Valsartan/hctz 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 sodium and water retention. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral resistance.

Serious Side Effects: Seek Medical Attention 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 help 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
+ Have your skin checked as directed by your doctor
+ 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 Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:

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 allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A known sulfa allergy.
Current treatment with 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dose of any medication without consulting your doctor first.

Important Warnings and Cautions

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when navigating 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 increased cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, discuss this with your doctor.

Lab Tests and Monitoring
Your doctor will schedule regular blood work and other lab tests to monitor your condition. Inform all healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab test results.

Potential Interactions and Effects
It may take several 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, consult your doctor. Additionally, discuss the use of alcohol, marijuana or other cannabis products, or prescription/OTC medications that may cause drowsiness 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 Considerations
If you have lupus, this medication may cause your condition to become active or worsen. Immediately inform your doctor if you experience any new or worsening symptoms.

• Aliskiren (in patients with diabetes or 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 reduce antihypertensive effect and increase risk of renal impairment)
• Other antihypertensive agents (additive hypotensive effect)
• Drugs that increase serum potassium (e.g., trimethoprim, cyclosporine, heparin)

• Bile acid sequestrants (e.g., cholestyramine, colestipol - may reduce absorption of HCTZ)
• Corticosteroids, ACTH (may intensify electrolyte depletion, particularly hypokalemia)
• Antidiabetic agents (oral agents and insulin - HCTZ may decrease glucose tolerance)
• Digitalis glycosides (hypokalemia/hypomagnesemia induced by HCTZ may predispose to digitalis toxicity)
• Muscle relaxants, non-depolarizing (e.g., tubocurarine - HCTZ may potentiate their effect)
• Pressor amines (e.g., norepinephrine - HCTZ may decrease arterial responsiveness)

• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)

• Dizziness
• Lightheadedness
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Excessive thirst or dry mouth (signs of dehydration)
• Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
• Signs of gout (joint pain, swelling, redness)
• Signs of hyperglycemia (increased thirst, urination, fatigue)

Contraindicated in the second and third trimesters of pregnancy 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. Use in the first trimester is generally avoided due to potential risks, though less severe than later trimesters.

Not recommended. Both valsartan and hydrochlorothiazide are excreted in human milk. Hydrochlorothiazide can suppress lactation. Due to the potential for serious adverse effects in the breastfed 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 lower doses and monitor renal function and electrolytes closely, as elderly patients are more likely to have impaired renal function and be on concomitant medications.

• Valsartan/HCTZ is a fixed-dose combination and should not be used as initial therapy for hypertension unless the patient has already been titrated to the individual components.
• Monitor for signs of angioedema, though rare with ARBs, it is a serious adverse effect.
• Patients should be advised to report any symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeats).
• Caution is advised when co-administering with NSAIDs due to increased risk of renal impairment and reduced antihypertensive effect.
• Avoid in patients with anuria or severe renal impairment (CrCl <30 mL/min).
• Patients with a history of gout should be monitored closely for increased uric acid levels.

• Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, loop diuretics, alpha-blockers)
• Monotherapy with valsartan or hydrochlorothiazide if combination is not needed or tolerated.

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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened.