Exforge HCT 10-160-12.5mg Tablets
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
Calcium Channel Blocker (CCB), Angiotensin Receptor Blocker (ARB), Thiazide Diuretic
Pregnancy Category
Category D (2nd and 3rd trimesters) / Category X (if used in 2nd or 3rd trimester due to ARB component)
FDA Approved
Apr 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Exforge HCT is a combination medicine containing three different drugs: amlodipine, valsartan, and hydrochlorothiazide. It is used to treat high blood pressure (hypertension). Amlodipine helps relax blood vessels, valsartan blocks a natural substance that narrows blood vessels, and hydrochlorothiazide is a 'water pill' that helps your body get rid of extra salt and water. Together, these actions help lower your blood pressure.
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.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
Be aware that this medication may increase your urine production, so it's essential to drink plenty of non-caffeinated fluids unless your doctor advises you to limit your fluid intake.
To minimize sleep disturbances, try to avoid taking your medication too close to bedtime.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store your medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the 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 with 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 the missed dose as soon as you remember.
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 the missed dose.
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.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
Be aware that this medication may increase your urine production, so it's essential to drink plenty of non-caffeinated fluids unless your doctor advises you to limit your fluid intake.
To minimize sleep disturbances, try to avoid taking your medication too close to bedtime.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store your medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the 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 with 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 the missed dose as soon as you remember.
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 the missed dose.
Lifestyle & Tips
- Take your 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.
- Monitor your blood pressure regularly at home as advised by your doctor.
- Limit sodium (salt) intake in your diet.
- Maintain a healthy weight.
- Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
- Limit alcohol consumption.
- Avoid grapefruit or grapefruit juice while taking this medication, as it can interact with amlodipine.
- Stay hydrated, especially during hot weather or exercise, but avoid excessive fluid intake unless advised by your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (10-160-12.5mg) orally once daily. This strength is typically used when blood pressure is not adequately controlled with dual therapy or as a maintenance dose.
Condition-Specific Dosing:
initial_therapy:
Not recommended as initial therapy for hypertension. Should be used after titration of individual components or dual therapy.
max_dose:
Amlodipine 10mg, Valsartan 320mg, Hydrochlorothiazide 25mg per day (maximum components in combination)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required for mild to moderate renal impairment (CrCl âĨ30 mL/min).
Moderate:
No dosage adjustment required for mild to moderate renal impairment (CrCl âĨ30 mL/min).
Severe:
Contraindicated in patients with anuria. Not recommended for patients with severe renal impairment (CrCl <30 mL/min) due to the hydrochlorothiazide component.
Dialysis:
Not recommended for patients on dialysis due to lack of data and potential for electrolyte imbalances.
Hepatic Impairment:
Mild:
Caution advised. Consider lower starting dose of amlodipine (e.g., 2.5 mg) if initiating individual components.
Moderate:
Caution advised. Consider lower starting dose of amlodipine (e.g., 2.5 mg). Valsartan exposure may be increased. Not recommended for severe hepatic impairment.
Severe:
Not recommended due to lack of data and potential for increased exposure to amlodipine and valsartan.
Pharmacology
Mechanism of Action
Exforge HCT combines three antihypertensive agents with complementary mechanisms to control blood pressure: Amlodipine (a dihydropyridine calcium channel blocker), Valsartan (an angiotensin II receptor blocker), and Hydrochlorothiazide (a thiazide diuretic). Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation and reduction in peripheral vascular resistance. Valsartan selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues, inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.
Pharmacokinetics
Absorption:
Bioavailability:
Amlodipine: 64-90%; Valsartan: 23% (absolute); Hydrochlorothiazide: 50-80%
Tmax:
Amlodipine: 6-12 hours; Valsartan: 2-4 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect:
Amlodipine: Not affected; Valsartan: Decreased AUC and Cmax by 48% and 59% respectively, but not clinically significant for BP control; Hydrochlorothiazide: Not significantly affected
Distribution:
Vd:
Amlodipine: 21 L/kg; Valsartan: 17 L; Hydrochlorothiazide: 0.8-1.7 L/kg
ProteinBinding:
Amlodipine: ~97.5%; Valsartan: 94-97%; Hydrochlorothiazide: 40-68%
CnssPenetration:
Amlodipine: Limited; Valsartan: Limited; Hydrochlorothiazide: Limited
Elimination:
HalfLife:
Amlodipine: 30-50 hours; Valsartan: ~6 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance:
Not available
ExcretionRoute:
Amlodipine: Urine (60% as metabolites, 10% unchanged); Valsartan: Feces (83%), Urine (13%); Hydrochlorothiazide: Urine (95% unchanged)
Unchanged:
Amlodipine: ~10%; Valsartan: ~13%; Hydrochlorothiazide: ~95%
Pharmacodynamics
OnsetOfAction:
Amlodipine: Gradual (hours); Valsartan: 2 hours; Hydrochlorothiazide: 2 hours
PeakEffect:
Amlodipine: 6-12 hours; Valsartan: 4-6 hours; Hydrochlorothiazide: 4 hours
DurationOfAction:
Amlodipine: 24 hours; Valsartan: 24 hours; Hydrochlorothiazide: 6-12 hours (antihypertensive effect up to 24 hours)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
FETAL TOXICITY: If pregnancy is detected, discontinue Exforge HCT 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 or seek immediate 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 stomach upset
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or stomach pain
+ Upset stomach or vomiting
+ Light-colored stools or yellow skin and eyes
Muscle spasms
New or worsening chest pain
Restlessness
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements
Eye problems, such as changes in vision or eye pain, which can lead to permanent vision loss if left untreated
Important Skin Cancer Warning
Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk, protect your skin from the sun and follow your doctor's instructions for regular skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lumps or growths, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals experience no side effects or only mild ones, others may encounter more bothersome symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dizziness, tiredness, or weakness
Headache
Upset stomach
* Back pain
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.
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 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 stomach upset
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or stomach pain
+ Upset stomach or vomiting
+ Light-colored stools or yellow skin and eyes
Muscle spasms
New or worsening chest pain
Restlessness
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements
Eye problems, such as changes in vision or eye pain, which can lead to permanent vision loss if left untreated
Important Skin Cancer Warning
Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk, protect your skin from the sun and follow your doctor's instructions for regular skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lumps or growths, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals experience no side effects or only mild ones, others may encounter more bothersome symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dizziness, tiredness, or weakness
Headache
Upset stomach
* Back pain
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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (especially when standing up)
- Unusual swelling of the hands, ankles, or feet that is new or worsening
- Persistent muscle cramps or weakness
- Signs of high potassium (e.g., slow or irregular heartbeat, muscle weakness)
- Signs of low sodium (e.g., headache, confusion, slurred speech, severe weakness, vomiting, seizures)
- Signs of kidney problems (e.g., little or no urination, swelling in your feet or ankles, feeling tired or short of breath)
- Signs of liver problems (e.g., nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes))
- Signs of an allergic reaction (e.g., hives, difficulty breathing, swelling of your face, lips, tongue, or throat)
- Unusual bleeding or bruising
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 use of dofetilide.
Presence of kidney disease or liver disease.
Inability to urinate.
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
* Breastfeeding status, as you should not breastfeed 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 the safety of taking this medication in conjunction with your other treatments and health issues. 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:
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 use of dofetilide.
Presence of kidney disease or liver disease.
Inability to urinate.
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
* Breastfeeding status, as you should not breastfeed 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 the safety of taking this medication in conjunction with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing 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, and have regular blood tests as advised by your doctor.
Interactions with Other Substances
This medication may affect certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor.
Potential Side Effects
It may take a few weeks to experience the full effects of this medication. Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose, which may increase the risk of heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk with your doctor.
Over-the-Counter (OTC) Products and Other 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. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may cause drowsiness with your doctor.
Precautions in Hot Weather and with Physical Activity
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, which can lead to low blood pressure, inform your doctor.
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.
Special Considerations
If you have lupus, this medication can cause your condition to become active or worsen. Inform your doctor immediately if you experience new or worsening symptoms. Liver problems have been associated with this medication, and in some cases, hospitalization has been necessary. Discuss this risk with your doctor.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing 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, and have regular blood tests as advised by your doctor.
Interactions with Other Substances
This medication may affect certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor.
Potential Side Effects
It may take a few weeks to experience the full effects of this medication. Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose, which may increase the risk of heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk with your doctor.
Over-the-Counter (OTC) Products and Other 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. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may cause drowsiness with your doctor.
Precautions in Hot Weather and with Physical Activity
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, which can lead to low blood pressure, inform your doctor.
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.
Special Considerations
If you have lupus, this medication can cause your condition to become active or worsen. Inform your doctor immediately if you experience new or worsening symptoms. Liver problems have been associated with this medication, and in some cases, hospitalization has been necessary. Discuss this risk with your doctor.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Dizziness
- Fainting
- Tachycardia (fast heart rate)
- Bradycardia (slow heart rate)
- Shock
- Electrolyte disturbances (e.g., severe hypokalemia, hyponatremia)
- Dehydration
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. May involve IV fluids, vasopressors for hypotension, and correction of electrolyte imbalances.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or moderate to severe renal impairment due to increased risk of hyperkalemia, hypotension, and renal impairment)
Major Interactions
- Lithium (increased serum lithium concentrations and toxicity due to reduced renal clearance by HCTZ and Valsartan)
- Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other agents that may increase potassium levels (e.g., trimethoprim-sulfamethoxazole, cyclosporine, heparin) (increased risk of hyperkalemia with Valsartan)
- NSAIDs, including selective COX-2 inhibitors (reduced antihypertensive effect of Valsartan and HCTZ, increased risk of renal impairment)
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (increased amlodipine exposure, leading to increased risk of hypotension and edema)
- Dual blockade of the Renin-Angiotensin-Aldosterone System (RAAS) with ACE inhibitors or aliskiren (increased risk of hypotension, hyperkalemia, and renal impairment compared to monotherapy)
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, St. John's Wort) (decreased amlodipine exposure, potentially reducing efficacy)
- Corticosteroids (systemic) (attenuated diuretic and antihypertensive effects of HCTZ)
- Bile acid sequestrants (e.g., cholestyramine, colestipol) (reduced absorption of HCTZ)
- Digoxin (HCTZ-induced hypokalemia may potentiate digoxin toxicity)
- Antidiabetic agents (insulin, oral hypoglycemics) (HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents)
- Muscle relaxants, non-depolarizing (e.g., tubocurarine) (HCTZ may potentiate their effect)
- Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
- Calcium salts (increased serum calcium levels due to HCTZ)
Minor Interactions
- Alcohol (may potentiate orthostatic hypotension)
- Barbiturates, narcotics (may potentiate orthostatic hypotension)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide therapy.
Timing: Prior to initiation
Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)
Rationale: To assess baseline electrolyte status, especially potassium due to HCTZ and valsartan effects.
Timing: Prior to initiation
Renal Function (BUN, Serum Creatinine, eGFR)
Rationale: To assess baseline kidney function, crucial for valsartan and HCTZ dosing and safety.
Timing: Prior to initiation
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: To assess baseline hepatic function, especially for amlodipine and valsartan.
Timing: Prior to initiation
Uric Acid
Rationale: HCTZ can increase uric acid levels.
Timing: Prior to initiation
Fasting Glucose
Rationale: HCTZ can affect glucose metabolism.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Persistent BP above target or symptomatic hypotension
Serum Electrolytes (Potassium, Sodium)
Frequency: Within 1-2 weeks of initiation/dose change, then 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 or >5.5 mEq/L; Sodium <130 or >150 mEq/L
Renal Function (BUN, Serum Creatinine, eGFR)
Frequency: Within 1-2 weeks of initiation/dose change, then every 3-6 months or as clinically indicated
Target: Stable within patient's baseline range
Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR
Uric Acid
Frequency: Periodically, especially if patient has history of gout
Target: Within normal limits
Action Threshold: Symptomatic hyperuricemia or gout flares
Fasting Glucose
Frequency: Periodically, especially in diabetic patients or those at risk
Target: Within normal limits or individualized target for diabetes
Action Threshold: Significant hyperglycemia
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Swelling (edema) in ankles/feet
- Muscle cramps or weakness
- Unusual thirst
- Dry mouth
- Nausea
- Vomiting
- Irregular heartbeat
- Signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with the valsartan component. Discontinue as soon as pregnancy is detected. Limited data on first trimester exposure, but risk cannot be excluded.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies with valsartan show risk. Amlodipine is Category C. HCTZ is Category B (but D in 2nd/3rd trimester). Overall, avoid if possible.
Second Trimester:
High risk of fetal injury (hypotension, oligohydramnios, anuria, renal failure, skull hypoplasia, death) due to valsartan.
Third Trimester:
High risk of fetal injury (hypotension, oligohydramnios, anuria, renal failure, skull hypoplasia, death) due to valsartan. Neonatal effects (hypotension, hyperkalemia) may also occur.
Lactation
Not recommended during breastfeeding. Amlodipine is present in human milk. Hydrochlorothiazide is excreted in human milk and can suppress lactation. It is unknown if valsartan is excreted in human milk. Due to 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.
Infant Risk:
Potential for hypotension, electrolyte disturbances, and other adverse effects in the infant. Risk of lactation suppression.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly (âĨ65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses of individual components if initiating therapy. Monitor renal function and electrolytes closely.
Clinical Information
Clinical Pearls
- Exforge HCT is a fixed-dose combination and should generally be used after patients have been titrated to effective doses of the individual components or dual therapy.
- Patients should be advised to avoid grapefruit and grapefruit juice due to potential interaction with amlodipine.
- Monitor for signs of hyperkalemia (due to valsartan) and hypokalemia (due to HCTZ), as these can occur despite the combination.
- Orthostatic hypotension can occur, especially at initiation or dose titration; advise patients to rise slowly from a sitting or lying position.
- Due to the HCTZ component, monitor for photosensitivity reactions; advise patients to use sun protection.
- This medication is not for initial therapy of hypertension; it's for patients whose blood pressure is not adequately controlled on dual therapy or for convenience once doses are established.
Alternative Therapies
- Individual components (Amlodipine, Valsartan, Hydrochlorothiazide)
- Other ARB/CCB combinations (e.g., Exforge, Azor, Twynsta)
- Other ARB/diuretic combinations (e.g., Diovan HCT, Benicar HCT)
- Other CCB/diuretic combinations
- ACE inhibitor-based triple therapies
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 (for generic)
General Drug Facts
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 details. 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 information about the medication taken, the amount, and the time it happened.