Diovan 40mg Tablets

Manufacturer NOVARTIS Active Ingredient Valsartan Tablets(val SAR tan) Pronunciation val SAR tan
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.
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Drug Class
Antihypertensive, Agent for Heart Failure
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Category D (2nd and 3rd trimesters), Category C (1st trimester) - generally contraindicated in 2nd/3rd trimesters due to fetal toxicity
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FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Valsartan is a medicine used to treat high blood pressure and heart failure. It works by relaxing blood vessels, which helps your blood pressure go down and makes it easier for your heart to pump blood. It's also used after a heart attack to improve survival.
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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 preparing 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 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 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 location, out of the reach of children and pets.

What to Do If You Miss 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.
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Lifestyle & Tips

  • Take your medication exactly as prescribed, usually once or twice daily.
  • Do not stop taking valsartan without talking to your doctor, even if you feel well.
  • Monitor your blood pressure regularly at home as advised by your doctor.
  • Limit your intake of high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens) and avoid potassium supplements or salt substitutes unless specifically instructed by your doctor, as this can lead to high 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.
  • Inform your doctor or dentist that you are taking valsartan before any surgery or dental procedures.

Dosing & Administration

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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
heart_failure_initial: 40 mg twice daily, titrate to target dose of 160 mg twice daily as tolerated
post_mi_initial: 20 mg twice daily, titrate to target dose of 160 mg twice daily as tolerated
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (6-16 years): Initial 1.3 mg/kg once daily (up to 40 mg), max 2.7 mg/kg (up to 160 mg) once daily. Not recommended for children <6 years or those with GFR <30 mL/min/1.73m2.
Adolescent: Hypertension (6-16 years): Initial 1.3 mg/kg once daily (up to 40 mg), max 2.7 mg/kg (up to 160 mg) once daily.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment required
Moderate: No dose adjustment required
Severe: Use with caution; monitor renal function and potassium. Not recommended for children with GFR <30 mL/min/1.73m2.
Dialysis: Not removed by hemodialysis. No specific dose adjustment, but use with caution and monitor closely.

Hepatic Impairment:

Mild: No dose adjustment required
Moderate: Initial dose of 40 mg once daily; maximum 80 mg once daily. Use with caution in patients with biliary obstructive disorders.
Severe: Not recommended (contraindicated in severe hepatic impairment with biliary cirrhosis or cholestasis).

Pharmacology

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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.
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Pharmacokinetics

Absorption:

Bioavailability: 23%
Tmax: 2-4 hours
FoodEffect: Food decreases AUC by 48% and Cmax by 59%. Administer without regard to food for hypertension, but consistently for heart failure.

Distribution:

Vd: 17 L
ProteinBinding: 95% (primarily to serum albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 6 hours
Clearance: Not available (systemic clearance approximately 2 L/hr)
ExcretionRoute: Feces (83%), Urine (13%)
Unchanged: Approximately 83% (feces) and 13% (urine) of the dose is excreted as unchanged drug.
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Pharmacodynamics

OnsetOfAction: Approximately 2 hours
PeakEffect: 4-6 hours
DurationOfAction: 24 hours

Safety & Warnings

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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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Swelling in the arms or legs
Changes in vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness, tiredness, or weakness
Stomach pain or diarrhea
Back pain
Joint pain
Headache
Flu-like symptoms

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Difficulty breathing or swallowing - seek immediate medical attention.
  • Severe dizziness or fainting.
  • Unusual tiredness or weakness.
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (e.g., decreased urination, swelling in feet or ankles).
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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:

Do not give this medication to children under 1 year of age, as it is not recommended for this age group.

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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Please note that it may take 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 any potential risks or interactions. 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, 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 (OTC) 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.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (low blood pressure)
  • Dizziness
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)

What to Do:

If overdose is suspected, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Valsartan is not removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73m2))
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • Salt substitutes containing potassium
  • NSAIDs (including selective COX-2 inhibitors)
  • Lithium
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Moderate Interactions

  • Other antihypertensive agents (additive hypotensive effect)
  • Diuretics (increased risk of hypotension)
  • CYP2C9 inhibitors (e.g., fluconazole, amiodarone) - minor interaction, valsartan is not significantly metabolized by CYP2C9
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Minor Interactions

  • Not available

Monitoring

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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 valsartan can affect renal perfusion.

Timing: Prior to initiation of therapy.

Serum Potassium (K+)

Rationale: To establish baseline and identify risk for hyperkalemia, especially in patients with renal impairment or those on potassium-sparing diuretics.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly after initiation/dose change, then monthly or as clinically indicated)

Target: <130/80 mmHg (general target, individualized)

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg)

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 3-6 months or as clinically indicated), more frequently in patients with renal impairment or heart failure.

Target: Stable within patient's baseline range

Action Threshold: Significant increase (e.g., >30% above baseline or SCr >2.5 mg/dL) or signs of acute kidney injury.

Serum Potassium (K+)

Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 3-6 months or as clinically indicated), more frequently in patients with renal impairment, diabetes, or those on potassium-sparing agents.

Target: 3.5-5.0 mEq/L

Action Threshold: Hyperkalemia (>5.5 mEq/L) or hypokalemia (<3.5 mEq/L).

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
  • Signs of worsening renal function (e.g., decreased urine output, swelling in ankles/feet)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Not recommended during the first trimester.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential risk. Not recommended.
Second Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and fetal death.
Third Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and fetal death.
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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.
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Pediatric Use

Approved for hypertension in children 6-16 years of age. Not recommended for children under 6 years or those with GFR <30 mL/min/1.73m2. Dosing is weight-based. Safety and efficacy for heart failure or post-MI in pediatric patients have not been established.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, older patients may be more sensitive to the hypotensive effects and may have age-related decreases in renal function, requiring careful monitoring of blood pressure, renal function, and electrolytes.

Clinical Information

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Clinical Pearls

  • Valsartan is a good alternative for patients who develop a cough with ACE inhibitors, as it does not affect bradykinin metabolism.
  • It is crucial to monitor serum potassium levels, especially in patients with renal impairment, diabetes, or those concurrently taking potassium-sparing diuretics or potassium supplements, due to the risk of hyperkalemia.
  • For heart failure, valsartan is typically initiated at a low dose and titrated slowly to the target dose to minimize the risk of hypotension.
  • Patients should be advised to report any signs of angioedema immediately, although it is less common with ARBs than with ACE inhibitors.
  • Consistent administration relative to food is important for heart failure patients due to the significant food effect on bioavailability.
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Alternative Therapies

  • Other Angiotensin II Receptor Blockers (ARBs) (e.g., Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan)
  • Angiotensin-Converting Enzyme (ACE) Inhibitors (e.g., Lisinopril, Enalapril, Ramipril)
  • Calcium Channel Blockers (CCBs) (e.g., Amlodipine, Nifedipine)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Other classes of antihypertensives depending on patient comorbidities.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (generic 40mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 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 overdose, including the medication taken, the amount, and the time it occurred.