Valsartan 320mg 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
Not applicable (Risk D in 2nd/3rd trimesters, Risk C in 1st trimester; now generally contraindicated)
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, which helps blood flow more easily and lowers blood pressure. This can reduce the strain on your heart.
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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 creating a liquid suspension.

If a liquid suspension is prepared, make 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 to ensure accurate dosing.

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.

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 the missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking valsartan without consulting your doctor, even if you feel well.
  • Monitor your blood pressure regularly at home if advised by your doctor.
  • Limit sodium intake in your diet as advised by your doctor or dietitian.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
  • Maintain a healthy lifestyle including regular exercise, a balanced diet, and limiting alcohol intake.
  • 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: 80-160 mg once daily; may increase 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.
heartFailure: Initial 40 mg twice daily; titrate to target 160 mg twice daily as tolerated.
postMyocardialInfarction: Initial 20 mg twice daily; titrate to target 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 (max 40 mg), titrate to max 2.7 mg/kg (max 160 mg) once daily.
Adolescent: Hypertension (16-18 years): Refer to adult dosing, typically 80-160 mg once daily, max 320 mg once daily.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: No dosage adjustment necessary, but monitor renal function and potassium closely.
Dialysis: Valsartan is not significantly removed by hemodialysis. No specific dose adjustment needed, but monitor closely.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
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 in severe hepatic impairment or biliary cirrhosis/cholestasis.

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 vasoconstrictive 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% (absolute oral bioavailability)
Tmax: 2-4 hours
FoodEffect: Food decreases the absorption of valsartan by about 40% and Cmax by about 50%. However, this does not significantly affect the clinical efficacy, so it can be taken with or without food.

Distribution:

Vd: 17 L (steady-state)
ProteinBinding: 94-97%
CnssPenetration: Limited

Elimination:

HalfLife: 6 hours (terminal elimination half-life)
Clearance: 2 L/h (renal clearance 0.62 L/h)
ExcretionRoute: Fecal (83%) and urinary (13%) excretion, primarily as unchanged drug.
Unchanged: Approximately 83% (feces) and 13% (urine) as unchanged drug.
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Pharmacodynamics

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

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 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 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 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 is not an exhaustive list of possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Swelling of the face, lips, tongue, or throat (signs of angioedema)
  • Difficulty breathing or swallowing
  • Signs of high potassium (e.g., unusual tiredness, muscle weakness, slow or irregular heartbeat)
  • Signs of kidney problems (e.g., swelling in ankles/feet, decreased urination)
  • Persistent cough (less common with ARBs than ACE inhibitors, but possible)
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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:

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 conditions with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other treatments. 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 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, stand up slowly after sitting or lying down, 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 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 with your doctor to ensure safe use. Additionally, if you are following 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 with 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
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate - less common)
  • Shock

What to Do:

Immediately seek emergency medical attention. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Administer intravenous fluids to support blood pressure. Valsartan is not removed by hemodialysis. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or moderate to severe renal impairment)
  • Sacubitril/valsartan (Entresto) - do not co-administer with valsartan alone due to risk of angioedema; a washout period is required when switching.
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • NSAIDs (including selective COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment and hyperkalemia.
  • Lithium - increased serum lithium concentrations and toxicity.
  • Other antihypertensives (e.g., ACE inhibitors, other ARBs, diuretics) - additive hypotensive effects.
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Moderate Interactions

  • Trimethoprim - increased risk of hyperkalemia.
  • Cyclosporine - increased risk of hyperkalemia.
  • Tacrolimus - increased risk of hyperkalemia.
  • Heparin - increased risk of hyperkalemia.
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Minor Interactions

  • Grapefruit juice - theoretical interaction, but not clinically significant for valsartan.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

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

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly or every 3-6 months once stable.

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

Action Threshold: Persistent elevation above target, or symptomatic hypotension.

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

Frequency: 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients with pre-existing renal impairment or on concomitant nephrotoxic drugs.

Target: Within patient's baseline range; eGFR >60 mL/min/1.73m²

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

Serum Potassium (K+)

Frequency: 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients at risk for hyperkalemia (e.g., renal impairment, diabetes, concomitant K-sparing diuretics/supplements).

Target: 3.5-5.0 mEq/L

Action Threshold: K+ >5.5 mEq/L (especially >6.0 mEq/L) or symptomatic hyperkalemia.

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Symptom Monitoring

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

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 (renal dysfunction, oligohydramnios, skeletal malformations, lung hypoplasia). Use during 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: Risk C (based on older classification); generally avoided due to theoretical risk, but less severe than later trimesters. Data are limited.
Second Trimester: Risk D; significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Risk D; significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
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Lactation

Limited data suggest valsartan is excreted into breast milk in animals; it is unknown if it is excreted in human milk. Due to the potential for serious adverse reactions 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. L3 (Moderately Safe).

Infant Risk: Potential for adverse effects on the infant's cardiovascular and renal systems. Monitor for hypotension, oliguria, and hyperkalemia.
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Pediatric Use

Approved for hypertension in children 6-16 years. Safety and efficacy not established in children younger than 6 years or for heart failure/post-MI indications. Dosing is weight-based. Close monitoring of renal function and potassium is crucial.

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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, monitoring renal function and potassium closely due to higher likelihood of decreased renal function and polypharmacy.

Clinical Information

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Clinical Pearls

  • Valsartan is an excellent alternative for patients who develop cough with ACE inhibitors, as ARBs generally do not cause this side effect.
  • Always check for concomitant use of potassium-sparing diuretics, potassium supplements, or NSAIDs, as these significantly increase the risk of hyperkalemia and renal dysfunction.
  • Educate patients on the importance of avoiding pregnancy while on valsartan due to the severe fetal risks.
  • While food decreases absorption, it does not significantly impact clinical efficacy, so consistency in taking it (e.g., always with food or always without) is more important than strict adherence to one or the other.
  • In heart failure, valsartan is often used in combination with other agents (e.g., beta-blockers, mineralocorticoid receptor antagonists) and requires careful titration to target doses.
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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
  • Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
  • Calcium Channel Blockers: Amlodipine, Nifedipine, Diltiazem, Verapamil
  • Beta-blockers: Metoprolol, Carvedilol, Bisoprolol
  • Direct Renin Inhibitors: Aliskiren (limited use)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (320mg)
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's 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 be sure 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.