Diovan 160mg 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
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D (1st trimester), Category X (2nd and 3rd trimesters)
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, which lowers blood pressure and reduces 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 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 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 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 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 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 as advised by your healthcare provider.
- Limit alcohol intake.
- Avoid potassium-rich salt substitutes unless approved by your doctor.
- Monitor your blood pressure regularly at home if advised.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: Initial 80-160 mg once daily. Heart Failure: Initial 40 mg twice daily.
Dose Range:
40 - 320 mg
Condition-Specific Dosing:
hypertension:
Initial 80-160 mg once daily; may be increased to 320 mg once daily. Full effect usually achieved within 2-4 weeks.
heart_failure:
Initial 40 mg twice daily; titrate to target dose of 160 mg twice daily as tolerated. Max 320 mg/day in divided doses.
post_myocardial_infarction:
Initial 20 mg twice daily; titrate to target dose of 160 mg twice daily as tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 160 mg). Adjust dose based on response and tolerability. Doses >160 mg not studied.
Adolescent:
Hypertension (6-16 years): Initial 1.3 mg/kg once daily (max 160 mg). Adjust dose based on response and tolerability. Doses >160 mg not studied.
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required. Monitor renal function.
Moderate:
No initial dose adjustment required. Monitor renal function.
Severe:
Use with caution. No specific dose adjustment recommended, but monitor renal function and potassium 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 due to lack of data and potential for worsening renal function.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
Use with caution. For patients with mild to moderate hepatic impairment (non-biliary cirrhosis), the maximum dose should not exceed 80 mg once daily.
Severe:
Not recommended for patients with severe hepatic impairment or biliary cirrhosis and cholestasis, as valsartan is primarily eliminated in the bile.
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 blood pressure. It does not inhibit ACE (kininase II), thus avoiding the bradykinin-mediated side effects like cough.
Pharmacokinetics
Absorption:
Bioavailability:
23% (range 10-35%)
Tmax:
2-4 hours
FoodEffect:
Food decreases the AUC by approximately 48% and Cmax by approximately 59%. However, this reduction is not considered clinically significant for the recommended dosing regimen.
Distribution:
Vd:
17 L
ProteinBinding:
94-97%
CnssPenetration:
Limited
Elimination:
HalfLife:
6-9 hours
Clearance:
Approximately 2 L/hour (renal clearance 0.62 L/hour)
ExcretionRoute:
Fecal (83%), Renal (13%)
Unchanged:
Approximately 70% (feces), 30% (urine)
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 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 unusual symptoms, contact your doctor for guidance:
Dizziness, fatigue, 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 not mentioned here. 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 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 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 unusual symptoms, contact your doctor for guidance:
Dizziness, fatigue, 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 not mentioned here. 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, seek emergency medical attention)
- Difficulty breathing or swallowing
- Unusual tiredness or weakness
- Irregular heartbeat or chest pain
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in feet/ankles)
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 Parents and Caregivers:
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 Parents and Caregivers:
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 of 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, rise slowly from a sitting or lying position 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 to ensure the medication is working effectively.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor to discuss potential interactions. Additionally, if you are following a low-salt or salt-free diet, inform your doctor to determine the best course of action.
Before consuming alcohol, consult your doctor to understand the potential risks and effects. 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, fluid loss, vomiting, or diarrhea, notify your doctor, as these symptoms may 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 prescribe an additional medication to be taken in conjunction with this one. 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, rise slowly from a sitting or lying position 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 to ensure the medication is working effectively.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor to discuss potential interactions. Additionally, if you are following a low-salt or salt-free diet, inform your doctor to determine the best course of action.
Before consuming alcohol, consult your doctor to understand the potential risks and effects. 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, fluid loss, vomiting, or diarrhea, notify your doctor, as these symptoms may 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 prescribe an additional medication to be taken in conjunction with this one. 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, less common)
What to Do:
If overdose is suspected, 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 moderate to severe renal impairment [GFR <60 mL/min/1.73 m²])
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements or salt substitutes containing potassium
- NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, including selective COX-2 inhibitors)
- Lithium
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effect)
- CYP2C9 inhibitors (e.g., fluconazole, amiodarone) - minimal interaction expected as valsartan is not extensively metabolized by CYP450
- CYP2C9 inducers (e.g., rifampin) - minimal interaction expected
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation of therapy.
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments, then periodically (e.g., monthly, quarterly) once stable.
Target: <130/80 mmHg (general target, may vary based on patient comorbidities)
Action Threshold: Persistent elevation above target, or symptomatic hypotension.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Stable within patient's baseline range.
Action Threshold: Significant increase (e.g., >30% from baseline or >0.5 mg/dL increase) or signs of acute kidney injury.
Serum Potassium (K+)
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or as clinically indicated, especially in patients with renal impairment or on concomitant medications that increase K+.
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L or symptomatic hyperkalemia.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
- Fatigue or weakness
- Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
- Symptoms of hyperkalemia (e.g., muscle weakness, irregular heartbeat, numbness/tingling)
- Signs of worsening renal function (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 significant risk of fetal injury and death. Use in the first trimester is generally avoided due to potential risks, though less severe than later trimesters. If pregnancy is detected, discontinue valsartan as soon as possible.
Trimester-Specific Risks:
First Trimester:
Category D. Limited human data suggest potential risk, but less severe than 2nd/3rd trimester. Animal studies show adverse effects. Generally, ARBs should be avoided if possible.
Second Trimester:
Category X. Significant risk of fetal injury including oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death.
Third Trimester:
Category X. Significant risk of fetal injury including oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death.
Lactation
It is not known whether valsartan is excreted in human milk. Due to the potential for serious adverse effects on 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. Generally not recommended.
Infant Risk:
Potential for serious adverse effects (e.g., hypotension, renal impairment) in the infant. Risk is considered moderate (L3).
Pediatric Use
Approved for hypertension in children 6-16 years of age. Dosing is weight-based. Safety and efficacy in children younger than 6 years have not been established. Not recommended for heart failure or post-MI in pediatric patients.
Geriatric Use
No overall differences in efficacy or safety were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age alone, but monitor renal function and potassium more closely due to higher prevalence of renal impairment and comorbidities in this population.
Clinical Information
Clinical Pearls
- Valsartan can cause symptomatic hypotension, especially in volume-depleted patients (e.g., those on high-dose diuretics). Correct volume depletion prior to initiation.
- Monitor serum potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements, due to the risk of hyperkalemia.
- Angioedema is a rare but serious side effect. Patients with a history of angioedema associated with ACE inhibitors may be at increased risk.
- Valsartan is less likely to cause cough compared to ACE inhibitors, making it a suitable alternative for patients who develop cough with ACE inhibitors.
- The full antihypertensive effect may take 2-4 weeks to develop.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Beta-blockers: Metoprolol, Carvedilol
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic 160mg per 30 tablets per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 taken, the amount, and the time it happened.