Amlodipine Besylate 10mgtablets
It is used to treat high blood pressure.It is used to treat some types of chest pain (angina).It is used in some people to lower the chance of having to go to the hospital for chest pain (angina) and needing certain heart procedures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Antianginal
Pharmacologic Class
Calcium Channel Blocker, Dihydropyridine
Pregnancy Category
Not available
FDA Approved
Aug 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Amlodipine is a medicine used to treat high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels, which allows blood to flow more easily and reduces the workload on your heart.
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.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food, as directed by your doctor.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To ensure the quality and safety of your medication:
Store your medication at room temperature, away from direct light.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom, as the humidity and temperature can affect its potency.
Protect your medication from heat and light to maintain its effectiveness.
Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
However, if it has been 12 hours or more since the missed dose, skip the 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 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.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food, as directed by your doctor.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To ensure the quality and safety of your medication:
Store your medication at room temperature, away from direct light.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom, as the humidity and temperature can affect its potency.
Protect your medication from heat and light to maintain its effectiveness.
Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
However, if it has been 12 hours or more since the missed dose, skip the 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 dose.
Lifestyle & Tips
- Continue to follow a healthy diet (e.g., low-sodium, low-fat).
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Quit smoking.
- Manage stress.
- Monitor your blood pressure regularly at home as instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg once daily, maximum 10 mg once daily
Dose Range:
2.5 - 10 mg
Condition-Specific Dosing:
hypertension:
Initial 5 mg once daily; may be increased to a maximum of 10 mg once daily. For frail or elderly patients, or patients with hepatic insufficiency, initial dose 2.5 mg once daily.
chronic_stable_angina:
Initial 5 mg once daily; may be increased to a maximum of 10 mg once daily.
vasospastic_angina:
Initial 5 mg once daily; may be increased to a maximum of 10 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For hypertension in patients 6-17 years: 2.5 mg once daily, may be titrated up to 5 mg once daily based on response and tolerability.
Adolescent:
For hypertension in patients 6-17 years: 2.5 mg once daily, may be titrated up to 5 mg once daily based on response and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Amlodipine is not dialyzable. No adjustment needed.
Hepatic Impairment:
Mild:
Consider lower initial dose (e.g., 2.5 mg once daily)
Moderate:
Consider lower initial dose (e.g., 2.5 mg once daily)
Severe:
Consider lower initial dose (e.g., 2.5 mg once daily)
Pharmacology
Mechanism of Action
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to peripheral arterial vasodilation, which directly reduces peripheral vascular resistance and lowers blood pressure. In angina, it dilates peripheral arterioles and coronary arteries, reducing afterload and improving myocardial oxygen supply.
Pharmacokinetics
Absorption:
Bioavailability:
64-90%
Tmax:
6-12 hours
FoodEffect:
Food does not affect the absorption of amlodipine.
Distribution:
Vd:
21 L/kg
ProteinBinding:
Approximately 97.5%
CnssPenetration:
Limited
Elimination:
HalfLife:
30-50 hours
Clearance:
Not available
ExcretionRoute:
Approximately 60% of the administered dose is excreted in the urine as inactive metabolites, and 20-25% is excreted in the feces.
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Gradual, 1-2 hours
PeakEffect:
6-12 hours
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Fast or abnormal heartbeat
Swelling
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
Drowsiness
Fatigue
Weakness
Flushing
Upset stomach
Stomach pain
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Fast or abnormal heartbeat
Swelling
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
Drowsiness
Fatigue
Weakness
Flushing
Upset stomach
Stomach pain
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
- Unusual swelling of hands, ankles, or feet that is severe or bothersome
- Chest pain that worsens or does not go away
- Shortness of breath
- Irregular heartbeat
- Yellowing of skin or eyes (jaundice)
- Severe skin rash
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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Regularly monitor your blood pressure as instructed by your healthcare provider. Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack, particularly in individuals with severe heart blood vessel disease. If you experience any chest pain, consult your doctor promptly.
If you have high blood pressure, consult your doctor before taking 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.
It is also important to discuss alcohol consumption with your doctor before drinking while taking this medication. Additionally, be aware that liver problems have occurred with this medication, sometimes requiring hospitalization. Inform your doctor about any concerns.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor.
Specific Instructions for Chest Pain
Do not use this medication to treat sudden chest pain, as it will not provide relief. Instead, consult your doctor for appropriate treatment.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Regularly monitor your blood pressure as instructed by your healthcare provider. Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack, particularly in individuals with severe heart blood vessel disease. If you experience any chest pain, consult your doctor promptly.
If you have high blood pressure, consult your doctor before taking 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.
It is also important to discuss alcohol consumption with your doctor before drinking while taking this medication. Additionally, be aware that liver problems have occurred with this medication, sometimes requiring hospitalization. Inform your doctor about any concerns.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor.
Specific Instructions for Chest Pain
Do not use this medication to treat sudden chest pain, as it will not provide relief. Instead, consult your doctor for appropriate treatment.
Overdose Information
Overdose Symptoms:
- Profound and prolonged systemic hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Reflex tachycardia (fast heart rate)
- Peripheral vasodilation with possible shock and death
What to Do:
Call 911 or your local emergency number immediately. For less severe cases, contact a poison control center (1-800-222-1222). Management includes symptomatic and supportive care, including elevation of extremities, fluid administration, and vasopressors if hypotension persists. Calcium gluconate may be beneficial to reverse the effects of calcium channel blockade.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May significantly increase amlodipine exposure, leading to increased risk of hypotension and edema. Monitor for symptoms of hypotension and edema and adjust amlodipine dose if necessary.
- Simvastatin: Co-administration with amlodipine increases simvastatin exposure. Limit simvastatin dose to 20 mg daily in patients on amlodipine.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): May decrease amlodipine plasma concentrations, potentially reducing efficacy. Monitor blood pressure and consider amlodipine dose adjustment.
- Other antihypertensives (e.g., beta-blockers, ACE inhibitors, diuretics): Additive hypotensive effects. Monitor blood pressure closely.
- Sildenafil: May cause additive blood pressure lowering effects. Consider lower initial doses of sildenafil.
- Grapefruit juice: May increase amlodipine exposure due to CYP3A4 inhibition. Avoid large quantities of grapefruit juice.
Minor Interactions
- Tacrolimus: Amlodipine may increase tacrolimus blood concentrations. Monitor tacrolimus levels and adjust dose if necessary.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy
Heart Rate (HR)
Rationale: To establish baseline.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: Amlodipine is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation of therapy, if hepatic impairment is suspected or known
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 (general adult target, may vary based on comorbidities)
Action Threshold: If BP remains uncontrolled or drops excessively (e.g., symptomatic hypotension)
Heart Rate (HR)
Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly or every 3-6 months once stable
Target: 60-100 bpm
Action Threshold: If symptomatic bradycardia or tachycardia occurs
Peripheral Edema
Frequency: Regularly, at each visit
Target: Absence of significant edema
Action Threshold: If significant or bothersome ankle/leg edema develops
Symptom Monitoring
- Dizziness
- Headache
- Flushing
- Palpitations
- Fatigue
- Nausea
- Abdominal pain
- Somnolence
- Peripheral edema (swelling of ankles/feet)
Special Patient Groups
Pregnancy
Amlodipine is not recommended for use in pregnancy unless the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects or miscarriage with amlodipine use during pregnancy, but uncontrolled hypertension during pregnancy carries risks to both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited human data, no clear evidence of increased risk.
Third Trimester:
Limited human data, no clear evidence of increased risk. However, uncontrolled hypertension in late pregnancy can lead to preeclampsia, gestational hypertension, and adverse fetal outcomes.
Lactation
Amlodipine is present in human milk. Limited data suggest that amlodipine levels in breast milk are low and unlikely to cause adverse effects in breastfed infants. However, monitor the infant for hypotension, bradycardia, and somnolence.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Approved for hypertension in pediatric patients 6-17 years of age. Dosing is lower than adult dosing (2.5 mg to 5 mg once daily). Safety and effectiveness in pediatric patients younger than 6 years of age have not been established.
Geriatric Use
Clearance of amlodipine is decreased in elderly patients, resulting in increased AUC and elimination half-life. Initiate therapy with the lowest dose (2.5 mg once daily) and titrate slowly. Monitor closely for adverse effects, especially peripheral edema.
Clinical Information
Clinical Pearls
- Amlodipine has a very long half-life, allowing for once-daily dosing and providing smooth blood pressure control over 24 hours.
- The most common side effect is peripheral edema (swelling of the ankles/feet), which is dose-dependent and can be managed by reducing the dose or adding a diuretic.
- Unlike some other calcium channel blockers, amlodipine has minimal negative inotropic effects at therapeutic doses, making it generally safe in patients with compensated heart failure.
- It is a first-line agent for hypertension and is particularly useful in patients with concomitant angina.
- Patients should be advised that the full blood pressure lowering effect may not be seen for several days to weeks due to its slow onset and long half-life.
Alternative Therapies
- Other Dihydropyridine Calcium Channel Blockers (e.g., Felodipine, Nifedipine, Nicardipine)
- Non-Dihydropyridine Calcium Channel Blockers (e.g., Verapamil, Diltiazem)
- ACE Inhibitors (e.g., Lisinopril, Enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
- Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
- Beta-Blockers (e.g., Metoprolol, Atenolol)
Cost & Coverage
Average Cost:
Typically $10-$30 for 30 tablets (generic) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic), Tier 2-3 (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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.