Lozap pills 100mg, 30pcs

Composition

Active ingredient:

losartan potassium 100 mg;

Auxiliary substances:

core:

MCC-160 mg;

mannitol-100 mg;

crospovidone-20 mg;

colloidal anhydrous silicon dioxide-4 mg;

talc-8 mg;

magnesium stearate-8 mg.

Film shell:  

sepifilm 752 (white) (hypromellose, MCC, macrogola 2000 stearate, titanium dioxide) — 13.8 mg; macrogol 6000-0.2 mg

Pharmacological action

Lozap is hypotensive.

Pharmacodynamics

Antihypertensive drug, is a specific angiotensin II receptor antagonist (AT subtype₁). It does not inhibit kinase II, an enzyme that destroys bradykinin. Reduces OPSS, the concentration of epinephrine and aldosterone in the blood, blood pressure, pressure in the small circle of blood circulation; reduces afterload, has a diuretic effect. Prevents the development of myocardial hypertrophy, increases exercise tolerance in patients with heart failure.

After a single dose, the antihypertensive effect (sBP and dBP decrease) reaches a maximum in 6 hours, then gradually decreases within 24 hours.

The maximum antihypertensive effect is achieved 3-6 weeks after the start of taking the drug.

Pharmacological data indicate that the plasma concentration of losartan in patients with cirrhosis of the liver is significantly increased, so patients with a history of liver disease should be prescribed at a lower dose.

Pharmacokinetics

Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. It has a “first pass” effect through the liver, is metabolized by carboxylation with the participation of the cytochrome P450 CYP2 C9 isoenzyme to form an active metabolite. Binding to plasma proteins is 99%. The time to reach the_cmax of losartan is 1 hour, the active metabolite is 3-4 hours after oral use. T_1/2 — 1,5–2 and its main metabolite — 6-9 hours, respectively. About 35% of the dose is excreted in the urine, about 60% – through the intestines.

Indications

Arterial hypertension; heart failure (as part of combination therapy, with intolerance or ineffectiveness of therapy with ACE inhibitors).

Contraindications

• hypersensitivity to the components of the drug;
• arterial hypotension;
• hyperkalemia;
• dehydration;
• pregnancy;
• lactation;
• age up to 18 years (efficacy and safety have not been established).

Side effects

Nervous system and sensory disorders:  1% or more — dizziness, asthenia, fatigue, headache, insomnia; less than 1% – anxiety, sleep disorders, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hypesthesia, migraine, tremor, ataxia, depression, syncope, tinnitus, taste disorders, vision changes, conjunctivitis.

Respiratory system disorders:  1% or more — nasal congestion, cough*, upper respiratory tract infections (fever, sore throat, sinusopathy*, sinusitis, pharyngitis); less than 1% – dyspnoea, bronchitis, rhinitis.

From the digestive tract:  1% or more — nausea, diarrhea*, dyspeptic symptoms*, abdominal pain; less than 1% — anorexia, dry mouth, toothache, vomiting, flatulence, gastritis, constipation.

From the musculoskeletal system:  1% or more — cramps, myalgia*, back pain, chest pain, leg pain; less than 1% – arthralgia, shoulder pain, knee pain, arthritis, fibromyalgia.

From the cardiovascular system:  orthostatic hypotension (dose-dependent), palpitations, tachy – or bradycardia, arrhythmia, angina pectoris, anemia.

From the genitourinary system:  less than 1% — urgent urination, urinary tract infections, impaired kidney function, decreased libido, impotence.

From the side of the skin:  less than 1% — dry skin, erythema, flushing, photosensitization, increased sweating, alopecia.

Allergic reactions:  less than 1% — urticaria, rash, pruritus, angioedema, including face, lips, pharynx and / or tongue.

Other services:  hyperkalemia (serum potassium >5.5 mmol / l).

Interaction

It can be prescribed with other antihypertensive agents.

There were no clinically significant interactions with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, and phenobarbital.

Patients with dehydration (previous treatment with high doses of diuretics) may experience a marked decrease in blood pressure.

Increases (mutually) the effect of other antihypertensive agents (diuretics, beta-blockers, sympatholytics).

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

How to take, course of use and dosage

Inside, regardless of the meal. The frequency of reception is 1 time per 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 doses or 1 time a day.

The initial dose for patients with heart failure is 12.5 mg once a day. As a rule, the dose is increased at weekly intervals (i. e. 12.5 mg / day,25 mg / day and 50 mg/day) up to an average maintenance dose of 50 mg once a day, depending on the patient’s tolerance to the drug.

When prescribing the drug to patients receiving high-dose diuretics, the initial dose of Lozap should be reduced to 25 mg once a day.

No dose adjustment is required in elderly patients or patients with impaired renal function, including patients on hemodialysis.

Patients with impaired liver function should be given lower doses of Lozap.

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

Overdose

Symptoms:  marked decrease Blood pressure, tachycardia, and bradycardia may occur due to parasympathetic (vagal) stimulation.

Treatment:  forced diuresis, symptomatic therapy; hemodialysis is not effective.

Special instructions

It is necessary to correct dehydration before prescribing Lozap or start treatment with a lower dose of the drug.

Drugs that affect the renin-angiotensin system may 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 treatment, the concentration of potassium in the blood should be regularly monitored, especially in elderly patients with impaired renal function.

Composition

Tablet Form of production

Storage conditions

In a dry place, at a temperature not exceeding 30 °C

Shelf life

2 years

Active ingredient

Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Prevention of heart attacks and strokes, Hypertension