Valsartan/hctz 320mg/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, decreased peripheral resistance, and reduced sodium and water retention. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine output
+ Dry mouth, dry eyes, or severe stomach upset
Signs of kidney problems, including:
+ Difficulty urinating or 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 lead to permanent vision loss if left untreated. These symptoms usually occur within hours to weeks of starting the medication.
Rarely, skin cancer has been 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

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 attention:

Dizziness or headache
* Nose or throat irritation

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.

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, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Current or planned use of dofetilide.
Difficulty urinating or inability to pass urine.
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Breast-feeding status, 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dose 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.

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 be cautious when climbing stairs.

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

Regularly undergo blood tests and other laboratory evaluations as advised by your doctor, as this medication may impact certain lab results. Inform all your healthcare providers and laboratory personnel that you are taking this medication. It may take several weeks to experience the full effects of the medication.

If you are using 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.

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 your doctor.

Also, talk to your doctor before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may cause drowsiness. 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 symptoms may lead to low blood pressure.

If you are taking cholestyramine or colestipol, consult your pharmacist about the best way to take these medications with this drug. Be aware of the potential for gout attacks. If you have lupus, this medication may exacerbate your condition or trigger a flare-up. Immediately report any new or worsening symptoms to your doctor.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment due to increased risk of hypotension, hyperkalemia, and renal impairment)
• Potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes (increased risk of hyperkalemia, especially with valsartan)

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs, including selective COX-2 inhibitors (attenuation of antihypertensive effect, increased risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients)
• Other antihypertensive agents (additive hypotensive effects)
• ACE inhibitors (increased risk of hypotension, hyperkalemia, and renal impairment with dual blockade)
• Digoxin (increased risk of digoxin toxicity due to HCTZ-induced hypokalemia/hypomagnesemia)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine) (potentiated effect of muscle relaxant by HCTZ)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines, but not sufficient to preclude their use)

• Antidiabetic agents (oral agents and insulin) (HCTZ may decrease glucose tolerance, requiring dosage adjustment of antidiabetic agents)
• Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)
• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol with HCTZ)
• Amantadine (increased risk of adverse effects of amantadine with HCTZ)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate) (increased myelosuppression with HCTZ)
• Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Dry mouth, thirst, decreased urination (signs of dehydration)
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Persistent cough (less common with ARBs than ACEIs, but possible)
• Blurred vision or eye pain (acute angle-closure glaucoma - rare but serious with HCTZ)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. First trimester exposure should be avoided if possible, though risks are less clear.

Not recommended during breastfeeding. Both valsartan and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse effects in the nursing infant (e.g., hypotension, electrolyte disturbances, inhibition of lactation by HCTZ), 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. Use is generally not recommended.

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. Elderly patients may be more susceptible to volume depletion and electrolyte imbalances, and renal function should be monitored closely.

• This combination is typically used when monotherapy with either an ARB or a thiazide diuretic is insufficient to control blood pressure.
• The 320mg/12.5mg strength is a high dose and should be reserved for patients who have not achieved blood pressure control on lower doses of valsartan/HCTZ or other antihypertensive regimens.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is rare with ARBs.
• Monitor for orthostatic hypotension, especially at initiation, with dose increases, or in volume-depleted patients.
• Hydrochlorothiazide can cause photosensitivity; advise patients to use sun protection.
• Thiazide diuretics can increase serum uric acid and glucose levels, and decrease potassium, sodium, and magnesium, while increasing calcium. Regular monitoring is crucial.

• Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, other diuretics)
• Monotherapy with an ARB (e.g., valsartan alone) or a thiazide diuretic (e.g., HCTZ alone) if appropriate for blood pressure control.

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, the amount, and the time it occurred.