Olmesartan Medoxomil 5mg 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 is a medication used to treat high blood pressure. It works by relaxing blood vessels, allowing blood to flow more easily and lowering your blood pressure. Lowering high 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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. To establish a routine, take your medication at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension. If a liquid suspension is prepared, make sure to shake it well before each use. When measuring liquid doses, use the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If a liquid suspension is prepared from tablets, store it in the refrigerator, but do not freeze. Discard any unused portion of the liquid suspension after 28 days. Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 dose.
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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. To establish a routine, take your medication at the same time every day. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension. If a liquid suspension is prepared, make sure to shake it well before each use. When measuring liquid doses, use the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If a liquid suspension is prepared from tablets, store it in the refrigerator, but do not freeze. Discard any unused portion of the liquid suspension after 28 days. Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 dose.
Lifestyle & Tips
- Take your 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 or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit alcohol intake.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Monitor your blood pressure regularly at home if advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
hypertension_initial:
10 mg or 20 mg orally once daily. For 5mg tablets, this would be a starting dose for patients who may be volume-depleted or on diuretics.
hypertension_maintenance:
20 mg orally once daily. Dose can be increased to 40 mg once daily if blood pressure is not adequately controlled after 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6 to <17 years: 10 mg orally once daily for patients weighing 20 to <35 kg; 20 mg orally once daily for patients weighing âĨ35 kg. Max 20 mg/day for 20 to <35 kg, max 40 mg/day for âĨ35 kg.
Adolescent:
6 to <17 years: 10 mg orally once daily for patients weighing 20 to <35 kg; 20 mg orally once daily for patients weighing âĨ35 kg. Max 20 mg/day for 20 to <35 kg, max 40 mg/day for âĨ35 kg.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary (CrCl 40-70 mL/min)
Moderate:
No dosage adjustment necessary (CrCl 20-40 mL/min)
Severe:
Consider lower starting dose (e.g., 10 mg once daily) and careful monitoring (CrCl <20 mL/min)
Dialysis:
Not dialyzable. Use with caution; consider lower starting dose and careful monitoring.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
Consider lower starting dose (e.g., 10 mg once daily) and careful monitoring
Severe:
Not recommended due to lack of experience in severe hepatic impairment.
Pharmacology
Mechanism of Action
Olmesartan medoxomil is a prodrug that is rapidly converted to olmesartan during absorption from the gastrointestinal tract. 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, including vascular smooth muscle and the adrenal gland. This blockade leads to vasodilation, reduction in peripheral vascular resistance, and decreased aldosterone secretion, resulting in a reduction in blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 26% (of olmesartan from olmesartan medoxomil)
Tmax:
1-2 hours
FoodEffect:
Food does not affect the bioavailability of olmesartan.
Distribution:
Vd:
Approximately 17 L
ProteinBinding:
Approximately 99% (primarily to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 1.3 L/h (renal clearance 0.6 L/h)
ExcretionRoute:
Biliary excretion (50-65%) and renal excretion (35-50%)
Unchanged:
Approximately 35-50% (renal)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks (for full effect)
PeakEffect:
Within 2 weeks (for full effect)
DurationOfAction:
24 hours (allows for 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
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 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. 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
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 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. 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
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:
- Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
- Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention
- Difficulty breathing or swallowing (angioedema) - seek immediate medical attention
- Persistent, severe diarrhea with significant weight loss (rare, but serious side effect)
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., swelling in ankles/feet, changes in urination)
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 and Caregivers:
Do not administer this medication to children under 1 year of age, as it is not recommended for this age group.
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 conditions with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments. 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 and Caregivers:
Do not administer this medication to children under 1 year of age, as it is not recommended for this age group.
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 conditions with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments. 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.
As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions you have with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are on a low-sodium or sodium-free diet, discuss this with your doctor to ensure safe management.
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, 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.
It is worth noting 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 optimal results. If you have any questions or concerns, do not hesitate to 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.
As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions you have with your doctor.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are on a low-sodium or sodium-free diet, discuss this with your doctor to ensure safe management.
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, 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.
It is worth noting 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 optimal results. If you have any questions or concerns, do not hesitate to 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:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is symptomatic and supportive. 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
- Lithium
- NSAIDs (including selective COX-2 inhibitors)
Moderate Interactions
- Other antihypertensive agents (additive effect)
- Colesevelam (may reduce olmesartan exposure; administer olmesartan at least 4 hours before colesevelam)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess the need for treatment.
Timing: Prior to initiation of therapy.
Serum Creatinine (SCr)
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation of therapy.
Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy.
Serum Potassium (K+)
Rationale: To establish baseline and monitor for hyperkalemia, especially in patients with renal impairment or those on potassium-sparing diuretics/supplements.
Timing: Prior to initiation of therapy.
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 target, may vary based on patient comorbidities)
Action Threshold: Persistent BP above target; consider dose adjustment or add-on therapy. Symptomatic hypotension; consider dose reduction.
Serum Creatinine (SCr) and BUN
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients with pre-existing renal impairment or those on concomitant nephrotoxic drugs.
Target: Stable or within acceptable limits for the patient.
Action Threshold: Significant increase (e.g., >30% from baseline or progressive increase); investigate cause, consider dose reduction or discontinuation.
Serum Potassium (K+)
Frequency: Within 1-2 weeks after initiation or dose increase, then periodically (e.g., every 6-12 months) or more frequently in patients with renal impairment, diabetes, or those on potassium-sparing diuretics/supplements.
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L; investigate cause, consider dose reduction, discontinuation, or management of hyperkalemia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (signs of hypotension)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing (angioedema)
- Persistent diarrhea with substantial weight loss (olmesartan-associated enteropathy)
- Muscle weakness
- Irregular heartbeat (signs of hyperkalemia)
- Signs of worsening renal function (e.g., decreased urine output, edema)
Special Patient Groups
Pregnancy
Olmesartan is contraindicated in pregnancy, especially during the second and third trimesters, due to the risk of fetal injury and death. If pregnancy is detected, discontinue as soon as possible.
Trimester-Specific Risks:
First Trimester:
Category D. Limited human data suggest risk, but potential benefits may outweigh risks in serious situations. However, ARBs are generally avoided.
Second Trimester:
Category X. Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Category X. Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Lactation
It is not known whether olmesartan 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 (Moderate risk - no human data, but potential for adverse effects based on drug class and animal data).
Pediatric Use
Safety and effectiveness have been established for hypertension in pediatric patients 6 to <17 years of age. Use in children younger than 6 years is not recommended due to lack of data. Dosing is weight-based.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly patients (âĨ65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is generally needed based solely on age, but consider age-related decline in renal function.
Clinical Information
Clinical Pearls
- Olmesartan medoxomil is a prodrug; it is converted to its active form, olmesartan, in the gut.
- 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.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a serious, though rare, side effect.
- A rare but serious side effect, olmesartan-associated enteropathy, can cause severe, chronic diarrhea with substantial weight loss, sometimes months to years after initiation. If suspected, discontinue olmesartan.
- Monitor potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements, due to the risk of hyperkalemia.
- The 5mg tablet is typically used as a starting dose for patients who may be volume-depleted or on diuretics, or for dose titration.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Candesartan, Telmisartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Captopril
- Thiazide Diuretics: Hydrochlorothiazide, Chlorthalidone
- Calcium Channel Blockers (CCBs): Amlodipine, Nifedipine, Diltiazem, Verapamil
- Beta-Blockers: Metoprolol, Atenolol, Carvedilol, Labetalol
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic per 30 tablets
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'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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.