Diovan HCT 160mg/25mg 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, 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 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
+ Sudden weight gain
Swelling in the arms or legs
Eye problems, such as:
+ Change in vision
+ Eye pain
These symptoms usually occur within hours to weeks of starting the medication and can lead to permanent vision loss if left untreated.
Skin changes, including:
+ New or changing skin lumps or growths
+ Changes in the color or size of a mole
Protect your skin from the sun and follow your doctor's instructions for regular skin checks.

Other Possible Side Effects

Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or if they bother you or do not go away, contact your doctor or seek medical attention:

Dizziness
Headache
Nose or throat irritation

Reporting Side Effects

This is not a comprehensive list of all 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 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, 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 change 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 exercise caution 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 increases in cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, discuss this with your doctor.

Regularly have your blood work and other laboratory tests checked as advised by your doctor, 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 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, talk to your doctor before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or OTC drugs 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 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 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 supplements or potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - due to risk of hyperkalemia
• Lithium (increased serum lithium levels and toxicity)

• NSAIDs (including selective COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
• Other antihypertensives (e.g., ACE inhibitors, beta-blockers, calcium channel blockers) - additive hypotensive effects.
• Digoxin (increased risk of digoxin toxicity due to HCTZ-induced hypokalemia)
• Corticosteroids, ACTH (enhanced electrolyte depletion, particularly hypokalemia)
• Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines.

• Antidiabetic agents (oral agents and insulin) - HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic dosage.
• Cholestyramine and colestipol resins (may impair absorption of HCTZ)
• Muscle relaxants, non-depolarizing (e.g., tubocurarine) - enhanced effect due to HCTZ.
• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
• Signs of dehydration (e.g., dry mouth, thirst, decreased urination)
• Unusual bruising or bleeding (rare, due to HCTZ effect on platelets)
• Yellowing of skin or eyes (jaundice - rare, liver issues)

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

Not recommended during breastfeeding. Both valsartan and hydrochlorothiazide are excreted in human milk. Potential for serious adverse reactions in the breastfed infant (e.g., hypotension, electrolyte disturbances).

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and monitor renal function and electrolytes closely due to increased risk of renal impairment and electrolyte imbalances in the elderly.

• This combination is often used when monotherapy with either valsartan or hydrochlorothiazide is insufficient to control blood pressure.
• Monitor for signs of angioedema, though rare, it is a serious side effect of ARBs.
• Patients should be advised to report any signs of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
• Caution is advised when co-administering with NSAIDs, as this can reduce the antihypertensive effect and increase the risk of renal dysfunction.
• Due to the HCTZ component, monitor uric acid levels, especially in patients with a history of gout, and blood glucose levels in diabetic patients.
• Advise patients to avoid sudden changes in position to minimize orthostatic hypotension.

• ACE inhibitors (e.g., Lisinopril, Enalapril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Other diuretics (e.g., Furosemide, Chlorthalidone)
• Direct Renin Inhibitors (e.g., Aliskiren - generally not first-line)

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.