Valsartan/hctz 160mg/12.5mg Tablet
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.
Drug Class
Antihypertensive
Pharmacologic Class
Angiotensin Receptor Blocker (ARB) / Thiazide Diuretic
Pregnancy Category
Category D
FDA Approved
Apr 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Valsartan/HCTZ is a combination medicine used to treat high blood pressure (hypertension). Valsartan is an 'ARB' that helps relax blood vessels, and hydrochlorothiazide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water. Together, they help lower your blood pressure, which can reduce your risk of stroke and heart attack.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Be aware that this medication may increase your urine production. To minimize sleep disturbances, try to avoid taking it too close to bedtime.
Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Be aware that this medication may increase your urine production. To minimize sleep disturbances, try to avoid taking it too close to bedtime.
Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking this medication without talking to your doctor, even if you feel well.
- Continue to follow a low-sodium diet as recommended by your doctor.
- Engage in regular physical activity and maintain a healthy weight.
- Limit alcohol intake as it can further lower blood pressure.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
- Monitor your blood pressure regularly at home if advised by your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
160 mg valsartan / 12.5 mg hydrochlorothiazide orally once daily
Dose Range:
160 - 320 mg
Condition-Specific Dosing:
initial_therapy:
May be initiated with 160 mg/12.5 mg once daily if blood pressure is not adequately controlled with monotherapy or if initial combination therapy is desired.
maximum_dose:
Maximum recommended dose is 320 mg valsartan / 25 mg hydrochlorothiazide once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl > 50 mL/min)
Moderate:
Use with caution (CrCl 30-50 mL/min). Monitor renal function and potassium.
Severe:
Contraindicated (CrCl < 30 mL/min) due to hydrochlorothiazide component.
Dialysis:
Not recommended. Valsartan is not significantly removed by hemodialysis. Hydrochlorothiazide is not dialyzable.
Hepatic Impairment:
Mild:
Use with caution. No dose adjustment needed.
Moderate:
Use with caution. Not recommended in patients with severe hepatic impairment or biliary cirrhosis.
Severe:
Not recommended.
Pharmacology
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 and reduced sodium and water retention. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.
Pharmacokinetics
Absorption:
Bioavailability:
Valsartan: ~23% (oral solution), ~25% (tablet); Hydrochlorothiazide: 65-75%
Tmax:
Valsartan: 2-4 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect:
Valsartan: Food decreases AUC by ~48% and Cmax by ~59%, but does not significantly affect therapeutic effect. Hydrochlorothiazide: Food may increase absorption.
Distribution:
Vd:
Valsartan: ~17 L; Hydrochlorothiazide: ~0.8 L/kg
ProteinBinding:
Valsartan: ~95% (serum albumin); Hydrochlorothiazide: 40-60%
CnssPenetration:
Valsartan: Limited; Hydrochlorothiazide: No
Elimination:
HalfLife:
Valsartan: ~6 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance:
Not available
ExcretionRoute:
Valsartan: Primarily fecal (83%), renal (13%); Hydrochlorothiazide: Primarily renal (unchanged)
Unchanged:
Valsartan: ~13% (urine); Hydrochlorothiazide: >95% (urine)
Pharmacodynamics
OnsetOfAction:
Valsartan: ~2 hours; Hydrochlorothiazide: ~2 hours
PeakEffect:
Valsartan: 4-6 hours; Hydrochlorothiazide: ~4 hours
DurationOfAction:
Valsartan: ~24 hours; Hydrochlorothiazide: 6-12 hours
Safety & Warnings
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.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Changes in urine output or dry mouth
+ Dry eyes or severe nausea and vomiting
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Swelling in the arms or legs
Eye problems, such as changes in vision or eye pain, which can occur within hours to weeks of starting this medication and may lead to permanent vision loss if left untreated
Skin changes, such as new or changing moles, or lumps, which may be a sign of skin cancer (rarely associated with hydrochlorothiazide)
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Dizziness or headache
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Changes in urine output or dry mouth
+ Dry eyes or severe nausea and vomiting
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Swelling in the arms or legs
Eye problems, such as changes in vision or eye pain, which can occur within hours to weeks of starting this medication and may lead to permanent vision loss if left untreated
Skin changes, such as new or changing moles, or lumps, which may be a sign of skin cancer (rarely associated with hydrochlorothiazide)
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Dizziness or headache
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting spells
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Persistent dry cough
- 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 feet or ankles)
- Yellowing of the skin or eyes (jaundice)
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 conditions to ensure safe treatment:
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 treatment with dofetilide.
Difficulty urinating.
Concurrent 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 treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Difficulty urinating.
Concurrent 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 treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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, get up slowly from a sitting or lying position, and be cautious 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 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. This medication may affect certain lab test results, so 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 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 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 avoid 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 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.
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, get up slowly from a sitting or lying position, and be cautious 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 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. This medication may affect certain lab test results, so 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 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 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 avoid 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 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.
Overdose Information
Overdose Symptoms:
- Profound hypotension (low blood pressure)
- Dizziness or lightheadedness
- Fainting
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
- Electrolyte imbalances (e.g., hypokalemia, hyponatremia)
- Dehydration
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Treatment is supportive and symptomatic. Intravenous fluids may be administered to correct hypotension and electrolyte imbalances. Hemodialysis is not effective for valsartan and minimally effective for hydrochlorothiazide.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or moderate to severe renal impairment (GFR < 60 mL/min/1.73 m²))
Major Interactions
- Lithium (increased serum lithium concentrations and toxicity)
- NSAIDs (including selective COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment)
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium (increased risk of hyperkalemia)
- Other antihypertensive agents (additive hypotensive effects)
- Digoxin (hypokalemia/hypomagnesemia induced by HCTZ can increase digoxin toxicity)
Moderate Interactions
- Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
- Antidiabetic agents (oral agents and insulin) (HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents)
- Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)
- Muscle relaxants, non-depolarizing (e.g., tubocurarine) (HCTZ may potentiate effect)
- Pressor amines (e.g., norepinephrine) (HCTZ may decrease arterial responsiveness)
- Allopurinol (increased risk of hypersensitivity reactions to allopurinol with HCTZ)
- Cyclosporine (increased risk of hyperuricemia and gouty complications with HCTZ)
Minor Interactions
- Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)
Monitoring
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, especially potassium due to ARB/diuretic combination and risk of hypo/hyperkalemia.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN)
Rationale: To assess baseline kidney function, as dose adjustments may be needed and to monitor for potential renal impairment.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, as valsartan is metabolized in the liver and dose adjustments may be needed in severe impairment.
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.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, at each clinic visit or as directed by physician, until stable and then periodically.
Target: <130/80 mmHg (general target, individualized based on patient comorbidities)
Action Threshold: Persistently elevated BP despite therapy, or symptomatic hypotension.
Serum Electrolytes (Potassium, Sodium)
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L
Action Threshold: Potassium < 3.0 mEq/L or > 5.5 mEq/L; Sodium < 130 mEq/L or > 150 mEq/L, or symptomatic changes.
Renal Function (Serum Creatinine, BUN)
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Creatinine: Stable within patient's baseline range; BUN: Stable within patient's baseline range.
Action Threshold: Significant increase in creatinine (>30% from baseline) or signs of acute kidney injury.
Serum Uric Acid
Frequency: Periodically (e.g., annually) or if symptoms of gout develop.
Target: Within normal limits for patient.
Action Threshold: Elevated levels with symptoms of gout.
Blood Glucose
Frequency: Periodically (e.g., annually) or more frequently in diabetic patients.
Target: Within target range for patient (e.g., HbA1c <7% for diabetics).
Action Threshold: Significant increase in blood glucose or worsening glycemic control.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Fatigue or weakness
- Muscle cramps or weakness (signs of electrolyte imbalance)
- Swelling of face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Persistent dry cough
- Unusual thirst or dry mouth
- Nausea or vomiting
- Irregular heartbeat
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is also generally avoided due to potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided due to potential theoretical risks to fetal development. Category C.
Second Trimester:
High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
Third Trimester:
High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
Lactation
Not recommended during breastfeeding. Hydrochlorothiazide is excreted in human milk and can suppress lactation. It is unknown if valsartan is excreted in human milk. Due to the potential for serious adverse effects on 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.
Infant Risk:
Risk of electrolyte disturbances, hypotension, and other adverse effects from hydrochlorothiazide. Unknown risk from valsartan.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in this population.
Geriatric Use
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. Monitor renal function and electrolytes closely, as elderly patients are more likely to have age-related decreases in renal function and be on concomitant medications that affect electrolytes.
Clinical Information
Clinical Pearls
- This combination is often used when monotherapy with either an ARB or a diuretic is insufficient to control blood pressure.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately.
- Monitor for electrolyte imbalances, especially hypokalemia (due to HCTZ) and hyperkalemia (due to valsartan, especially with potassium-sparing diuretics or supplements).
- Thiazide diuretics can increase serum uric acid and glucose levels; monitor these parameters, especially in patients with a history of gout or diabetes.
- Advise patients to stay well-hydrated, especially during hot weather or exercise, to prevent dehydration and electrolyte imbalances.
- Take consistently at the same time each day to maintain steady blood pressure control.
Alternative Therapies
- Other classes of antihypertensives (e.g., ACE inhibitors, calcium channel blockers, beta-blockers, other diuretics)
- Lifestyle modifications (dietary changes, exercise, weight management, stress reduction)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
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's a good idea 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.