Amlodipine-Valsartan 5-160mg 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
Calcium Channel Blocker (CCB) / Angiotensin II Receptor Blocker (ARB) Combination
Pregnancy Category
Category D
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of two drugs, amlodipine and valsartan, used to treat high blood pressure. Amlodipine helps relax blood vessels, making it easier for blood to flow. Valsartan blocks a natural substance in your body that narrows blood vessels, also helping to relax them. Together, they work to lower your blood pressure, which can help prevent strokes, heart attacks, and kidney problems.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and 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
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
Missing 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and 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
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
Missing 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 one.
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.
- Monitor your blood pressure regularly at home as advised by your doctor.
- Maintain a healthy diet, low in sodium and rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
- Limit alcohol intake.
- Avoid smoking.
- Manage stress effectively.
- Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One 5 mg/160 mg tablet orally once daily
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
initial_therapy:
Starting dose is typically 5 mg/160 mg once daily. May be titrated up to a maximum of 10 mg/320 mg once daily based on blood pressure response and tolerability.
add_on_therapy:
Can be substituted for the individually titrated components or added to existing therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Use with caution. Valsartan is not recommended in patients with severe renal impairment (CrCl <10 mL/min) or on dialysis.
Dialysis:
Valsartan is not recommended in patients on dialysis. Amlodipine is not dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment required for valsartan. For amlodipine, consider starting with the lowest dose (e.g., 2.5 mg amlodipine component) in patients with mild to moderate hepatic impairment.
Moderate:
Use with caution. For amlodipine, consider starting with the lowest dose (e.g., 2.5 mg amlodipine component).
Severe:
Use with caution. Amlodipine dose adjustment is required. Valsartan has not been studied in severe hepatic impairment.
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 reduced 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 prevents the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption, ultimately lowering blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
Amlodipine: 64-90%; Valsartan: 23% (absolute)
Tmax:
Amlodipine: 6-12 hours; Valsartan: 2-4 hours
FoodEffect:
Amlodipine: Not affected by food; Valsartan: Food decreases AUC by approximately 40% and Cmax by approximately 50%, but this is not clinically significant for blood pressure lowering.
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 hours
Clearance:
Not available
ExcretionRoute:
Amlodipine: Renal (60% as metabolites, 10% unchanged), Fecal (20-25%); Valsartan: Fecal (83% unchanged), Renal (13% unchanged)
Unchanged:
Amlodipine: ~10% (renal); Valsartan: ~83% (fecal), ~13% (renal)
Pharmacodynamics
OnsetOfAction:
Amlodipine: Gradual, within hours; Valsartan: Within 2 hours
PeakEffect:
Amlodipine: 6-12 hours; Valsartan: 4-6 hours
DurationOfAction:
Amlodipine: 24 hours; Valsartan: 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 immediately or seek emergency 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Nose or throat irritation
* Symptoms of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Nose or throat irritation
* Symptoms of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 (signs of low blood pressure)
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Yellowing of the skin or eyes (jaundice)
- Unusual tiredness or weakness
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in legs/feet)
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, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase your risk of certain complications.
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 other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase your risk of certain complications.
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 other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 you. 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, adhere to the schedule for blood work and other laboratory tests as recommended by your doctor.
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 to understand any potential interactions.
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 symptoms 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 you. 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, adhere to the schedule for blood work and other laboratory tests as recommended by your doctor.
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 to understand any potential interactions.
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 symptoms 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:
- Profound hypotension (very low blood pressure)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Peripheral vasodilation (excessive widening of blood vessels)
- Shock with fatal outcome
- Hyperkalemia (due to valsartan)
What to Do:
Immediately seek emergency medical attention or call a poison control center (e.g., 1-800-222-1222). Management is supportive, including elevation of extremities, fluid resuscitation, and vasopressors for hypotension. Calcium gluconate may be administered intravenously for calcium channel blocker overdose. Hemodialysis is not effective for amlodipine or valsartan removal.
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
- Lithium
- NSAIDs (including selective COX-2 inhibitors)
- CYP3A4 inhibitors (strong, e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)
- CYP3A4 inducers (strong, e.g., rifampin, St. John's Wort, carbamazepine, phenobarbital, phenytoin)
Moderate Interactions
- Grapefruit juice
- Other antihypertensive agents (additive effect)
- Simvastatin (amlodipine increases simvastatin exposure)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess efficacy of treatment.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: Valsartan can cause hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing diuretics/supplements.
Timing: Prior to initiation of therapy.
Renal Function (SCr, BUN, eGFR)
Rationale: Valsartan can cause acute renal failure, 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; valsartan is minimally metabolized. Baseline assessment is prudent.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly/quarterly.
Target: <130/80 mmHg (individualized based on guidelines and patient comorbidities)
Action Threshold: If BP remains uncontrolled or if symptomatic hypotension occurs.
Serum Potassium
Frequency: Periodically, especially after dose changes, in patients with renal impairment, or those on concomitant medications affecting potassium.
Target: 3.5-5.0 mEq/L
Action Threshold: If K+ >5.5 mEq/L or significant changes occur.
Renal Function (SCr, BUN)
Frequency: Periodically, especially after dose changes, in patients with renal impairment, or those on concomitant medications affecting renal function (e.g., NSAIDs).
Target: Stable within patient's baseline range
Action Threshold: If SCr increases significantly (e.g., >30% from baseline) or eGFR decreases significantly.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Peripheral edema (swelling of ankles/feet)
- Headache
- Flushing
- Palpitations
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat, difficulty breathing)
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. Drugs that act directly on the renin-angiotensin system (like valsartan) can cause injury and death to the developing fetus. If pregnancy is detected, discontinue as soon as possible.
Trimester-Specific Risks:
First Trimester:
Limited data, but risk cannot be excluded. Exposure during the first trimester is not associated with major congenital malformations, but continued exposure into the second and third trimesters is associated with significant fetal harm.
Second Trimester:
Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Lactation
Not recommended during breastfeeding. Both amlodipine and valsartan are excreted in breast milk. Due to the potential for serious adverse reactions 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:
Risk of hypotension, hyperkalemia, and renal impairment in the infant. Amlodipine may cause drowsiness in the infant.
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. Consider starting at the lower end of the dosing range, especially if hepatic impairment is present, due to potential for decreased clearance of amlodipine.
Clinical Information
Clinical Pearls
- This combination is useful for patients whose blood pressure is not adequately controlled with either amlodipine or valsartan alone.
- Peripheral edema is a common side effect of amlodipine; valsartan may help mitigate this by causing vasodilation.
- Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this can be life-threatening.
- Counsel patients on the importance of avoiding potassium supplements and salt substitutes unless specifically instructed by their physician due to the risk of hyperkalemia with valsartan.
- Patients should be advised to avoid grapefruit and grapefruit juice while taking this medication due to potential interaction with amlodipine.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs) (e.g., losartan, irbesartan, candesartan)
- Other Calcium Channel Blockers (CCBs) (e.g., nifedipine, diltiazem, verapamil)
- ACE Inhibitors (e.g., lisinopril, enalapril, ramipril)
- Thiazide Diuretics (e.g., hydrochlorothiazide, chlorthalidone)
- Beta-blockers (e.g., metoprolol, carvedilol)
- Other combination antihypertensive therapies
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (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 your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.