Vasotenz, 50 mg 30 pcs.

A specific angiotensin II receptor antagonist (AT1 subtype). It inhibits kinase II – bradykinin degrading enzyme. Reduces OPPS, blood concentrations of adrenaline and aldosterone, BP, pressure in the small circle of the circulation. It reduces post-load and has a diuretic effect.

Inhibits the development of myocardial hypertrophy, increases exercise tolerance in patients with heart failure.

The hypotensive effect (decrease in systolic and diastolic BP) reaches a maximum after 6 h, then gradually decreases over 24 h.

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

Indications

– arterial hypertension;

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

Active ingredient

Composition

1 tablet – losartan potassium 100 mg

Supplementary 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,

talc – 1.84 mg,

propylene glycol – 1.84 mg.

How to take, the dosage

The drug is taken orally, regardless of meals, the frequency of administration is 1 time per day.

In arterial hypertension the average daily dose is 50 mg. In individual cases, to achieve a greater effect, the dose is increased to 100 mg in 2 doses or once daily.

When the drug is given to patients receiving high-dose diuretics, the starting dose of Vasotenz should be reduced to 25 mg once daily.

The starting dose for patients with heart failure is 12.5 mg once daily. Typically, the dose is increased at weekly intervals (i.e., 12.5 mg/day, 25 mg/day, and 50 mg/day) to an average maintenance dose of 50 mg once daily, depending on patient tolerance.

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

In elderly patients, and in patients with impaired renal function, including dialysis patients, no adjustment of the starting dose is necessary.

Interaction

No clinically significant interaction with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital was noted.

In patients with dehydration (prior treatment with high-dose diuretics) a significant decrease in BP may occur.

It potentiates (mutually) the effect of other hypotensive agents (diuretics, beta-adrenoblockers, sympatholytics).

Induces the risk of hyperkalemia when combined with potassium-saving diuretics and potassium preparations.

Special Instructions

Dehydration should be corrected before prescribing Vasotenz or treatment should be initiated with a lower dose of the drug.

Drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine concentrations in patients with bilateral renal stenosis or arterial stenosis of the sole kidney.

The blood potassium concentration should be monitored regularly during treatment, especially in elderly patients with impaired renal function.

The drug may be administered with other hypotensive agents.

Use in pediatrics

The safety and effectiveness of the drug in children have not been established.

Contraindications

– arterial hypotension;

– hyperkalemia;

– dehydration;

– pregnancy;

– lactation (breast-feeding) period;

– age under 18 years (efficacy and safety have not been established);

– hypersensitivity to the components of the drug.

With cautiousness the drug should be prescribed in case of hepatic insufficiency.

Side effects

CNS and peripheral nervous system disorders: ≥1% – dizziness, asthenia, headache, fatigue, insomnia; <1% – anxiety, sleep disturbance, somnolence, memory disturbances, peripheral neuropathy, paresthesias, hypoesthesia, migraine, tremor, ataxia, depression, syncope.

Sensory organs: ringing in the ears, impaired taste, changes in vision, conjunctivitis.

Respiratory system: ≥1% – nasal congestion, cough*, upper respiratory tract infections (elevated body temperature, sore throat, sinusopathy*, sinusitis, pharyngitis); <1% – dyspnea, bronchitis, rhinitis.

Digestive system disorders: ≥1% – nausea, diarrhea*, dyspeptic phenomena*, abdominal pain; <1% – anorexia, dry mouth, toothache, vomiting, flatulence, gastritis, constipation.

Muscular system disorders: ≥1% – cramps, myalgia*, pain in the back, chest, legs; <1% – arthralgia, pain in the shoulder, knee, arthritis, fibromyalgia.

Cardiovascular system side: Orthostatic hypotension (dose-dependent), palpitations, tachy or bradycardia, arrhythmias, angina pectoris.

Urogenital system disorders:<1% – imperative urge to urinate, urinary tract infections, impaired renal function, impaired libido, impotence.

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

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

Others: hyperkalemia (serum potassium over 5.5 mmol/l), anemia.

* Side effects have been reported, the incidence of which is comparable to placebo.

The association of side effects occurring with an incidence of <1% with the use of losartan has not been proven.

In most cases, Vasotenz is well tolerated and side effects are transient and do not require withdrawal.

Overdose

Symptoms:pronounced BP decrease, tachycardia, due to parasympathetic (vagus) stimulation bradycardia may occur.

Treatment: forced diuresis, symptomatic therapy; hemodialysis is ineffective.

Similarities