Valsartan 80mg Tablets

Manufacturer OHM LABS 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, Heart Failure Agent
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Category D (2nd and 3rd trimesters)
FDA Approved
Dec 1996
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DEA Schedule
Not Controlled

Overview

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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 reduce the strain on your heart.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Unless your doctor advises you to limit your fluid intake, be sure to 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, shake the bottle well before each use. When measuring a liquid dose, 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, away from the bathroom. If a liquid suspension is prepared from the tablets, it can be stored at room temperature or in the refrigerator. If stored at room temperature, discard any unused portion after 30 days. If stored in the refrigerator, discard any unused portion after 75 days.

Keep all medications in a safe place, out of the reach of children and pets.

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 to make up for a missed dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once or twice daily, with or without food.
  • Do not stop taking valsartan without consulting your doctor, even if you feel well.
  • Avoid potassium supplements, salt substitutes containing potassium, and excessive intake of potassium-rich foods unless advised by your doctor.
  • Limit alcohol intake as it can further lower blood pressure.
  • Maintain a healthy diet (low in sodium, rich in fruits and vegetables), regular exercise, and manage stress to support blood pressure control.
  • Monitor your blood pressure at home as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 80 mg or 160 mg once daily. Heart Failure: Initial 40 mg twice daily. Post-MI: Initial 20 mg twice daily.
Dose Range: 20 - 320 mg

Condition-Specific Dosing:

hypertension: Initial 80 mg or 160 mg once daily; dose can be increased to a maximum of 320 mg once daily.
heartFailure: Initial 40 mg twice daily; titrate to a target dose of 160 mg twice daily as tolerated.
postMyocardialInfarction: Initial 20 mg twice daily; titrate to a 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 (maximum 40 mg); titrate up to 2.7 mg/kg (maximum 160 mg) once daily. Not recommended for children under 6 years of age.
Adolescent: Hypertension (6-16 years): Initial 1.3 mg/kg once daily (maximum 40 mg); titrate up to 2.7 mg/kg (maximum 160 mg) once daily.
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Dose Adjustments

Renal Impairment:

Mild: No initial dosage adjustment required.
Moderate: No initial dosage adjustment required.
Severe: Use with caution; monitor renal function and potassium levels closely. Not significantly removed by hemodialysis.
Dialysis: Not significantly removed by hemodialysis; no supplemental dose needed after dialysis. Monitor for hypotension.

Hepatic Impairment:

Mild: No initial dosage adjustment required.
Moderate: Initial 40 mg once daily; maximum dose 80 mg once daily. Use with caution.
Severe: Not recommended due to lack of data and potential for increased exposure.

Pharmacology

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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, reduced blood pressure, and decreased sodium and water retention.
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Pharmacokinetics

Absorption:

Bioavailability: 23%
Tmax: 2-4 hours
FoodEffect: Food decreases the AUC by 48% and Cmax by 59%. While food reduces absorption, it does not significantly affect the clinical efficacy, so it can be taken with or without food.

Distribution:

Vd: 17 L
ProteinBinding: 94-97% (primarily to serum albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 6-9 hours
Clearance: Not available (total plasma clearance approximately 2 L/h)
ExcretionRoute: Feces (83%), Urine (13%)
Unchanged: Approximately 83% excreted unchanged in feces, 13% in urine.
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Pharmacodynamics

OnsetOfAction: Within 2 hours (antihypertensive effect)
PeakEffect: 4-6 hours (antihypertensive effect)
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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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 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Swelling of the face, lips, tongue, or throat (signs of angioedema - seek emergency medical help immediately)
  • Difficulty breathing or swallowing
  • Unusual tiredness or weakness
  • Muscle cramps or weakness, irregular heartbeat (signs of high potassium)
  • Decreased urination or swelling in your feet/ankles (signs of kidney problems)
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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, such as foods or drugs. Describe the symptoms you experienced with these allergies.
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 with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution 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. Discuss any concerns or questions with your doctor.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are on a low-sodium or sodium-free diet, discuss this with your doctor.

Before consuming alcohol, talk to your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions 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 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.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. Treatment is supportive and symptomatic; lay the patient supine with legs elevated. Intravenous fluids may be administered to correct hypotension. Valsartan is not significantly removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m²))
  • Sacubitril/valsartan (Entresto) (within 36 hours of last valsartan dose due to increased risk of angioedema)
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
  • Potassium supplements - increased risk of hyperkalemia
  • Salt substitutes containing potassium - increased risk of hyperkalemia
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased risk of renal impairment (including acute renal failure) and reduced antihypertensive effect, especially in elderly, volume-depleted, or renally impaired patients.
  • Lithium - increased serum lithium concentrations and lithium toxicity.
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Moderate Interactions

  • Other antihypertensive agents - additive hypotensive effects.
  • ACE inhibitors - increased risk of hyperkalemia, hypotension, and renal impairment (dual blockade of RAAS generally not recommended).
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Minor Interactions

  • Not many clinically significant minor interactions reported.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension, heart failure, or post-MI.

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 hemodynamics, especially in patients with pre-existing renal impairment or heart failure.

Timing: Prior to initiation of therapy.

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as valsartan can cause hyperkalemia, particularly in patients with renal impairment or those on potassium-sparing diuretics/supplements.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly once stable).

Target: Individualized based on indication (e.g., <130/80 mmHg for hypertension in many guidelines).

Action Threshold: Persistent hypotension (e.g., symptomatic, SBP <90 mmHg) or inadequate BP control.

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

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or more frequently in patients with pre-existing renal impairment, heart failure, or concomitant nephrotoxic drugs.

Target: Within patient's baseline range or acceptable limits.

Action Threshold: Significant increase (e.g., >30% above baseline or progressive increase) or signs of acute kidney injury.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or more frequently in patients at risk for hyperkalemia (e.g., renal impairment, diabetes, concomitant potassium-sparing agents).

Target: 3.5-5.0 mEq/L.

Action Threshold: K+ >5.5 mEq/L (consider dose reduction or discontinuation), or symptomatic hyperkalemia.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
  • Fatigue or weakness
  • Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat, numbness/tingling)
  • Signs of worsening renal function (e.g., decreased urine output, swelling in ankles/feet)

Special Patient Groups

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Pregnancy

Valsartan is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. Exposure during the first trimester is also not recommended, and alternative therapies should be considered if pregnancy is planned or detected.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal data suggest potential for fetal harm. Generally, ARBs should be avoided if pregnancy is planned or detected.
Second Trimester: Significant risk of fetal injury and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal anuria/renal failure.
Third Trimester: Significant risk of fetal injury and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal anuria/renal failure.
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Lactation

Not recommended. 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: Unknown, but potential for serious adverse effects (e.g., hypotension, renal effects) in the infant.
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Pediatric Use

Not recommended for children under 6 years of age. For children 6-16 years with hypertension, dosing is weight-based. Safety and efficacy for other indications (e.g., heart failure, post-MI) have not been established in pediatric patients.

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Geriatric Use

No dosage adjustment is generally required based on age alone. However, elderly patients may be more sensitive to the effects of valsartan (e.g., hypotension, renal impairment) and may have age-related decline in renal function, requiring careful monitoring of blood pressure, renal function, and electrolytes.

Clinical Information

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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 a history of angioedema, especially if switching from an ACE inhibitor, though the risk with ARBs is lower.
  • Monitor renal function and potassium levels closely, particularly in patients with pre-existing renal impairment, heart failure, or those on concomitant medications that affect potassium or renal function (e.g., NSAIDs, potassium-sparing diuretics).
  • Educate patients about the importance of avoiding potassium supplements and salt substitutes unless specifically advised by their physician.
  • Emphasize the critical importance of discontinuing valsartan immediately if pregnancy is detected due to severe fetal toxicity.
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Alternative Therapies

  • Other Angiotensin II Receptor Blockers (ARBs): Losartan, Irbesartan, Candesartan, Olmesartan, Telmisartan, Azilsartan
  • Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
  • Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
  • Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
  • Diuretics: Hydrochlorothiazide, Furosemide
  • Other antihypertensives depending on patient comorbidities and specific indications.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (generic 80mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.