Valsartan 40mg Tablets
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
Angiotensin II Receptor Blocker (ARB), Antihypertensive
Pharmacologic Class
Angiotensin II Receptor Antagonist
Pregnancy Category
Contraindicated in pregnancy (2nd and 3rd trimesters); Risk of fetal toxicity in 1st trimester
FDA Approved
Dec 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Valsartan is a medication used to treat high blood pressure, heart failure, and to improve survival after a heart attack. It works by relaxing blood vessels, allowing blood to flow more easily and lowering blood pressure. This helps to reduce the strain on your heart.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, be sure to shake it well before each use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. If a liquid suspension is prepared from the tablets, it can be stored at room temperature or in the refrigerator. If stored at room temperature, discard any unused portion after 30 days. If stored in the refrigerator, discard any unused portion after 75 days.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, be sure to shake it well before each use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. If a liquid suspension is prepared from the tablets, it can be stored at room temperature or in the refrigerator. If stored at room temperature, discard any unused portion after 30 days. If stored in the refrigerator, discard any unused portion after 75 days.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Valsartan exactly as prescribed by your doctor, usually once or twice daily.
- It can be taken with or without food, but try to take it the same way each day.
- Do not stop taking Valsartan without talking to your doctor, even if you feel well.
- Limit your intake of high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens) and avoid potassium supplements or salt substitutes unless advised by your doctor, as Valsartan can increase potassium levels.
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as recommended by your doctor.
- Limit alcohol consumption.
- If you have high blood pressure, continue to monitor it regularly at home as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 80 mg or 160 mg once daily. Heart Failure: Initial 40 mg twice daily, titrate to 160 mg twice daily as tolerated. Post-MI: Initial 20 mg twice daily, titrate to 160 mg twice daily as tolerated.
Dose Range:
20 - 320 mg
Condition-Specific Dosing:
Hypertension:
Initial 80-160 mg once daily; max 320 mg/day
Heart Failure:
Initial 40 mg twice daily; target 160 mg twice daily
Post-Myocardial Infarction:
Initial 20 mg twice daily; target 160 mg twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 40 mg), titrate to max 2.7 mg/kg (max 160 mg). Not recommended for children <6 years or those with eGFR <30 mL/min/1.73 m2.
Adolescent:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 40 mg), titrate to max 2.7 mg/kg (max 160 mg).
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required. Monitor renal function and potassium levels.
Severe:
Use with caution. Not recommended for patients with severe renal impairment (CrCl <10 mL/min) or on dialysis due to limited data and potential for hyperkalemia. Monitor renal function and potassium levels closely.
Dialysis:
Valsartan is not removed by hemodialysis. No supplemental dose needed after dialysis. Use with caution and monitor closely.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required. Max dose 80 mg once daily for patients with mild to moderate hepatic impairment without cholestasis.
Severe:
Contraindicated in 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.
Pharmacokinetics
Absorption:
Bioavailability:
23%
Tmax:
2-4 hours
FoodEffect:
Food decreases the AUC by about 48% and Cmax by about 59%. Valsartan should be administered without regard to food, but consistent administration (e.g., always with food or always without food) is recommended.
Distribution:
Vd:
17 L
ProteinBinding:
94-97%
CnssPenetration:
Limited
Elimination:
HalfLife:
6 hours
Clearance:
0.8 L/hr (renal clearance 0.09 L/hr)
ExcretionRoute:
Feces (83%), Urine (13%)
Unchanged:
83% (feces), 13% (urine)
Pharmacodynamics
OnsetOfAction:
Approximately 2 hours (antihypertensive effect)
PeakEffect:
4-6 hours (antihypertensive effect)
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
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
While rare, some people may experience severe and potentially life-threatening side effects when 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or persist, contact your doctor:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or persist, contact your doctor:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 your face, lips, tongue, or throat (signs of angioedema, a serious allergic reaction)
- Difficulty breathing or swallowing
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in your feet or ankles, unusual tiredness)
- If you become pregnant, stop taking Valsartan immediately and contact your doctor.
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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you are taking a medication that contains aliskiren and have either diabetes or kidney problems.
If you are breastfeeding, as you should not breastfeed while taking this medication.
For Parents and Caregivers:
If your child is under 1 year of age, do not administer this medication, as it is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you are taking a medication that contains aliskiren and have either diabetes or kidney problems.
If you are breastfeeding, as you should not breastfeed while taking this medication.
For Parents and Caregivers:
If your child is under 1 year of age, do not administer this medication, as it is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
The full effects of this medication may not be apparent for several weeks. As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are following a low-salt or salt-free diet, discuss this with your doctor.
Before consuming alcohol, talk to your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms can lead to low blood pressure.
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 and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or supplements.
It is also important to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, discuss them with your doctor.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
The full effects of this medication may not be apparent for several weeks. As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are following a low-salt or salt-free diet, discuss this with your doctor.
Before consuming alcohol, talk to your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms can lead to low blood pressure.
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 and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or supplements.
It is also important to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Dizziness
- Fainting
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. If ingestion was recent, gastric lavage may be considered. Intravenous fluids may be administered to correct hypotension. Valsartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or moderate to severe renal impairment (GFR <60 mL/min/1.73 m2))
- ACE inhibitors (dual blockade of the renin-angiotensin-aldosterone system (RAAS) is generally not recommended due to increased risk of hypotension, hyperkalemia, and renal impairment)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Salt substitutes containing potassium
- NSAIDs (including selective COX-2 inhibitors) - may attenuate antihypertensive effect and increase risk of renal impairment and hyperkalemia, especially in elderly, volume-depleted, or renally impaired patients.
- Lithium - increased serum lithium concentrations and toxicity.
Moderate Interactions
- Other antihypertensive agents (e.g., diuretics, beta-blockers, calcium channel blockers) - additive hypotensive effects.
- CYP2C9 inhibitors (e.g., fluconazole) - may increase valsartan exposure, though valsartan is minimally metabolized by CYP450.
Minor Interactions
- Not many specific minor interactions are clinically significant enough to warrant routine listing beyond general caution with other medications.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN)
Rationale: To assess baseline kidney function, as ARBs can affect renal hemodynamics and are contraindicated in severe renal impairment for certain conditions.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly or every 3-6 months once stable.
Target: Individualized, typically <130/80 mmHg or as per guideline recommendations for specific conditions.
Action Threshold: If BP remains uncontrolled, consider dose titration or adding additional antihypertensive agents. If hypotensive, consider dose reduction.
Renal Function (Serum Creatinine, BUN)
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients with pre-existing renal impairment or those on concomitant medications affecting renal function (e.g., NSAIDs).
Target: Stable or within acceptable limits for the patient.
Action Threshold: Significant increase in creatinine (>30% from baseline or reaching critical levels) may warrant dose reduction or discontinuation. Consult physician.
Serum Potassium
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients at risk for hyperkalemia (e.g., renal impairment, diabetes, concomitant potassium-sparing diuretics/supplements).
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium >5.5 mEq/L may warrant dose reduction or discontinuation. Consult physician.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing, indicating hypotension)
- Fatigue or weakness
- Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
- Signs of worsening renal function (e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Contraindicated in the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is also associated with potential risks.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal studies suggest potential for fetal harm. Risk of major congenital malformations is not definitively established but cannot be ruled out. Discontinuation is recommended as soon as pregnancy is detected.
Second Trimester:
Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Neonatal adverse effects include hypotension, hyperkalemia, and renal failure.
Lactation
Not recommended during breastfeeding. It is unknown if valsartan is excreted in human milk. Due to the potential for serious adverse effects in the breastfed 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.
Infant Risk:
Moderate risk (L3). Potential for hypotension, hyperkalemia, and renal impairment in the infant. Consider alternative agents with better safety profiles during lactation.
Pediatric Use
Not recommended for children under 6 years of age or in pediatric patients with an eGFR <30 mL/min/1.73 m2. For children 6-16 years with hypertension, dosing is weight-based. Close monitoring of blood pressure, renal function, and potassium is essential.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the hypotensive effects and may have age-related decline in renal function. Monitor renal function and potassium levels closely.
Clinical Information
Clinical Pearls
- Valsartan is an excellent choice for patients who develop cough with ACE inhibitors, as ARBs do not typically cause this side effect.
- Always check potassium levels before and during therapy, especially in patients with renal impairment or those on potassium-sparing diuretics.
- Counsel patients on the importance of avoiding potassium supplements and salt substitutes unless specifically advised by their physician.
- Emphasize the critical importance of discontinuing the medication immediately if pregnancy is detected.
- While food reduces absorption, consistent administration (either always with food or always without) is more important than strict adherence to an empty stomach.
- Valsartan is often used in combination with other antihypertensives, such as hydrochlorothiazide (Diovan HCT) or amlodipine (Exforge), for enhanced blood pressure control.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan, Azilsartan
- ACE Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
- Other Antihypertensives (e.g., alpha-blockers, direct vasodilators)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.