Diovan HCT 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, decreased peripheral resistance, and reduced blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This reduces plasma volume and peripheral resistance, contributing to its antihypertensive effect.

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
+ 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 throwing up
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ A big weight gain
Swelling in the arms or legs
Eye problems, which can lead to lasting eyesight loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
+ Change in eyesight
+ Eye pain (usually occurs within hours to weeks of starting this medication)
Rarely, certain types of skin cancer have been reported in people taking hydrochlorothiazide. To minimize your risk, protect your skin from the sun and have your skin checked as directed by your doctor. Contact your doctor immediately if you notice:
+ A change in color or size of a mole
+ Any new or changing skin lump or growth

Other Side Effects

Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

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, 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 allergic reaction you experienced.
A known sulfa allergy.
Current use of dofetilide.
Difficulty urinating.
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 medications 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.

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, get up slowly from a sitting or lying position, and 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 advised, and be aware that this medication may cause increases in cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, discuss this with your doctor.

Follow your doctor's instructions for having your blood work and other laboratory tests checked, as this medication may affect the results of certain tests. 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 with your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe management.

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 drugs that may cause drowsiness with your doctor.

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 conditions may lead to low blood pressure.

If you are taking cholestyramine or colestipol, consult with your pharmacist about the best way to take these medications with your current drug. Be aware of the potential for gout attacks, and if you have lupus, note that this medication can activate or worsen the condition. Immediately report any new or worsening symptoms to your doctor.

• Aliskiren (in patients with diabetes or renal impairment)
• Concomitant use with ACE inhibitors (in patients with diabetic nephropathy)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• NSAIDs, including selective COX-2 inhibitors (reduced antihypertensive effect, increased risk of renal impairment)
• Other antihypertensive agents (additive hypotensive effects)
• Corticosteroids (enhanced electrolyte depletion, particularly hypokalemia)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia)

• Antidiabetic agents (insulin, oral hypoglycemics) (may require dose adjustment due to HCTZ's hyperglycemic effect)
• Cholestyramine and colestipol resins (reduced absorption of hydrochlorothiazide)
• Muscle relaxants, non-depolarizing (e.g., tubocurarine) (enhanced effect)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Alcohol, barbiturates, or narcotics (potentiation of orthostatic hypotension)

• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
• Calcium salts (increased serum calcium levels due to decreased excretion)

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Nausea or vomiting
• Swelling of hands, ankles, or feet (though less common with diuretics)
• Signs of allergic reaction (rash, itching, swelling)
• Symptoms of gout (joint pain, swelling, redness)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death (renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death). Discontinue as soon as pregnancy is detected.

Not recommended. Hydrochlorothiazide is excreted in human milk and can suppress lactation. It is unknown if valsartan is excreted in human milk, but due to the potential for adverse effects on the nursing 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 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 the lowest effective dose and monitor renal function and electrolytes closely due to increased susceptibility to adverse effects (e.g., hypotension, electrolyte imbalances, renal impairment).

• This combination is often used when monotherapy with either an ARB or a thiazide diuretic is insufficient to control blood pressure.
• Take consistently at the same time each day to maintain stable blood pressure control.
• Patients should be advised to report any symptoms of dizziness, lightheadedness, or muscle cramps, which could indicate hypotension or electrolyte imbalance.
• Avoid abrupt discontinuation, as this can lead to rebound hypertension.
• Educate patients on the importance of regular blood pressure monitoring at home.
• Caution should be exercised in patients with a history of gout or hyperuricemia, as HCTZ can elevate uric acid levels.

• Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Lifestyle modifications (diet, exercise, weight management, stress reduction)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.