Olmesartan Medoxomil 20mg Tablets
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Category D (1st trimester), Category X (2nd and 3rd trimesters)
FDA Approved
Apr 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Olmesartan medoxomil is a medication used to treat high blood pressure (hypertension). It belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels, allowing blood to flow more easily, which helps to lower blood pressure and reduce the risk of heart attack, stroke, 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, as directed. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
To stay hydrated, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, be sure to shake it well before use and measure the dose carefully using the provided measuring device or one obtained from your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding storage in a bathroom. If a liquid suspension is made from the tablets, refrigerate it and do not freeze. Discard any unused portion after 28 days. Keep all medications in a safe location, out of the reach of children and pets.
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 the 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, as directed. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
To stay hydrated, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. If you have difficulty swallowing pills, you can discuss the option of creating a liquid suspension with your doctor or pharmacist. If a liquid suspension is prepared, be sure to shake it well before use and measure the dose carefully using the provided measuring device or one obtained from your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding storage in a bathroom. If a liquid suspension is made from the tablets, refrigerate it and do not freeze. Discard any unused portion after 28 days. Keep all medications in a safe location, out of the reach of children and pets.
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 the missed one.
Lifestyle & Tips
- Take medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Maintain a healthy lifestyle: eat a balanced diet low in sodium, engage in regular physical activity, limit alcohol intake, and quit smoking.
- Monitor blood pressure regularly at home as advised by your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
- Inform your doctor or dentist that you are taking olmesartan before any surgery or dental procedures.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
initialDose:
10 mg once daily for patients requiring less aggressive blood pressure reduction.
maximumDose:
40 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6 to <17 years: Initial dose 10 mg orally once daily. May increase to 20 mg once daily if blood pressure is not adequately controlled. For patients weighing <35 kg, initial dose 10 mg once daily, maximum 20 mg once daily.
Adolescent:
6 to <17 years: Initial dose 10 mg orally once daily. May increase to 20 mg once daily if blood pressure is not adequately controlled. For patients weighing <35 kg, initial dose 10 mg once daily, maximum 20 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Consider lower initial dose (e.g., 10 mg once daily) and careful monitoring. Not recommended for patients with severe renal impairment (CrCl <20 mL/min) due to limited experience.
Dialysis:
Not recommended for patients on dialysis due to limited experience.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
Consider lower initial dose (e.g., 10 mg once daily) and careful monitoring. Maximum dose 20 mg once daily.
Severe:
Not recommended due to limited experience.
Pharmacology
Mechanism of Action
Olmesartan medoxomil is a prodrug that is rapidly converted to olmesartan, the active moiety. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. It blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (e.g., vascular smooth muscle, adrenal gland). This action inhibits the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of olmesartan on blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 26%
Tmax:
1-2 hours
FoodEffect:
Food does not significantly affect the bioavailability of olmesartan.
Distribution:
Vd:
Approximately 17 L
ProteinBinding:
>99% (primarily to plasma albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 1.3 L/h (renal clearance 0.6-0.7 L/h)
ExcretionRoute:
Biliary excretion (50-65%) and renal excretion (35-50%)
Unchanged:
Approximately 35-50% (renal), 50-65% (biliary)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks (for full antihypertensive effect)
PeakEffect:
2-4 weeks (for maximal blood pressure reduction)
DurationOfAction:
24 hours (allowing once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue Olmesartan Medoxomil 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
While rare, some people may experience severe and potentially life-threatening side effects when 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 significant 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
Severe dizziness or fainting
Persistent diarrhea
Severe diarrhea
Significant weight loss
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness
This is not an exhaustive list of all 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 significant 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
Severe dizziness or fainting
Persistent diarrhea
Severe diarrhea
Significant weight loss
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness
This is not an exhaustive list of all 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 (especially when standing up)
- Unusual tiredness or weakness
- Swelling of the face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in feet or ankles)
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.
If you are taking a medication that contains aliskiren and have either diabetes or kidney problems.
If you are breastfeeding or plan to breastfeed.
For Parents or Guardians:
If your child is under 1 year of age, do not administer this medication. It is not suitable for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other treatments and health conditions. 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.
If you are taking a medication that contains aliskiren and have either diabetes or kidney problems.
If you are breastfeeding or plan to breastfeed.
For Parents or Guardians:
If your child is under 1 year of age, do not administer this medication. It is not suitable for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.
When taking colesevelam, administer it at least 4 hours after taking this medication. Before using any 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, or certain natural products or aids, consult your doctor.
It is also important to discuss alcohol consumption with your doctor before drinking. 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 conditions may lead to low blood pressure.
Note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, discuss them with your doctor.
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, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.
When taking colesevelam, administer it at least 4 hours after taking this medication. Before using any 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, or certain natural products or aids, consult your doctor.
It is also important to discuss alcohol consumption with your doctor before drinking. 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 conditions may lead to low blood pressure.
Note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, your doctor may need to prescribe an additional medication to achieve the desired effect. If you have any questions or concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Profound hypotension (low blood pressure)
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
- Dizziness
- Fainting
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center. The national poison control center number is 1-800-222-1222. Treatment is supportive and symptomatic. If ingestion is recent, gastric lavage may be considered. Administer intravenous fluids to support blood pressure. Olmesartan is not dialyzable.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Salt substitutes containing potassium
- Lithium (increased serum lithium concentrations and toxicity)
- NSAIDs (including selective COX-2 inhibitors - may attenuate antihypertensive effect and increase risk of renal impairment)
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effect)
- Diuretics (increased risk of hypotension)
- Colesevelam (decreased systemic exposure of olmesartan, administer olmesartan 4 hours before colesevelam)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum Creatinine and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments, then periodically (e.g., monthly until stable, then every 3-6 months).
Target: <130/80 mmHg (or individualized target based on guidelines and patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose increase or add-on therapy. If symptomatic hypotension occurs, reduce dose or discontinue.
Serum Creatinine and BUN
Frequency: Periodically, especially in patients with pre-existing renal impairment, heart failure, or those on concomitant diuretics or NSAIDs (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months).
Target: Within normal limits or stable from baseline.
Action Threshold: Significant increase (e.g., >30% from baseline or above upper limit of normal) may warrant dose reduction or discontinuation.
Serum Potassium
Frequency: Periodically, especially in patients with renal impairment, diabetes, or those on concomitant potassium-sparing diuretics or supplements (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months).
Target: 3.5-5.0 mEq/L
Action Threshold: If >5.5 mEq/L, consider dose reduction, discontinuation, or management of hyperkalemia.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
- Fatigue or weakness
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat, tingling sensations)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat, difficulty breathing or swallowing)
- Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
Special Patient Groups
Pregnancy
Olmesartan is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. It should be discontinued as soon as pregnancy is detected. Exposure during the first trimester is generally considered less risky but still warrants discontinuation.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered lower risk than later trimesters. Still, discontinuation is recommended upon detection of pregnancy.
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. Neonatal adverse effects include hypotension, hyperkalemia, and renal failure.
Lactation
Limited data suggest that olmesartan is excreted into breast milk in rats. It is unknown if it is excreted in human milk. Due to the potential for adverse effects on the nursing 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:
L3 - Moderately safe. Potential for hypotension, hyperkalemia, and renal effects in the infant. Monitor infant for signs of adverse effects.
Pediatric Use
Approved for hypertension in children 6 to <17 years of age. Dosing is weight-based for children <35 kg. Safety and effectiveness have not been established in pediatric patients younger than 6 years.
Geriatric Use
No overall difference in efficacy or safety has been observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is generally needed based solely on age, but careful monitoring of renal function and electrolytes is prudent, especially in those with age-related decline in renal function.
Clinical Information
Clinical Pearls
- Olmesartan medoxomil is a prodrug; the active form is olmesartan.
- Unlike ACE inhibitors, ARBs like olmesartan do not typically cause a cough, making them a good alternative for patients who develop cough with ACE inhibitors.
- Monitor for hyperkalemia, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
- Advise patients to avoid salt substitutes containing potassium.
- The full antihypertensive effect may take 2-4 weeks to develop.
- Contraindicated in pregnancy due to significant fetal harm, especially in the 2nd and 3rd trimesters.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Candesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Beta-blockers: Metoprolol, Atenolol, Carvedilol
- Other antihypertensive classes depending on patient comorbidities and guidelines.
Cost & Coverage
Average Cost:
Varies, typically $10-$30 per 30 tablets (generic 20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with 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.