Diovan 320mg 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
Antihypertensive, Heart Failure Agent
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D
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 your heart pump blood more efficiently.
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 try to take it 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 trouble swallowing pills, you can ask your doctor or pharmacist about creating a liquid suspension. If a liquid suspension is prepared, be sure to shake it well before each use. When measuring liquid doses, use the device that comes with the medication or ask your pharmacist for a suitable measuring device.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If a liquid suspension is made from the tablets, you can store it 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 location, 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's 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 try to take it 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 trouble swallowing pills, you can ask your doctor or pharmacist about creating a liquid suspension. If a liquid suspension is prepared, be sure to shake it well before each use. When measuring liquid doses, use the device that comes with the medication or ask your pharmacist for a suitable measuring device.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If a liquid suspension is made from the tablets, you can store it 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 location, 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's 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 medication exactly as prescribed, usually once or twice daily.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Monitor your blood pressure regularly at home if advised by your doctor.
- Limit high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens) and avoid salt substitutes containing potassium, unless advised by your doctor.
- Maintain a healthy diet (low in sodium, rich in fruits and vegetables).
- Engage in regular physical activity as recommended by your doctor.
- Limit alcohol intake.
- Avoid becoming dehydrated, especially during hot weather or exercise.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 80-160 mg once daily; may be increased to 320 mg once daily. Heart Failure: Initial 40 mg twice daily; titrate to target 160 mg twice daily. Post-MI: Initial 20 mg twice daily; titrate to target 160 mg twice daily.
Dose Range:
20 - 320 mg
Condition-Specific Dosing:
Hypertension:
Initial 80-160 mg once daily; maximum 320 mg once daily.
Heart Failure:
Initial 40 mg twice daily; titrate to highest tolerated dose, up to 160 mg twice daily.
Post-Myocardial Infarction:
Initial 20 mg twice daily; titrate to highest tolerated dose, up to 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 up to 2.7 mg/kg (max 160 mg) once daily. Not recommended for children <6 years or those with GFR <30 mL/min/1.73m².
Adolescent:
Hypertension (16-18 years): Dosing similar to adult hypertension, typically 80-160 mg once daily, max 320 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No initial dosage adjustment required.
Moderate:
No initial dosage adjustment required.
Severe:
Not recommended for patients with severe renal impairment (CrCl <10 mL/min) or end-stage renal disease.
Dialysis:
Not recommended for patients on dialysis. Valsartan is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No initial dosage adjustment required.
Moderate:
Consider lower initial doses (e.g., 40 mg once daily) and titrate cautiously. Max dose 80 mg once daily in patients with mild to moderate hepatic impairment without cholestasis.
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 vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral vascular resistance, and reduced sodium and water retention, ultimately lowering blood pressure. It does not inhibit ACE, thus avoiding bradykinin-related side effects like cough.
Pharmacokinetics
Absorption:
Bioavailability:
23%
Tmax:
2-4 hours
FoodEffect:
Food decreases the absorption (AUC by 48% and Cmax by 59%), but this is not considered clinically significant for hypertension. For heart failure and post-MI, it is recommended to take consistently with or without food.
Distribution:
Vd:
17 L (adults)
ProteinBinding:
>94% (primarily to serum albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
6 hours
Clearance:
Approximately 2 L/hour (renal clearance 0.62 L/hour)
ExcretionRoute:
Primarily feces (83%) and urine (13%)
Unchanged:
Approximately 83% (feces) and 13% (urine) of the dose is excreted as unchanged drug.
Pharmacodynamics
OnsetOfAction:
Approximately 2 hours
PeakEffect:
4-6 hours (for blood pressure lowering)
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue Diovan 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 significant 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 any other unusual symptoms, contact your doctor for advice:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 significant 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 any other unusual symptoms, contact your doctor for advice:
Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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:
- Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
- Fainting spells
- Swelling of the face, lips, tongue, or throat (angioedema) - seek emergency medical attention immediately
- Difficulty breathing or swallowing
- Severe fatigue or muscle weakness
- Irregular heartbeat
- Decreased urination
- Yellowing of 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. 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 Children:
If your child is under 1 year of age, do not administer this medication, as it is not suitable 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 issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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. 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 Children:
If your child is under 1 year of age, do not administer this medication, as it is not suitable 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 issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be careful when climbing stairs.
The full effects of this medication may not be apparent for several weeks. As directed by your healthcare provider, regularly check your blood pressure and undergo blood tests to monitor your condition. If you have any concerns or questions, discuss them with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor to ensure safe use. Additionally, if you are on a low-sodium or sodium-free diet, inform your doctor to discuss any necessary adjustments.
Before consuming alcohol, talk to your doctor to understand the potential risks and interactions. In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, vomiting, diarrhea, or loose stools, notify 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, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be careful when climbing stairs.
The full effects of this medication may not be apparent for several weeks. As directed by your healthcare provider, regularly check your blood pressure and undergo blood tests to monitor your condition. If you have any concerns or questions, discuss them with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor to ensure safe use. Additionally, if you are on a low-sodium or sodium-free diet, inform your doctor to discuss any necessary adjustments.
Before consuming alcohol, talk to your doctor to understand the potential risks and interactions. In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, vomiting, diarrhea, or loose stools, notify 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 (low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. If ingestion is recent, gastric lavage may be considered. Valsartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
- Sacubitril/valsartan (Entresto) - do not co-administer with valsartan alone due to risk of angioedema (requires 36-hour washout period)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- NSAIDs (including selective COX-2 inhibitors)
- Lithium
- Other antihypertensive agents (additive hypotensive effects)
Moderate Interactions
- ACE inhibitors (increased risk of hypotension, hyperkalemia, renal dysfunction, angioedema - dual blockade generally not recommended)
- Diuretics (increased risk of hypotension, especially with initial doses)
- Cyclosporine
- Ritonavir
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as valsartan can affect renal perfusion.
Timing: Prior to initiation
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as valsartan can cause hyperkalemia.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with suspected impairment.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly after dose changes, then monthly/quarterly)
Target: <130/80 mmHg (general target, individualized)
Action Threshold: Persistent uncontrolled BP, symptomatic hypotension
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 6-12 months, or more frequently in patients with renal impairment or on concomitant diuretics/NSAIDs)
Target: Within normal limits, or stable from baseline
Action Threshold: Significant increase (>30% from baseline or progressive increase), acute kidney injury
Serum Potassium (K+)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 6-12 months, or more frequently in patients with renal impairment, diabetes, or on concomitant potassium-sparing diuretics/supplements)
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L (hyperkalemia)
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (signs of hypotension)
- Swelling of face, lips, tongue, throat (angioedema)
- Unusual fatigue
- Muscle weakness
- Irregular heartbeat (signs of hyperkalemia)
- Decreased urine output (signs of renal dysfunction)
Special Patient Groups
Pregnancy
CONTRAINDICATED in pregnancy. Valsartan can cause fetal harm or death when administered to a pregnant woman. Discontinue as soon as pregnancy is detected.
Trimester-Specific Risks:
First Trimester:
While risks are lower than in later trimesters, exposure should be avoided. Data are limited, but potential for teratogenicity cannot be excluded.
Second Trimester:
Significant risk of fetal injury, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Highest risk of severe fetal injury and death, including renal failure, anuria, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Lactation
Use with caution. It is unknown if 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.
Infant Risk:
L3 - Moderately safe. Potential for adverse effects on the infant (e.g., hypotension, hyperkalemia, renal effects) exists, especially in preterm or neonates. Monitor infant for signs of hypotension or hyperkalemia.
Pediatric Use
Not recommended for children under 6 years of age or in pediatric patients with a GFR <30 mL/min/1.73m². Dosing for hypertension in children 6-16 years is weight-based. Safety and efficacy for heart failure or post-MI in pediatric patients have not been established.
Geriatric Use
No overall differences in efficacy or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start at the lower end of the dosing range and titrate cautiously, especially considering potential for age-related decreases in renal function.
Clinical Information
Clinical Pearls
- Valsartan is an effective ARB for hypertension, heart failure, and post-MI, offering a good alternative for patients who develop cough with ACE inhibitors.
- Always check for pregnancy status before initiating in women of childbearing potential due to the black box warning.
- Monitor renal function and serum potassium, especially in patients with pre-existing renal impairment, heart failure, or those on concomitant diuretics or NSAIDs.
- Avoid concomitant use with aliskiren in diabetic patients or those with renal impairment due to increased risk of adverse events.
- A 36-hour washout period is required when switching from valsartan to sacubitril/valsartan (Entresto) to minimize angioedema risk.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (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 depending on specific indication and patient profile.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$100+ per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.