective inhibitors of COX-2, can reduce the effectiveness of diuretics and other antihypertensive agents, including losartan.
In patients with impaired renal function receiving NSAID therapy (including COX-2 inhibitors), angiotensin II receptor antagonist therapy can lead to further impairment of kidney function, including acute kidney failure, which is usually reversible.

The hypotensive effect of losartan, as well as other antihypertensive drugs, can be reduced by taking indomethacin.

Hydrochlorothiazide

With simultaneous use with thiazide diuretics, ethanol, barbiturates and narcotics can potentiate the risk of developing orthostatic hypotension.

When used simultaneously with hypoglycemic agents (for ingestion and insulin), a dose adjustment of hypoglycemic agents may be required.

When taken in combination with other antihypertensive drugs - additive effect.

Colestramine and colestipol disrupt the absorption of hydrochlorothiazide.

With simultaneous application with GCS, ACTH, there is a marked decrease in electrolyte levels, in particular, hypokalemia.

Hydrochlorothiazide reduces the severity of response to the intake of pressor amines (eg, epinephrine, norepinephrine).

Hydrochlorothiazide enhances the effect of muscle relaxants with a nondepolarizing action type (eg, tubocurarine).

Diuretics reduce renal clearance of lithium and increase the risk of toxic effects of lithium (simultaneous use is not recommended).

NSAIDs (including COX-2 inhibitors) can reduce the diuretic, natriuretic and hypotensive effects of diuretics.

In connection with the effect on calcium metabolism, the use of thiazide diuretics can distort the results of the study of the function of parathyroid glands.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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