Diovan HCT 160mg/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, 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 also increases potassium and bicarbonate excretion while decreasing calcium excretion.

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
+ Significant 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)
Rarely, skin cancer has been reported in people taking hydrochlorothiazide. To minimize risk, protect your skin from the sun and follow your doctor's recommendations for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness
Headache
Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Concurrent 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 issues with your doctor and pharmacist. They will help determine the safety of taking this medication with your other drugs 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, stand up slowly after sitting or lying down, 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 lab 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 mindful of fluid loss and drink plenty of fluids. If you experience excessive sweating, vomiting, diarrhea, or other signs of fluid loss, inform your doctor, as these can lead to low blood pressure.

If you take 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 [CrCl <60 mL/min])

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Salt substitutes containing potassium
• Non-steroidal anti-inflammatory drugs (NSAIDs, including COX-2 inhibitors)
• Lithium
• Other Angiotensin Receptor Blockers (ARBs)
• Angiotensin-Converting Enzyme (ACE) inhibitors (dual blockade)

• Antidiabetic agents (oral agents, insulin)
• Cholestyramine, colestipol
• Digoxin
• Corticosteroids, ACTH
• Pressor amines (e.g., norepinephrine)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine)
• Alcohol, barbiturates, narcotics

• Allopurinol
• Calcium salts

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Fatigue
• Muscle cramps or weakness
• Nausea or vomiting
• Dry mouth
• Excessive thirst
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing)
• Signs of electrolyte imbalance (e.g., palpitations, irregular heartbeat, confusion)

Contraindicated. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Discontinue as soon as pregnancy is detected.

Not recommended. Valsartan is excreted in the milk of lactating rats, and hydrochlorothiazide is excreted in human breast milk. 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 in pediatric patients have not been established. Use is generally not recommended.

No overall difference in efficacy or safety has been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Initiate therapy at the lower end of the dosing range and monitor renal function and electrolytes closely.

• Take Diovan HCT consistently at the same time each day, with or without food.
• Patients should be advised to avoid potassium supplements or salt substitutes containing potassium unless specifically directed by their healthcare provider.
• Monitor for signs of angioedema, especially after the first dose or dose increase. Advise patients to seek immediate medical attention if swelling of the face, lips, tongue, or throat occurs.
• This medication may cause dizziness or lightheadedness, especially when standing up quickly. Patients should be advised to rise slowly from a sitting or lying position.
• Diovan HCT is contraindicated in patients with anuria or known hypersensitivity to sulfonamide-derived drugs (due to hydrochlorothiazide component).

• Other Angiotensin Receptor Blockers (ARBs) monotherapy
• ACE inhibitors (ACEIs)
• Calcium Channel Blockers (CCBs)
• Beta-blockers
• Other classes of diuretics (e.g., loop diuretics, potassium-sparing diuretics)
• Direct Renin Inhibitors (e.g., Aliskiren)

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'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.