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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide
Brand Name
Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide
Generic Name
Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide
Active Ingredient
AmlodipineCategory
Thiazide Diuretic [EPC]
Salt Form
Besylate
Variants
5
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide, you must consult a qualified healthcare professional.
| 5 mg/1 | TABLET, FILM COATED | ORAL | 70436-016 |
| 10 mg/1 | TABLET, FILM COATED | ORAL | 70436-018 |
Detailed information about Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide
Amlodipine is a potent, long-acting dihydropyridine calcium channel blocker (CCB) used primarily to treat hypertension and coronary artery disease. It works by relaxing vascular smooth muscle to lower blood pressure and improve myocardial oxygen delivery.
For the majority of adult patients with hypertension, the standard starting dose of amlodipine is 5 mg once daily. Depending on the patient's blood pressure response and clinical goals, the healthcare provider may increase the dose to a maximum of 10 mg once daily. Most of the antihypertensive effect is usually observed within 7 to 14 days of starting a specific dose.
For the treatment of chronic stable or vasospastic angina, the recommended dose for adults is 5 mg to 10 mg once daily. Clinical trials have shown that most patients with coronary artery disease require the 10 mg dose for adequate symptom control. According to the ALLHAT trial (2002), amlodipine is highly effective at preventing cardiovascular complications when dosed appropriately.
Amlodipine is FDA-approved for use in children and adolescents aged 6 to 17 years for the treatment of hypertension. The typical effective dose in this population is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been extensively studied in pediatric patients and are generally not recommended. The safety and efficacy of amlodipine in children younger than 6 years of age have not been established.
The pharmacokinetics of amlodipine are not significantly influenced by renal impairment (kidney dysfunction). Therefore, patients with renal failure may usually start at the standard adult dose. Amlodipine is not dialyzable, meaning it is not removed from the blood during dialysis sessions.
Because amlodipine is extensively metabolized by the liver, the plasma half-life is prolonged in patients with hepatic insufficiency (liver failure). For these individuals, healthcare providers typically recommend a lower starting dose of 2.5 mg once daily. Titration (adjusting the dose) should proceed slowly and with close monitoring.
In patients aged 65 and older, the clearance of amlodipine is decreased, resulting in an increase in the area under the curve (AUC) of approximately 40% to 60%. Consequently, the recommended starting dose for elderly patients is 2.5 mg once daily. This 'start low and go slow' approach helps minimize the risk of hypotension and edema (swelling).
If you miss a dose of amlodipine, take it as soon as you remember. However, if it has been more than 12 hours since your scheduled time, skip the missed dose and take your next dose at the regular time. Do not double the dose to catch up, as this significantly increases the risk of severe hypotension (dangerously low blood pressure).
An overdose of amlodipine can cause excessive peripheral vasodilation and potential reflex tachycardia. Symptoms of a significant overdose include:
In the event of an overdose, seek emergency medical attention immediately. Clinical management typically involves gastric lavage (stomach pumping) if caught early, followed by cardiovascular support, including elevation of the extremities and administration of intravenous fluids and vasopressors (medications to raise blood pressure). Calcium gluconate may be administered intravenously to reverse the effects of calcium channel blockade.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking this medication without medical guidance, as sudden discontinuation can cause a rebound increase in blood pressure.
The most frequently reported side effect of amlodipine is peripheral edema (swelling of the ankles or feet). This occurs because amlodipine dilates the small arteries (pre-capillary) more than the veins (post-capillary), causing fluid to leak into the surrounding tissues. This effect is dose-dependent; it is more common at the 10 mg dose (approximately 10.8%) than at the 5 mg dose (3.0%).
Other common side effects include:
Amlodipine is a potent vasodilator. While it is highly effective at lowering blood pressure, patients must be aware that its effects are gradual. It is not intended for the immediate relief of an acute hypertensive crisis (extremely high blood pressure requiring instant reduction). Patients should be monitored for 'orthostatic hypotension'—a sudden drop in blood pressure when standing up—which can lead to falls and injuries, particularly in the elderly.
As of 2026, there are no FDA black box warnings for Amlodipine. It is widely recognized for its safety and efficacy in the general population.
There are few absolute contraindications for drug combinations with amlodipine, but certain drugs should be avoided if possible:
Amlodipine must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis include:
Amlodipine is currently classified under the older FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some developmental toxicity at doses many times higher than the human dose. According to the American College of Obstetricians and Gynecologists (ACOG), other agents like nifedipine (another CCB) or labetalol are often preferred for managing hypertension in pregnancy due to more extensive data. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Limited data from published clinical studies indicate that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on nursing infants have been observed. While generally considered compatible with breastfeeding by the World Health Organization (WHO), nursing mothers should monitor their infants for signs of low blood pressure or lethargy.
Amlodipine is approved for children aged 6 to 17 years. The primary use in this population is for essential hypertension. It has been shown to be effective and well-tolerated in this age group. It is NOT approved for children under the age of 6. There is no evidence that amlodipine affects growth or development in children, but long-term studies are limited.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. It is a member of the dihydropyridine class of calcium channel blockers. Specifically, it inhibits the influx of calcium ions through L-type (long-lasting) voltage-gated channels. By binding to the alpha-1 subunit of the channel, amlodipine keeps the channel in its inactive or 'closed' state, preventing the surge of calcium into the cell that is necessary for muscle contraction. Unlike non-dihydropyridines, amlodipine has minimal effect on the sinoatrial (SA) and atrioventricular (AV) nodes of the heart at therapeutic doses.
The onset of action for amlodipine is slow (6-12 hours for peak effect), which prevents the 'reflex tachycardia' (fast heart rate) that occurs when blood pressure drops too rapidly. The duration of effect is at least 24 hours, making once-daily dosing effective. There is a linear relationship between the dose and the reduction in blood pressure. Long-term use does not typically lead to tolerance (loss of effectiveness).
| Parameter | Value |
Common questions about Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide
Amlodipine is a prescription medication primarily used to treat hypertension (high blood pressure) and various forms of coronary artery disease, including chronic stable angina and vasospastic (Prinzmetal's) angina. By lowering blood pressure, it helps prevent serious cardiovascular events such as strokes and heart attacks. It belongs to the dihydropyridine calcium channel blocker class, which works by relaxing the blood vessels to allow blood to flow more easily. Your healthcare provider may prescribe it alone or in combination with other heart medications. It is also used in children aged 6 to 17 years specifically for hypertension management.
The most common side effect of amlodipine is peripheral edema, which is swelling in the ankles, feet, or lower legs caused by fluid retention. Other frequently reported side effects include dizziness, flushing (redness and warmth in the face), and palpitations or a racing heart. Some patients also report feeling unusually tired or having mild stomach pain and nausea. These effects are often dose-dependent, meaning they are more likely to occur at the 10 mg dose than at the 5 mg dose. Most side effects are mild, but you should always report persistent or worsening symptoms to your doctor.
It is generally recommended to limit or avoid alcohol while taking amlodipine because both substances can lower your blood pressure. When combined, alcohol can enhance the blood-pressure-lowering effects of amlodipine, potentially leading to symptoms like severe dizziness, lightheadedness, or even fainting. Alcohol can also increase the risk of headaches and fatigue while on this medication. If you choose to drink, do so in moderation and observe how your body reacts. Always consult your healthcare provider about what level of alcohol consumption is safe for your specific health profile.
Amlodipine is classified as a Pregnancy Category C medication, meaning there are no definitive studies in humans to prove its safety, though animal studies have shown potential risks at high doses. Because of this, it is usually only prescribed during pregnancy if the benefits to the mother significantly outweigh the potential risks to the fetus. Doctors often prefer other antihypertensive medications with more established safety data for pregnant women, such as labetalol or nifedipine. If you are pregnant or planning to become pregnant, you must discuss your blood pressure management with your obstetrician. Never stop taking your blood pressure medication without medical supervision, as uncontrolled hypertension poses its own risks to pregnancy.
Amlodipine starts working within a few hours of the first dose, but its full blood-pressure-lowering effects are not usually seen immediately. Because it is a long-acting medication with a slow onset, it typically takes 7 to 14 days of consistent daily use to reach its maximum effectiveness. You should not expect an instant drop in blood pressure after the first pill. It is designed to provide stable, 24-hour control rather than rapid fluctuations. Your doctor will likely wait at least two weeks before deciding if your dose needs to be adjusted based on your response.
No, you should never stop taking amlodipine suddenly without first consulting your healthcare provider. While amlodipine does not typically cause a 'rebound' effect as severely as some other heart medications, stopping it abruptly will cause your blood pressure to rise, which can increase your risk of a heart attack or stroke. If you need to discontinue the medication due to side effects, your doctor will provide a plan to gradually reduce your dose or switch you to a different therapy. Consistent use is key to the long-term management of hypertension and angina. Always ensure you have a refill available so you do not miss any doses.
If you miss a dose of amlodipine, take it as soon as you remember. However, if more than 12 hours have passed since your scheduled dose time, you should skip the missed dose and wait until your next regularly scheduled time. Do not take two doses at once to make up for the missed one, as this can cause your blood pressure to drop too low, leading to dizziness or fainting. To help you remember, try taking your medication at the same time every day, such as right after brushing your teeth in the morning. If you frequently miss doses, consider using a pill organizer or a smartphone reminder app.
Amlodipine does not typically cause 'true' weight gain in the form of increased body fat. However, it is a well-known cause of peripheral edema, which is fluid retention in the legs and ankles. This extra fluid can lead to a slight increase in the number you see on the scale. If you notice rapid weight gain (several pounds in a few days) along with significant swelling or difficulty breathing, you should contact your doctor immediately, as this could indicate a more serious issue like heart failure. True metabolic weight gain is not a recognized side effect of this medication according to clinical trials.
Amlodipine can be taken with many other medications, and it is often combined with other blood pressure drugs like ACE inhibitors or diuretics for better control. However, it does have some important interactions. For example, it can increase the levels of simvastatin (a cholesterol drug) in your blood, so the simvastatin dose is usually limited to 20 mg. It can also interact with certain immunosuppressants like tacrolimus and cyclosporine. Always provide your doctor and pharmacist with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are taking to ensure there are no dangerous interactions.
Yes, amlodipine is widely available as a generic medication (amlodipine besylate) and is typically very affordable. The generic version is bioequivalent to the original brand-name drug, Norvasc, meaning it has the same active ingredient, strength, and effectiveness. It is available in 2.5 mg, 5 mg, and 10 mg tablets. Most insurance plans prefer the generic version. Because it is so commonly used, it is stocked by almost all pharmacies. Whether you take the brand name or the generic, the clinical effects and potential side effects remain the same.
Other drugs with the same active ingredient (Amlodipine)
Some patients may experience the following, though they are less frequent:
Rare but documented side effects include:
While amlodipine is generally well-tolerated, some reactions require emergency intervention.
> Warning: Stop taking Amlodipine and call your doctor or emergency services immediately if you experience any of the following:
When taken over many years, amlodipine remains effective and generally safe. The most persistent long-term issue is chronic peripheral edema, which some patients find bothersome. In some cases, healthcare providers may add an ACE inhibitor to the regimen, as these drugs can help 'balance' the pressure in the capillaries and reduce the swelling caused by amlodipine. There is no evidence that long-term use of amlodipine causes damage to the kidneys or increases the risk of cancer.
There are currently no FDA Black Box Warnings for Amlodipine. It is considered to have a high safety profile when used as directed. However, this does not mean the drug is without risk. It must be used with caution in patients with severe aortic stenosis (narrowing of the heart's aortic valve) and those with severe hepatic impairment.
Report any unusual symptoms, especially new or worsening chest pain, to your healthcare provider immediately. Regular follow-ups are necessary to monitor the drug's effectiveness and to check for side effects like edema or changes in heart rhythm.
Patients taking amlodipine should undergo regular monitoring to ensure the medication is working safely and effectively. This typically includes:
Amlodipine may cause dizziness or fatigue, especially during the first few days of treatment or after a dose increase. Patients should observe how the medication affects them before driving, operating heavy machinery, or performing tasks that require alertness. If you feel dizzy or lightheaded, sit or lie down immediately.
Alcohol can have an additive effect with amlodipine in lowering blood pressure. Consuming alcohol while taking this medication may increase the risk of dizziness, fainting, and headaches. It is generally advised to limit alcohol intake while on antihypertensive therapy. Discuss your alcohol consumption habits with your doctor.
Do not stop taking amlodipine abruptly. While it does not typically cause a 'withdrawal syndrome' like beta-blockers, stopping it suddenly will cause your blood pressure to rise again, potentially increasing the risk of stroke or heart attack. If the medication must be stopped, your doctor will likely provide a tapering schedule or transition you to another medication.
> Important: Discuss all your medical conditions, especially liver disease or heart valve problems, with your healthcare provider before starting Amlodipine.
Amlodipine is not known to significantly interfere with most common clinical laboratory tests. It does not affect blood sugar, cholesterol, or uric acid levels.
For each major interaction, the mechanism usually involves the CYP3A4 enzyme pathway. Inhibition of this enzyme leads to higher drug levels and toxicity, while induction leads to lower levels and treatment failure. Always provide a complete list of your medications to your pharmacist to check for potential interactions.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers.
There is a potential for cross-sensitivity among members of the dihydropyridine class. If you have had a severe skin reaction (like Stevens-Johnson Syndrome) to one dihydropyridine, your doctor will likely avoid the entire class. However, there is no cross-sensitivity between amlodipine and non-dihydropyridines like verapamil or diltiazem.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of heart valve disease or liver problems, before prescribing Amlodipine.
Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg), reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Amlodipine is not significantly cleared by the kidneys. Approximately 10% of the drug is excreted unchanged in the urine. Therefore, no initial dose adjustment is required for patients with renal impairment. However, these patients should still be monitored for systemic effects as they may be more sensitive to changes in blood pressure.
As the liver is the primary site of metabolism, hepatic impairment significantly increases the half-life of amlodipine (from ~35 hours to ~56 hours). Patients with any degree of liver dysfunction must be started on the 2.5 mg dose. Failure to adjust the dose in these patients can lead to drug accumulation and severe side effects.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are planning to become pregnant or have a history of liver disease.
|---|---|
| Bioavailability | 64% - 90% |
| Protein Binding | 93% - 98% |
| Half-life | 30 - 50 hours (up to 56h in hepatic impairment) |
| Tmax (Time to Peak) | 6 - 12 hours |
| Metabolism | Hepatic (Extensive via CYP3A4) |
| Excretion | Renal 60% (as metabolites), Fecal 20-25% |
Amlodipine is classified as a Dihydropyridine Calcium Channel Blocker. It is distinct from other classes of antihypertensives like ACE inhibitors (which affect the renin-angiotensin system) or Beta-blockers (which affect the sympathetic nervous system). Within its class, it is grouped with medications like Nifedipine, Felodipine, and Lercanidipine.