Diocor Solo 80 (valsartan, hydrochlorothiazide) coated tablets 80 mg. №10

Description

Diocor Solo 80 mg. №10 Storage
active substance: valsartan;

1 film-coated tablet contains valsartan 80 mg or 160 mg;

Diocor Solo 80 mg. №10 Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, coating for coating Opadry II White (polyethylene glycol, alcohol 17 and polyvinyl alcohol).

Diocor Solo 80 mg. №10 Dosage form
Film-coated tablets.

Basic physical and chemical properties:

Diocor Solo 80 – round tablets with a biconvex surface, coated with a white film coating, with a line;

Diocor Solo 160 – round tablets with a biconvex surface, coated with a white film coating.

Pharmacotherapeutic group
Simple drugs of angiotensin II antagonists.

ATX code C09C A03.

Pharmacological properties

Pharmacodynamics.

Valsartan is an active specific angiotensin II receptor antagonist for oral use. It acts selectively on AT1 subtype receptors responsible for the known effects of angiotensin II. Elevated plasma angiotensin II levels after AT1 receptor blockade by valsartan may stimulate an unblocked AT2 receptor that balances the effect of the AT1 receptor. Valsartan does not show any partial agonist activity against the AT1 receptor, but has a much greater (approximately 20,000 times) affinity for the AT1 receptor than for the AT2 receptor. Valsartan does not inhibit ACE (an angiotensin-converting enzyme), also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. The use of the drug in patients with hypertension leads to a decrease in blood pressure without affecting the heart rate. The onset of hypotensive effect is observed within 2 hours, maximum – within 4-6 hours after oral administration; duration of action – more than 24 hours. The maximum therapeutic effect develops in 4 weeks from the beginning of treatment and remains at long therapy. When used with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved. Sudden withdrawal of the drug is not accompanied by the development of withdrawal syndrome. With long-term use of the drug in patients with hypertension, it was found that the drug had no significant effect on the level of total cholesterol, uric acid, as well as in studies on an empty stomach – on the concentration of triglycerides and glucose in serum. The drug reduces the number of hospitalizations for heart failure, slows the progression of heart failure, improves the functional class according to the NYHA classification, increases the ejection fraction, and reduces the symptoms of heart failure and improves quality of life compared to placebo.

Indication
Hypertension.

Treatment of arterial hypertension in adults and children aged 6 to 18 years.

Postinfarction condition.

Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction.

Heart failure.

Treatment of symptomatic heart failure in adult patients when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as adjunctive therapy with ACE inhibitors when beta-blockers cannot be used.

Contraindication
Hypersensitivity to valsartan or to any of the excipients.
Pregnancy or pregnancy planning.Severe hepatic insufficiency, biliary cirrhosis and cholestasis.
Congenital angioneurotic edema or that has developed during prior treatment with an ACE inhibitor or angiotensin II receptor antagonist.
Concomitant use of angiotensin receptor antagonists, including Diocor Solo, or angiotensin-converting enzyme inhibitors with aliskiren in patients with diabetes mellitus (type 1 or 2) or renal impairment (glomerular filtration rate) <60 ml / hV.
There are no data in patients with severe renal impairment (creatinine clearance less than 10 ml / min).