Shell composition: Opadry Yellow 03F82329 for 40 mg tablets only; Opadry Pink 03F84641 for 80 mg tablets only; Opadry Yellow 03F520004 for 160 mg tablets only; Opadry Purple 02F50251 for 320 mg tablets only.
Dosage form
Film-coated tablets.
Main physicochemical properties:
40 mg dosage: biconvex, oval-shaped tablets, film-coated, yellow, embossed with: “L” and “12”, separated by a break line on one side and smooth on the other;
80 mg dosage: biconvex, oval-shaped tablets, film-coated, pale red, embossed with “L13” on one side and plain on the other;
160 mg dosage: biconvex, oval tablets, coated with a gray-orange film coating, embossed with “L14” on one side and plain on the other;
Dosage 320 mg: biconvex, oval-shaped tablets, film-coated, dark gray-violet, embossed with "L15" on one side and plain on the other.
Pharmacotherapeutic group
Simple angiotensin II antagonist drugs.
ATX code C09C A03.
Pharmacological properties
Pharmacodynamics.
Valsartan is a potent, specific angiotensin II receptor antagonist for oral administration. It acts selectively on the AT1 receptor subtype, which is responsible for the known effects of angiotensin II. Increased plasma levels of angiotensin II following blockade of the AT1 receptor with valsartan may stimulate the unblocked AT2 receptor, which counteracts the effect of the AT1 receptor. Valsartan does not exhibit any partial agonist activity at the AT1 receptor, but has a much higher (approximately 20,000-fold) affinity for the AT1 receptor than for the AT2 receptor.
Valsartan does not inhibit ACE (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 arterial hypertension leads to a decrease in blood pressure without affecting the pulse rate.
The onset of the hypotensive effect is noted within 2 hours, the maximum - within 4-6 hours after oral administration; the duration of action is more than 24 hours. The maximum therapeutic effect develops 4 weeks after the start of treatment and is maintained during long-term therapy. When used with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Abrupt discontinuation of the drug is not accompanied by the development of withdrawal syndrome.
With long-term use of the drug in patients with arterial hypertension, it was found that the drug had no significant effect on the level of total cholesterol, uric acid, and in fasting studies - on the concentration of triglycerides and glucose in blood serum.
The use of the drug leads to a decrease in hospitalizations for heart failure, a slowdown in the progression of heart failure, an improvement in the functional class according to the NYHA classification, an increase in the ejection fraction, as well as a decrease in heart failure symptoms and an improvement in the quality of life compared to placebo.
Studies have demonstrated the effectiveness of valsartan in reducing overall mortality after myocardial infarction and from cardiovascular pathology. Valsartan was also effective in reducing mortality from cardiovascular pathology and hospitalizations due to heart failure, as well as recurrent myocardial infarction. Valsartan had a positive effect on such an indicator as the period of time after an acute myocardial infarction to the appearance of the first manifestations of cardiovascular pathology leading to death.
Children
Valsartan reduced systolic and diastolic blood pressure in a dose-dependent manner. Overall, the three valsartan dose levels (low, medium, and high) significantly reduced systolic blood pressure by 8, 10, and 12 mmHg from baseline, respectively.
Clinical experience in children under 6 years of age
Valsartan is not recommended for use in this age group.
Pharmacokinetics.
Absorption
After oral administration of valsartan tablets, peak plasma concentrations are reached within 2–4 hours and 1–2 hours after oral administration of the solution. The mean absolute bioavailability of the tablets and solution is 23% and 39%, respectively. Food reduces exposure (as determined by AUC) to valsartan by approximately 40% and the maximum plasma concentration (Cmax) by approximately 50%, although plasma valsartan concentrations are similar in the fasting and fed groups approximately 8 hours after administration. However, the decrease in AUC is not accompanied by a clinically significant decrease in therapeutic effect, and valsartan can be taken without regard to food intake.
Distribution
The volume of distribution of valsartan at steady state after intravenous administration is approximately 17 L, indicating that valsartan is not extensively distributed into tissues. Valsartan is extensively bound to serum proteins (94–97%), primarily to serum albumin.
Valsartan is not extensively metabolized, with only approximately 20% of the dose excreted as metabolites. The hydroxymetabolite has been identified in plasma at low concentrations (less than 10% of the AUC of valsartan). This metabolite is pharmacologically inactive.
Breeding
The pharmacokinetic curve of valsartan is multiexponential (T½α<1 h and T½ß about 9 hours). Valsartan is excreted mainly in the feces (approximately 83% of the dose) and urine (approximately 13% of the dose), mainly unchanged. After intravenous administration, plasma clearance of valsartan is about 2 l/h, and renal clearance is 0.62 l/h (approximately 30% of total clearance). The half-life of valsartan is 6 hours.
Patients with heart failure (use of 40 mg, 80 mg and 160 mg tablets)
The mean time to reach Cmax and the half-life of valsartan in patients with heart failure and in healthy volunteers are similar. The AUC and Cmax values of valsartan are almost proportional to the dose if it exceeds the clinical dosing range (from 40 to 160 mg 2 times a day). The average accumulation coefficient is approximately 1.7. The estimated clearance of valsartan after oral administration is approximately 4.5 l/h. Age does not affect the estimated clearance in patients with heart failure.
Pharmacokinetics in specific patient groups
Elderly patients
In some elderly patients, the systemic exposure to valsartan was somewhat greater than in younger patients, but this has not been shown to be of any clinical significance.
Patients with renal impairment
No correlation was found between renal function and systemic exposure to valsartan. Therefore, no dose adjustment is required in patients with renal impairment (creatinine clearance > 10 ml/min). There are currently no data on the safety of use in patients with creatinine clearance < 10 ml/min or in patients undergoing dialysis, therefore valsartan should be used with caution in such patients. Valsartan is highly bound to plasma proteins and is unlikely to be removed by hemodialysis.
Patients with hepatic impairment
Approximately 70% of the absorbed dose is excreted in the bile, mainly unchanged. Valsartan is not significantly metabolized, and as expected, the systemic exposure to valsartan does not correlate with the degree of hepatic impairment. Therefore, no dose adjustment of valsartan is required in patients with non-biliary hepatic insufficiency and in the absence of cholestasis. It has been shown that in patients with biliary cirrhosis or biliary obstruction, the AUC of valsartan increases approximately twofold.
Children
In hypertensive children aged 1 to 16 years who received a single dose of valsartan suspension (mean dose 0.9–2 mg/kg, maximum dose 80 mg), the clearance (L/h/kg) of valsartan was reported to be comparable across the age range from 1 to 16 years with similar clearance in adults receiving the same drug.
Patients with renal impairment
The use of the drug in children with creatinine clearance < 30 ml/min and in children undergoing dialysis has not been studied, therefore valsartan is not recommended in such patients. No dose adjustment is required in children with creatinine clearance > 30 ml/min. Renal function and serum potassium should be closely monitored.
Indication
Arterial hypertension (40 mg tablets)
Treatment of arterial hypertension in children aged 6 to 18 years.
Arterial hypertension (80 mg, 160 mg and 320 mg tablets).
Treatment of arterial hypertension in adults and children aged 6 to 18 years.
Post-infarction condition (tablets 40 mg, 80 mg and 160 mg).
Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction following a recent (12 hours - 10 days) myocardial infarction.
Heart failure (40 mg, 80 mg and 160 mg tablets).
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.
Severe liver failure, biliary cirrhosis and cholestasis.
Pregnancy or planning to become pregnant (see section "Use during pregnancy or breastfeeding").
Concomitant use of angiotensin receptor antagonists, including Valsartan, or angiotensin-converting enzyme inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2).
Hereditary angioedema or angioedema that developed during previous treatment with an ACE inhibitor or angiotensin II receptor antagonist.
There are no data on patients with severe renal impairment (creatinine clearance less than 10 ml/min).
Interaction with other medicinal products and other types of interactions
Caution should be exercised when concomitantly using ARA drugs, including Valsartan, with other drugs that block the RAAS, such as ACE inhibitors or aliskiren.
The concomitant use of angiotensin receptor antagonists, including Valsartan, or angiotensin-converting enzyme inhibitors with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73 m2).
Concomitant use is not recommended.
Lithium
Reversible increases in serum lithium concentrations and toxicity have been reported with concomitant use of ACE inhibitors. Due to the lack of experience with the concomitant use of valsartan and lithium, this combination is not recommended. If the combination is considered necessary, careful monitoring of serum lithium levels is recommended.
Potassium
Potassium-sparing diuretics (e.g. spironolactone, triamterone, amiloride), potassium supplements, salt substitutes containing potassium and other medicinal products that may increase potassium levels (heparin, etc.) may lead to increases in serum potassium levels and, in patients with heart failure, to increases in creatinine levels.
If the use of a medicinal product that affects potassium levels in combination with valsartan is considered necessary, monitoring of potassium levels in the blood plasma is recommended.
Caution is required during concomitant use
Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day, and nonselective NSAIDs
When angiotensin II antagonists are used concomitantly with NSAIDs, attenuation of the antihypertensive effect may occur. In addition, concomitant use of angiotensin II antagonists and NSAIDs may increase the risk of worsening of renal function and increase serum potassium levels. Therefore, monitoring of renal function is recommended at the beginning of treatment, as well as adequate hydration of the patient.
Conveyors
In vitro studies have shown that valsartan is a substrate for the hepatic uptake transporter OATP1B1/OATP1B3 and the hepatic efflux transporter MRP2. The clinical significance of these findings is unknown. Concomitant use of inhibitors of the uptake transporter (e.g. rifampicin, cyclosporine) or efflux transporter (e.g. ritonavir) may increase systemic exposure to valsartan. Appropriate precautions should be taken when initiating or discontinuing concomitant use of these medicinal products.
Others
In drug interaction studies, no clinically significant interactions of valsartan with any of the following drugs were observed: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
Children
Caution is advised when valsartan is co-administered with other agents that inhibit the renin-angiotensin-aldosterone system in children and adolescents with hypertension, which may increase serum potassium levels. Renal function and serum potassium should be closely monitored.
Application features
Hyperkalemia
Concomitant use of potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended. Potassium levels should be monitored as necessary.
Hypotension
Symptomatic hypotension may occur in rare cases after initiation of valsartan therapy.
Renal impairment. There are currently no data on the safety of the drug in patients with creatinine clearance < 10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in such patients. No dose adjustment is required for adult patients with creatinine clearance > 10 ml/min.
The concomitant use of angiotensin receptor antagonists, including Valsartan, or angiotensin-converting enzyme inhibitors with aliskiren is contraindicated in patients with renal impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73 m2).
Hepatic impairment: Valsartan should be used with caution in patients with mild to moderate hepatic impairment without cholestasis.
Renal artery stenosis. The safety of the drug in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney has not been established. Short-term use of Valsartan in 12 patients with vasorenal hypertension secondary to unilateral renal artery stenosis did not cause any significant changes in renal hemodynamic parameters, serum creatinine, or blood urea nitrogen. Since other drugs that affect the renin-angiotensin-aldosterone system (RAAS) may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, monitoring of renal function is recommended as a safety measure during treatment with valsartan.
Kidney transplantation
There are currently no data on the safety of Valmisar in patients who have recently undergone a kidney transplant.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism should not use Valmisar, as they do not have an activated renin-angiotensin system.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with other vasodilators, the drug should be administered with extreme caution to patients with aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Pregnancy
Angiotensin II receptor antagonists are contraindicated during pregnancy. Unless continued therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment should be stopped immediately, and, if appropriate, alternative therapy should be started.
The combination of captopril and valsartan did not show any additional clinical benefit, but the risk of adverse reactions increased compared with treatment with either drug alone. Therefore, the combination of valsartan with an ACE inhibitor is not recommended.
Caution should be exercised in patients after myocardial infarction. Evaluation of patients after myocardial infarction should always include assessment of renal function.
The use of Valmisar in patients after myocardial infarction often leads to some reduction in blood pressure, but there is usually no need to discontinue therapy due to ongoing symptomatic hypotension, provided that the dosage instructions are followed.
Heart failure (40 mg, 80 mg and 160 mg tablets)
The triple combination of an ACE inhibitor, a beta-blocker and Valmisar has not shown any clinical effect in patients with heart failure. This combination is likely to increase the risk of adverse effects and is therefore not recommended. Caution should be exercised in patients with heart failure and renal function should always be assessed.
The use of Valmisar in patients with heart failure often leads to some reduction in blood pressure, but there is usually no need to discontinue therapy due to ongoing symptomatic hypotension, provided that the dosage instructions are followed.
In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and, in isolated cases, with acute renal failure and/or fatal outcome. Since valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Valsartan may be associated with impaired renal function.
History of angioedema
Angioedema, including laryngeal and glottis edema resulting in airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue, has been reported in patients treated with valsartan; some of these patients had previously experienced angioedema while taking other drugs, including ACE inhibitors. The development of angioedema requires immediate discontinuation of the drug. Valsartan should not be re-administered in such cases.
Other conditions with stimulation of the renin-angiotensin system (320 mg tablets)
In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and, in isolated cases, with acute renal failure and/or fatal outcome. Since valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Valsartan may be associated with impaired renal function.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Concomitant use of ARA drugs, including Valmisar, with other drugs that affect the RAAS is associated with an increased incidence of arterial hypotension, hyperkalemia, and changes in renal function compared to monotherapy. Monitoring of blood pressure, renal function, and electrolytes is recommended in patients receiving Valmisar and other drugs that affect the RAAS.
Kidney dysfunction
Use in children with creatinine clearance < 30 ml/min and in children undergoing dialysis has not been studied, therefore valsartan is not recommended for use in such patients. No dose adjustment is required for children with creatinine clearance > 30 ml/min. Renal function and serum potassium should be closely monitored during treatment with valsartan. This is particularly true when valsartan is used in the presence of other conditions (high fever, dehydration) in which renal function is likely to be impaired.
The concomitant use of angiotensin receptor antagonists, including Valsartan, or angiotensin-converting enzyme inhibitors with aliskiren is contraindicated in patients with renal impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73 m2).
Liver dysfunction
As in adults, Valsartan is contraindicated in children with severe hepatic impairment, biliary cirrhosis and patients with cholestasis. There is limited clinical experience with Valsartan in children with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in such patients.
Use during pregnancy or breastfeeding
The use of angiotensin II receptor antagonists (AIIRAs) is contraindicated in pregnant women or women planning to become pregnant.
Epidemiological data on the risk of teratogenic effects following the use of ACE inhibitors during the first trimester of pregnancy are inconclusive, but a small increase in risk cannot be excluded. Since there are no controlled epidemiological data on the absence of risk with angiotensin II receptor antagonists, a risk of teratogenic effects may also exist for this class of drugs. Patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately and, if appropriate, an alternative treatment with an approved treatment for pregnancy should be started.
It is known that the use of angiotensin II receptor antagonists during the second and third trimesters of pregnancy induces human fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia).
If AIIRAs have been used from the second trimester of pregnancy, ultrasound examination is recommended to check kidney function and the condition of the skull bones.
Newborns whose mothers have taken AIIRAs should be closely monitored for the development of hypotension.
Due to the lack of information on the use of valsartan during breastfeeding, Valsartan is not recommended for use in women who are breastfeeding.
Fertility
Valsartan at doses up to 200 mg/kg/day did not cause adverse effects on reproductive function in rats. Doses up to 200 mg/kg/day are 6 times the maximum recommended human dose on a mg/m2 basis (calculations were made for an oral dose of 320 mg/day to a 60 kg patient).
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effects on the ability to drive and use machines have been conducted. It should be borne in mind that dizziness or weakness may occur when driving or using machines.
Method of administration and doses
Valmisar can be taken regardless of meals; the tablets should be swallowed with water.
The recommended initial dose 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.
Valmisar can also be used with other antihypertensive agents. Concomitant use of diuretics such as hydrochlorothiazide will further reduce blood pressure.
Therapy in clinically stable patients can be started as early as 12 hours after myocardial infarction. After an initial dose of Valmisar 20 mg (1/2 tablet of 40 mg) 2 times a day, the dose should be increased to 40 mg, 80 mg and 160 mg 2 times a day over the next few weeks.
The target maximum dose is 160 mg twice daily. In general, it is recommended that a dosage level of 80 mg twice daily be reached after 2 weeks of treatment initiation and a maximum dose of 160 mg twice daily be reached after 3 months, depending on patient tolerability. If symptomatic hypotension or renal dysfunction occurs, dose reduction should be considered.
Valmisar 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.
The recommended starting dose of Valmisar is 40 mg twice daily. Gradual dose increases to 80 mg and 160 mg twice daily should be made at intervals of not less than 2 weeks to the highest dose, depending on the patient's tolerance. The question of reducing the dose 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 for the treatment of heart failure. However, the triple combination of an ACE inhibitor, a beta-blocker, and Valsartan is not recommended.
Patients with heart failure require monitoring of renal function.
Application to specific patient groups
Elderly patients
Elderly patients do not require dose adjustment.
Kidney failure
No dose adjustment is required in adult patients with creatinine clearance > 10 ml/min. Concomitant use of Valsartan with aliskiren is contraindicated in patients with renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2).
Diabetes mellitus
The simultaneous use of Valmisar with aliskiren is contraindicated in patients with diabetes mellitus.
Liver failure
Valsartan 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.
Children
Valmisar is used to treat hypertension in children aged 6 to 18 years. The safety and efficacy of Valmisar in children aged 1 to 6 years have not been established. The drug is not recommended for the treatment of heart failure or post-infarction conditions in children due to a lack of data on safety and efficacy.
Arterial hypertension in children
Children and adolescents aged 6 to 18 years
The starting dose is 40 mg once daily for children weighing less than 35 kg and 80 mg once daily for children weighing 35 kg or more. The dose should be adjusted based on blood pressure response. The maximum doses studied in clinical trials are shown in Table 1.
Doses higher than those indicated have not been studied and are therefore not recommended.
Table 1
Body weight
Maximum dose of Valmisar
From ≥ 18 kg to < 35 kg
80 mg
From ≥ 35 kg to < 80 kg
160 mg
From ≥ 80 kg to ≤ 160 kg
320 mg
Children under 6 years old
The safety and effectiveness of Valmisar in children aged 1 to 6 years have not been established.
Use in children aged 6 to 18 years with renal insufficiency
Use in children with creatinine clearance < 30 ml/min and in children undergoing dialysis has not been studied, therefore Valmisar is not recommended for use in such patients. No dose adjustment is required for children with creatinine clearance > 30 ml/min. Renal function and serum potassium should be closely monitored.
Use in children aged 6 to 18 years with hepatic impairment
As in adults, Valmisar is contraindicated in children with severe hepatic impairment, biliary cirrhosis and patients with cholestasis. Clinical experience with Valmisar in children with mild to moderate hepatic impairment is limited. The dose should not exceed 80 mg in such patients.
Heart failure and recent myocardial infarction in children
Valsartan is not recommended for the treatment of heart failure or recent myocardial infarction in children due to a lack of data on safety and efficacy.
Children.
The medicine can be used in children as indicated in the sections “Indications” and “Method of administration and dosage”.
Overdose
Overdose may result in severe hypotension, which may lead to depression of consciousness, vascular collapse and/or shock. Therapeutic measures depend on the time of administration and the type and severity of symptoms; stabilization of the circulatory system is of paramount importance. If hypotension occurs, the patient should be placed in the supine position and blood volume should be corrected.
It is unlikely that Valmisar can be removed from the body by hemodialysis.
Side effects
The frequency of adverse reactions is estimated as follows: very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/100000), including isolated reports. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions reported during post-marketing and laboratory studies for which it is not possible to determine the frequency of adverse reactions are listed with a frequency of "not known".
Table 2
Adverse reactions observed when using the drug in patients with arterial hypertension
Increased liver function tests, including increased serum bilirubin levels
Skin and subcutaneous tissue disorders
Unknown
Angioedema, rash, pruritus, bullous dermatitis
Musculoskeletal and connective tissue disorders
Unknown
Myalgia
Renal and urinary tract disorders
Unknown
Renal failure and renal impairment, increased serum creatinine
General disorders
Infrequently
Increased fatigue
Reactions observed in patients with arterial hypertension regardless of causal relationship to the study drug: arthralgia, asthenia, back pain, diarrhea, dizziness, headache, insomnia, decreased libido, nausea, edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.
Children
Arterial hypertension
The antihypertensive effect of valsartan has been evaluated in children aged 6 to 18 years. With the exception of isolated gastrointestinal disorders (such as abdominal pain, nausea, vomiting) and dizziness, no significant differences in the type, frequency or severity of adverse reactions were identified between the safety profile for children aged 6 to 18 years and the previously reported safety profile for adult patients.
Neurocognitive and developmental assessments of children aged 6 to 16 years revealed no clinically significant overall adverse effects following treatment with Valsartan for up to 1 year.
In a double-blind, randomized study in 90 children aged 1 to 6 years, followed by an open-label extension of one year, two deaths and isolated cases of marked elevations in hepatic transaminases were reported. These events occurred in a population with significant comorbidities. A causal relationship to Valsartan has not been established. In a second study in 75 children aged 1 to 6 years, no significant elevations in hepatic transaminases or deaths were observed during treatment with valsartan.
Hyperkalemia was more common in children aged 6 to 18 years with underlying chronic kidney disease.
The safety profile observed in controlled clinical trials in adult patients with myocardial infarction and/or heart failure differs from the overall safety profile observed in patients with hypertension. This may be relevant for patients with underlying disease. Adverse reactions observed in adult patients with myocardial infarction and/or heart failure are listed below.
Table 3
Adverse reactions observed when using the drug in patients with post-infarction state and/or heart failure (studied only in adult patients)
Blood and lymphatic system disorders
Unknown
Thrombocytopenia
On the part of the immune system
Unknown
Hypersensitivity, including serum min
Specifications
Characteristics
Active ingredient
Valsartan
Adults
Can
Country of manufacture
India
Diabetics
It is impossible.
Dosage
160 мг
Drivers
With caution
For allergies
With caution
For children
With a body weight of more than 35 kg
Form
Film-coated tablets
Method of application
Inside, solid
Nursing
It is impossible.
Pregnant
It is impossible.
Primary packaging
blister
Producer
McLeods Pharmaceuticals
Quantity per package
30 pcs
Trade name
Valmisar
Vacation conditions
By prescription
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