Valsartan
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.
Is the drug valsartan safe to use?
· 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.
Is valsartan a diuretic drug?
· What Is Valsartan Used For? Valsartan medication is approved to treat two main conditions: Hypertension - Hypertension is also known as high blood pressure. ARBs are most often prescribed to treat high blood pressure. By preventing the narrowing of blood vessels, ARBs can lower a person's blood pressure.
What is valsartan prescribed for?
What Conditions does VALSARTAN Treat? kidney disease from diabetes ; high blood pressure ; dysfunction of left ventricle of heart following heart attack ; chronic heart failure
What type of drug is valsartan?
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 …
What is valsartan FDA approved for?
Diovan® is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
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.
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.
When should valsartan be taken?
You will usually take valsartan once or twice a day. If you take it once a day, your doctor may suggest that you take your first dose before bedtime, because it can make you feel dizzy. After the very first dose, you can take valsartan at any time, although it's best to take it at the same time every day.
Does valsartan help kidney function?
It is possible that long-term treatment with an angiotensin II receptor blocker, valsartan, is effective at retarding the deterioration of renal function in patients with nondiabetic renal disease by a mechanism independent of blood pressure reduction.
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.
What are the contraindications of valsartan?
The following conditions are contraindicated with this drug....Who should not take VALSARTAN?low amount of sodium in the blood.high levels of potassium in the blood.low levels of a type of white blood cell called neutrophils.renal artery stenosis.low blood pressure.liver problems.severe renal impairment.pregnancy.More items...
Who should not take valsartan?
Two drugs are never used with valsartan because of the risk of low blood pressure, high blood potassium, or kidney damage: Aliskiren (in people with diabetes only) Isocarboxazid.
Does valsartan affect heart rate?
Diovan (valsartan) does not directly cause a drop in heart rate, but it might have that effect indirectly in a small percentage of people who take it. Diovan is prescribed to treat high blood pressure and heart failure, and to prolong life after a heart attack.
What is the first drug of choice for hypertension?
The strongest body of evidence indicates that for most patients with hypertension, thiazide diuretics are the best proven first-line treatment in reducing morbidity and mortality.
What kind of drug is valsartan?
Valsartan is in a class of medications called angiotensin II receptor antagonists. 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.
How safe is valsartan?
Valsartan is a high blood pressure drug that is considered generally safe and tolerated better by patients than alternative treatments.
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 medication is approved to treat two main conditions: Hypertension - Hypertension is also known as high blood pressure. ARBs are most often prescribed to treat high blood pressure. By preventing the narrowing of blood vessels, ARBs can lower a person's blood pressure. Heart failure - Valsartan has been shown to reduce hospitalizations ...
Does Valsartan cause back pain?
Back pain. Cough. These are the most common side effects experienced by valsartan patients. However, these are not the only side effects. Patients taking valsartan should consult their drug labeling for the full list of potential adverse effects and drug information. Source: Diovan Drug Label.
Is Losartan the same as Valsartan?
Losartan is not the same as valsartan. However, they are both ARBs. Read a full comparison of these two drugs here >>>. Losartan medications were also affected by the contamination. Because of this, many batches of losartan drugs were recalled in 2018 and 2019. Learn more about the recall of losartan medications.
Does Valsartan cause kidney problems?
Kidney Problems - Valsartan increases the risk of acute kidney failure in some patients. The kidney function in these at-risk patients should be monitored while using valsartan.
Is Valsartan safe for pregnancy?
Fetal Toxicity - Valsartan poses serious risks to an unborn baby. Women should not take valsartan during pregnancy. Pregnant women should work with their doctor to find a safe alternative treatment. Hypotension - Hypotension is also known as low blood pressure.
Can Valsartan cause cancer?
The contaminants found in valsartan may cause cancer in humans. Valsartan patients who developed cancer while taking the drug are now filing valsartan lawsuits. These claims allege the drug companies are responsible for people's cancer diagnoses.
Does Valsartan help with heart failure?
Heart failure - Valsartan has been shown to reduce hospitalizations for heart failure. For patients with left ventricular failure or dysfunction, valsartan can be useful after a heart attack. Valsartan can reduce these patients' risk of death from a cardiovascular event. Valsartan is prescribed for use in adults and children over six years of age.
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.
What is the limit of valsartan?
The assay is based on protein precipitation with methanol and reversed-phase chromatography with fluorimetric detection. ... The limit of quantitation was 98 ng/mL using 0.2 mL of plasma.
Is Valsartan toxic to rats?
Approximate LD50 >2000 mg/kg (Gavage, rat) **Reproductive Toxicology Studies** No teratogenic effects were seen when valsartan was given to pregnant mice and rats at oral doses up to 600 mg/kg/day and to pregnant rabbits at oral doses reaching up to 10 mg/kg/day. Despite this, marked decreases in fetal weight, pup birth weight, pup survival rate, and delays in developmental milestones were noted in studies in which parental rats were treated with valsartan at oral, maternally toxic doses of 600 mg/kg/day during the organogenesis period or during late gestation and lactation. **Pregnancy** When used in pregnancy, drugs that act directly on the renin-angiotensin system (RAAS) can cause injury and death to the developing fetus. When pregnancy is detected, valsartan should be discontinued as soon as possible.
What is a drug with therapeutic equivalent?
The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, incl valsartan, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.
Is Valsartan a prodrug?
Valsartan has pharmacologic actions similar to those of losartan; however, unlike losartan, valsartan is not a prodrug and its pharmacologic activity does not depend on hydrolysis in the liver. Valsartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone -secreting effects, by selectively inhibiting access of angiotensin II to AT1 receptors within many tissues, including vascular smooth muscle and the adrenal gland. By comparison, angiotensin-converting enzyme (ACE, kininase II) inhibitors block the conversion of angiotensin I to angiotensin II; however, the blockade of angiotensin II production by ACE inhibitors is not complete since the vasopressor hormone can be formed via other enzymes that are not blocked by ACE inhibitors. Because valsartan, unlike ACE inhibitors, does not inhibit ACE, the drug does not interfere with response to bradykinins and substance P; a beneficial consequence is the absence of certain ACE inhibitor-induced adverse effects (e.g., cough), but possible renal and/or cardioprotective effects may be sacrificed. Valsartan also does not interfere with angiotensin II synthesis.
How long does Valsartan last?
Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours.
How much of Valsartan is recovered?
The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites. The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan.
When will Valsartan be available?
FDA approves a new generic valsartan. For Immediate Release: March 12, 2019. Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.
What is the FDA investigating for nitrosamine?
Since last summer, the FDA has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products. The FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the U.S. market, and continues evaluating other ARBs to ensure they are free of impurities. FDA scientists have made important strides in understanding how these impurities may form during the manufacturing process and the agency is working with international drug regulatory agencies to make new testing methods available. The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities. Now that this risk has been identified, the agency is implementing new requirements to guard against the development of these impurities in drugs.
What is the FDA?
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
What is the role of the FDA in preventing a drug shortage?
For example, the FDA can expedite review of a new or generic drug application that, if approved, may help mitigate or prevent such a shortage and to do so, prioritizes these inspections and reviews. The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. FDA scientists are using the information learned from its investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can’t form these impurities.
Does the FDA have a process change for ARBs?
The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities. Now that this risk has been identified, the agency is implementing new requirements to guard against the development of these impurities in drugs.
Is Valsartan free of nitrosamine?
We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”. Since last summer, the FDA has conducted a major investigation to address the presence ...
Does Valsartan cause high creatinine?
The most common side effects associated with valsartan are dizziness, hypotension, high levels of potassium in the blood (hyperkalemia) and increased blood creatinine. Today’s approval of the new generic of Diovan was granted to Alkem Laboratories Limited.
Why is Valsartan prescribed?
Why is this medication prescribed? Valsartan belongs to the class of medications known as angiotensin II inhibitors. It is used to treat high blood pressure. It is also used to treat heart failure and it can lower the need for hospitalization that happens from heart failure.
What is Valsartan used for?
Valsartan is mainly used for treatment of high blood pressure, congestive heart failure, and to increase the chances of living longer after a heart attack.
Can Valsartan be taken with food?
The dose of valsartan will vary for each particular patients. Follow your doctor’s orders or the directions on the label. Take valsartan with a full glass of water . Additionally, this medication can be taken with or without food.
How does Valsartan work?
Valsartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes blood vessels which in turn lowers the blood pressure. This drug may also be used to help protect the kidneys from damage due to diabetes.
Does Valsartan help with heart attack?
Valsartan can also treat left ventri cular dysfunction after a heart attack. Left ventricular dysfunction occurs when the left ventricle (the main pumping chamber of the heart) stiffens and enlarges and can cause the lungs to fill with blood. High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the ...
What is the name of the drug that is used to treat heart failure?
In 2002, the US Food & Drug Administration approved a leading high blood pressure medicine Diovan ® (valsartan) to treat heart failure in patients who are intolerant of angiotensin-converting-enzyme (ACE) inhibitors, a common type of heart failure therapy. Valsartan, an angiotensin II receptor blocker ...
Is Valsartan safe for pregnancy?
When used during the second and third trimesters of pregnancy, valsartan can cause injury and even death to the developing baby. Do not take valsartan if you are pregnant or could become pregnant during treatment.
Introduction
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.
Background
Valsartan (val sar' tan) was the second angiotensin II receptor blocker (ARB) to be approved for use in the United States and is widely used for therapy of hypertension.
Hepatotoxicity
Valsartan has been associated with a low rate of serum aminotransferase elevations (<2%) that in controlled trials was no higher than with placebo therapy. These elevations were transient and rarely required dose modification. Rare instances of clinically apparent acute liver injury have been reported in association with valsartan therapy.
Mechanism of Injury
The cause of the liver injury that has been associated with valsartan is not known, but it resembles idiosyncratic liver injury due to a hypersensitivity reaction. Valsartan does not appear to be metabolized by the cytochrome P450 system to a major degree.
Outcome and Management
The instances of acute liver injury reported with valsartan use have been self limited and have not resulted in acute liver failure or chronic liver injury. While corticosteroids have been used in cases of severe cholestasis due to ARBs, their efficacy has not been shown and their use is best avoided.
What is Valsartan generic?
Valsartan is the generic name for an ARB medication frequently marketed in the United States under the brand names Diovan and Prexxartan.
When were ARBs first introduced?
In the 1970s, scientists began studying in earnest and observing the adverse impact of high angiotensin and vasoconstriction tied to the risk of myocardial infarction and stroke. Later in that decade, the first Angiotensin-Converting Enzyme (ACE) inhibitors were introduced. In the 1980s, scientists and drug manufacturers began rolling out the first ARBs such as Losartan. The ARB known as Valsartan was developed and introduced by Novartis AG in 1990 and gained FDA approval in 1996 under the brand name Diovan. It currently holds the largest market share for ARB’s of its kind in the world.
Does Valsartan have side effects?
Valsartan does have some side effects associated with its use. Patients should advise their doctor if they experience any of the following symptoms with severity and/or other time:
Can Valsartan be used during pregnancy?
Valsartan contains a “box warning” concerning use during pregnancy. In particular, ARB drugs, such as Valsartan, which affect the renin-angiotensin regulating system in the human body can have serious side effects on an unborn fetus if taken during the second or third trimester.
Can Valsartan interact with over the counter medications?
Patients taking Valsartan should always consult their prescribing physician for a full list of all possible drug and over-the-counter medications that could interact adversely with Valsartan. Some of the products suspected or known to interact with Valsartan include:
What is Valsartan used for?
Valsartan, sold under the trade name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. It is taken by mouth. Versions are available as the combination valsartan/hydrochlorothiazide, valsartan/amlodipine, valsartan/amlodipine/hydrochlorothiazide, or valsartan/sacubitril.
What are the side effects of Valsartan?
The U.S. prescribing information lists the following drug interactions for valsartan: 1 Other inhibitors of the renin-angiotensin system may increase the risks of low blood pressure, kidney problems, and hyperkalemia. 2 Potassium sparing diuretics, potassium supplements, salt substitutes containing potassium may increase the risk of hyperkalemia. 3 NSAIDs may increase the risk of kidney problems and may interfere with blood pressure-lowering effects. 4 Valsartan may increase the concentration of lithium. 5 Valsartan and other angiotensin-related blood pressure medications may interact with the antibiotics co-trimoxazole or ciprofloxacin to increase risk of sudden death due to cardiac arrest.
Is Valsartan a combination drug?
Valsartan is combined with amlodipine or hydrochlorothiazide (HCTZ) (or both) into single-pill formulations for treating hypertension with multiple drugs. Valsartan is also available as the combination valsartan/sacubitril. It is used to treat heart failure with reduced ejection fraction.
How much did Valsartan sell in 2010?
In 2010, valsartan (trade name Diovan) achieved annual sales of $2.052 billion in the United States and $6.053 billion worldwide. The patents for valsartan and valsartan/hydrochlorothiazide expired in September 2012.
Does Valsartan accumulate in plasma?
Owing to its relatively short elimination half life attribution, valsartan concentration in plasma doesn't accumulate in response to repeated dosing.
Does Valsartan block angiotensin II?
This mechanism of action is different than that of the ACE inhibitor drugs, which block the conversion of angiotensin I to angiotensin II . As valsartan acts at the receptor, it can provide more complete angiotensin II antagonism since angiotensin II is generated by other enzymes as well as ACE.
Does food affect Valsartan?
With the tablet, food decreases the valsartan tablet taker's exposure to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, evidenced by AUC change.