Valsartan/hctz 80mg/12.5mg 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 inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation and reduction in blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This reduces plasma volume and peripheral vascular resistance, contributing to its antihypertensive effect.

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat (fast or irregular)
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe nausea or vomiting
Signs of kidney problems, including:
+ Difficulty urinating
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Swelling in the arms or legs
Eye problems, such as changes in vision or eye pain, which can occur within hours to weeks of starting this medication and may lead to permanent vision loss if left untreated
Rarely, skin cancer has been reported in people taking hydrochlorothiazide; protect your skin from the sun and have regular skin checks as advised by your doctor; report any changes in mole color or size, or new or changing skin growths to your doctor immediately

Other Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor or seek medical help:

Dizziness
Headache
Nose or throat irritation

This is not an exhaustive list of possible 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 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 symptoms you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Difficulty urinating.
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.

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

If you have diabetes, closely monitor your blood sugar levels as directed by your healthcare provider. Regularly check your blood pressure as instructed.

Be aware that this medication may cause increased cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, discuss this with your doctor. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor, and inform all healthcare providers and laboratory personnel that you are taking this medication. Note that this medication may affect certain laboratory test results.

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

Before using over-the-counter (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, consult with your doctor. Also, discuss the use of alcohol, marijuana or other cannabis products, or prescription and OTC medications that may cause drowsiness with your doctor.

In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid 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 are taking cholestyramine or colestipol, consult with your pharmacist about the proper way to take these medications with this drug. Be aware of the potential for gout attacks.

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

• Aliskiren (in patients with diabetes or renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Other agents that increase serum potassium (e.g., heparin, trimethoprim)

• Lithium (increased lithium levels and toxicity)
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs) including COX-2 inhibitors (reduced antihypertensive effect, increased risk of renal impairment)
• Angiotensin-converting enzyme (ACE) inhibitors (increased risk of hypotension, hyperkalemia, and renal impairment - dual blockade of RAAS is generally not recommended)
• Other antihypertensive agents (additive hypotensive effects)

• Corticosteroids (enhanced electrolyte depletion, particularly hypokalemia)
• Barbiturates, narcotics, alcohol (additive orthostatic hypotension)
• Antidiabetic drugs (thiazides may decrease glucose tolerance, requiring adjustment of antidiabetic dosage)
• Cholestyramine and colestipol resins (may impair absorption of hydrochlorothiazide)
• Digitalis glycosides (hypokalemia/hypomagnesemia induced by HCTZ may predispose to digitalis toxicity)
• Skeletal muscle relaxants, non-depolarizing (enhanced effect)

• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)

• Dizziness
• Lightheadedness
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Swelling in ankles/feet (edema)
• Unusual thirst or dry mouth
• Changes in urination frequency
• Signs of allergic reaction (rash, itching, swelling)
• Signs of angioedema (swelling of face, lips, tongue, throat)

Contraindicated. Valsartan, an ARB, can cause fetal injury and death when administered to pregnant women. Hydrochlorothiazide can also cross the placenta and may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions.

Not recommended. Hydrochlorothiazide is excreted in human milk and can suppress lactation. Valsartan is also likely excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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 effectiveness 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 titrate carefully, monitoring renal function and electrolytes closely due to increased susceptibility to adverse effects (e.g., hypotension, electrolyte imbalances, renal impairment).

• This combination is not indicated for initial therapy of hypertension. It is typically used when monotherapy with either valsartan or hydrochlorothiazide is insufficient.
• Monitor for signs of angioedema, a rare but serious side effect, especially with the first few doses.
• Educate patients on the importance of consistent daily dosing and not missing doses.
• Advise patients to report any symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeats, excessive thirst).
• Caution patients about orthostatic hypotension, especially at the start of therapy, with dose increases, or when standing up quickly.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics due to the risk of hyperkalemia from valsartan.
• Avoid concomitant use with NSAIDs, which can reduce the antihypertensive effect and increase the risk of renal impairment.

• Other ARBs (e.g., valsartan monotherapy)
• Other diuretics (e.g., hydrochlorothiazide monotherapy, loop diuretics)
• ACE inhibitors (e.g., lisinopril, enalapril)
• Calcium channel blockers (e.g., amlodipine, nifedipine)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Direct renin inhibitors (e.g., aliskiren - generally not recommended in combination with ARBs/ACEIs)

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, including the amount and time of ingestion.