Valsartan/hctz 320mg/25mg Tablets

Valsartan selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland, thereby inhibiting the vasoconstrictive and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Sudden weight gain
Swelling in the arms or legs
Eye problems, such as:
+ Changes in vision
+ Eye pain (usually occurring within hours to weeks of starting the medication)
Skin cancer (rarely reported in people taking hydrochlorothiazide):
+ Protect your skin from the sun and follow your doctor's instructions for skin checks
+ Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

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 unusual symptoms, contact your doctor or seek medical attention:

Dizziness
Headache
Nose or throat irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Difficulty urinating or inability to pass urine.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Breast-feeding, as you should not breast-feed while taking this medication.

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 treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider. Be aware that this medication may cause increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor.

Lab Tests and Monitoring
Have your blood work and other lab tests done as scheduled by your doctor. Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.

Potential Interactions and Side Effects
It may take a few weeks to experience the full effects of this medication. If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Over-the-Counter (OTC) Products and Substances
Before using OTC 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, or certain natural products or aids, consult your doctor. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may slow your actions with your doctor.

Heat and Fluid Loss
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Lupus
If you have lupus, this medication may cause your condition to become active or worsen. Immediately inform your doctor if you experience any new or worsening symptoms.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment (GFR <60 mL/min/1.73 m²))
• Potassium supplements or potassium-sparing diuretics (due to risk of hyperkalemia, especially with valsartan)

• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including selective COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment, hyperkalemia)
• Other antihypertensive agents (additive hypotensive effects)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia)
• Skeletal muscle relaxants, non-depolarizing (prolonged paralysis due to hypokalemia)

• Antidiabetic agents (oral agents and insulin) (may require dosage adjustment due to HCTZ's effect on glucose tolerance)
• Cholestyramine and colestipol resins (reduced absorption of HCTZ)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Alcohol, barbiturates, or narcotics (additive orthostatic hypotension)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
• Amantadine (increased risk of adverse effects of amantadine)

• Calcium salts (increased serum calcium levels due to HCTZ)

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Signs of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat, excessive thirst, dry mouth)
• Swelling of face, lips, tongue, or throat (angioedema)
• Persistent dry cough (less common with ARBs than ACEIs)
• Unusual weight gain or swelling (fluid retention)

CONTRAINDICATED in the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is generally not recommended due to potential risks.

Not recommended. Both valsartan and hydrochlorothiazide are excreted into breast milk. Due to the potential for serious adverse effects in the nursing infant (e.g., hypotension, electrolyte disturbances), 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 have not been established in pediatric patients. Not recommended for use in children.

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 with lower doses and monitor renal function and electrolytes more closely due to increased susceptibility to adverse effects and age-related decline in renal function.

• Valsartan/HCTZ is a once-daily combination therapy, which can improve patient adherence.
• The 320mg/25mg strength is typically the maximum dose and is used when lower strengths have not achieved adequate blood pressure control.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is less common with ARBs than ACE inhibitors.
• Monitor for orthostatic hypotension, especially at initiation, with dose increases, or in patients who are volume-depleted.
• Educate patients on the importance of avoiding potassium supplements or salt substitutes unless specifically instructed by their physician, due to the valsartan component.
• Due to the hydrochlorothiazide component, monitor for electrolyte imbalances, particularly hypokalemia, hyponatremia, and hypomagnesemia, and hypercalcemia.

• Single-agent ARBs (e.g., Valsartan)
• Single-agent Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Atenolol)
• Other classes of diuretics (e.g., loop diuretics, potassium-sparing diuretics)
• Alpha-blockers (e.g., Doxazosin)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.