Diovan 80mg 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; Angiotensin II Receptor Blocker (ARB)
Pharmacologic Class
Angiotensin II Receptor Antagonist
Pregnancy Category
Not available
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, which helps blood flow more easily and lowers blood pressure.
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, 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 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, 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 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
- Continue to follow a low-sodium diet as recommended by your doctor.
- Engage in regular physical activity.
- Limit alcohol intake.
- Avoid potassium-rich foods or salt substitutes unless advised by your doctor.
- Monitor your blood pressure regularly at home as instructed.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 80 mg once daily. Heart Failure: 40 mg twice daily. Post-Myocardial Infarction: 20 mg twice daily.
Dose Range:
20 - 320 mg
Condition-Specific Dosing:
Hypertension:
Initial: 80 mg once daily. May be increased to 160 mg or 320 mg once daily. Max: 320 mg/day.
Heart Failure:
Initial: 40 mg twice daily. Titrate to target dose of 160 mg twice daily as tolerated.
Post-Myocardial Infarction:
Initial: 20 mg twice daily. Titrate to target dose of 160 mg twice daily as tolerated. Dosing may begin as early as 12 hours post-MI.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 40 mg). Max 2.7 mg/kg (max 160 mg).
Adolescent:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 40 mg). Max 2.7 mg/kg (max 160 mg).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
No dosage adjustment required, but monitor renal function closely. Use with caution in patients with severe renal impairment (CrCl < 30 mL/min).
Dialysis:
Valsartan is not significantly removed by hemodialysis. No specific dosage adjustment, but use with caution and monitor.
Hepatic Impairment:
Mild:
No dosage adjustment required.
Moderate:
Consider lower initial doses (e.g., 40 mg once daily) and titrate cautiously. Max dose 80 mg/day in patients with mild to moderate hepatic impairment without cholestasis.
Severe:
Not recommended in patients with severe hepatic impairment or biliary cirrhosis/cholestasis.
Pharmacology
Mechanism of Action
Valsartan selectively blocks the binding of angiotensin II to the AT1 receptor in many 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 blood pressure. It does not inhibit ACE, thus avoiding the bradykinin-mediated cough associated with ACE inhibitors.
Pharmacokinetics
Absorption:
Bioavailability:
23% (absolute oral bioavailability)
Tmax:
2-4 hours
FoodEffect:
Food decreases the absorption of valsartan, resulting in a reduction in AUC by about 48% and Cmax by about 59%. Administer without regard to food, but consistency is recommended.
Distribution:
Vd:
17 L (at steady state)
ProteinBinding:
94-97%
CnssPenetration:
Limited
Elimination:
HalfLife:
6-9 hours
Clearance:
2 L/hr (renal clearance 0.62 L/hr)
ExcretionRoute:
Feces (83%) and urine (13%)
Unchanged:
Approximately 20% (urine) and 70% (feces)
Pharmacodynamics
OnsetOfAction:
Approximately 2 hours
PeakEffect:
4-6 hours
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 Attention Immediately
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 medical help right away:
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. 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 or seek medical help:
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 for medical advice. 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 medical help right away:
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. 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 or seek medical help:
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 for medical advice. 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, though rare)
- 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 ankles/feet, unusual tiredness)
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 recommended for children younger than 1 year.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. 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 recommended for children younger than 1 year.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. 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 position, and be careful when climbing stairs.
You may need to wait several weeks to experience the full effects of this medication. 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 product, consult your doctor to ensure safe use. Additionally, if you are on a low-salt or salt-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 your fluid intake to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, 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 or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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 to ensure you receive the best possible care.
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 position, and be careful when climbing stairs.
You may need to wait several weeks to experience the full effects of this medication. 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 product, consult your doctor to ensure safe use. Additionally, if you are on a low-salt or salt-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 your fluid intake to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, 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 or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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 to ensure you receive the best possible care.
Overdose Information
Overdose Symptoms:
- Profound hypotension (low blood pressure)
- Dizziness
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate, less common)
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Intravenous fluids may be administered to support blood pressure. Valsartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Lithium (increased serum lithium concentrations and toxicity)
- NSAIDs (including selective COX-2 inhibitors - may attenuate antihypertensive effect and increase risk of renal impairment)
- ACE inhibitors (dual blockade of RAAS increases risk of hypotension, hyperkalemia, and renal impairment)
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effect)
- Diuretics (increased risk of hypotension)
- Rifampin, Phenobarbital, St. John's Wort (may decrease valsartan exposure)
- Colesevelam (may decrease valsartan absorption)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess efficacy.
Timing: Prior to initiation.
Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation.
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated) until stable, then periodically.
Target: <130/80 mmHg (or individualized target based on guidelines and patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose titration or addition of other agents. If symptomatic hypotension occurs, reduce dose or discontinue.
Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)
Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with pre-existing renal impairment or on concomitant diuretics/NSAIDs.
Target: Stable or within acceptable limits for patient's baseline.
Action Threshold: Significant increase (e.g., >30% from baseline or Cr >2.5 mg/dL) may warrant dose reduction, discontinuation, or further investigation.
Serum Potassium (K+)
Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with renal impairment, diabetes, or on concomitant potassium-sparing agents.
Target: 3.5-5.0 mEq/L
Action Threshold: K+ >5.5 mEq/L may warrant dose reduction, discontinuation, or management of hyperkalemia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Swelling (angioedema, though rare with ARBs)
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
- Signs of worsening renal function (e.g., decreased urine output, edema)
Special Patient Groups
Pregnancy
CONTRAINDICATED during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. First trimester exposure may also carry risk.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal data suggest potential risk. Generally avoided if possible.
Second Trimester:
Significant risk of fetal injury (e.g., oligohydramnios, fetal skull hypoplasia, anuria, renal failure, lung hypoplasia, skeletal deformations, death).
Third Trimester:
Significant risk of fetal injury (e.g., oligohydramnios, fetal skull hypoplasia, anuria, renal failure, lung hypoplasia, skeletal deformations, death).
Lactation
Not recommended during breastfeeding. Valsartan is excreted in the milk of lactating rats. 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:
Potential for serious adverse effects (e.g., hypotension, hyperkalemia, renal impairment) in the nursing infant.
Pediatric Use
Approved for hypertension in children 6-16 years. Safety and efficacy not established in children under 6 years or for heart failure/post-MI indications.
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 lower end of dosing range and titrate carefully, monitoring renal function and electrolytes.
Clinical Information
Clinical Pearls
- Valsartan is an ARB, generally preferred over ACE inhibitors for patients who develop cough with ACE inhibitors.
- Avoid concomitant use with aliskiren in patients with diabetes or renal impairment due to increased risk of adverse events.
- Monitor potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is less common with ARBs than ACE inhibitors.
- Consistency in administration (with or without food) is recommended due to food's effect on absorption.
Alternative Therapies
- Other Angiotensin 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 depending on indication (e.g., alpha-blockers, direct vasodilators)
Cost & Coverage
Average Cost:
Check current per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic valsartan); Tier 3 or higher (for brand Diovan or combination products)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.