valsartan oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor right away.

How to use Valsartan

Read the Patient Information Leaflet if available from your pharmacist before you start taking valsartan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well for at least 10 seconds before each dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Keep taking this medication even if you feel well. 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. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Although valsartan may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause serious kidney problems or make them worse. Your doctor will check your kidney function while you are taking valsartan. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about 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

Before taking valsartan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, dehydration, high level of potassium in the blood.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Liquid products may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using valsartan. Valsartan may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

See also Precautions section.

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. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: aliskiren, lithium, drugs that may increase the level of potassium in the blood (such as sparsentan, ACE inhibitors including benazepril/lisinopril, birth control pills containing drospirenone).

Some products have ingredients that could raise your blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Does Valsartan interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

Lab and/or medical tests (such as kidney function tests, potassium levels) should be done while you are taking this medication. Keep all medical and lab appointments.

Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure, and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store this medication at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

If you are using the suspension form of this medication, store it at room temperature for up to 30 days, or in the refrigerator for up to 75 days. Do not freeze.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

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This medicine is a yellow, oval, film-coated, tablet imprinted with “839” and “AN”.

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This medicine is a yellow, oval, film-coated, tablet imprinted with “839” and “AN”.

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This medicine is a yellow, oval, film-coated, tablet imprinted with “839” and “AN”.

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valsartan 80 mg tablet

Color: light redShape: oblongImprint: M V13

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Valsartan Blood Pressure Drug | How It Works, Risks & Recalls

Valsartan is a blood pressure medication used to treat high blood pressure and heart failure. It belongs to a class of drugs called angiotensin II receptor blockers (ARB). Valsartan is also prescribed after a heart attack to lower blood pressure and improve the patient’s chance of living longer.

Valsartan is a type of blood pressure drug called an angiotensin II receptor blocker (ARB). Other medications in the valsartan drug class include irbesartan (Avapro), losartan (Cozaar), and candesartan (Atacand).

Novartis manufactured the first brand-name valsartan drug, Diovan, and the U.S. Food and Drug Administration approved it in 1996. Novartis lost its patent in 2012, and generic manufacturers began producing and distributing the drug.

Some brand names of valsartan include Diovan, Entresto, Exforge and Byvalson.

Doctors prescribe valsartan to treat high blood pressure and heart failure. The medication may also improve the chance of living longer when prescribed to patients who have problems with the heart’s left ventricle following a heart attack.

The FDA announced a recall of several drug products containing valsartan in July 2018 because it found a cancer-causing chemical called N-nitrosodimethylamine (NDMA) in some batches. As of 2022, people who took the tainted drugs are filing valsartan lawsuits.

Lawsuit Information

People who took NDMA-contaminated valsartan and later developed cancer are filing lawsuits against more than 20 manufacturers. Read more about this pending litigation.

View Lawsuits

Lowering Blood Pressure with Valsartan

Valsartan blocks the angiotensin II receptor. Angiotensin II is a hormone produced in the body that can cause blood vessels to narrow, raising blood pressure.

By blocking the angiotensin II receptor, the drug keeps blood vessels from narrowing. This lowers blood pressure and improves blood flow.

EXPAND

Researchers tested the drug’s effectiveness in seven placebo controlled clinical trials that lasted four to 12 weeks. Patients took dosages from 10 mg to 320 mg per day. Their diastolic pressure at the start of the trials ranged from 95 mmHg to 115 mmHg.

The studies found valsartan starts to lower blood pressure in about two hours and reaches its maximum effectiveness in six hours. The effects last for 24 hours, though it becomes less effective throughout the day at lower doses.

Valsartan vs Losartan and Lisinopril

A study published in Clinical Therapeutics in 2001 found valsartan and losartan were similarly effective in reducing blood pressure in patients with mild to moderate hypertension.

Losartan was also associated with a decrease in serum uric acid levels. Valsartan did not decrease those levels. High levels of uric acid are associated with gout.

A different study published in Clinical Therapeutics in 2004 found both valsartan and lisinopril were highly effective in controlling blood pressure in patients with mild to severe hypertension. But valsartan was associated with a considerably lower risk for adverse events, especially cough.

Instructions for Taking the Drug Safely

Take valsartan at the dose and for the duration directed by your doctor. Take the drug at the same time each day with or without food. Store the drug at room temperature, and keep it away from heat and moisture.

Patients should take missed doses as soon as they remember. If it’s close to the next dose, just take the one dose. Do not take extra valsartan to offset a missed dose.

In case of a valsartan overdose, seek immediate, emergency medical help, or call the poison help line at 1-800-222-1222.

Possible symptoms of an overdose include fast or slow heartbeat. People who overdose on valsartan may feel dizzy or like they might pass out.

Recommended Dose Depends on Diagnosis

Valsartan comes in four dose strengths: 40 mg 80 mg, 160 mg and 320 mg. Doctors will prescribe the appropriate strength depending on the patient’s age and diagnosis.

Adult hypertension:

80 mg or 160 mg once daily to start. Then, the prescribing doctor may adjust the dose to between 80 mg and 320 mg once daily.

Hypertension in patients 6 years old to 16 years old:

1.3 mg/kg once daily (up to 40 mg) to start. Then, the prescribing doctor may adjust the dose to between 1.3 mg/kg and 2.7 mg/kg daily (up to 160 mg total).

Heart failure:

40 mg twice daily to start. Then, the prescribing doctor may adjust the dose to between 40 mg and 160 mg twice daily.

After a heart attack:

20 mg twice daily to start. Then, the prescribing doctor may adjust the dose up to 160 mg twice daily. The target maintenance dose is 160 mg twice daily.

Side Effects, Warnings and Interactions

According to the valsartan medication insert, the most common side effects for people taking the drug to treat hypertension include headache, dizziness, fatigue, flu symptoms and abdominal pain.

For people taking the drug for heart failure, common side effects include dizziness, low blood pressure, diarrhea, joint and back pain, tiredness and high blood potassium.

People who took the drug after a heart attack stopped taking the drug because they experienced low blood pressure, decreased kidney function or a rash.

Black Box Warning

The drug’s label includes a black box warning for fetal toxicity. It indicates pregnant women should not use valsartan. The drug can cause injury or death to the developing fetus. If women become pregnant, they should stop taking the medication as soon as possible.

Other warnings for valsartan include:

• Low blood pressure: Valsartan may cause low blood pressure, leading to dizziness or lightheadedness. This is more likely to occur in patients also taking other medications that lower blood pressure, like diuretics (water pills).
• 
  High blood potassium: Valsartan may cause an increase in potassium levels, which can lead to heart problems. This is more likely to occur in patients who have kidney problems, heart failure or are taking other medications that increase blood potassium.

Precautions

The American College of Cardiology says before taking valsartan, patients should tell their doctor if they have kidney, liver or heart disease, or if they are dehydrated.

Patients who start treatment because of heart failure or after a heart attack may experience a reduction in blood pressure, but it’s usually not necessary to stop treatment because of continued low blood pressure so long as the dosing instructions are followed. Health care professionals may treat excessive hypotension with an infusion of saline.

Drugs like valsartan may cause changes in kidney function or cause acute renal failure. Patients with conditions such as chronic kidney disease or severe congestive heart failure are at increased risk for kidney failure while on the drug. Doctors should monitor kidney function and may stop therapy if kidney function becomes impaired.

Drug Interactions

Valsartan interacts with a number of drugs. Patients should tell their doctor about any prescriptions, over-the-counter-medications and supplements they’re taking. These include potassium supplements, salt substitutes, lithium and drugs used to treat HIV/AIDS.

Drugs that may interact with valsartan include:

• Certain diuretics
• Ritonavir
• Cyclosporine
• Rifampin
• Nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin or meloxicam

Recalls Due to Contamination

In 2018, the FDA warned that manufacturers found unacceptable amounts of the chemical N-Nitrosodimethylamine (NDMA) in some batches of valsartan. The toxic chemical may have been present in the drugs for as long as four years.

Several companies recalled batches of valsartan because of contamination with the suspected cancer-causing chemical. Unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), N-Nitrosodiethylamine (NDEA) and NDMA were also found in other drug products containing losartan and irbesartan, which resulted in more recalls.

Valsartan Facts

Please seek the advice of a medical professional before making health care decisions.

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Valsartan Film-coated tablets 80 mg 30 pcs

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Product code:
209287

Manufacturer:
Vertex

Country of origin:
Russia

Release form:
Tablets

Active ingredients:
Valsartan

Dispensing procedure:
By prescription

There are contraindications, consult your doctor

Payment and methods of obtaining

Price:

348 ₽

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Manufacturer:
Vertex

Country of origin:
Russia

Release form:
Tablets

Active ingredients:
Valsartan

Dispensing procedure:
Prescription

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Characteristics

Characteristics

Information

Instructions for use

Description

Angiotensin II receptor antagonist.

Active ingredients

Valsartan

Release form

Tablets

Composition

Valsartan 160 mg.

Excipients: lactose monohydrate – 69.6 mg, microcrystalline cellulose – 64 mg, povidone K30 – 8 mg, croscarmellose sodium – 12 mg, colloidal silicon dioxide – 3.2 mg, magnesium stearate – 3.2 mg.

Composition of the film coating: [(hypromellose – 6 mg, talc – 2 mg, titanium dioxide – 1.06 mg, macrogol 4000 – 0.9 mg, iron oxide red – 0.04 mg) or (dry mixture for film coating containing hypromellose (60% ), talc (20%), titanium dioxide (10.6%), macrogol 4000 (9%), iron oxide red (0. 4%)] – 2.5 mg

Pharmacological effect

Antihypertensive agent. It is a specific angiotensin II receptor antagonist. It has a selective antagonistic effect on AT1 receptors, which are responsible for the implementation of the effects of angiotensin II.

Due to the blockade of AT1 receptors, the plasma concentration of angiotensin II increases, which can stimulate unblocked AT2 receptors. It does not have agonistic activity against AT1 receptors. The affinity of valsartan for AT1 receptors is approximately 20,000 times higher than for AT2 receptors.

Does not inhibit ACE. Does not interact with or block other hormone receptors or ion channels that are important for the regulation of the functions of the cardiovascular system. Does not affect the level of total cholesterol, TG, glucose and uric acid in plasma.

The onset of the antihypertensive effect of valsartan after oral administration in a single dose is observed within 2 hours after administration, the maximum effect is achieved within 4-6 hours.

Pharmacokinetics

After oral administration, valsartan is rapidly absorbed from the gastrointestinal tract, the degree of absorption is characterized by individual differences. Absolute bioavailability averages 23%. The pharmacokinetic curve of valsartan has a multi-exponential character (T1 / 2 in the alpha phase is 1 h and T1 / 2 in the beta phase is about 9 h), the kinetics is linear.

There were no changes in pharmacokinetic parameters during the course application.

When taking valsartan with food, AUC decreases by 48%, while approximately 8 hours after taking valsartan plasma concentrations are the same in patients who took it with food and on an empty stomach. The decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect.

When taking valsartan 1 time / day, cumulation is slightly pronounced. Plasma concentrations of valsartan in women and men were the same.

Plasma protein binding, predominantly to albumin, is 94-97%. Vd in the equilibrium state is about 17 liters.

Plasma clearance of valsartan is about 2 l/h. Excreted with feces – 70% and with urine – 30%, mainly unchanged.

In biliary cirrhosis or obstruction of the biliary tract, the AUC of valsartan increases by approximately 2 times.

Indications

Treatment of arterial hypertension.

Treatment of chronic heart failure (NYHA functional class II-IV) in patients receiving conventional therapy with diuretics, digitalis preparations, and ACE inhibitors or beta-blockers.

Contraindications

Pregnancy, hypersensitivity to valsartan.

Pregnancy and lactation

Valsartan is contraindicated during pregnancy.

It is not known whether valsartan is excreted in human breast milk. Use during lactation (breastfeeding) is not recommended.

Method of administration and doses

Take orally at a dose of 80 mg 1 time per day or 40 mg 2 times a day, daily. In the absence of an adequate effect, the daily dose may be gradually increased.
The maximum daily dose is 320 mg in 2 divided doses.

Side effects

From the side of the cardiovascular system: arterial hypotension, postural dizziness, postural hypotension.

From the side of the central nervous system: dizziness, headache.

From the digestive system: diarrhea, nausea, increased bilirubin levels.

From the urinary system: rarely – impaired renal function, increased levels of creatinine and urea nitrogen (especially in chronic heart failure).

From the side of metabolism: hyperkalemia.

From the side of the hematopoietic system: neutropenia, decrease in hemoglobin and hematocrit.

Allergic reactions: rarely – angioedema, rash, itching, serum sickness, vasculitis.

Other: fatigue, general weakness, cough, pharyngitis, increased risk of viral infections.

Interaction with other drugs

With the simultaneous use of diuretics in high doses, arterial hypotension may develop.

With the simultaneous use of potassium-sparing diuretics, heparin, dietary supplements or salt substitutes containing potassium, hyperkalemia may develop.

Co-administration with indomethacin may reduce the antihypertensive effect of valsartan.

When used simultaneously with lithium carbonate, a case of lithium intoxication has been described.

Special instructions

With hyponatremia and / or a decrease in BCC, as well as during therapy with high doses of diuretics, in rare cases, valsartan can cause severe arterial hypotension. Before starting treatment, correction of water-salt metabolism disorders should be carried out.

In patients with renovascular hypertension secondary to renal artery stenosis, serum urea and creatinine levels should be regularly monitored during treatment. Data on the safety of use in patients with CC less than 10 ml / min are not available.

Use with extreme caution in patients with biliary obstruction.

Due to inhibition of the RAAS in predisposed patients, changes in renal function are possible. When using ACE inhibitors and angiotensin receptor antagonists in patients with severe chronic heart failure, oliguria and / or an increase in azotemia were observed, and acute renal failure with a risk of death rarely developed.

The safety and efficacy of valsartan in children has not been established.

Influence on the ability to drive vehicles and control mechanisms

When using valsartan, it is recommended to be careful when driving a car and operating mechanisms.

Storage conditions

At a temperature not exceeding 25°C. Keep out of the reach of children.

Prescription

Yes

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Valsartan Teva tablets 80 mg No. 30

Valsartan – Teva is a simple angiotensin II antagonist drug for the treatment of hypertension, post-infarction and heart failure.

Composition

• 1 tablet contains valsartan 80 mg;
• excipients: magnesium stearate, croscarmellose sodium, talc, colloidal silicon dioxide, microcrystalline cellulose, povidone, lactose;
• mixture: Opadry II 85G34643 Pink (polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, lecithin, iron oxide red (E172), iron oxide yellow (E172))

Contraindications

Hypersensitivity to valsartan, soybean oil, peanut oil or any of the excipients.

Congenital angioedema or which developed during previous treatment with an ACE inhibitor or angiotensin II receptor antagonists.

Severe liver failure, biliary cirrhosis and cholestasis.

Method of administration

Dosage

Arterial hypertension

The recommended initial dose of valsartan is 80 mg 1 time per day. The antihypertensive effect is achieved within 2 weeks, and the maximum effect is achieved within 4 weeks. In some patients with inadequately controlled blood pressure, the dose can be increased to 160 mg and up to a maximum of 320 mg.

Recent myocardial infarction

Clinically stable patients can start therapy as early as 12 hours after myocardial infarction. After an initial dose of valsartan 20 mg twice daily, the dose should be increased to 40 mg, 80 mg and 160 mg twice daily over the next few weeks. The initial dose is administered in the form of a 40 mg tablet, which can be divided into equal parts. The target maximum dose is 160 mg twice daily. In general, it is recommended that a dosage level of 80 mg twice daily be reached 2 weeks after the start of treatment and a maximum dose of 160 mg twice daily be reached after 3 months, depending on the patient’s tolerance to treatment.

Application considerations

Hyperkalemia

Concomitant use of potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (eg heparin) is not recommended. If necessary, the level of potassium should be monitored.

Pregnant women

The use of angiotensin II receptor antagonists is contraindicated during the entire period of pregnancy, as well as in women planning a pregnancy.

Children

Valsartan-Teva can be used to treat hypertension in children over 6 years of age. The safety and efficacy of valsartan in children aged 1 to 6 years have not been established.

Drivers

Studies of the effect on the ability to drive vehicles and work with mechanisms have not been conducted. It should be borne in mind that while driving vehicles or working with mechanisms, dizziness or weakness may occur.

Overdose

Due to an overdose of valsartan, severe arterial hypotension may develop, which can lead to depression of consciousness, vascular collapse and / or shock.