Amlodipine-Valsartan 10-320mg Tabs
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 II Receptor Blocker (ARB) / Calcium Channel Blocker (CCB)
Pregnancy Category
Category D
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a combination of two drugs, amlodipine and valsartan, used to lower high blood pressure. Amlodipine helps relax blood vessels, and valsartan blocks a natural substance in the body that narrows blood vessels. Lowering blood pressure helps prevent strokes, heart attacks, and kidney problems.
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're feeling well.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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 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 a missed one.
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're feeling well.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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 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 a 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 as advised by your doctor.
- Limit or avoid alcohol consumption.
- Avoid smoking.
- Monitor your blood pressure regularly at home as instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg amlodipine / 320 mg valsartan orally once daily. This is a maximum strength combination.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
hypertension:
Initial therapy typically starts with lower doses (e.g., 5/160 mg or 10/160 mg) and is titrated based on blood pressure response. The 10/320 mg strength is for patients whose blood pressure is not adequately controlled on lower doses or on monotherapy with amlodipine 10 mg or valsartan 320 mg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required.
Moderate:
No initial dose adjustment required.
Severe:
Use with caution. Monitor renal function and potassium levels. Valsartan is primarily excreted unchanged in feces, but renal function can be affected by ARBs. Amlodipine is not significantly dialyzable.
Dialysis:
Amlodipine is not dialyzable. Valsartan is not significantly removed by hemodialysis. Use with caution and monitor closely.
Hepatic Impairment:
Mild:
No initial dose adjustment required.
Moderate:
Consider lower initial doses of amlodipine-containing products (e.g., 5 mg amlodipine component). Amlodipine is extensively metabolized by the liver. Valsartan is minimally affected.
Severe:
Not recommended due to lack of studies and potential for increased amlodipine exposure. Use with extreme caution if necessary, with significant dose reduction and close monitoring.
Pharmacology
Mechanism of Action
Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, thereby lowering blood pressure. Valsartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased aldosterone secretion, and reduced sodium and water reabsorption, ultimately lowering blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
Amlodipine: 64-90%; Valsartan: ~23%
Tmax:
Amlodipine: 6-12 hours; Valsartan: 2-4 hours (for combination: Amlodipine: 6-8 hours, Valsartan: 3 hours)
FoodEffect:
Amlodipine: Not significantly affected by food; Valsartan: Food decreases AUC by 48% and Cmax by 59%, but this is not considered clinically significant for efficacy.
Distribution:
Vd:
Amlodipine: ~21 L/kg; Valsartan: ~17 L
ProteinBinding:
Amlodipine: ~97.5%; Valsartan: 94-97%
CnssPenetration:
Amlodipine: Limited; Valsartan: Limited
Elimination:
HalfLife:
Amlodipine: 30-50 hours; Valsartan: 6-9 hours
Clearance:
Not available (specific values for combination)
ExcretionRoute:
Amlodipine: Renal (60% as metabolites, 10% unchanged), Fecal (20-25%); Valsartan: Fecal (83% unchanged), Renal (13% unchanged)
Unchanged:
Amlodipine: ~10%; Valsartan: ~13% (renal), ~83% (fecal)
Pharmacodynamics
OnsetOfAction:
Gradual (BP reduction within 2 hours for valsartan, 24-48 hours for amlodipine)
PeakEffect:
Amlodipine: 6-12 hours; Valsartan: 2-4 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue Amlodipine-Valsartan 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
+ 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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Nose or throat irritation
* Signs of a common cold
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 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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Nose or throat irritation
* Signs of a common cold
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 lightheadedness, especially when standing up (orthostatic hypotension)
- Fainting spells
- Significant swelling in your ankles, feet, or legs that is new or worsening
- Difficulty breathing or unusual shortness of breath
- Unusual weight gain
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat, numbness or tingling)
- Yellowing of the skin or eyes (jaundice)
- Dark urine, severe stomach pain (signs of liver problems)
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.
Kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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.
Kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests checked.
Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. Discuss this with your doctor.
Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult with your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Similarly, if you are on a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication.
It may take several weeks to experience the full effects of this medication. Before consuming alcohol, talk to your doctor about potential interactions.
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 conditions may lead to low blood pressure.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests checked.
Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. Discuss this with your doctor.
Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult with your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Similarly, if you are on a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication.
It may take several weeks to experience the full effects of this medication. Before consuming alcohol, talk to your doctor about potential interactions.
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 conditions may lead to low blood pressure.
If you are 65 years 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)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Dizziness
- Fainting
- Shock
- Hyperkalemia (high potassium levels)
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive. Lay the patient supine with legs elevated. Administer IV fluids and vasopressors for hypotension. Atropine for bradycardia. Calcium gluconate for severe amlodipine overdose. Hemodialysis is not effective for amlodipine and has limited effectiveness for valsartan.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment [eGFR <60 mL/min/1.73 m2])
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Salt substitutes containing potassium
- NSAIDs (including COX-2 inhibitors)
- Lithium
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital)
- Simvastatin (limit simvastatin dose to 20 mg/day)
- Dantrolene (IV)
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effects)
- Grapefruit juice (can increase amlodipine levels)
- Digoxin (minor increase in digoxin levels with valsartan)
- Cimetidine (minor increase in amlodipine levels)
Minor Interactions
- Antacids (no significant effect on absorption)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess efficacy of treatment.
Timing: Prior to initiation of therapy.
Serum Electrolytes (Potassium, Sodium)
Rationale: Valsartan can cause hyperkalemia, especially in patients with renal impairment or on potassium-sparing diuretics. Sodium levels are important for overall fluid balance.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Serum Creatinine, eGFR)
Rationale: Valsartan can cause acute renal dysfunction, especially in patients with pre-existing renal impairment or bilateral renal artery stenosis.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: Amlodipine is extensively metabolized by the liver; hepatic impairment can increase amlodipine exposure.
Timing: Prior to initiation of therapy, especially in patients with suspected hepatic impairment.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly after initiation/dose change, then monthly or every 3-6 months once stable)
Target: <130/80 mmHg (or individualized target based on guidelines and patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose titration or addition of other agents. If BP is too low, consider dose reduction.
Serum Potassium
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, more frequently in patients with renal impairment or on concomitant medications affecting potassium)
Target: 3.5-5.0 mEq/L
Action Threshold: If potassium >5.5 mEq/L, investigate cause, consider dose reduction or discontinuation. If potassium <3.5 mEq/L, investigate cause and supplement if necessary.
Renal Function (SCr, BUN, eGFR)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, more frequently in patients with renal impairment or on concomitant medications affecting renal function)
Target: Stable baseline values
Action Threshold: If SCr increases significantly (>30% from baseline or >0.5 mg/dL), investigate cause, consider dose reduction or discontinuation. If eGFR decreases significantly, investigate cause.
Peripheral Edema
Frequency: At each visit
Target: Absence or minimal
Action Threshold: If significant or bothersome edema develops, consider dose reduction of amlodipine component or addition of a diuretic.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Swelling in ankles, feet, or legs (peripheral edema)
- Fatigue
- Headache
- Flushing
- Palpitations
- Shortness of breath
- Unusual weight gain
- Muscle weakness or cramps (signs of hyperkalemia)
- Irregular heartbeat (signs of hyperkalemia)
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with valsartan. Discontinue as soon as pregnancy is detected.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential risk cannot be excluded. Consider alternative antihypertensive agents if pregnancy is planned or detected early.
Second Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformities, anuria, hypotension, death).
Third Trimester:
High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformities, anuria, hypotension, death).
Lactation
Not recommended during breastfeeding. Both amlodipine and valsartan are excreted in the milk of lactating rats. The potential for serious adverse reactions in breastfed infants is unknown.
Infant Risk:
Risk of adverse effects on the infant is unknown but cannot be excluded. Consider alternative medications or advise against breastfeeding.
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 and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring for hypotension, renal impairment, and peripheral edema.
Clinical Information
Clinical Pearls
- This combination is often used when monotherapy with either a CCB or an ARB is insufficient to control blood pressure.
- Peripheral edema is a common dose-dependent side effect of amlodipine; the ARB component (valsartan) may help mitigate this by causing venodilation.
- Advise patients to avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by their physician, due to the risk of hyperkalemia with valsartan.
- Patients should be educated on the signs and symptoms of hypotension (dizziness, lightheadedness) and hyperkalemia (muscle weakness, irregular heartbeat).
- Take the medication at the same time each day to maintain consistent blood levels and blood pressure control.
Alternative Therapies
- Thiazide diuretics (e.g., hydrochlorothiazide)
- Beta-blockers (e.g., metoprolol, carvedilol)
- ACE inhibitors (e.g., lisinopril, enalapril)
- Other calcium channel blockers (e.g., nifedipine, diltiazem)
- Other angiotensin receptor blockers (e.g., losartan, irbesartan)
- Alpha-blockers (e.g., prazosin, doxazosin)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure safe and effective treatment, 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.