Название документа
  • Valmisar of the tab. of p/o of 160 mg No. 30

Valmisar 160 - medicament of antagonists of angiotensin II, for treatment of arterial hypertension at adults and children from 6 to 18 years. Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic systolic dysfunction of a left ventricle after recently postponed myocardial infarction (12 hours – 10 days). Treatment of symptomatic heart failure at adult patients when it is impossible to apply inhibitors of angiotensin-converting enzyme (APF) or as auxiliary therapy with APF inhibitors when it is impossible to apply beta-blockers.

Structure

  • active ingredient: valsartan;
  • 1 tablet contains
  • : 160 mg of a valsartan;
  • other components: microcrystalline cellulose, krospovidon, silicon dioxide colloidal anhydrous, magnesium stearate;
  • structure of a cover: Opadry Yellow 03F82329 only for tablets on 40 mg; Opadry Pink 03F84641 only for tablets on 80 mg; Opadry Yellow 03F520004 only for tablets on 160 mg; Opadry Purple 02F50251 for tablets on 320.

Contraindication

  • Hypersensitivity to a valsartan or any excipient.
  • Heavy liver failure, biliary cirrhosis and cholestasia.
  • Pregnancy or planning of pregnancy.
  • Simultaneous use of antagonists of a receptor of angiotensin, including Valmisar, or inhibitors of angiotensin-converting enzyme with aliskireny to patients with diabetes or a renal failure (speed of glomerular filtration (SGF) <60 ml/min. / 1.73 sq.m).

Side reactions

Reaction which were observed at patients with arterial hypertension irrespective of a causal relationship with the studied drug: arthralgia, asthenia, dorsodynias, diarrhea, dizziness, headache, insomnia, decrease libido, nausea, hypostases, pharyngitis, rhinitis, sinusitis, upper airways; viral infections.

Route of administration

Valmisar can be applied irrespective of food, tablets should be washed down with water.

Arterial hypertension (only tablets of 80 mg, 160 mg and 320 mg)

Recommended initial dosage makes 80 mg of 1 times a day. The antihypertensive effect is reached during 2 weeks, and the maximum effect – during 4 weeks. At some patients with inadequately controlled ABP the dose can be raised to 160 mg and to maximum – 320 mg.

Recently postponed myocardial infarction (only 40 mg, 80 mg and 160 mg)

Therapy to clinically stable patients can already be begun with

in 12 h after a myocardial infarction. After an initial dose of a valsartan of 20 mg (1/2 tablets of 40 mg) 2 times a day it is necessary to raise a dose to 40 mg, 80 mg and 160 mg 2 times a day within several weeks.

Target maximum dose makes 160 mg 2 times a day. In general it is recommended that the level of a dosage of 80 mg 2 times a day was reached in 2 weeks after an initiation of treatment and the maximum dose of 160 mg 2 times a day was reached in 3 months depending on shipping by the patient of treatment. When developing symptomatic arterial hypotension or renal dysfunction it is necessary to consider a question of a dose decline.

Heart failure (only 40 mg, 80 mg and 160 mg)

Recommended initial dose of Valmisar makes 40 mg 2 times a day. Gradual increase in a dose to 80 mg and 160 mg 2 times a day it is necessary to spend with intervals not less than 2 weeks to the highest dose depending on shipping the patient. It is necessary to consider a question of a dose decline of the accompanying diuretics. The maximum daily dose applied at clinical trials made 320 mg and was distributed on several receptions.

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Feature of use

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Use during pregnancy or feeding by a breast

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Use of antagonists of receptors of angiotensin II (AIIRA) is contraindicated to pregnant women or women who are going to become pregnant.

a breast Valmisar is not recommended to apply

due to the lack of information on use of a valsartan during feeding nursing.

Children

Medicine children can apply

.

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Ability to influence speed of response at control of motor transport or other mechanisms

Researches on influence on ability to run motor transport and to work with other mechanisms it was not carried out. It must be kept in mind that at control of motor transport or work with other mechanisms the developing of dizziness or weakness is possible.

Overdose

as a result of overdose can develop the profound arterial hypotension that can lead to oppression of consciousness, vascular collapse and/or shock. Therapeutic actions depend on time of reception and type and weight of symptoms; blood circulation stabilization has paramount value. When developing arterial hypotension the patient has to be in a prone position, it is also necessary to carry out correction of volume of blood.

It is improbable

that valsartan it is possible to bring out of an organism by a hemodialysis.

Interaction with other medicines and other types of interactions

Double blockade the system renin-angiotensin-aldosteronovoy (SRAA) medicaments of the MACAW, IAPF groups or aliskireny.

Should be careful at simultaneous use of medicaments of the MACAW group, including to Valmisar, with other medicaments blocking RAAS, such as medicaments of the IAPF group or aliskiren.

Simultaneous use of antagonists of a receptor of angiotensin, including Valmisar, or inhibitors of angiotensin-converting enzyme with aliskireny it is contraindicated to patients with diabetes or a renal failure (speed of glomerular filtration (SGF) <60 ml/min. / 1.73 sq.m).

Storage conditions

to Store

at a temperature not over 25 With in original packing.

to Store

out of children's reach.

Characteristics
Active ingredients Valsartan
Amount of active ingredient 160 mg
Applicant Macleods
Code of automatic telephone exchange C09CA03 Valzartan
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer MAKLEODS PHARMASYYUTIKALS LIMITED
Quantity in packing 30 tablets
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 25 °C
Trade name Valmisar

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Valmisar of the tab. of p/o of 160 mg No. 30

  • Product Code: 182311
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  • $21.76


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