Valsartan 20mg/5ml Sol, 120ml
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It is used to treat heart failure (weak heart).It is used to help heart function after a heart attack.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Heart Failure Agent, Post-Myocardial Infarction Agent
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D/X
FDA Approved
Dec 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Valsartan is a medicine used to treat high blood pressure, heart failure, and to improve survival after a heart attack. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. This can reduce the strain on your heart.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.
Measuring Your Dose
If you are taking a liquid form of this medication, make sure to measure your dose accurately. Use the measuring device that comes with the medication, or ask your pharmacist for a device to measure your dose correctly.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.
Measuring Your Dose
If you are taking a liquid form of this medication, make sure to measure your dose accurately. Use the measuring device that comes with the medication, or ask your pharmacist for a device to measure your dose correctly.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take valsartan exactly as prescribed by your doctor, usually once or twice a day. The oral solution can be measured with a dosing syringe or spoon.
- Do not stop taking valsartan without talking to your doctor, even if you feel well.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Limit alcohol intake as it can further lower blood pressure.
- Maintain a healthy diet (low in sodium, rich in fruits and vegetables), regular exercise, and manage stress to help control blood pressure.
- Inform your doctor or dentist that you are taking valsartan before any surgery or dental procedures.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: Initial 80 mg or 160 mg once daily. Heart Failure: Initial 40 mg twice daily. Post-MI: Initial 20 mg twice daily.
Dose Range:
20 - 320 mg
Condition-Specific Dosing:
Hypertension:
Initial 80 mg or 160 mg once daily; dose can be increased to a maximum of 320 mg once daily. Oral solution concentration is 20mg/5ml.
Heart Failure:
Initial 40 mg twice daily; titrate to target dose of 160 mg twice daily as tolerated. Oral solution concentration is 20mg/5ml.
Post-Myocardial Infarction:
Initial 20 mg twice daily; titrate to target dose of 160 mg twice daily as tolerated. Oral solution concentration is 20mg/5ml.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (maximum 40 mg). Adjust dose based on response to a maximum of 2.7 mg/kg (maximum 160 mg) once daily. Oral solution is suitable for this population.
Adolescent:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (maximum 40 mg). Adjust dose based on response to a maximum of 2.7 mg/kg (maximum 160 mg) once daily. Oral solution is suitable for this population.
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required.
Severe:
Use with caution; monitor renal function and potassium levels closely. Not recommended for patients with severe renal impairment (CrCl <10 mL/min) or on dialysis.
Dialysis:
Valsartan is not significantly removed by hemodialysis. Not recommended for patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required for mild to moderate hepatic impairment without cholestasis. Use with caution.
Severe:
Not recommended for patients with severe hepatic impairment or biliary cirrhosis/cholestasis.
Pharmacology
Mechanism of Action
Valsartan is an angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral vascular resistance, and reduced sodium and water retention, thereby lowering blood pressure and reducing cardiac preload and afterload.
Pharmacokinetics
Absorption:
Bioavailability:
23% (oral solution may vary slightly but generally low)
Tmax:
2-4 hours
FoodEffect:
Food decreases the extent of absorption (AUC) by about 40% and peak plasma concentration (Cmax) by about 50%. Valsartan can be administered with or without food, but for consistency, it is often recommended to take it at the same time relative to food.
Distribution:
Vd:
17 L (adults)
ProteinBinding:
94-97%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6 hours
Clearance:
Not available
ExcretionRoute:
Primarily feces (83%), secondarily urine (13%)
Unchanged:
Approximately 83% (feces) and 13% (urine) of the dose is excreted as unchanged drug.
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
4-6 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
FETAL TOXICITY: When pregnancy is detected, discontinue valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Swelling in the arms or legs
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Swelling in the arms or legs
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (signs of low blood pressure)
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Signs of high potassium (e.g., unusual tiredness, muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., swelling in your hands, ankles, or feet; unusual weight gain; decreased urination)
- Yellowing of the skin or eyes (jaundice)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions to ensure your safety and well-being.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions to ensure your safety and well-being.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions to Ensure Your Safety
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Monitoring Your Condition
It may take several weeks to experience the full effects of this medication.
Regularly check your blood pressure as instructed by your healthcare provider.
Have blood tests done as recommended by your doctor, and discuss the results with them.
Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
If you are on a low-salt or salt-free diet, discuss this with your doctor.
Before consuming alcohol, talk to your doctor.
Staying Safe in Various Situations
In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.
Special Considerations
If you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter products that may increase blood pressure, such as:
+ Cough or cold medications
+ Diet pills
+ Stimulants
+ Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
+ Certain natural products or aids
This medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. If you have questions, discuss them with your doctor.
Pediatric Use
* Before giving this medication to a child under 6 years old, consult with your doctor.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions to Ensure Your Safety
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Monitoring Your Condition
It may take several weeks to experience the full effects of this medication.
Regularly check your blood pressure as instructed by your healthcare provider.
Have blood tests done as recommended by your doctor, and discuss the results with them.
Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
If you are on a low-salt or salt-free diet, discuss this with your doctor.
Before consuming alcohol, talk to your doctor.
Staying Safe in Various Situations
In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.
Special Considerations
If you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter products that may increase blood pressure, such as:
+ Cough or cold medications
+ Diet pills
+ Stimulants
+ Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
+ Certain natural products or aids
This medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. If you have questions, discuss them with your doctor.
Pediatric Use
* Before giving this medication to a child under 6 years old, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
If you suspect an overdose, seek immediate medical attention. Call your local poison control center (e.g., 1-800-222-1222 in the US) or emergency services (911).
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment [GFR <60 mL/min/1.73 m2])
- Sacubitril/valsartan (Entresto) - do not co-administer with valsartan alone due to risk of angioedema; a washout period is required.
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia.
- Potassium supplements - increased risk of hyperkalemia.
- NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, including COX-2 inhibitors) - may attenuate the antihypertensive effect and increase the risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
- Lithium - increased serum lithium concentrations and lithium toxicity.
Moderate Interactions
- Other antihypertensive agents - additive hypotensive effects.
- ACE inhibitors - increased risk of hypotension, hyperkalemia, and renal impairment (dual blockade of RAAS).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing for hypertension, heart failure, or post-MI.
Timing: Prior to initiation of therapy.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as valsartan can affect renal hemodynamics, especially in patients with pre-existing renal impairment or heart failure.
Timing: Prior to initiation of therapy.
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as valsartan can cause hyperkalemia, particularly in patients with renal impairment or those on potassium-sparing diuretics/supplements.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments, until stable. Then periodically as clinically indicated.
Target: Individualized based on patient's condition (e.g., <130/80 mmHg for many hypertensive patients, or as per guideline targets for heart failure).
Action Threshold: Persistent hypotension (e.g., symptomatic hypotension, SBP <90 mmHg) or inadequate BP control.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Periodically, especially after dose changes, with concomitant medications affecting renal function (e.g., NSAIDs), or in patients with pre-existing renal impairment or heart failure.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant increase from baseline (e.g., >30% increase or SCr >2.5 mg/dL), indicating potential acute kidney injury.
Serum Potassium (K+)
Frequency: Periodically, especially after dose changes, with concomitant medications affecting potassium (e.g., potassium-sparing diuretics, potassium supplements), or in patients with renal impairment or heart failure.
Target: 3.5-5.0 mEq/L
Action Threshold: K+ >5.5 mEq/L (hyperkalemia) or symptomatic hyperkalemia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat, paresthesias)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat, difficulty breathing or swallowing)
- Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
Special Patient Groups
Pregnancy
Valsartan is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. It should be discontinued as soon as pregnancy is detected. Use in the first trimester is generally discouraged due to potential risks.
Trimester-Specific Risks:
First Trimester:
Category D. While risks are lower than in later trimesters, exposure during the first trimester may still be associated with an increased risk of major congenital malformations. Discontinue as soon as pregnancy is detected.
Second Trimester:
Category X. Significant risk of fetal injury and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal anuria/renal failure.
Third Trimester:
Category X. Significant risk of fetal injury and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal anuria/renal failure.
Lactation
It is not known whether valsartan is excreted in human milk. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Generally, not recommended.
Infant Risk:
Moderate risk (L3) - potential for adverse effects on the infant, including hypotension and renal effects. Monitor infant for signs of hypotension or kidney dysfunction.
Pediatric Use
Approved for hypertension in children 6-16 years of age. Dosing is weight-based. Safety and effectiveness in children younger than 6 years have not been established. The oral solution formulation is particularly useful for pediatric dosing.
Geriatric Use
No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor renal function and potassium levels more closely in elderly patients, who may have age-related decline in renal function.
Clinical Information
Clinical Pearls
- Valsartan is a common alternative for patients who develop a cough with ACE inhibitors, as ARBs do not typically cause this side effect.
- The oral solution formulation is beneficial for patients who have difficulty swallowing tablets, including pediatric patients.
- Careful monitoring of serum potassium and renal function is crucial, especially in patients with heart failure, renal impairment, or those receiving concomitant potassium-sparing diuretics or NSAIDs.
- Valsartan is a key component in the treatment of heart failure with reduced ejection fraction (HFrEF) and post-myocardial infarction, often used in combination with other agents.
- Educate patients about the importance of avoiding potassium supplements and salt substitutes unless specifically advised by their physician.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
- Calcium Channel Blockers: Amlodipine, Nifedipine, Diltiazem, Verapamil
- Diuretics: Thiazide diuretics (e.g., hydrochlorothiazide), Loop diuretics (e.g., furosemide)
- Other antihypertensives (e.g., alpha-blockers, direct vasodilators)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 120ml bottle (20mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.