Valsartan diovan side effects. Diovan Side Effects: Comprehensive Guide to Valsartan’s Impacts on Health
What are the common side effects of Diovan. How does Diovan affect blood pressure. Can Diovan cause serious kidney problems. Is Diovan safe during pregnancy. How does Diovan compare to other blood pressure medications.
Understanding Diovan: A Powerful Medication for Cardiovascular Health
Diovan, also known by its generic name valsartan, is a widely prescribed medication for managing high blood pressure and certain heart conditions. As an angiotensin II receptor blocker (ARB), Diovan works by relaxing blood vessels, thereby improving blood flow and reducing strain on the heart. While its efficacy in treating cardiovascular issues is well-established, it’s crucial to understand the potential side effects that may accompany its use.
The Mechanism of Action: How Diovan Works
Diovan’s primary function is to block the effects of angiotensin II, a hormone that causes blood vessels to constrict. By preventing this constriction, Diovan allows blood vessels to remain relaxed and open, facilitating easier blood flow throughout the body. This mechanism not only helps in lowering blood pressure but also reduces the workload on the heart, making it an effective treatment for various cardiovascular conditions.
Common Side Effects of Diovan: What Patients Should Know
While Diovan is generally well-tolerated, it can cause several common side effects. These effects may vary depending on the condition being treated and the individual’s response to the medication. Some of the most frequently reported side effects include:
- Dizziness
- Headache
- Fatigue
- Abdominal pain
- Diarrhea
- Back pain
- Joint pain
Are these side effects permanent? In most cases, these side effects are temporary and tend to subside as the body adjusts to the medication. However, if these symptoms persist or worsen over time, it’s important to consult with a healthcare provider.
Diovan’s Impact on Blood Pressure: A Double-Edged Sword
While Diovan’s primary purpose is to lower high blood pressure, it can sometimes lead to low blood pressure, especially when starting treatment or increasing the dosage. This effect can manifest as dizziness, particularly when standing up quickly from a sitting or lying position. How can patients manage this side effect? Patients are advised to rise slowly from seated or lying positions and to stay well-hydrated to minimize the risk of dizziness related to low blood pressure.
Serious Side Effects of Diovan: When to Seek Medical Attention
Although less common, Diovan can potentially cause serious side effects that require immediate medical attention. These include:
- Kidney problems
- Hyperkalemia (high potassium levels)
- Severe allergic reactions
- Fetal harm or pregnancy loss (in pregnant women)
How can patients recognize serious side effects? Symptoms such as unexplained swelling, difficulty urinating, irregular heartbeat, or severe dizziness may indicate a serious reaction to Diovan. In such cases, immediate medical consultation is crucial.
Kidney Function and Diovan: A Delicate Balance
Diovan’s effect on kidney function is a critical aspect of its use. While it can be beneficial for some patients with kidney disease, it may also potentially cause or worsen kidney problems in others. Regular monitoring of kidney function through blood tests is essential for patients taking Diovan, especially those with pre-existing kidney issues or risk factors.
Diovan and Pregnancy: Understanding the Risks
One of the most significant warnings associated with Diovan relates to its use during pregnancy. The FDA has issued a boxed warning, the strongest type of warning, regarding the risk of fetal harm when Diovan is used during pregnancy, particularly in the second and third trimesters.
Why is Diovan contraindicated in pregnancy? Diovan can cause injury and even death to the developing fetus. It may lead to reduced amniotic fluid, impaired fetal renal function, and other severe complications. For this reason, Diovan is strictly contraindicated during pregnancy, and women of childbearing age should use effective contraception while taking this medication.
Dosage Considerations: Balancing Efficacy and Side Effects
The dosage of Diovan plays a crucial role in both its effectiveness and the likelihood of experiencing side effects. Typically, Diovan is available in tablet form, with common dosages including 40 mg, 80 mg, 160 mg, and 320 mg.
Comparing Diovan 80 mg and 160 mg: Side Effect Profiles
Do higher doses of Diovan lead to more side effects? While most side effects of Diovan are not dose-dependent, some differences have been observed between the 80 mg and 160 mg dosages. Higher doses, such as the 160 mg tablet, may be associated with a slightly increased risk of orthostatic hypotension (low blood pressure upon standing) and dizziness compared to lower doses.
How should patients approach dosage changes? It’s crucial for patients to follow their healthcare provider’s instructions regarding dosage. Any changes in dosage should be made under medical supervision, and patients should report any new or worsening side effects after a dosage adjustment.
Long-Term Effects of Diovan: What Research Tells Us
Understanding the long-term effects of Diovan is crucial for patients who may require this medication for extended periods. While Diovan has been extensively studied and used for many years, ongoing research continues to shed light on its long-term impacts.
Diovan and Cancer Risk: Separating Fact from Fiction
Does Diovan increase cancer risk? This question has been a topic of concern and research. Based on clinical trials and post-marketing surveillance, there is no evidence to suggest that Diovan causes cancer. Cancer was not reported as a side effect in the drug’s clinical trials, and it is not considered a known risk associated with Diovan use.
However, it’s worth noting that in 2018, the FDA recalled certain batches of valsartan (the generic form of Diovan) due to contamination with a potential carcinogen. This recall was specific to certain manufacturers and batches and was not related to the inherent properties of valsartan itself.
Interactions and Precautions: Maximizing Safety with Diovan
To ensure the safe and effective use of Diovan, it’s crucial to be aware of potential drug interactions and necessary precautions. Diovan may interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects.
Key Interactions to Watch For
- NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
- Potassium supplements or salt substitutes
- Lithium
- Other blood pressure medications
How do these interactions affect Diovan’s efficacy? Some interactions may reduce Diovan’s blood pressure-lowering effects, while others might increase the risk of side effects like hyperkalemia or kidney problems. It’s essential for patients to inform their healthcare providers about all medications, supplements, and herbal products they are taking.
Special Precautions for Certain Groups
Certain groups of patients may require special consideration when taking Diovan:
- Elderly patients: May be more sensitive to blood pressure changes
- Patients with liver or kidney disease: May require dosage adjustments
- Individuals with a history of angioedema: May be at increased risk of this side effect
- Patients undergoing surgery or anesthesia: May experience enhanced blood pressure-lowering effects
How should these groups approach Diovan use? Close monitoring and potential dosage adjustments may be necessary for these patient populations to ensure safe and effective treatment.
Managing Side Effects: Strategies for Diovan Users
While side effects can be concerning, many can be effectively managed with proper strategies and medical guidance. Understanding how to mitigate and cope with potential side effects can significantly improve the overall experience of taking Diovan.
Practical Tips for Common Side Effects
- Dizziness: Rise slowly from sitting or lying positions, stay hydrated
- Headache: Ensure adequate rest and hydration, consider over-the-counter pain relievers if approved by your doctor
- Fatigue: Maintain a regular sleep schedule, engage in light exercise as tolerated
- Abdominal pain: Eat smaller, more frequent meals, avoid trigger foods
When should patients seek medical advice for side effects? While many side effects are mild and manageable, persistent or severe symptoms should always be reported to a healthcare provider. They can assess whether the benefits of continuing Diovan outweigh the risks and consider alternative treatments if necessary.
The Importance of Regular Monitoring
Regular medical check-ups and laboratory tests are crucial for patients taking Diovan. These may include:
- Blood pressure checks
- Kidney function tests
- Electrolyte levels (particularly potassium)
- Liver function tests
How often should these tests be conducted? The frequency of monitoring may vary depending on individual factors such as age, overall health, and the presence of other medical conditions. Typically, more frequent monitoring is required when starting Diovan or adjusting the dosage.
Comparing Diovan to Other Blood Pressure Medications
Understanding how Diovan compares to other blood pressure medications can help patients and healthcare providers make informed decisions about treatment options. While Diovan belongs to the class of angiotensin II receptor blockers (ARBs), there are several other classes of antihypertensive medications available.
Diovan vs. ACE Inhibitors
ACE (Angiotensin-Converting Enzyme) inhibitors, such as lisinopril or enalapril, work similarly to ARBs like Diovan. However, there are some key differences:
- Side effect profile: ACE inhibitors are more likely to cause a dry cough
- Effectiveness: Both classes are generally similar in effectiveness for blood pressure control
- Indications: ARBs may be preferred in certain populations, such as those with a history of ACE inhibitor-induced cough
How do patients choose between ARBs and ACE inhibitors? The choice often depends on individual factors, including side effect tolerance, specific health conditions, and cost considerations. Your healthcare provider can help determine which option is best suited for your needs.
Diovan vs. Calcium Channel Blockers
Calcium channel blockers (CCBs), such as amlodipine or nifedipine, work by a different mechanism than Diovan. They relax blood vessels by blocking calcium entry into cells. Comparing these medications:
- Side effects: CCBs may cause ankle swelling and constipation more frequently than ARBs
- Effectiveness: Both classes are effective in lowering blood pressure, but may have different benefits for specific conditions
- Combination therapy: Diovan is sometimes combined with a CCB for enhanced blood pressure control
Can Diovan be used with other blood pressure medications? Yes, Diovan is often used in combination with other antihypertensive drugs for better blood pressure control. However, such combinations should always be under the guidance of a healthcare provider to minimize the risk of adverse effects.
Future Perspectives: Ongoing Research and Developments
The field of cardiovascular medicine is constantly evolving, and research into medications like Diovan continues to advance our understanding of their long-term effects, potential new uses, and ways to optimize treatment.
Emerging Research on ARBs
Current research is exploring various aspects of ARBs, including:
- Potential neuroprotective effects in conditions like Alzheimer’s disease
- Role in reducing the risk of diabetes in high-risk populations
- Possible benefits in certain types of cancer prevention or treatment
- Development of new formulations or delivery methods for improved efficacy and reduced side effects
How might future research impact Diovan use? While these areas of research are promising, it’s important to note that current prescribing practices should be based on well-established indications and guidelines. Future findings may expand the use of Diovan or lead to modifications in how it’s prescribed and monitored.
Personalized Medicine Approaches
The concept of personalized medicine is gaining traction in cardiovascular treatment. This approach aims to tailor medication choices and dosages based on individual genetic profiles, lifestyle factors, and other personal characteristics.
How could personalized medicine affect Diovan prescribing? In the future, genetic testing might help predict which patients are most likely to benefit from Diovan or who might be at higher risk for certain side effects. This could lead to more targeted and effective use of the medication, potentially improving outcomes and reducing adverse effects.
As research continues to evolve, patients taking Diovan should stay informed about new developments and discuss any questions or concerns with their healthcare providers. Regular follow-ups and open communication are key to ensuring the best possible outcomes with Diovan therapy.
Side effects and what to do about them
Diovan (valsartan) is a brand-name medication that’s prescribed for high blood pressure and certain heart problems. As with other drugs, Diovan can cause side effects, such as dizziness.
Diovan belongs to a drug class called angiotensin II receptor blockers (ARBs). The drug is available in a generic version.
Read on to learn about potential common, mild, and serious side effects of Diovan. For a general overview of the drug, including details about its uses, see this article.
Diovan can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Diovan in clinical trials. These side effects can vary depending on which condition the drug is being used to treat.
More common side effects in people taking Diovan for high blood pressure include:
- abdominal pain
- fatigue
- headache
- dizziness*
More common side effects in people taking Diovan for heart failure include:
- diarrhea
- fatigue
- joint pain
- back pain
- dizziness*
- low blood pressure*
More common side effects in people taking Diovan after a heart attack include:
- high levels of creatinine, a waste product that your kidneys usually clear
- low blood pressure*
- cough*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Diovan use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Diovan’s prescribing information.
Mild side effects that have been reported with Diovan include:
- abdominal pain
- joint pain
- back pain
- diarrhea
- fatigue
- headache
- cough*
- dizziness*
- mild allergic reaction†
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Diovan and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Diovan. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.
Diovan may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Diovan’s prescribing information.
If you develop serious side effects while taking Diovan, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported include:
- Kidney problems.*
- Low blood pressure.*
- Hyperkalemia (high levels of potassium).*
- Risk of fetal harm or pregnancy loss.†
- Severe allergic reaction.‡
* For more information about this side effect, see “Side effect specifics” below.
† Diovan has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Pregnancy and breastfeeding while taking Diovan” section in “Precautions for Diovan” below.
‡ An allergic reaction is possible after taking Diovan. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.
Diovan may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
How do the side effects of Diovan 80 mg compare with those seen in Diovan 160 mg?
It’s possible for Diovan’s 160-milligram (mg) tablet to cause different side effects than the 80-mg tablet. In clinical trials, most side effects typically weren’t dose related. This means that the dose did not affect the likelihood of these side effects.
However, in rare cases, higher doses of Diovan caused orthostatic hypotension. This is low blood pressure when you stand up or change positions. Dizziness was also more common in people taking higher doses.
If you notice new side effects after a dosage increase, tell your doctor. They can determine if your symptoms are related to the higher dose and suggest ways to manage them.
Can Diovan cause cancer?
No, Diovan isn’t expected to cause cancer. In the drug’s clinical trials, cancer wasn’t reported. For this reason, it isn’t a known side effect of Diovan.
Diovan contains the active drug valsartan. In 2018, the Food and Drug Administration (FDA) recalled certain batches of drugs containing valsartan. The FDA issued this recall due to the presence of a chemical called N-nitrosodimethylamine (NDMA) in some drugs. NDMA has the potential to cause cancer in humans.
For updates or questions about drug recalls, talk with your doctor or pharmacist.
Is erectile dysfunction or weight gain a side effect of Diovan?
No, erectile dysfunction (ED) and weight gain aren’t expected side effects of Diovan. Neither side effect was reported in clinical trials of the drug.
Diovan is prescribed for high blood pressure. Other drugs prescribed for high blood pressure, such as diuretics and beta-blockers, may cause ED. If you have ED, talk with your doctor. They can determine the most likely cause and suggest ways to manage it.
Weight gain can be symptom of worsening heart failure or another condition. Keep in mind that doctors often prescribe Diovan for heart failure. If you have heart failure and notice any weight changes, tell your doctor right away.
Learn more about some of the side effects that Diovan may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Diovan.
Kidney problems
It’s possible for Diovan to cause kidney problems. This includes kidney failure and changes in kidney function.
Symptoms of kidney problems can include:
- changes in the amount of urine you produce
- confusion
- muscle cramps
- nausea
- swelling in the feet or ankles
What you can do
When you start taking Diovan, your doctor may regularly monitor your kidney function. This will include checking your levels of creatinine, a waste product that your kidneys usually clear. High creatinine levels may mean your kidneys aren’t working as well as they should. If you develop kidney problems, your doctor may recommend taking a breaking from Diovan or stopping it altogether.
If you have any symptoms of kidney problems, talk with your doctor right away.
Low blood pressure
It’s possible to experience low blood pressure from taking Diovan. In clinical trials, this was a common side effect of the drug. The risk of low blood pressure can depend on the condition you’re taking Diovan to treat. It can also depend on whether you take any other medications.
In clinical trials, this side effect was a common reason people taking Diovan after a heart attack stopped treatment.
Low blood pressure symptoms can include the following:
- blurry vision
- darkening vision
- dizziness or lightheadedness
- fainting
- fatigue
What you can do
If you have symptoms of low blood pressure while taking Diovan, lie down until you feel better. Let your doctor know about your symptoms. They may recommend lowering your dosage of Diovan or other medications that affect blood pressure.
High levels of potassium
Hyperkalemia (high levels of potassium) can occur while taking Diovan. If you have kidney problems, the risk of developing this side effect may be higher.
Mild hyperkalemia typically doesn’t cause noticeable symptoms. However, severe hyperkalemia may cause symptoms that include:
- difficulty breathing
- heart palpitations
- nausea
- numbness
- weakness
What you can do
Your doctor may monitor your potassium levels while you’re taking Diovan. If your levels are high, your doctor may reduce your dosage or recommend you stop taking Diovan.
If you experience any of the above symptoms, tell your doctor right away.
Cough
It’s possible to develop a cough while taking Diovan. This was a common reason that people taking Diovan after a heart attack stopped treatment.
However, a cough can also be a symptom of worsening heart failure. Keep in mind that doctors often prescribe Diovan to treat heart failure.
What you can do
If you develop a new cough while taking Diovan, let your doctor know. If necessary, they may adjust your treatment plan.
Dizziness
Dizziness was one of the most common side effects reported in clinical trials of Diovan. Dizziness can be a symptom of low blood pressure. It can also lead to fainting and falls, so it’s important not to ignore it.
What you can do
If you feel dizzy while taking Diovan, lie down until you feel better. This can help reduce the risk of fainting or falling.
If you experience frequent dizziness, let your doctor know. They can determine if the dizziness is due to low blood pressure and suggest ways to treat it.
Allergic reaction
As with most drugs, Diovan can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Diovan. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Diovan comes with several warnings, including a boxed warning.
Boxed warning: Risk of fetal harm or pregnancy loss
This drug has a boxed warning for the risk of fetal harm or pregnancy loss. This is a serious warning from the Food and Drug Administration (FDA). For details, see the “Pregnancy and breastfeeding while taking Diovan” section below.
Other precautions
Be sure to talk with your doctor about your health history before you take Diovan. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Allergic reaction. If you’ve had an allergic reaction to Diovan or any of its ingredients, your doctor will likely not prescribe Diovan. Ask your doctor what other medications may be better options for you.
Diabetes. If you have diabetes and take Tekturna (aliskiren), you shouldn’t take Diovan. Taking these drugs together with diabetes may increase the risk of kidney problems. If you have diabetes and take Tekturna, talk with your doctor. They can advise what other medications may be better options for you.
Kidney problems. Diovan can cause kidney problems. If you already have a kidney condition, taking this drug could make it worse. It may also increase your risk of hyperkalemia (high potassium levels) during treatment. Before you start taking Diovan, tell your doctor about any kidney problems you have. They can advise whether Diovan is safe for you.
Low blood pressure. Diovan can cause low blood pressure. This most commonly occurs in people with heart failure or people taking Diovan after a heart attack. If you have either of these conditions, your doctor may closely monitor your blood pressure during treatment.
Alcohol with Diovan
There are no known interactions between alcohol and Diovan.
However, alcohol can cause some of the same side effects as Diovan, including dizziness, headache, and low blood pressure. Drinking alcohol during treatment with Diovan could make these side effects worse.
If you have questions about drinking alcohol while taking Diovan, talk with your doctor or pharmacist.
Pregnancy and breastfeeding while taking Diovan
It isn’t safe to take Diovan during pregnancy. Diovan has a boxed warning for the risk of fetal harm and pregnancy loss if it’s taken during pregnancy. This is a serious warning from the Food and Drug Administration (FDA).
Additionally, you should not take Diovan while breastfeeding. In animal studies, Diovan passed into the milk of lactating animals. It’s important to note that animal studies don’t always predict what may happen in humans. However, due to this risk, your doctor likely won’t prescribe Diovan if you’re breastfeeding.
If you’re breastfeeding or planning to breastfeed, talk with your doctor before starting treatment. They’ll help determine safe feeding options for your child and other treatments for your condition.
Risk of fetal harm or pregnancy loss
Taking Diovan during pregnancy can cause fetal harm or pregnancy loss. If you become pregnant during treatment, contact your doctor immediately. They’ll likely advise that you stop taking Diovan as soon as possible.
If you can become pregnant, talk with your doctor about birth control options while taking Diovan.
Diovan has some common side effects that are usually mild. However, serious side effects are possible. If you’d like to learn more about Diovan, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Diovan. For details about other aspects of Diovan, refer to this article.
- Drug comparison. To learn how Diovan compares with losartan, read this article.
- A look at high blood pressure, heart failure, and heart attack. For details about high blood pressure, heart failure, and heart attack, see our cardiovascular health hub.
Disclaimer: Medical News Today 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 another 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.
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💊 Composition of Diovan ® ✅ Application of Diovan ® Keep it for yourself Look for alternatives Interaction Description of the active ingredients of the preparation Diovan ® The scientific information provided is general and cannot be used to make decisions. Renewal date: 2020. 03.25 Marketing authorization holder: NOVARTIS PHARMA, AG Made:NOVARTIS PHARMA STEIN, AG (Switzerland) ATX code: C09CA03 (Valsartan) Active substance: Rec.INN WHO registered Dosage form
Release form, packaging and composition |
I10 | Essential [primary] hypertension |
I50.0 | Congestive heart failure |
Dosing regimen
The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
Take orally at a dose of 80 mg 1 time / day or 40 mg 2 times / day, daily. In the absence of an adequate effect, the daily dose may be gradually increased.
The maximum daily dose of 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.
Contraindications for use
Pregnancy, hypersensitivity to valsartan.
Use in pregnancy and lactation
Valsartan is contraindicated in pregnancy.
It is not known whether valsartan is excreted in human breast milk. Use during lactation (breastfeeding) is not recommended.
In experimental studies valsartan has been shown to be excreted in breast milk in rats.
Use in impaired renal function
In patients with renovascular hypertension secondary to renal artery stenosis, serum urea and creatinine levels should be monitored regularly during treatment. Data on the safety of use in patients with CC less than 10 ml / min are not available.
Due to inhibition of the RAAS in predisposed patients, changes in renal function are possible.
Use in children
The safety and efficacy of valsartan in children has not been established.
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 mechanisms
When using valsartan, it is recommended to be careful when driving a car and operating mechanisms.
Drug interactions
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.
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Diovan ® . Description of the drug in the reference book Vidal.
instructions for use, price, analogues, composition, indications
1 tablet contains 40 mg, 80 mg or 160 mg of valsartan;
inactive ingredients: microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromelose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172; only for tablets) 40 mg and 160 mg).
Arterial hypertension.
Heart failure (class II-IV according to the classification of the New York Heart Association (NYHA)).
Postinfarction condition (in clinically stable patients with signs, symptoms and radiographic findings of left ventricular failure and / or left ventricular systolic dysfunction).
Hypersensitivity to valsartan or any of the components of the drug. Second and third trimesters of pregnancy. Childhood.
The use of Diovan, like any other drug that has a direct effect on the RAAS, is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy. You should not start therapy with valsartan during pregnancy. Unless it is not possible to change an angiotensin receptor antagonist to another alternative therapy, patients planning pregnancy should be switched to therapy with drugs that have a well-established safety profile for pregnant women. If pregnancy is detected during treatment with Diovan, the drug should be discontinued as soon as possible and, if necessary, other therapy should be prescribed.
The action of ACE inhibitors on the uterus, if prescribed to pregnant women in the second and third trimesters, leads to damage and death of the developing fetus; this risk may extend to the angiotensin receptor antagonist group. There are reports of cases of spontaneous abortion, oligohydramnios and impaired renal function in newborns when pregnant women accidentally took valsartan. If an angiotensin receptor antagonist has been taken since the second trimester of pregnancy, ultrasound of the function of the kidneys and bones of the skull is recommended. In newborns whose mothers have taken an angiotensin receptor antagonist, blood pressure should be carefully monitored to prevent the possible development of hypotension. It is not known whether valsartan passes into human breast milk. Therefore, it is not recommended to use Diovan in nursing mothers.
Arterial hypertension. The recommended dose of Diovan is 80 mg or 160 mg once a day, regardless of the race, age and sex of the patient. The antihypertensive effect is achieved in the first 2 weeks of treatment; The maximum effect is observed after 4 weeks. For those patients who fail to achieve an adequate reduction in blood pressure, the daily dose of Diovan can be increased to 320 mg or diuretics are additionally prescribed.
Diovan can also be administered in conjunction with other antihypertensive agents. Heart failure. The recommended starting dose of Diovan is 40 mg twice daily. The dose of Diovan should be increased by the “titration” method to 80 mg or 160 mg 2 times a day, i.e. to the maximum, well-tolerated dose. The maximum daily dose of Diovan in clinical studies was 320 mg taken in divided doses.
Evaluation of patients with heart failure should always include an assessment of renal function.
postinfarction condition. Treatment can be started as early as 12 hours after myocardial infarction. After an initial dose of 20 mg twice daily, the dose of valsartan should be increased to 40 mg, 80 mg and 160 mg twice daily over the next few weeks. To obtain the initial dose, the 40 mg tablet is divided in half.
The planned maximum dose is 160 mg twice a day. In general, it is recommended that patients reach the dose level of 80 mg twice daily for up to 2 weeks after the start of treatment and that the planned maximum dose be reached within three months, based on patient tolerance of valsartan during the dose titration period. If symptomatic hypotension or renal dysfunction occurs, dose reduction should be considered.
Valsartan can be used in patients treated with other drugs used after myocardial infarction, for example, thrombolytics, acetylsalicylic acid, beta-blockers and statins.
Evaluation of patients after myocardial infarction should always include an assessment of renal function.
NOTE regarding all indications: in patients with impaired renal function or in patients with non-biliary hepatic insufficiency and without cholestasis, dose adjustment is not required.
The frequency of occurrence of adverse reactions is estimated as follows: “very often” – > 1/10, “often” – from > 1/100, < 1/10, "sometimes" - from > 1/1000, < 1/100, "rarely "- from > 1/10000, < 1/1000, "very rarely" - < 1/100000.
Infections and invasions: often – viral infections; rarely – infections of the upper respiratory tract, pharyngitis, sinusitis; very rarely – rhinitis.
From the circulatory and lymphatic systems: often – neutropenia; very rarely – thrombocytopenia.
On the part of the immune system: very rarely – hypersensitivity reactions, including serum sickness.
Metabolic disorders: sometimes – hyperkalemia.
Mental disorders: sometimes – insomnia, decreased libido.
From the nervous system: often – postural dizziness *; sometimes – dizziness *; rarely – vertigo; very rarely – headache ## .
On the part of vision and labyrinth disorders: sometimes – vertigo.
From the side of the cardiovascular system: often – orthostatic hypotension; sometimes – heart failure*, hypotension* ## ; very rarely – vasculitis.
From the respiratory system: sometimes – cough.
From the digestive system: sometimes – diarrhea, abdominal pain; very rare – nausea.
Skin and subcutaneous disorders: very rarely – angioedema**, rash, itching.
From the musculoskeletal system: sometimes – back pain; very rarely – arthralgia, myalgia.
From the urinary system: very rarely – impaired renal function * * ## , acute renal failure **, renal failure **.
General disorders: sometimes – weakness, asthenia, edema.
Postinfarction condition has been reported; Symptoms of heart failure have been reported; ** postinfarction condition was reported as a rare side effect; t reported more frequent cases of heart failure (often: dizziness, impaired renal function, hypotension; sometimes: headache, nausea).
With prolonged use of valsartan in patients with heart failure, no additional side effects were noted.
Due to the occurrence of side effects, treatment was discontinued in 5.8% of patients who took valsartan and in 7.7% of patients who took captopril.
Results of laboratory researches. In rare cases, the use of valsartan may be accompanied by a decrease in hemoglobin and hematocrit levels. In controlled clinical trials, in 0.8% and 0.4% of patients who received Diovan, there was a significant decrease (> 20%) in hematocrit and hemoglobin, respectively. For comparison, in patients receiving placebo, a decrease in both hematocrit and hemoglobin was noted in 0. 1% of cases.
Neutropenia was detected in 1.9% of patients treated with valsartan and in 1.6% of patients treated with an ACE inhibitor.
In controlled clinical studies in patients with hypertension, a significant increase in serum creatinine, potassium and total bilirubin was observed, respectively, in 0.8%, 4.4% and 6% of patients who took Diovan, and in 1.6 %, 6.4% and 12.9% of patients who took an ACE inhibitor. There are reports of cases of increased liver function in patients receiving valsartan.
In heart failure, an increase in creatinine levels of more than 50% was observed in 3.9% of patients who took Diovan, compared with 0.9% in the placebo group. At the same time, an increase in serum potassium levels by more than 20% was observed in 10.0% of patients who received Diovan, and in 5.1% who received placebo. In 4.2% of patients who took valsartan, 4.8% of patients who took the combination of valsartan and captopril, and 3. 4% of patients who took captopril, a 2-fold increase in serum creatinine was observed in the post-infarction period.
In 16.6% of patients with heart failure, an increase in the level of urea nitrogen in the blood was observed.
An overdose of Diovan may result in marked hypotension, which may lead to depression of consciousness, collapse and/or shock. If the drug has been taken recently, induce vomiting. Hypotension is usually treated with intravenous saline. It is unlikely that valsartan can be removed from the body by hemodialysis.
Clinically significant interactions with other drugs have not yet been noted. The following drugs have been studied in clinical trials: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, and glibenclamide.
Since Diovan is not metabolized to any significant extent, it is unlikely to have clinically significant interactions with other drugs at the metabolic level, which are the result of induction or inhibition of the cytochrome P450 system. Despite the fact that valsartan is highly bound to plasma proteins, in vitro studies have not revealed any interaction at this level with a number of molecules that have the same high binding to plasma proteins, for example, diclofenac, furosemide and warfarin .
Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium preparations or salts containing potassium may lead to an increase in serum potassium concentration. If such combined treatment is deemed necessary, caution should be exercised.
The combination of valsartan with captopril did not add any efficacy compared to captopril alone. There were no differences in overall mortality based on age, gender, race, underlying treatment, or underlying disease. Valsartan was as effective as captopril in reducing all-cause mortality after myocardial infarction. All-cause mortality was similar in the valsartan groups (19.9%), captopril (19.5%), and the valsartan + captopril group (19. 3%). Valsartan was also effective in prolonging time to and reducing CV mortality, hospitalization for heart failure, recurrent myocardial infarction, resuscitated cardiac arrest, non-fatal stroke (secondary composite endpoint).
In addition, the benefit of treatment with the combination of valsartan + captopril, valsartan monotherapy and captopril monotherapy was confirmed in patients taking beta-blockers.
Patients with a deficiency in the body of sodium and / or circulating blood volume (CBV). In patients with a severe deficiency in the body of sodium and / or BCC, for example, receiving high doses of diuretics, in rare cases, symptomatic hypotension may occur at the beginning of treatment with Diovan. Before starting treatment with Diovan, it is necessary to correct the sodium content in the body and / or the volume of circulating blood, for example, by reducing the dose of the diuretic.
If hypotension develops, the patient should be laid down and, if necessary, an intravenous infusion of saline should be given. After the blood pressure stabilizes, treatment with Diovan can be continued.
Stenosis of the renal artery. Short-term use of Diovan in 12 patients with renovascular hypertension secondary to unilateral renal artery stenosis did not lead to any significant changes in renal hemodynamics, serum creatinine or blood urea nitrogen. However, given that other drugs that affect the renin-angiotensin-aldosterone system (RAAS) can cause an increase in serum urea and creatinine levels in patients with bilateral or unilateral renal artery stenosis, systematic monitoring of these indicators is recommended as a precautionary measure. .
Kidney dysfunction. Patients with impaired renal function do not require dose adjustment. However, in case of severe disorders (creatinine clearance <10 ml / min), caution is recommended, since there is no information on the use of the drug in such cases.
Impaired liver function. In patients with hepatic insufficiency, no dose adjustment is required. Valsartan is excreted mainly unchanged in the bile, and it has been shown that in patients with biliary tract obstruction, the clearance of valsartan is reduced. When prescribing valsartan to patients with obstruction of the biliary tract, special care should be taken.
Heart failure/Post myocardial infarction. In patients with heart failure or post-infarction who take Diovan at usual doses, there is a slight decrease in blood pressure, but discontinuation of therapy due to long-term symptomatic therapy is usually not necessary if the instructions for dosing the drug are followed. Caution is needed in patients with heart failure or a post-infarction condition who are starting therapy.
Due to inhibition of the renin-angiotensin-aldosterone system in sensitive patients, changes in renal function are possible. In patients with severe heart failure, in whom renal function depends on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists may be accompanied by oliguria and / or an increase in azotemia and (rarely) acute renal failure and / or death.