Treatment FAQ

valsartan is indicated for the treatment of which disease

by Clair Huel Published 3 years ago Updated 2 years ago
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Descriptions. Valsartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

What are the side effects of valsartan?

Apr 26, 2021 · Valsartan is used to treat high blood pressure (hypertension) in adults and children who are at least 1 year old. Lowering blood pressure may lower your risk of a stroke or heart attack . Valsartan is also used in adults to treat heart failure and lower your risk of needing to be hospitalized, and to lower your risk of death after a heart attack.

What conditions does valsartan treat?

Oct 27, 2021 · INDICATIONS AND USAGE Hypertension. Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Is the drug valsartan safe to use?

To minimize hypotensive effects in patients with heart failure or left ventricular dysfunction post-myocardial infarction, initial doses are lower than those used in the treatment of hypertension. Valsartan is indicated for the treatment of heart failure in patients intolerant to ACE inhibitors (ACEIs); however, valsartan is not recommended to be used in combination with ACEIs due to …

How effective is valsartan for high blood pressure?

Valsartan is indicated for the treatment of hypertension to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It is also indicated for the treatment of heart failure (NYHA class II-IV) and for left ventricular dysfunction or failure after myocardial infarction when the use of an angiotensin-converting enzyme inhibitor (ACEI) is not …

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What is the indication for valsartan?

Diovan®(valsartan) is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

What is being treated if a patient is prescribed valsartan?

Valsartan: medicine to treat high blood pressure and heart failure - NHS.

What is valsartan used for and side effects?

Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure.

Is valsartan used for heart failure?

Valsartan is an important addition to the armamentarium of drugs that have been shown to be effective in patients with heart failure post myocardial infarction.

Is valsartan a beta blocker?

What Is Diovan? Diovan (valsartan) is an angiotensin II receptor blocker used for the control of hypertension, heart failure, and post heart attack. Diovan is available as a generic.

Is valsartan good for kidneys?

Bedtime administration of valsartan is considered to normalize circadian rhythm and protect the kidneys and heart in CKD patients. However, more clinical trials are needed to confirm this benefit.

Can valsartan increased creatinine?

In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of Diovan-treated patients compared to 0.9% of placebotreated patients. In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.

What is the problem with valsartan?

In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan, used to treat high blood pressure and heart failure, because of contamination with an impurity, the potentially cancer-causing chemical N-nitrosodimethylamine, or NDMA.

What are the most common side effects of valsartan?

The most common side effects of valsartan include:Nausea.Cough.Dizziness.Tiredness.Diarrhea.Headache.Pain in the abdomen.Lower blood pressure.More items...

Which is better valsartan or amlodipine?

Conclusions: Amlodipine monotherapy was more effective than valsartan monotherapy in controlling 24-h ambulatory BP and morning BP in hypertensive patients.

Is valsartan a diuretic?

Diovan HCT (valsartan/hydrochlorothiazide) is a combination of an angiotensin receptor blocker and a diuretic used for treating hypertension (high blood pressure). A generic formulation is available.

Is valsartan a vasodilator?

Valsartan blocks the angiotensin receptor. By blocking the action of angiotensin, valsartan dilates blood vessels and reduces blood pressure.

Before Taking This Medicine

You should not use valsartan if you are allergic to it.To make sure valsartan is safe for you, tell your doctor if you have: 1. kidney disease (or...

How Should I Take Valsartan?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take...

What Happens If I Miss A Dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...

What Should I Avoid While Taking Valsartan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of valsartan.Do not use potassium supplements or salt...

Valsartan Dosing Information

Usual Adult Dose for Congestive Heart Failure:Initial dose: 40 mg orally twice a dayMaintenance dose: 80 to 160 mg twice a day. The dose should be...

What Other Drugs Will Affect Valsartan?

Tell your doctor about all your current medicines and any you start or stop using, especially: 1. cyclosporine; 2. a diuretic (water pill); 3. lith...

What is Valsartan used for?

Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Is Valsartan a class II drug?

Heart Failure. Valsartan Tablets are indicated to reduce the risk of hospitalization for heart failure in patients with heart failure (NYHA class II-IV). There is no evidence that Valsartan Tablets provide added benefits when it is used with an adequate dose of an ACE inhibitor [see Clinical Studies (14.2)] .

Can Valsartan cause hypertension?

Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision.

Can Valsartan cause fetal harm?

Valsartan Tablets can cause fetal harm when ad ministered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan ( see Clinical Considerations ).#N#When pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible.#N#The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.#N#Clinical Considerations#N#Disease-associated maternal and/or embryo/fetal risk#N#Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Is Valsartan toxic to rats?

No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the MRHD on a mg/m 2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day.#N#In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed.

Is Valsartan in human milk?

There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan.

Is Valsartan soluble in water?

Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan Tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.

Can Valsartan be used for surgery?

In patients undergoing major surgery or during anesthesia with agents that lower blood pressure, valsartan may enhance hypotensive effects via angiotensin II blockade. Therefore, valsartan should be used with caution prior to surgery. If hypotension occurs during surgery and/or anesthesia and is considered to be due to blockade of angiotensin II formation, it can be corrected by volume expansion.

Does valsartan lower blood pressure?

Although angiotensin II receptor antagonists are effective in reducing blood pressure in Black patients (a low renin population), there is generally a smaller antihypertensive response compared to other ethnic populations. A greater proportion of Black patients will attain blood pressure goals when angiotensin II receptor antagonists such as valsartan are combined with a diuretic.

Is Valsartan equivalent to a tablet?

The commercially available valsartan oral solution is not therapeutically equivalent to the tablets. Additionally, the extemporaneous oral suspension is not equivalent to the tablets; when the suspension is replaced by a tablet, the dose of valsartan may have to be increased.

Can you breastfeed with Valsartan?

Breast-feeding is not recommended during treatment with valsartan. There are no data on the presence of valsartan in human milk , the effects on the breastfed infant, or the effects on milk production. [29130] [62719] The ACE inhibitors captopril, enalapril, benazepril, and quinapril are excreted in human breast milk in very small quantities; therefore, a clinically significant risk to a breast-feeding infant is not expected unless high doses are required. [27500] [29147] [46352] [46354] [63903] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Can you take Valsartan in a newborn?

Use of valsartan is not recommended in neonates and infants younger than 1 year. It is unknown whether postnatal use of valsartan before renal function maturation is complete has long-term deleterious effects on the kidney. In humans, maturation of glomerular filtration and tubular function may continue until approximately 2 years of age. In children and adolescents with hypertension where underlying renal abnormalities may be more common, monitor renal function and serum potassium closely. No clinically significant differences in the safety profile of valsartan have been identified between pediatric patients aged 1 to 17 years and adults. Hyperkalemia was more frequently reported in pediatric patients aged 1 to 17 years who had underlying chronic kidney disease. Elevations in AST and/or ALT have been reported with children 1 to 6 years of age; however, a casual relationship to valsartan could not be established due to the presence of significant comorbidities. [29130]

Is Valsartan hypotensive?

Greater sensitivity to the hypotensive effects of valsartan is possible in geriatric patients due to an age-related decline in renal function. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). According to OBRA, antihypertensive regimens should be individualized to achieve the desired outcome while minimizing adverse effects. Antihypertensives may cause dizziness, postural hypotension, fatigue, and there is an increased risk for falls. Angiotensin receptor blockers (ARBs) may cause angioedema, chronic persistent non-productive cough, and may worsen renal failure. Some agents require a gradual taper to avoid adverse consequences caused by abrupt discontinuation. There are many drug interactions that can potentiate the effects of antihypertensives. Combination therapy of an ARB with a potassium-sparing diuretic or potassium supplementation has the potential for life-threatening elevations of serum potassium.

Is Valsartan a CYP2C9?

Valsartan is a CYP2C9 substrate and aprepitant is a CYP2C9 inducer. Administration of a CYP2C9 substrate, tolbutamide, on days 1, 4, 8, and 15 with a 3-day regimen of oral aprepitant (125 mg/80 mg/80 mg) decreased the tolbutamide AUC by 23% on day 4, 28% on day 8, and 15% on day 15.

What is Valsartan used for?

Valsartan is an angiotensin II receptor blocker used alone or in combination with other agents to treat hypertension and reduce cardiovascular mortality after myocardial infarction. Valsartan is associated with a low rate of transient serum aminotransferase elevations and has been linked to rare instances of acute liver injury.

Does Valsartan affect angiotensin II?

Valsartan inhibits the pressor effects of angiotensin II with oral doses of 80 mg inhibiting the pressor effect by about 80% at peak with approximately 30% inhibition persisting for 24 hours. Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan. In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid. **Hypotension** Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision. Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. **Impaired Renal Function** Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan. **Hyperkalemia** Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required.

How long does it take for Valsartan to peak?

After one oral dose, the antihypertensive activity of valsartan begins within approximately 2 hours and peaks within 4-6 hours in most patients. Food decreases the exposure to orally administered valsartan by approximately 40% and peak plasma concentration by approximately 50%. AUC and Cmax values of valsartan genereally increase linearly with increasing dose over the therapeutic dose range. Valsartan does not accumulate appreciably in plasma following repetitive administration.

Does Valsartan have a high metabolism?

Valsartan undergoes minimal liver metabolism and is not biotransformed to a high degree, as only approximately 20% of a single dose is recovered as metabolites. The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan. In vitro metabolism studies involving recombinant CYP 450 enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valeryl-4-hydroxy valsartan. Valsartan does not inhibit CYP 450 isozymes at clinically relevant concentrations. CYP 450 mediated drug interaction between valsartan and coadministered drugs are unlikely because of the low extent of metabolism.

Is n-butylamine soluble in water?

White or practically white crystalline powder. Practically odorless. Slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. / Hydrochlorothiazide /

What precautions should be taken to prevent accidental release?

Accidental Release Measures. Personal precautions: Avoid dust formation. Avoid breathing vapors, mist or gas. Environmental precautions: Do not let product enter drains. Methods and materials for containment and cleaning up: Sweep up and shovel. Keep in suitable, closed containers for disposal.

Is respirator protection required?

Respiratory protection: Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95 (US) or type P1 (EN 143) dust masks. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).

Can Valsartan be used alone?

Valsartan tablets, USP may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure. Valsartan tablets, USP are indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, valsartan tablets, USP significantly reduced hospitalizations for heart failure.

Does Valsartan lower blood pressure?

Valsartan tablets, USP can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels.

How long does Valsartan last?

Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks.

Can Valsartan be taken with food?

Valsartan tablets may be administered with other antihypertensive agents. Valsartan tablets may be administered with or without food. 2.2 Pediatric Hypertension 6 to 16 years of age. For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total).

What are the effects of oligohydramnios on the renin-angiotens

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible. [see Use in Specific Populations (8.1)].

What is angiotensin II?

Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

Is Valsartan carcinogenic?

There was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at doses up to 160 and 200 mg/kg/day, respectively . These doses in mice and rats are about 2.6 and 6 times, respectively, the maximum recommended human dose on a mg/m 2 basis. (Calculations assume an oral dose of 320 mg/day and a 60 kg patient.)

Can you take Valsartan while pregnant?

Do not take valsartan if you are pregnant. If you become pregnant while you are taking valsartan, stop taking valsartan and call your doctor immediately. Valsartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

What is Valsartan used for?

Valsartan is used in adults and in children 1 year of age and older alone or in combination with other medications to treat high blood pressure. It is also used in adults to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack.

How does high blood pressure affect the heart?

It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body.

What happens if you don't treat high blood pressure?

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body . Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle ...

What happens if you damage your heart?

Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure.

How to control blood pressure?

In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

How long does it take for Valsartan to work?

Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of valsartan. Continue to take valsartan even if you feel well.

What is Valsartan used for?

Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Does Valsartan help with heart failure?

In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.

Where to report side effects?

You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Precautions.

Can birth control cause serious harm?

Warnings: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication.

Can high blood pressure make you feel sick?

Most people with high blood pressure do not feel sick. Tell your doctor if you do not get better or if you get worse (for example, your blood pressure readings remain high or increase). Side Effects. Dizziness or lightheadedness may occur as your body adjusts to the medication.

Can drug interactions change your medication?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

Is First Databank copyrighted?

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

How does Valsartan work?

What Is Valsartan and How Does It Work? Valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks (myocardial infarctions, or MI ).

Does Valsartan lower blood pressure?

Valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks (myocardial infarctions, or MI ). Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, ...

Is high blood pressure a part of cardiovascular risk management?

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

Can you stop taking a medicine before checking with your doctor?

Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Does Valsartan lower blood pressure?

Valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets, USP.

What are the effects of oligohydramnios on the renin-angiotens

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible. [see Use in Specific Populations (8.1)].

Can adverse reaction rates be directly compared to rates in clinical studies of another drug?

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

What are the most common manifestations of overdosage?

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted.

What is angiotensin II?

Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

Is Valsartan carcinogenic?

There was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at doses up to 160 and 200 mg/kg/day, respectively . These doses in mice and rats are about 2.6 and 6 times, respectively, the maximum recommended human dose on a mg/m 2 basis. (Calculations assume an oral dose of 320 mg/day and a 60 kg patient.)

Should women be told about Valsartan?

Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to valsartan during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Does Valsartan cause heart failure?

This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks. Valsartan is also used to treat heart failure and left ventricular failure after a heart attack.

Can Valsartan be used with other medications?

Valsartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

What happens if you have high blood pressure?

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure.

What is Valsartan used for?

Valsartan is also used to treat heart failure and left ventricular failure after a heart attack. Left ventricular failure occurs when the left side of the heart (the main pumping chamber) becomes stiff and enlarged or swollen. This causes pooling of blood in the lungs because the heart is not pumping properly.

How does Valsartan work?

It works by blocking a substance in the body that causes blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart. This medicine is available only with your doctor's prescription.

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