Valsartan 80mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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)
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.
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).
Minor Interactions
- Not many clinically significant minor interactions reported.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide initial dosing for hypertension, heart failure, or post-MI.
Timing: Prior to initiation of therapy.
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.
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.
Routine Monitoring
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.
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.
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.
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
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:
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.
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.
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
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.
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.