Valsartan 160mg Tablets

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-related side effects (e.g., cough) associated with ACE inhibitors.

Serious 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.

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. Describe the symptoms you experienced with the allergy.
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 Children:
If your child is under 1 year of age, do not administer this medication, as it is not recommended for children younger than 1 year.

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. They will help determine if 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 consulting your doctor first.

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 monitor your blood pressure and undergo blood tests to ensure the medication is working effectively. Discuss any concerns or questions with your doctor.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor to avoid potential interactions. Additionally, if you are following a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of the medication.

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, inform your doctor, as these symptoms can 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 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.

• Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73m²))
• Sacubitril/valsartan (Entresto) - do not co-administer with valsartan alone due to risk of angioedema; a washout period is required when switching from ACE inhibitors to sacubitril/valsartan.

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia.
• Potassium supplements or salt substitutes containing potassium - increased risk of hyperkalemia.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors - may attenuate the antihypertensive effect and increase the risk of renal impairment, including acute renal failure, especially in elderly, volume-depleted, or renally impaired patients.
• Lithium - increased serum lithium concentrations and lithium toxicity.

• Other antihypertensive agents - additive hypotensive effects.
• Diuretics - increased risk of symptomatic hypotension, especially with initial doses.
• CYP2C9 inhibitors (e.g., fluconazole, amiodarone) - potential for increased valsartan exposure (minor interaction as valsartan is minimally metabolized by CYP enzymes).

• Not available

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Fatigue or weakness
• 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)

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 patients should discontinue valsartan as soon as pregnancy is detected.

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.

Safety and effectiveness for hypertension have been established in pediatric patients 6 to 16 years of age. Use in pediatric patients <6 years of age or for indications other than hypertension is not established. Dosing is weight-based. Close monitoring of blood pressure, renal function, and electrolytes is crucial.

No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age alone, but consider potential for decreased renal function and increased sensitivity to hypotensive effects. Monitor renal function and potassium closely.

• Valsartan is an excellent choice for patients who develop cough with ACE inhibitors, as it does not affect bradykinin metabolism.
• Always check for pregnancy status in women of childbearing potential before initiating valsartan.
• Monitor potassium levels, especially when co-administered with potassium-sparing diuretics, potassium supplements, or in patients with renal impairment.
• NSAIDs can reduce the antihypertensive effect of valsartan and increase the risk of renal dysfunction; advise caution with concomitant use.
• Valsartan is a key component in the treatment of heart failure with reduced ejection fraction (HFrEF), often used in combination with other agents.
• The combination product sacubitril/valsartan (Entresto) has shown superior outcomes in HFrEF compared to valsartan alone, but requires a washout period if switching from an ACE inhibitor.

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

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 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.