Valsartan 320mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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
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.
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)
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. 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.
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, 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.
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
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.
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.
Moderate Interactions
- Trimethoprim - increased risk of hyperkalemia.
- Cyclosporine - increased risk of hyperkalemia.
- Tacrolimus - increased risk of hyperkalemia.
- Heparin - increased risk of hyperkalemia.
Minor Interactions
- Grapefruit juice - theoretical interaction, but not clinically significant for valsartan.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation
Routine Monitoring
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.
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.
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.
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
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:
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).
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.
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
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.
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)