Olmesartan Medoxomil 40mg 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 & 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. It works by blocking a natural substance in your body that tightens blood vessels. By blocking this substance, olmesartan helps relax your blood vessels, allowing blood to flow more easily and lowering your blood pressure. This helps prevent strokes, heart attacks, and kidney problems.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel 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. Measure the liquid dose accurately using the measuring device provided with the medication. If no device is 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 the 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 place, 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'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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel 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. Measure the liquid dose accurately using the measuring device provided with the medication. If no device is 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 the 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 place, 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'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.
- 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 specifically instructed 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:
10 - 40 mg
Condition-Specific Dosing:
hypertension_initial:
20 mg orally once daily
hypertension_maintenance:
10 mg to 40 mg orally once daily, adjusted based on blood pressure response
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6 to <17 years: 20 kg to <35 kg: 10 mg orally once daily; âĨ35 kg: 20 mg orally once daily. Max 20 mg/day for 20 to <35 kg, max 40 mg/day for âĨ35 kg.
Adolescent:
6 to <17 years: 20 kg to <35 kg: 10 mg orally once daily; âĨ35 kg: 20 mg orally once daily. Max 20 mg/day for 20 to <35 kg, max 40 mg/day for âĨ35 kg.
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment required, monitor renal function.
Moderate:
No initial dose adjustment required, monitor renal function.
Severe:
Consider lower initial dose (e.g., 10 mg once daily) and careful titration. Monitor renal function closely.
Dialysis:
Not dialyzable. Use with caution, monitor closely.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Not studied. Use with caution.
Pharmacology
Mechanism of Action
Olmesartan medoxomil is a prodrug that is rapidly converted to the active drug, 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 (e.g., vascular smooth muscle, adrenal gland). This action inhibits the negative feedback regulation of renin secretion, but the resulting increased plasma renin activity and angiotensin II plasma concentrations do not overcome the effect of olmesartan on blood pressure.
Pharmacokinetics
Absorption:
Bioavailability:
26%
Tmax:
1-2 hours
FoodEffect:
Food decreases Cmax by approximately 15% but has minimal effect on AUC. Olmesartan medoxomil can be administered with or without food.
Distribution:
Vd:
Approximately 17 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
1.3 L/h (renal clearance 0.6-0.7 L/h)
ExcretionRoute:
Biliary (50-65%), Renal (35-50%)
Unchanged:
Not applicable (prodrug)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks (full effect)
PeakEffect:
Within 2 weeks (full effect)
DurationOfAction:
24 hours (with 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 only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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)
- Swelling of the face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- Persistent cough (less common than with ACE inhibitors)
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet, unusual tiredness)
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. Describe the symptoms you experienced with the allergy.
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 Children:
If your child is under 1 year of age, do not administer this medication. It is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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. Describe the symptoms you experienced with the allergy.
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 Children:
If your child is under 1 year of age, do not administer this medication. It is not recommended for children younger than 1 year.
Additional Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Follow your doctor's instructions for monitoring your blood pressure and having regular blood tests. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, discuss this with your doctor. Additionally, if you are on a low-sodium or sodium-free diet, consult with your doctor.
If you are taking colesevelam, take 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, talk to your doctor. Also, discuss with your doctor before consuming alcohol.
Be cautious in hot weather or during physical activity, 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 important to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, an additional medication may be necessary. If you have any questions or concerns, discuss them with your doctor.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Follow your doctor's instructions for monitoring your blood pressure and having regular blood tests. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, discuss this with your doctor. Additionally, if you are on a low-sodium or sodium-free diet, consult with your doctor.
If you are taking colesevelam, take 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, talk to your doctor. Also, discuss with your doctor before consuming alcohol.
Be cautious in hot weather or during physical activity, 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 important to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, an additional medication may be necessary. 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, less common)
- Dizziness
- Fainting
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Administer intravenous fluids to support blood pressure. Olmesartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or moderate to severe renal impairment [GFR <60 mL/min/1.73 m2])
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Salt substitutes containing potassium
- NSAIDs (including selective COX-2 inhibitors)
- Lithium
Moderate Interactions
- Other antihypertensive agents (additive hypotensive effect)
- Colesevelam (may reduce systemic exposure of olmesartan)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN)
Rationale: To assess baseline renal status, especially important in patients with pre-existing renal impairment or those at risk for acute kidney injury.
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 (e.g., weekly initially, then monthly or as clinically indicated) until controlled, then periodically.
Target: <130/80 mmHg (or individualized target based on patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose adjustment or addition of other agents. If BP is too low (symptomatic hypotension), reduce dose or discontinue.
Renal Function (Serum Creatinine, BUN)
Frequency: Periodically (e.g., 1-2 weeks after initiation or dose change, then every 3-6 months, or as clinically indicated), especially in patients with pre-existing renal impairment or those on concomitant medications affecting renal function.
Target: Stable within patient's baseline range
Action Threshold: Significant increase in creatinine (>30% from baseline or absolute increase >0.5 mg/dL) may warrant dose reduction or discontinuation.
Serum Potassium
Frequency: Periodically (e.g., 1-2 weeks after initiation or dose change, then every 3-6 months, or as clinically indicated), especially in patients with renal impairment or those on concomitant potassium-elevating medications.
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium >5.5 mEq/L may warrant dose reduction, discontinuation, or intervention.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (signs of hypotension)
- Swelling of face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing
- Persistent cough (less common than with ACEIs, but possible)
- Unusual fatigue or weakness
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally discouraged due to potential risks.
Trimester-Specific Risks:
First Trimester:
Category D. Limited human data, but potential for fetal harm cannot be excluded. Use generally discouraged.
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
Not recommended during breastfeeding. It is unknown if olmesartan is excreted in human milk, but it is excreted in the milk of lactating rats. Due to the potential for adverse effects on the nursing infant (e.g., hypotension, renal effects), 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 level: L4 (Possibly Hazardous). Potential for hypotension, hyperkalemia, and renal impairment in the infant.
Pediatric Use
Approved for hypertension in children 6 to <17 years of age. Dosing is weight-based. Safety and effectiveness have not been established in pediatric patients younger than 6 years of age.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is generally not necessary based on age alone, but careful monitoring of renal function is recommended, as elderly patients are more likely to have decreased renal function.
Clinical Information
Clinical Pearls
- Olmesartan medoxomil is a prodrug; it is converted to the active drug olmesartan in the GI tract.
- Unlike ACE inhibitors, ARBs like olmesartan do not typically cause a persistent dry cough, making them an alternative for patients who cannot tolerate ACE inhibitors.
- Patients should be advised to avoid potassium supplements and salt substitutes containing potassium unless specifically instructed by their physician, due to the risk of hyperkalemia.
- The full antihypertensive effect may take up to 2 weeks to be achieved.
- There is a Black Box Warning regarding fetal toxicity; it is contraindicated in the 2nd and 3rd trimesters of pregnancy.
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
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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.