Diovan HCT 320-25mg 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 and reduced sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This leads to a reduction in 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 immediate medical attention:

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat (fast or irregular)
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe nausea or vomiting
Signs of kidney problems, including:
+ Difficulty urinating
+ 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. 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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 conditions to ensure safe treatment:

Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A confirmed 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 status, as this medication is not recommended during breast-feeding.

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 existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

If you have diabetes, it is crucial to monitor your blood sugar levels closely. 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 have your blood work and other laboratory tests checked as advised by your doctor, and 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, and certain natural products or aids, consult with 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 prevent 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 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 inform your doctor if you notice any new or worsening symptoms.

• Aliskiren (in patients with diabetes or renal impairment)
• Concomitant use with ACE inhibitors (due to increased risk of hyperkalemia, hypotension, and renal impairment)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium
• NSAIDs (including selective COX-2 inhibitors)
• Other antihypertensive agents (additive hypotensive effects)
• Corticosteroids (may antagonize diuretic effect)
• Digitalis glycosides (increased risk of toxicity with hypokalemia/hypomagnesemia)
• Non-depolarizing skeletal muscle relaxants (prolonged effect)

• Antidiabetic agents (may require dose adjustment)
• Cholestyramine and colestipol resins (may impair HCTZ absorption)
• Alcohol, barbiturates, or narcotics (additive orthostatic hypotension)
• Pressor amines (e.g., norepinephrine, reduced response)
• Allopurinol (increased risk of hypersensitivity reactions)
• Amantadine (increased risk of adverse effects)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate - increased myelosuppression)

• Not available

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Unusual fatigue or weakness
• Muscle cramps or weakness (electrolyte imbalance)
• Nausea or vomiting
• Dry mouth
• Increased thirst
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Difficulty breathing
• Persistent cough
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Severe skin rash or blistering

Contraindicated in the 2nd and 3rd trimesters due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is also generally avoided due to potential risks.

Not recommended. Both valsartan and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypotension, hyperkalemia/hypokalemia, effects on renal function), 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 were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring renal function and electrolytes closely due to increased susceptibility to adverse effects and comorbidities.

• This combination is typically used when monotherapy with either an ARB or a thiazide diuretic is insufficient to control blood pressure.
• The 320/25 mg strength is a high dose and usually reserved for patients whose blood pressure is not adequately controlled on lower strengths or other antihypertensive regimens.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in volume-depleted patients.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately.
• Due to the opposing effects on potassium (valsartan tends to increase, HCTZ tends to decrease), potassium levels may remain relatively stable, but close monitoring is still crucial.
• Advise patients to avoid sudden changes in position to minimize dizziness.

• ACE Inhibitor/Diuretic combinations (e.g., Lisinopril/HCTZ)
• Calcium Channel Blocker/ARB combinations (e.g., Amlodipine/Valsartan)
• Beta-blocker/Diuretic combinations
• Other classes of antihypertensives (e.g., alpha-blockers, direct vasodilators)
• Monotherapy with an ARB or a thiazide diuretic if appropriate

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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.