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Diocor Solo Composition:
active ingredient: valsartan; 1 coated tablet contains valsartan 80 mg or 160 mg; excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry II White shell coating (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171)).
Treatment of arterial hypertension in adults and children aged 6 to 18 years.
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.
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.
Hypersensitivity to valsartan or to any of the excipients. Pregnancy or pregnancy planning (see “Use during pregnancy or breastfeeding”). Severe hepatic insufficiency, biliary cirrhosis and cholestasis. Congenital angioneurotic edema or that has developed during previous 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)
Dosage & Administration
Diocor Solo can be used regardless of food intake, tablets should be washed down with water.
The recommended starting dose of Diocor Solo is 80 mg once daily. The antihypertensive effect is achieved within 2 weeks, and the maximum effect – within 4 weeks. In some patients with inadequately controlled blood pressure, the dose may be increased to 160 mg and to a maximum of 320 mg.
Diocor Solo can also be used with other antihypertensive drugs. Concomitant use of diuretics such as hydrochlorothiazide will further lower blood pressure in such patients.
Recently suffered a myocardial infarction
Therapy for clinically stable patients can be started as early as 12 hours after myocardial infarction. After the initial dose of valsartan 20 mg (tablets can not be divided into parts, it is necessary to take dosage forms in the appropriate dosage) 2 times a day should increase the dose to 40 mg (tablets can not be divided into parts, it is necessary to take dosage forms in the appropriate dosage), 80 mg and 160 mg 2 times a day for the next few weeks.
The target maximum dose is 160 mg 2 times a day. In general, it is recommended that the dosage level of 80 mg twice daily be reached 2 weeks after the start of treatment and the maximum dose of 160 mg twice daily be reached after 3 months, depending on the patient’s tolerability of treatment. If symptomatic hypotension or renal dysfunction occurs, dose reduction should be considered.
Valsartan can be used in patients who have been treated with other drugs after a myocardial infarction, such as thrombolytics, acetylsalicylic acid, beta-blockers, statins and diuretics. Combination with ACE inhibitors is not recommended.
Patients after myocardial infarction should always be monitored for renal function.
The recommended starting dose of valsartan is 40 mg (tablets should not be divided into the same doses, it is necessary to take dosage forms in the appropriate dosage) 2 times a day. Gradual dose escalation to 80 mg and 160 mg twice daily should be performed at intervals of at least 2 weeks to the highest dose, depending on the patient’s tolerability. Dose reduction of concomitant diuretics should be considered. The maximum daily dose used in clinical trials was 320 mg and was divided into several doses.
Valsartan can be used in combination with other drugs to treat heart failure. However, a triple combination of an ACE inhibitor, a beta-blocker and valsartan is not recommended.
Patients with heart failure need monitoring of renal function.
Application to certain groups of patients
No dose adjustment is required for elderly patients.
No dose adjustment is required for adult patients with creatinine clearance> 10 ml / min. Concomitant use of Diocor Solo with aliskiren in patients with impaired renal function (glomerular filtration rate (GFR) 2) is contraindicated.
Concomitant use of Diocor Solo with aliskiren in patients with diabetes is contraindicated.
Diocor Solo is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and patients with cholestasis. For patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
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