Micardis 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 is used to lower the chance of heart attack, stroke, and death in some people.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
FDA Approved
Apr 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Telmisartan is a medication used to treat high blood pressure (hypertension) and to reduce the risk of heart attack, stroke, or death from heart problems in certain high-risk adults. It works by relaxing blood vessels, which allows blood to flow more easily and lowers blood pressure.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Take your medication at the same time every day to establish a routine.
Special Instructions for Certain Brands
If your medication comes in a blister pack, be sure to:
Remove the tablet from the blister pack immediately before taking it.
Peel back the foil on the blister pack to access the tablet. Do not push the tablet through the foil, as this may cause it to break.
Staying Hydrated
Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it in its original container at room temperature.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure 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'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 a missed dose.
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Take your medication at the same time every day to establish a routine.
Special Instructions for Certain Brands
If your medication comes in a blister pack, be sure to:
Remove the tablet from the blister pack immediately before taking it.
Peel back the foil on the blister pack to access the tablet. Do not push the tablet through the foil, as this may cause it to break.
Staying Hydrated
Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it in its original container at room temperature.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure 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'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 a missed dose.
Lifestyle & Tips
- Continue to follow a healthy diet (e.g., low-sodium, DASH diet).
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Quit smoking.
- Monitor your blood pressure regularly at home as instructed by your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
40 mg once daily
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
hypertension:
Initial dose 40 mg once daily. Dose may be adjusted from 20 mg to 80 mg once daily based on blood pressure response.
cardiovascular_risk_reduction:
80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity and mortality.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary, but caution is advised due to limited experience in severe renal impairment or hemodialysis. Telmisartan is not removed by hemodialysis.
Dialysis:
Not removed by hemodialysis. No specific dose adjustment, but monitor renal function and potassium levels.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
Maximum dose of 40 mg once daily.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Telmisartan is an angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced blood pressure. It does not inhibit ACE (kininase II), thus it does not potentiate bradykinin-mediated effects like cough.
Pharmacokinetics
Absorption:
Bioavailability:
42-58%
Tmax:
0.5-1 hour
FoodEffect:
Food slightly reduces the bioavailability of telmisartan (AUC decreases by approximately 6% with 40 mg and 20% with 160 mg), but this is not considered clinically significant for the recommended dosing range.
Distribution:
Vd:
Approximately 500 L
ProteinBinding:
>99.5%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 24 hours
Clearance:
Not available (primarily biliary excretion)
ExcretionRoute:
Primarily biliary/fecal (>97%)
Unchanged:
>97%
Pharmacodynamics
OnsetOfAction:
Within 3 hours
PeakEffect:
4-8 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue MICARDIS 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
Although rare, some people may experience severe and potentially life-threatening side effects while 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 high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Dizziness or fainting
Swelling in the arms or legs
Angioedema, a rare but potentially life-threatening reaction, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Difficulty breathing or swallowing
+ Unusual hoarseness
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:
Stuffy nose
Sinus irritation
Back pain
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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, some people may experience severe and potentially life-threatening side effects while 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 high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Dizziness or fainting
Swelling in the arms or legs
Angioedema, a rare but potentially life-threatening reaction, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Difficulty breathing or swallowing
+ Unusual hoarseness
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:
Stuffy nose
Sinus irritation
Back pain
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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)
- 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, numbness or tingling)
- Unusual tiredness or weakness
- Decreased urination or swelling in the legs/ankles (signs of kidney problems)
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 conditions to ensure safe treatment:
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 dehydrated or have electrolyte imbalances.
If you are currently taking or have recently taken any of the following medications: Benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you are breast-feeding. Note that you should not breast-feed while taking this medication.
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. They will help determine if it is safe to take this medication with your other drugs and health issues. 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 conditions to ensure safe treatment:
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 dehydrated or have electrolyte imbalances.
If you are currently taking or have recently taken any of the following medications: Benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
If you are taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you are breast-feeding. Note that you should not breast-feed while taking this medication.
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. They will help determine if it is safe to take this medication with your other drugs and health issues. 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 drug, 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 undergo blood tests as recommended. If you have any questions or concerns, discuss them with your doctor.
If you are on a low-salt or salt-free diet, consult with your doctor. Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
When taking this medication for high blood pressure, consult your doctor before using 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.
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, notify your doctor, as these conditions may lead to low blood pressure.
It is also important to 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 drug, 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 undergo blood tests as recommended. If you have any questions or concerns, discuss them with your doctor.
If you are on a low-salt or salt-free diet, consult with your doctor. Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
When taking this medication for high blood pressure, consult your doctor before using 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.
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, notify your doctor, as these conditions may lead to low blood pressure.
It is also important to 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 heartbeat)
- Bradycardia (slow heartbeat)
- Dizziness
- Acute renal failure
What to Do:
If an overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive. Telmisartan is not removed by hemodialysis.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes mellitus or renal impairment [GFR <60 mL/min/1.73 m2])
Major Interactions
- Lithium (increased serum lithium concentrations and toxicity)
- NSAIDs (including selective COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment)
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or other agents that may increase potassium levels (e.g., heparin, trimethoprim) (increased risk of hyperkalemia)
- Digoxin (increased peak and trough plasma concentrations of digoxin)
Moderate Interactions
- Diuretics (e.g., thiazide or loop diuretics) (increased risk of symptomatic hypotension, especially after initiation)
- ACE inhibitors (increased risk of hypotension, hyperkalemia, and renal impairment when used in combination with telmisartan, especially in patients with established atherosclerotic cardiovascular disease, heart failure, or diabetes with end-organ damage; dual blockade of the RAS is generally not recommended)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as telmisartan can affect renal hemodynamics, especially in patients with pre-existing renal impairment or heart failure.
Timing: Prior to initiation of therapy.
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as telmisartan can cause hyperkalemia, particularly 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 as clinically indicated)
Target: <130/80 mmHg (or individualized target based on patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose adjustment or addition of other antihypertensive agents. If symptomatic hypotension occurs, reduce dose or discontinue.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months or as clinically indicated)
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase (e.g., >30% from baseline or progressive increase) may indicate renal dysfunction; consider dose reduction, discontinuation, or investigation for renal artery stenosis.
Serum Potassium (K+)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months or as clinically indicated, more frequently in patients at risk for hyperkalemia)
Target: 3.5-5.0 mEq/L
Action Threshold: If K+ >5.5 mEq/L, investigate cause, consider dose reduction or discontinuation, and manage hyperkalemia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (especially upon standing)
- Fatigue
- Swelling of hands, ankles, or feet (peripheral edema)
- Symptoms of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat, difficulty breathing)
Special Patient Groups
Pregnancy
Telmisartan is contraindicated in pregnancy, especially during the second and third trimesters, due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Exposure during the first trimester should also be avoided due to potential risks.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal data suggest potential for fetal harm. Generally, ARBs should be avoided if possible.
Second Trimester:
Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester:
High risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Neonatal adverse effects include hypotension, hyperkalemia, and renal failure.
Lactation
It is not known whether telmisartan is excreted in human milk. Due to the potential for serious adverse effects on the breastfed 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. Generally not recommended.
Infant Risk:
Potentially hazardous (L4) - risk of hypotension, hyperkalemia, and renal effects in the infant. Consider alternative agents with better safety profiles during lactation.
Pediatric Use
Safety and effectiveness of telmisartan in pediatric patients have not been established. Use is not recommended.
Geriatric Use
No dosage adjustment is necessary based on age. However, elderly patients may be more sensitive to the effects of telmisartan, particularly regarding blood pressure reduction and renal function. Monitor blood pressure, renal function, and potassium levels closely.
Clinical Information
Clinical Pearls
- Telmisartan has a long half-life (approximately 24 hours), allowing for convenient once-daily dosing.
- It is a good alternative for patients who develop a cough with ACE inhibitors, as it does not affect bradykinin metabolism.
- Telmisartan has demonstrated cardiovascular protective effects beyond blood pressure lowering, particularly in reducing cardiovascular morbidity and mortality in high-risk patients (e.g., those with established atherosclerotic cardiovascular disease or type 2 diabetes with end-organ damage).
- Administer with caution in patients with severe congestive heart failure, severe renal impairment, or bilateral renal artery stenosis, as it may worsen renal function.
- Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although this is less common with ARBs than with ACE inhibitors.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Candesartan, Olmesartan, 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
- Direct Renin Inhibitors: Aliskiren (limited use)
Cost & Coverage
Average Cost:
Varies, typically $10-$30 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or Non-Formulary (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.