Quality

Diovan

Diovan (Valsartan)

Pharmacological action

The specific antagonist of receptors of angiotensin II. Selectively blocks receptors of subtype AT1 which are responsible for known effects of angiotensin II. A consequence of blockade of AT1-receptors is rising of plasma concentration of angiotensin II which can stimulate not blocked AT2-receptors. Diovan does not enter interaction and does not block receptors of other hormones or the ionic channels having great value for regulation of functions of cardiovascular system.
At Diovan treatment of patients with an arterial hypertensia the depression of a BP which is not accompanied by change of the CARDIAC CONTRACTIONS RATE becomes perceptible.
After appointment in a single dose of a preparation at the majority of patients the beginning of antihypertensive action becomes perceptible within 2 h, and the maximum depression of a BP is reached within 4-6 hours. After preparation reception antihypertensive action remains more than 24 h. Along with hemodynamic Diovan effects, at the expense of the mediated blockade of synthesis of Aldosteronum, reduces a delay of sodium and water in an organism.
It is established, that the preparation did not render essential influence on concentration of the general cholesterol, urinary acid, and also at research on an empty stomach - on concentration of triglycerides and a glucose in blood serum.


Diovan application leads to reduction of number of hospitalisation concerning, to retardation of advance of a heart failure, improvement of functional class NYHA, augmentation of fraction of emission, and also reduction of expression of signs and symptoms of a heart failure.

Indications

- An arterial hypertensia;
- A chronic heart failure (II-IV a functional class on classification NYHA) at the patients receiving standard therapy, including diuretics. Application of all listed preparations is not obligatory.

Dosage regimen

Tablets should be accepted inside, not chewing.
At an arterial hypertensia recommended Diovan dose makes 80 mg of 1 times/24h daily without dependence from race, age and a floor of the patient. The antihypertensive effect is observed in the first 2 weeks of treatment; the maximum effect becomes perceptible in 4 weeks. That patient at whom it is not possible to reach adequate depression of a BP, daily Diovan dose can be enlarged to 160 mg or diuretics are in addition prescribed.
With disturbance of function of kidneys or the patient with hepatic insufficiency of changes of a dose of a preparation it is not required to patients, if only hepatic insufficiency is not caused or not accompanied by a cholestasia.
At a chronic heart failure recommended initial Diovan dose makes 40 mg 2 times/24h daily. Diovan dose should be enlarged gradually to 80 mg 2 times/24h, and at good shipping - 160 mg 2 times/days Thus can be demanded depression of doses of simultaneously accepted diuretics. Maximum daily Diovan dose makes 320 mg in 2 receptions.

Side effect

It has not been shown dependence of frequency any of the undesirable phenomena from a dose or duration of treatment; therefore the undesirable phenomena which were becoming perceptible at application of various Diovan doses, have been united. Frequency of the undesirable phenomena also has not been bound to a sex, age or a racial accessory. All undesirable phenomena observed with frequency 1 % and more in group of patients have been included in the table, Diovan receiving, irrespective of their causal relationship with a studied preparation.

Other undesirable phenomena which than 1 % became perceptible with frequency less, included: peripheric edemas, an asthenia, a sleeplessness, an eruption,strong giddiness. The causal relationship of these undesirable phenomena with tionship of these undesirable phenomena with Diovan application is not established.
Postmarketing data testify to very rare cases of a Quincke's disease, an eruption, an itch and other reactions of the raised sensitivity / allergic reactions, including a serum disease and a vasculitis. There are very rare reports on disturbance of function of kidneys.


Changes of laboratory indicators
In rare instances Diovan application can be accompanied by depression of level of haemoglobin and a hematocrit.
Essential rising of concentration of a creatinine, potassium and the general bilirubin in blood serum has been noted, accordingly, at 0.8 %, 4.4 % and 6 % of the patients Diovan accepting.
There are reports on cases of rising of activity of hepatic transaminases for the patients receiving Diovan.

Contraindications

- Pregnancy;
- The lactemia period;
- A hypersensibility to preparation components.

Pregnancy and lactemia

Considering the mechanism of action of antagonists of angiotensin II, it is impossible to exclude risk for a foetus. Therefore it is not recommended to apply Diovan in thoracal feeding.

Special indicatings

With care it is necessary to prescribe Diovan at a bilateral stenosis of renal arteries, a stenosis of an artery of a unique kidney, at observance of a diet with sodium restriction, at renal insufficiency.
During Diovan treatment with an essential arterial hypertensia it is not required from patients of the regular control of laboratory indicators.
Diovan application by a short course for 12 patients with the renovascular hypertensia which has developed again owing to a unilateral renal artery stenosis, has not led to a little essential changes of a renal hemodynamic, concentration of a creatinine of blood serum or a blood urea nitrogen.
In case of development of the expressed depression of a BP of the patient it is necessary to lay, feet to raise and, if necessary, to spend i.v. infusion of 0.9 % of a solution of sodium of Sodium chloridum. After the BP is stabilised, Diovan treatment can be continued.
With disturbance of function of kidneys it is not required to patients to correction of a dose of a preparation. However at the expressed disturbances it is recommended to be careful, since data on preparation application in such cases while are absent.

At arterial hypertensia Diovan can be prescribed both as monotherapy, and together with other antihypertensive agents, in particular, with diuretics.
Use in pediatrics
As controllable researches by efficiency and safety of Diovan application at children and teenagers about 18 years are elderly was not spent, it is not obviously possible to formulate concrete references on application for the given group of patients.
Influence on ability to driving of motor transport and to management of mechanisms
At Diovan appointment the same as also other antihypertensive agents, it is recommended to be careful at driving of the car and management of mechanisms.

Overdosage

Though while there are no data on Diovan overdosage, the basic implication which it would be possible to expect, the expressed depression of a BP is.
Treatment: to cause vomiting (if the preparation has been accepted recently); at the expressed depression of a BP i.v. enter 0.9 % of a solution of sodium of Sodium chloridum. Valsartan deducing by means of a hemodialysis is improbable.

Medicinal interaction

Clinically significant interactions of Diovan preparation with other medical products till now it has not been noted. Interactions with following preparations have been studied: Cimetidinum, warfarin, Furosemidum, digoxin, indometacin.
As Diovan is not exposed to a little essential metabolism, for it clinically significant interactions with other medicinal preparations - inductors or inhibitors of system of cytochrome P450 are improbable.

Conditions and periods of storage

B.Preparat's list should be stored in original packing, in a place inaccessible to children, at temperature not above 30 C; to protect from moisture influence. A period of validity - 3 years.

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