Valsartan Side Effects | Chicago Product Liability Lawyers Moll Law Group

Experienced Lawyers Handling Valsartan Claims

In 2018, the FDA issued recalls of several types of generic Valsartan. Certain versions of the drug may include contaminated components that expose consumers to increased risks of cancer and other significant side effects. Some patients who took blood pressure medication that contained Valsartan were later diagnosed with cancer, liver damage, or tumors. If you suffer from cancer, liver damage, or tumors, or if you have certain other substantial side effects, you may be able to sue for damages in a product liability lawsuit. The skillful Valsartan injury lawyers at Moll Law Group may be able to bring a product liability lawsuit on your behalf.

Is Hair Loss a Side Effect of Valsartan?

Hair loss is a common side effect of Valsartan.

Can Valsartan Make You Gain Weight?

Weight gain is a side effect of Valsartan. You should contact your doctor if you have unexplained weight gain or swelling in the hands, ankles, or feet.

Can Valsartan Cause Kidney Problems?

Yes. Sometimes Valsartan can cause a condition in which skeletal muscle tissue breaks down, and the result is kidney failure. Signs that should push you to call a doctor include dark-colored urine, unusual tiredness, and fever.

Can Valsartan Cause Eye Problems?

Valsartan may cause eye problems. These problems can occur within hours or weeks of starting the drug, and it is important to talk to a doctor about blurred vision, eye pain, and other vision changes, since these eye problems can lead to vision loss.

Does Valsartan Increase BP?

Valsartan is an angiotensin II receptor antagonist used to treat high blood pressure (hypertension). It is important to be aware that stopping Valsartan can cause your blood pressure to rise, such that chances of stroke or heart attack are increased. You should consult your doctor about stopping Valsartan.

Does Valsartan Thin Your Blood?

Valsartan works by relaxing blood vessels so that blood can flow more easily.

Does Valsartan Cause Increased Urination?

Diovan is a combination of Valsartan and hydroclorothiazide, a diuretic, and it has been reported to cause nocturia, or frequent night urination. Valsartan has caused little or no increase in urination by itself.

Has Valsartan Been Recalled by the FDA?

Numerous recalls of Valsartan have occurred. The FDA expanded its Valsartan recall after finding carcinogens in some Valsartan medications. It continues to investigate and test all angiotensin II receptor blockers for the presence of NDEA and NDMA.

Is Valsartan Carcinogenic?

Trace amounts of carcinogenic chemical N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) were found in Valsartan. The presence of the carcinogen is linked to factories in China that assist with supplying Valsartan to generic drug makers. Not every Valsartan drug contains these carcinogens; sometimes they are introduced through the manufacturing process.

Can Valsartan Cause Blurred Vision?

Yes, Valsartan may cause blurred vision in some people. It is important to let your doctor know of this side effect.

Does Valsartan Cause Erectile Dysfunction?

Valsartan is not known to cause erectile dysfunction.

Does Valsartan Affect the Liver?

Valsartan is usually broken down by the liver. However, it may cause a decrease in liver function. Some Valsartan medications include carcinogens that may cause liver tumors. Exposure to high levels of one of the carcinogens can also cause liver damage.

Does Valsartan Cause a Cough?

Valsartan is a drug that behaves like an ACE inhibitor but does not cause a cough, which is a common problem with ACE inhibitors.

Is Valsartan a Diuretic?

No, Valsartan is not a diuretic, but it is sometimes combined with diuretic drugs. For example, Diovan is a combination of Valsartan and hydrochlorothiazide, a diuretic.

Does Valsartan Lower Heart Rate?

Valsartan is prescribed to treat high blood pressure and heart failure. Valsartan in the form of Diovan reduces blood pressure partially by lowering heart rate and lessening the volume of blood. However, it is not supposed to reduce heart rate more than a beta blocker by itself would.

Is Valsartan a blood thinner?

Valsartan is not a blood thinner. Blood thinners work by keeping platelets from sticking together and forming a clot. Valsartan works by relaxing and widening the blood vessels.

Can Valsartan Make You Tired?

Tiredness can be a side effect of Valsartan. It is important to let your doctor know about severe or persistent fatigue.

Can Valsartan Cause Leg Cramps?

Valsartan can increase potassium in the body, and this potassium increase may produce leg cramps.

Does Valsartan Cause Gout?

Some people taking Valsartan may experience an acute gout attack because of heightened levels of uric acid in the blood.

Does Valsartan Increase Uric Acid?

Some studies have shown a significant increase in uric acid serum levels caused by Valsartan.

Consult a Valsartan Claims Attorney

If you were harmed by Valsartan, you may have a basis to sue for damages by bringing a product liability lawsuit. Moll Law Group is a Chicago-based product liability firm that has been involved in lawsuits in which billions of dollars were recovered. Contact us at 312.462.1700 or via our online form.

Side Effects, Dosage, Uses, and More

This drug has a boxed warning. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.

• You shouldn’t take this drug if you’re pregnant or planning to become pregnant. This drug can harm or end your pregnancy. Talk with a doctor about other ways to treat your condition if you become pregnant. If you get pregnant while taking this drug, stop taking it and call a doctor right away.

1. Valsartan oral tablet is available as a brand-name drug and a generic drug. Brand name: Diovan.
2. Valsartan oral tablet is used to lower blood pressure, treat heart failure, or increase your chance of survival after a heart attack.

• Low blood pressure warning: This drug can cause your blood pressure to drop too low. This can cause dizziness, lightheadedness, and headache. You may have a higher risk if you’re dehydrated or take high doses of diuretics (water pills).
• High blood potassium warning: This drug can increase your potassium levels. Your risk may be higher if you have kidney problems or heart failure. A doctor may check your potassium levels with blood tests while you’re taking this drug.
• Pregnancy warning: This drug can cause injury and death to a developing fetus. If you become pregnant while taking it, discontinue use and talk to a doctor.

Valsartan oral tablet is a prescription drug that’s available as the brand-name drug Diovan. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Valsartan may be taken as part of a combination therapy with other drugs.

Why it’s used

Valsartan is used to:

• lower high blood pressure
• treat heart failure and reduce the risk of being hospitalized from heart failure
• improve survival after a heart attack

How it works

Valsartan belongs to a class of drugs called angiotensin II receptor blockers (ARBs). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Valsartan works by blocking the effect of angiotensin II. This makes your blood vessels relax more. It also allows your kidney to get rid of extra water and salt. This helps lower your blood pressure.

Valsartan oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with valsartan if you’re taking it for high blood pressure include:

• headache
• dizziness
• flu-like symptoms, such as fever and body aches
• tiredness
• stomach (abdominal) pain

The more common side effects that can occur with valsartan if you’re taking it for heart failure include:

• dizziness
• low blood pressure
• diarrhea
• joint and back pain
• tiredness
• symptoms of high blood potassium, such as heart rhythm problems, muscle weakness, and slow heart rate

The more common side effects that can occur with valsartan if you’re taking it to increase survival after you’ve had a heart attack include:

• low blood pressure
• cough
• skin rash

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with a doctor or pharmacist.

Serious side effects

Call a doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Low blood pressure: Symptoms can include:
  • feeling faint
  • dizziness
• Kidney disease: If you already have kidney disease, this drug could make your kidney function worse. Symptoms of kidney disease can include:
  • swelling in your feet, ankles, or hands
  • unexplained weight gain

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

Valsartan oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, a doctor should manage all of your medications carefully. Be sure to tell a doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with a doctor or pharmacist.

Examples of drugs that can cause interactions with valsartan are listed below.

Blood pressure drugs

When taken with valsartan, these drugs can increase your risk of low blood pressure, high blood potassium, and kidney problems. Examples of these drugs include:

• angiotensin receptor blockers (ARBs), such as:
  • candesartan
  • irbesartan
  • losartan
  • olmesartan
  • telmisartan
  • valsartan
  • azilsartan
• angiotensin-converting enzyme (ACE) inhibitors, such as:
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • lisinopril
  • moexipril
  • perindopril
  • quinapril
  • ramipril
  • trandolapril
• renin inhibitors, such as:
  • aliskiren

Potassium supplements

Taking these drugs with valsartan can increase the amount of potassium in your body.

Certain diuretics

Taking potassium-sparing diuretics with valsartan can increase the amount of potassium in your body. Examples of these drugs include:

• spironolactone
• amiloride
• triamterene

Mood stabilizers

Taking these drugs with valsartan can increase the effects of these medications. Examples of these drugs include:

• lithium

Nonsteroidal anti-inflammatory drugs (NSAIDs)

These drugs can decrease your kidney function when taken with valsartan. Examples of these drugs include:

• ibuprofen
• naproxen

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms include:

• trouble breathing
• swelling of your throat or tongue
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with severe heart failure or kidney disease: This drug may increase your risk of kidney problems and reduce how much urine you make. If you have kidney disease, you should not take valsartan and aliskiren together.

For people with diabetes: You should not take valsartan if you’re taking the drug aliskiren.

Warnings for other groups

For pregnant people: This drug can cause harm to the fetus when taken during pregnancy. Studies show a risk of adverse effects and death to the fetus when a pregnant person takes the drug.

If you plan to become pregnant, talk to a doctor about alternative ways to manage your blood pressure.

Call a doctor right away if you become pregnant while taking this drug and discontinue use as soon as possible.

For people who are breastfeeding: It isn’t known if this drug passes into breast milk. If it does, it may cause serious effects in a child who is breastfed. You should talk with a doctor about the risks of taking this drug and breastfeeding. You may need to decide whether you’ll take this drug or breastfeed.

For children: This drug isn’t recommended for children younger than 6 years. It can be used in children older than 6 years for the treatment of high blood pressure.

If your child has a kidney problem, they may need to be monitored more closely for kidney changes and blood potassium levels while they’re taking this drug.

All possible dosages and forms may not be included here. A doctor will tell you what dosage is right for you. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Drug forms and strengths

Generic: Valsartan

• Form: oral tablet
• Strengths: 40 milligrams (mg), 80 mg, 160 mg, 320 mg

Brand: Diovan

• Form: oral tablet
• Strengths: 40 mg, 80 mg, 160 mg, 320 mg

Dosage for high blood pressure (hypertension)

Adult dosage (ages 17–64 years)

• Starting dosage: 80–160 mg taken once per day.
• Dosage range: 80–320 mg taken once per day.

Child dosage (ages 1–16 years)

• Starting dosage: 1. 0 mg per kilogram (kg) of body weight taken by mouth once daily (up to 40 mg total per day).
• Dosage range: 1.0–4.0 mg/kg of body weight taken once daily (up to 40–160 mg total per day).

Child dosage (ages 0–11 months)

This drug shouldn’t be used in children younger than 1 year.

Older adult dosage (ages 65 years and older)

There are no specific recommendations for dosing for older adults. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re an older adult, you may need a lower dosage or a different treatment schedule.

Dosage for heart failure

Adult dosage (ages 18–64 years)

• Starting dosage: 40 mg taken twice per day
• Dosage range: 40–160 mg taken twice per day
• Target maintenance dosage: 160 mg taken twice per day

Child dosage (ages 0–17 years)

This drug shouldn’t be used in children younger than 18 years.

Older adult dosage (ages 65 years and older)

There are no specific recommendations for dosing for older adults. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re an older adult, you may need a lower dosage or a different treatment schedule.

Dosage to increase survival after heart attack

Adult dosage (ages 18–64 years)

• Starting dosage: 20 mg taken twice per day
• Dosage range: 20–160 mg taken twice per day
• Target maintenance dosage: 160 mg taken twice per day

Child dosage (ages 0–17 years)

This drug shouldn’t be used in children younger than 18 years.

Older adult dosage (ages 65 years and older)

There are no specific recommendations for dosing for older adults. Older adults may process drugs more slowly. A normal adult dosage may cause levels of this drug to be higher than normal in your body. If you’re an older adult, you may need a lower dosage or a different treatment schedule.

Special dosage considerations

Valsartan hasn’t been studied in people with severe kidney or liver problems. If possible, a different drug should be used. If valsartan must be used, a doctor may use a lower dosage and monitor for side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Valsartan oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it at all: Your blood pressure will stay high. This may raise your risk of a heart attack and stroke.

If you stop taking it suddenly: Your blood pressure may suddenly increase.

If you don’t take it on schedule: You may not feel any different, but your blood pressure may not be controlled. This can put you at higher risk of heart attack and stroke.

What to do if you miss a dose: If you forget to take your dose, take it as soon as you remember. If it’s just a few hours before the time for your next dose, then wait and only take one dose at that time.

Never try to catch up by taking two doses at once. This could cause dangerous side effects.

If you take too much: If you take too much valsartan, you might have these symptoms:

• a feeling that your heart is pounding
• weakness
• dizziness

If you think you’ve taken too much of this drug, call a doctor or local poison control center.

If your symptoms are severe, call 911 or go to the nearest emergency room right away.

How to tell if the drug is working: You may not be able to tell if the drug is working. A doctor will check your blood pressure and other symptoms of your condition regularly to tell if this drug is working for you.

Keep these considerations in mind if a doctor prescribes valsartan for you.

General

• This drug should be taken at the same time every day.
• You may be able to cut or crush certain strengths of valsartan tablets. Ask a doctor or pharmacist whether you can cut or crush your tablets.

Storage

• Store this drug at room temperature between 59°F and 86°F (15°C and 30°C).
• Keep this drug closed in its original container in a dry place.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. A doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

You may need to check your blood pressure at home. To do this, you may need to purchase a blood pressure monitor. You should keep a log with the date, time of day, and your blood pressure readings. Bring this log with you to your doctor appointments.

Clinical monitoring

During treatment with this drug, a doctor may check your:

• blood pressure
• kidney function
• electrolyte levels

Hidden costs

You may need to purchase a blood pressure monitor to check your blood pressure at home. These are available at most pharmacies.

Prior authorization

Many insurance companies require a prior authorization for Diovan. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

Valsartan is typically covered by insurance at a lower copay. However, not all insurance plans are the same, so be sure to check with your insurance provider about coverage.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with a doctor about other options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Amlodipine, Valsartan, and Hydrochlorothiazide | Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ^® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Exforge HCT

Warning

• Not to be taken by pregnant women. The use of the drug during pregnancy may cause birth defects or intrauterine death of the child. If you become pregnant or plan to become pregnant while taking this drug, contact your doctor immediately.

What is this drug used for?

• Used to treat high blood pressure.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
• If you are allergic to sulfonamides.
• while taking dofetilide.
• If you have any of the following health conditions: kidney disease or liver disease.
• When unable to urinate.
• If you are taking a medicine containing aliskiren if you have diabetes or kidney disease.
• If you are breastfeeding. Do not breastfeed while taking this drug.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Avoid driving and other activities that require increased attention until you see how this drug affects you.
• To reduce the risk of dizziness or loss of consciousness, get up slowly from a lying or sitting position. Walking up and down stairs should be done with care.
• If you have high blood sugar (diabetes), you should check your blood sugar regularly.
• Check your blood pressure as directed.
• Perform blood tests as directed by your doctor. Consult with your doctor.
• This drug may affect the results of some lab tests. Tell all your health care workers and laboratory staff that you are taking this drug.
• If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, check with your doctor.
• If you are on a salt-free or low-salt diet, please consult your doctor.
• It may take several weeks for full results to be seen.
• In rare cases, after the first use of this drug or after increasing the dose, chest pain may first occur or worsen. Myocardial infarction may also occur. The risk may be increased in people with very severe heart blood vessel disease. Consult your doctor.
• Talk to your doctor before taking an over-the-counter drug that can raise blood pressure. These drugs include cough and cold medicines, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and some natural products.
• Check with your doctor before using alcohol, marijuana or other forms of cannabis, or prescription or over-the-counter drugs that can slow you down.
• Caution should be exercised in hot weather and during vigorous activity. Drink plenty of fluids to prevent dehydration.
• Tell your doctor if you have excessive sweating, fluid loss, vomiting, or loose stools. This can lead to a decrease in blood pressure.
• If you are taking cholestyramine or colestipol, talk with your pharmacist about how to take them with this drug.
• Watch for gout attacks.
• If you have lupus, this drug may turn on lupus or make it worse. If any new symptom occurs or symptoms worsen, contact your healthcare provider immediately.
• Liver problems have happened with this drug. In some cases, hospitalization was required to treat liver disorders. Consult your doctor.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Contact your doctor or seek medical attention right away if you have any of the following signs or symptoms that may be associated with serious side effects:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of high blood sugar such as confusion, drowsiness, unusual thirst and hunger, increased urination, flushing, rapid breathing, and fruity breath.
• Signs of fluid and electrolyte imbalances such as mood changes, confusion, muscle pain or weakness, fast or irregular heart rate, severe dizziness or loss of consciousness, extreme thirst, seizures, feeling very tired or weak, decreased appetite, inability to urinate or change in the amount of urine produced, dry mouth, dry eyes, severe nausea or vomiting.
• Signs of kidney problems, including not passing urine, changes in the volume of urine, blood in the urine, or rapid weight gain.
• Signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
• Muscle spasm.
• With the appearance or aggravation of chest pain.
• Anxiety.
• Swelling of the hands or feet.
• Muscle stiffness, trembling, or abnormal muscle movements.
• This drug may cause certain eye problems. If left untreated, these problems can lead to long-term vision loss. In cases where such problems with the eyes occurred, symptoms such as blurred vision or eye pain usually appeared in the period from the first hours to the first weeks after the start of the drug. If you experience these symptoms, contact your doctor immediately.
• In rare cases, the use of hydrochlorothiazide has been associated with the development of certain types of skin cancer. Protect your skin from the sun and have skin exams as directed by your doctor. If there is a change in the color or size of a birthmark, or any new or changing skin tumors or growths, contact your healthcare provider immediately.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Talk to your doctor or get medical help if these or any other side effects bother you or don’t go away:

• Feeling dizzy, tired or weak.
• Headache.
• Nausea.
• Back pain.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www. fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

• Take this drug with or without food.
• Keep taking this drug as instructed by your doctor or other health care professional, even if you feel well.
• Take this drug at about the same time of day.
• This drug may cause frequent urination. This can lead to sleep disturbances, so try not to take the drug shortly before going to bed.
• Drink plenty of non-caffeinated fluids, unless your doctor tells you to drink less fluids.

What if I miss a dose of a drug?

• Take the missed dose as soon as you can.
• If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.

How do I store and/or discard this drug?

• Store at room temperature in a dry place. Do not store in the bathroom.
• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• Some medicines may come with other patient information leaflets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last revision date

2023-02-22

Copyright

© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Date last updated

Monday, December 12, 2022

Vipcor – Wise Pharma

Pharmacological action

Combination antihypertensive drug containing: amlodipine (a dihydropyridine derivative) and valsartan (angiotensin II receptor antagonist). The combination of these components has a mutually complementary hypotensive effect, which leads to a more pronounced decrease in blood pressure than when they are used separately.

The amlodipine/valsartan combination has been proven clinically effective in patients with mild to moderate arterial hypertension (mean diastolic BP ≥95 mm Hg and <110 mm Hg) without complications compared with placebo. The level of blood pressure reduction in the sitting position in arterial hypertension with diastolic blood pressure ≥110 mm Hg. Art. and <120 mmHg. Art. comparable to the combination of an ACE inhibitor and a thiazide diuretic. When using a combination of amlodipine / valsartan, comparable blood pressure control is achieved with a lower likelihood of developing peripheral edema in patients with previously achieved blood pressure control and severe peripheral edema during amlodipine therapy.

When taking a combination of amlodipine / valsartan in a single dose, the hypotensive effect persists for 24 hours. The antihypertensive effect persists for a long time. Sudden discontinuation of the drug is not accompanied by a sharp increase in blood pressure (no withdrawal syndrome). Therapeutic efficacy does not depend on the age, sex, race of the patient and BMI.

Amlodipine is a dihydropyridine derivative, a calcium channel blocker. It has antianginal and hypotensive effects. Inhibits the transmembrane transition of calcium ions into cardiomyocytes and smooth muscle cells of the vascular wall. The antihypertensive effect of amlodipine is due to a direct relaxing effect on the smooth muscle cells of the vascular wall. The mechanism of the antianginal action of amlodipine is not fully understood, presumably it is associated with the following effects: causes expansion of peripheral arterioles, reducing OPSS (afterload), which leads to a decrease in myocardial oxygen demand; causes expansion of the coronary arteries and arterioles in both intact and ischemic areas of the myocardium, which increases the supply of oxygen to the myocardium, incl. in patients with Prinzmetal’s angina. Amlodipine reduces the severity of left ventricular hypertrophy. It does not affect myocardial contractility and conduction, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases GFR, and has a weak natriuretic effect.

In patients with arterial hypertension, taking amlodipine 1 time / day provides a clinically significant decrease in blood pressure (in the supine and standing position) for 24 hours. The antihypertensive effect develops slowly, and therefore the development of acute arterial hypotension is uncharacteristic. In patients with angina pectoris, taking amlodipine 1 time / day increases exercise tolerance, the time to the development of an angina attack and to ischemic ST segment depression, reduces the frequency of angina attacks and the need to take nitroglycerin (short-acting forms).

Clinical efficacy of amlodipine in patients with stable exertional angina, vasospastic angina and angiographically confirmed coronary artery disease has been proven.

Amlodipine does not adversely affect lipid metabolism and does not cause changes in the lipid profile of blood plasma. Amlodipine can be used in patients with asthma, diabetes and gout.

With a single oral administration, the effect of amlodipine begins after 2-4 hours and persists for 24 hours. The maximum hypotensive effect is achieved no earlier than 4 weeks from the start of the drug. The hemodynamic effects of the drug remain unchanged with long-term use.

Valsartan is a selective angiotensin II receptor antagonist (type AT ₁ ) for oral administration. Selectively blocks AT ₁ subtype receptors, which are responsible for the effects of angiotensin II. An increase in plasma angiotensin II concentration due to blockade of AT ₁ receptors under the action of valsartan can stimulate unblocked receptors of the AT ₂ subtype, which counteract the effects of stimulation of AT ₁ receptors. Valsartan has no agonistic activity against AT ₁ receptors. The affinity of valsartan for AT ₁ subtype receptors is approximately 20,000 times higher than for AT ₂ subtype receptors.

Valsartan does not interact with or block other hormone receptors or ion channels involved in the regulation of the functions of the cardiovascular system.

Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. Due to the lack of influence on ACE, the effects of bradykinin or substance P are not potentiated, therefore, when using angiotensin II receptor antagonists, the development of dry cough is unlikely. It has been proven that the incidence of dry cough in the treatment with valsartan is significantly lower than with the use of ACE inhibitors. In the treatment of arterial hypertension, valsartan reduces blood pressure without affecting heart rate.

After oral administration of valsartan in a single dose, the hypotensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after its administration. With repeated use of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved after 2-4 weeks and is maintained at the achieved level during long-term therapy. Sudden discontinuation of valsartan is not accompanied by a significant increase in blood pressure or other adverse events (withdrawal syndrome).

The pharmacokinetics of amlodipine and valsartan are linear.

Amlodipine / Valsartan

After oral administration of amlodipine / valsartan combination C _max valsartan and amlodipine in blood plasma are reached after 3 hours and 6-8 hours, respectively. The rate and extent of absorption is equivalent to the bioavailability of valsartan and amlodipine when taken separately.

Amlodipine

After oral administration, amlodipine is slowly and almost completely absorbed from the gastrointestinal tract. Simultaneous food intake does not affect the absorption of amlodipine. From _max in blood plasma is reached 6-12 hours after administration. The average absolute bioavailability is 64-80%. The average V _d is 21 l / kg of body weight, which indicates that most of the amlodipine is in the tissues, and the smaller part is in the blood. Most of the amlodipine in the blood (97.5%) binds to plasma proteins. C _ss in blood plasma are reached after 7-8 days of constant intake of amlodipine. Amlodipine crosses the BBB and the placental barrier.

Amlodipine undergoes slow but active hepatic metabolism with no significant first pass effect through the liver. Metabolites do not have significant pharmacological activity.

After a single dose of amlodipine, T _1/2 varies from 35 to 50 hours, with repeated use it is approximately 45 hours. About 60% of the oral dose is excreted by the kidneys mainly in the form of metabolites, 10% unchanged, 20-25 % – through the intestines with bile. The total clearance of amlodipine is 0.116 ml/s/kg (7 ml/min/kg, 0.42 l/h/kg). Amlodipine is not removed by hemodialysis.

Prolongation of T _1/2 in patients with hepatic insufficiency suggests that with prolonged use, the accumulation of amlodipine in the body will be higher (increases to 60 hours).

Valsartan

After oral administration of valsartan C _max is reached in 2-3 hours. The average absolute bioavailability is 23%. When taking valsartan with food, there is a decrease in bioavailability (according to the AUC value) by about 40%, and C _max – by about 50%. Approximately 8 hours after oral administration, the plasma concentrations of valsartan in the group of patients taking the drug with food and in the group taking the drug on an empty stomach are aligned. The decrease in AUC is not clinically significant, so valsartan can be taken with or without food.

V _d valsartan in the period of equilibrium after intravenous administration is about 17 liters, which indicates the absence of extensive distribution of valsartan in tissues. Valsartan is largely associated with serum proteins (94-97%), mainly with serum albumin.

Valsartan is not extensively metabolized. About 20% of the dose taken is determined in the blood plasma as metabolites. The hydroxyl metabolite is determined in plasma at low concentrations (less than 10% of the AUC of valsartan). This metabolite is pharmacologically inactive.

Valsartan is excreted in two phases: α-phase with T _1/2α less than 1 hour and β-phase with T _1/2β – about 9 hours. Valsartan is excreted mainly unchanged through the intestines (about 83%) and kidneys (about 13%). After intravenous administration, the plasma clearance of valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of the total clearance). T _1/2 valsartan is 6 hours.

points on the Child-Pugh scale) the degree of bioavailability (according to the AUC value) of valsartan doubles compared with healthy volunteers of the corresponding age, sex and body weight.

Indications of the active substances of the drug Amlodipine-Valsartan-Richter

• arterial hypertension in patients who are indicated for combination therapy with amlodipine and valsartan.