Diovan HCT 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 reabsorption. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion.

Serious Side Effects: Seek Medical Help 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 attention right away:

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
+ Trouble 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
+ Passing urine more often
+ 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
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine production
+ Dry mouth or dry eyes
+ Severe upset stomach or vomiting
Signs of kidney problems, including:
+ Unable to pass urine
+ Changes in urine production
+ 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

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

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 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.
Inability to urinate.
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 dose 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 high cholesterol and triglyceride levels. If you already 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 test results.

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 reactions with your doctor.

Heat and Fluid Loss
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms 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 Warning
If you have lupus, this medication may cause your condition to become active or worsen. Inform your doctor immediately 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-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements or salt substitutes containing potassium
• Lithium (increased serum lithium concentrations and toxicity)
• Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors (may attenuate antihypertensive effect, increase risk of renal impairment)
• Other antihypertensive agents (additive hypotensive effect)
• Drugs that affect renal function (e.g., cyclosporine, tacrolimus)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)

• Digitalis glycosides (increased risk of digitalis toxicity with hypokalemia/hypomagnesemia)
• Cholestyramine and colestipol resins (may impair absorption of HCTZ)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) (potentiated effect)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Antidiabetic drugs (oral agents and insulin) (may require dose adjustment of antidiabetic drug)
• Alcohol, barbiturates, or narcotics (potentiation of orthostatic hypotension)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Nausea or vomiting
• Dry mouth, increased thirst (signs of dehydration/electrolyte imbalance)
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Decreased urine output, swelling in ankles/feet (signs of worsening renal function)
• Blurred vision, eye pain (acute angle-closure glaucoma - rare HCTZ side effect)

Contraindicated during pregnancy. Discontinue as soon as pregnancy is detected. Exposure to valsartan during the second and third trimesters of pregnancy can cause injury and death to the developing fetus. Hydrochlorothiazide can cross the placental barrier and may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions.

Not recommended during breastfeeding. Both valsartan and hydrochlorothiazide are excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., hypotension, hyperkalemia with valsartan; electrolyte disturbances, jaundice with 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 in pediatric patients have not been established. 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. Elderly patients may be more susceptible to the hypotensive effects and electrolyte imbalances (especially hyponatremia and hypokalemia) and may have reduced renal function. Close monitoring of blood pressure, renal function, and electrolytes is recommended.

• Diovan HCT 320mg/12.5mg is a high-dose combination, typically reserved for patients not adequately controlled on lower doses or monotherapy.
• Always check serum electrolytes (especially potassium and sodium) and renal function before starting and periodically during therapy, particularly in patients with pre-existing renal impairment or those on concomitant medications that affect electrolytes.
• Educate patients about the signs of hypotension (dizziness, lightheadedness) and electrolyte imbalance (muscle cramps, weakness, irregular heartbeat).
• Advise female patients of childbearing potential about the severe risks of fetal toxicity and the need to discontinue the drug immediately if pregnancy is detected.
• Thiazide diuretics like HCTZ can increase uric acid and blood glucose levels; monitor these parameters in susceptible patients (e.g., those with gout or diabetes).
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics due to the risk of hyperkalemia with valsartan.
• NSAIDs can reduce the antihypertensive effect and increase the risk of renal impairment; use with caution.

• Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, Loop Diuretics)
• Monotherapy with valsartan or hydrochlorothiazide if blood pressure is controlled on a single agent.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with 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 overdose, including the medication taken, the amount, and the time it occurred.