Valsartan/hctz 160mg/12.5mg Tablets

Manufacturer MYLAN /VIATRIS Active Ingredient Valsartan and Hydrochlorothiazide(val SAR tan & hye droe klor oh THYE a zide) Pronunciation val SAR tan & hye droe klor oh THYE a zide
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB) / Thiazide Diuretic Combination
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Pregnancy Category
Category D
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FDA Approved
Dec 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Valsartan/HCTZ is a combination medicine used to treat high blood pressure (hypertension). Valsartan helps relax blood vessels, and hydrochlorothiazide helps your body get rid of extra salt and water. Together, they help lower your blood pressure, which can reduce your risk of heart attack and stroke.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. Be aware that this medication may increase your urine production, so try to avoid taking it too close to bedtime to minimize sleep disturbances.

To stay hydrated, drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily, with or without food.
  • Do not stop taking this medication without consulting your doctor, even if you feel well.
  • Limit sodium (salt) intake in your diet as directed by your doctor or dietitian.
  • Engage in regular physical activity as recommended by your doctor.
  • Maintain a healthy weight.
  • Limit alcohol consumption.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Stay hydrated, especially during exercise or hot weather, but avoid excessive fluid intake unless advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 160 mg valsartan / 12.5 mg hydrochlorothiazide orally once daily
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

initial_therapy: Not recommended as initial therapy for hypertension unless the patient's blood pressure is not adequately controlled with monotherapy.
titration: Dosage may be increased after 1 to 2 weeks of therapy to a maximum of 320 mg valsartan / 25 mg hydrochlorothiazide once daily, as needed to control blood pressure.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment required (CrCl > 50 mL/min)
Moderate: Use with caution; not recommended for patients with CrCl < 30 mL/min
Severe: Contraindicated (CrCl < 30 mL/min or anuria)
Dialysis: Not removed by hemodialysis; contraindicated in anuria.

Hepatic Impairment:

Mild: No dosage adjustment required
Moderate: Valsartan component: Max dose 80 mg once daily. Use with caution.
Severe: Not recommended (due to lack of experience and potential for increased valsartan exposure).

Pharmacology

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Mechanism of Action

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 reabsorption. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion. The combination provides additive antihypertensive effects.
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Pharmacokinetics

Absorption:

Bioavailability: Valsartan: ~23%; Hydrochlorothiazide: ~65-75%
Tmax: Valsartan: 2-4 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Valsartan: Food decreases AUC by ~48% and Cmax by ~59%; Hydrochlorothiazide: Food can increase absorption slightly.

Distribution:

Vd: Valsartan: ~17 L; Hydrochlorothiazide: 0.8-1.7 L/kg
ProteinBinding: Valsartan: ~94-97%; Hydrochlorothiazide: ~40-60%
CnssPenetration: Valsartan: Limited; Hydrochlorothiazide: Limited

Elimination:

HalfLife: Valsartan: ~6 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Valsartan: ~2 L/hr; Hydrochlorothiazide: ~300 mL/min
ExcretionRoute: Valsartan: Primarily feces (83%) and urine (13%); Hydrochlorothiazide: Primarily urine (>95%)
Unchanged: Valsartan: ~13% (urine); Hydrochlorothiazide: >95% (urine)
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Pharmacodynamics

OnsetOfAction: Valsartan: ~2 hours; Hydrochlorothiazide: ~2 hours
PeakEffect: Valsartan: 4-6 hours; Hydrochlorothiazide: 4-6 hours
DurationOfAction: Valsartan: ~24 hours; Hydrochlorothiazide: 6-12 hours (combination provides 24-hour blood pressure control)

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Valsartan/HCTZ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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Side Effects

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
+ 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)
Skin changes, including:
+ New or changing skin lumps or growths
+ Changes in the color or size of a mole

Other Possible Side Effects

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

Dizziness
Headache
Nose or throat irritation

Reporting Side Effects

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Swelling of the face, lips, tongue, or throat (signs of angioedema – seek emergency medical attention)
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual tiredness or weakness
  • Muscle cramps or weakness, irregular heartbeat (signs of electrolyte imbalance)
  • Signs of kidney problems (e.g., little or no urination, swelling in your feet or ankles)
  • Signs of high blood sugar (e.g., increased thirst, increased urination, dry mouth, fruity breath odor)
  • Sudden decrease in vision or eye pain (may indicate acute angle-closure glaucoma, seek immediate medical attention)
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Before Using This Medicine

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 adjust the dose of any medication without first consulting your doctor.
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Precautions & Cautions

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 getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

If you have diabetes (high blood sugar), closely monitor your blood sugar levels as directed by your healthcare provider. Regularly check your blood pressure as advised by your doctor.

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. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor, and inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.

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 or aids, consult with your doctor. Also, discuss with your doctor before consuming alcohol, marijuana or other forms of cannabis, or taking prescription or OTC drugs 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 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 inform your doctor if you notice any new or worsening symptoms.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (low blood pressure)
  • Dizziness
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)
  • Electrolyte depletion (e.g., hypokalemia, hyponatremia)
  • Dehydration

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is symptomatic and supportive. Lay the patient supine with legs elevated. Intravenous fluids may be administered to correct hypotension and electrolyte imbalances. Hemodialysis is not effective for removing valsartan or hydrochlorothiazide.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment [CrCl < 60 mL/min])
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Major Interactions

  • Lithium (increased lithium toxicity due to decreased renal clearance by HCTZ)
  • NSAIDs (including COX-2 inhibitors: reduced antihypertensive effect, increased risk of renal impairment)
  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia due to valsartan)
  • ACE inhibitors (dual blockade of the RAAS increases risk of hypotension, hyperkalemia, and renal impairment)
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Moderate Interactions

  • Antidiabetic agents (HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic dose)
  • Cholestyramine and colestipol resins (may impair absorption of HCTZ)
  • Corticosteroids, ACTH (enhanced electrolyte depletion, particularly hypokalemia)
  • Pressor amines (e.g., norepinephrine: HCTZ may reduce arterial responsiveness)
  • Digitalis glycosides (hypokalemia/hypomagnesemia induced by HCTZ may predispose to digitalis toxicity)
  • Muscle relaxants, non-depolarizing (HCTZ may potentiate their effect)
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Minor Interactions

  • Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
  • Other antihypertensive agents (additive hypotensive effect)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide therapy.

Timing: Prior to initiation of therapy.

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To assess baseline electrolyte status, as both components can affect levels.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function, as both components can affect renal function and dose adjustment may be needed.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, as valsartan is metabolized in the liver.

Timing: Prior to initiation of therapy.

Serum Uric Acid

Rationale: Hydrochlorothiazide can increase uric acid levels.

Timing: Prior to initiation of therapy.

Blood Glucose

Rationale: Hydrochlorothiazide can affect glucose metabolism.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, at each clinic visit or as directed by physician.

Target: <130/80 mmHg or individualized target based on patient comorbidities.

Action Threshold: Persistently elevated BP despite therapy, or symptomatic hypotension.

Serum Potassium

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated).

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L (hypokalemia) or >5.5 mEq/L (hyperkalemia).

Serum Creatinine and eGFR

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated).

Target: Stable within normal limits or patient's baseline.

Action Threshold: Significant increase in creatinine (>30% from baseline) or significant decrease in eGFR.

Serum Sodium

Frequency: Periodically (e.g., every 3-6 months, or as clinically indicated).

Target: 135-145 mEq/L

Action Threshold: <130 mEq/L (hyponatremia).

Serum Uric Acid

Frequency: Periodically (e.g., annually or as clinically indicated, especially if patient has history of gout).

Target: Normal limits for age/gender.

Action Threshold: Elevated levels leading to symptoms of gout.

Blood Glucose

Frequency: Periodically (e.g., annually or as clinically indicated, especially in diabetic patients).

Target: Individualized target for diabetic control.

Action Threshold: Significant hyperglycemia.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (signs of hypotension)
  • Unusual fatigue or weakness
  • Muscle cramps or weakness (signs of electrolyte imbalance, especially hypokalemia)
  • Nausea or vomiting
  • Swelling of face, lips, tongue, or throat (signs of angioedema)
  • Difficulty breathing or swallowing
  • Persistent dry cough (less common with ARBs than ACEIs, but possible)
  • Increased thirst or urination (signs of hyperglycemia or dehydration)
  • Joint pain or swelling (signs of gout exacerbation)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with valsartan. Exposure during the first trimester should be avoided if possible. If pregnancy is detected, discontinue as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited data, but potential risk cannot be excluded. Hydrochlorothiazide is generally considered low risk in the first trimester, but valsartan is not.
Second Trimester: High risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure, death) due to valsartan.
Third Trimester: High risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure, death) due to valsartan.
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Lactation

Not recommended during breastfeeding. Hydrochlorothiazide is excreted into breast milk and can reduce milk production. Valsartan is also likely excreted into breast milk, and its effects on the infant are unknown but potentially harmful (e.g., hypotension, renal effects).

Infant Risk: L3 (Moderately safe, but caution advised. Potential for adverse effects on the infant, including hypotension, electrolyte imbalance, and effects on renal function. Risk of decreased milk supply with HCTZ).
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

No overall differences in efficacy 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 due to increased likelihood of decreased renal function and polypharmacy in this population.

Clinical Information

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Clinical Pearls

  • This combination is typically used when monotherapy with either an ARB or a thiazide diuretic is insufficient to control blood pressure.
  • Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but serious side effect.
  • Monitor serum potassium levels closely, as valsartan can cause hyperkalemia and HCTZ can cause hypokalemia, leading to unpredictable effects on potassium.
  • Educate patients on the importance of avoiding potassium supplements or salt substitutes unless specifically instructed by their physician.
  • Patients should be advised to stand up slowly to minimize orthostatic hypotension, especially at the start of therapy or with dose increases.
  • Hydrochlorothiazide can increase uric acid levels and may precipitate gout attacks in susceptible individuals.
  • Hydrochlorothiazide can also cause photosensitivity; advise patients to use sun protection.
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Alternative Therapies

  • Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, Loop Diuretics, Alpha-blockers)
  • Monotherapy with an ARB (e.g., Valsartan alone)
  • Monotherapy with a Thiazide Diuretic (e.g., Hydrochlorothiazide alone)
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Cost & Coverage

Average Cost: $15 - $100+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.