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Nowadays, fixed drug combinations are very important part of pharmacotherapy in essential arterial hypertension. The ameliorated activity of RAAS system (ACE inhibitors or sartans) along with calcium-ion channel inhibitor results in additive decrease of blood pressure with concomitant beneficial safety profile. Both telmisartan and amlodipine possess very favorable pharmacological properties, what is reflected in results of performed clinical trials, in which they were used as combinations.Key words: amlodipine - calcium channel blockers - fixed combination - hypertension - sartans - telmisartan.

We are presenting a current view on a fixed-dose combination of amlodipine and candesartan in the treatment of hypertension. Major studies on the individual preparations as well as studies examining their combination are included. This fixed-dose combination expands our possibilities with regard to attaining the blood pressure target values, in particular in patients with risk factors or patients with comorbidities. Finally, the benefit mainly consists in the greater compliance of the patient with a minimum adverse effects.

(EN) In the first part of this work, analytical methods for determination of impurities of active pharmaceutical ingredients (API) in combined pharmaceutical dosage forms were developed and validated. Development of the methods covered both the optimization of sample preparation procedure and chromatographic conditions. The methods were validated according to International Conference on Harmonization guideline and both of them were confirmed to be able to analyze stability samples. Impurities in paracetamol, codeine phosphate hemihydrate and pitophenone hydrochloride in the presence of fourth API fenpiverinium bromide were separated by using ion-pair reversed phase chromatography with gradient elution. Symmetry C18, 250 x 4,6 mm, 5 µm heated to 35 řC was used as a separation column. A diode array detector was used. The detection wavelengths were set as follows: 220 nm for paracetamol impurity K, 245 nm for paracetamol and its other impurities and 285 nm for codeine, pitophenone and their impurities. Impurities in valsartan, amlodipine besylate and hydrochlorothiazide were separated by reversed phase UHPLC method with gradient elution. Chromatographic column Zorbax Eclipse C8 RRHD, 100 x 3,0 mm, 1,8 µm heated to 30 řC and spectrophotometric detection were used. The detection wavelengths were set as...

Combination of drugs from different classes of antihypertensives provides an additional antihypertensive effect thus minimising the probability of adverse effects related to the dose of antihypertensive. Combination therapy is indicated for the following groups of hypertensive patients: (a) all hypertensive patients whose systolic blood pressure exceeds the target systolic blood pressure value by20 mm Hg, or whose diastolic blood pressure exceeds the target diastolic blood pressure value by10 mm Hg; (b) in patients with diabetes mellitus (because the target values are130/80 mm Hg); (c) patients with target organ damage; (d) patients with a kidney or cardiovascular disease (patients with IHD, patients after a cerebrovascular accident); (e) patients with overall cardiovascular risk according the SCOREor = 5%. The advantage of fixed combinations resides in the fact that they increase compliance with treatment by reducing the number of pills taken by the patients. A fixed combination of the ACE inhibitor perindopril and the calcium channel blocker amlodipine proves optimal as has been shown by the results of the ASCOT-BPLA study. The launch of the above combination on this market should therefore be welcome. The fixed combination of perindopril and amlodipine will be indicated for hypertensive patients with uncontrolled hypertension or cardiovascular risk factors. This fixed combination will also be ideal for patients with a higher risk of diabetes mellitus, i.e. patients with a higher fasting glycaemia, in patients with impaired glucose tolerance and in patients with the metabolic syndrome. We strongly believe that it will improve the control of hypertension in our hypertensive patients, and improve the cardioprotective and nephroprotective effect of hypertension therapy.

In 15 centres of the Czech Republic the antihypertensive effect of Amlodipine-Norvasc of Pfizer Co. was tested in 155 patients with mild or medium severe hypertension. The patients were treated by monotherapy, using doses of 5 mg (92%) and 10 mg (8%) per day. In all investigated hypertensive subjects a statistically significant decline of the systolic and diastolic blood pressure occurred in the course of the 12-week investigation (P smaller than 0.01) without affecting the heart rate. The rate of undesirable effects of treatment was very low: only three patients (1.9%) discontinued treatment on account of undesirable effects. The most frequent ones included perimalleolar oedema, the sensation of fullness, headache, cardiac palpitations, vertigo and insomnia. Evaluation of the antihypertensive effectiveness and tolerance of the preparation by the physician and patient is positive, and Amlodipine-Norvasc of Pfizer Co. holds therefore, because of its pharmacokinetic and pharmacodynamic properties, an important place among calcium channel inhibitors of the second generation.