Micardis 40mg Tablets (new)
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
Not applicable (FDA has moved to a risk summary system for pregnancy)
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, allowing blood to flow more easily.
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 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 to feel better. To establish a routine, take your medication at the same time every day.
If your medication comes in a blister pack, remove the tablet just before taking it. To do this, peel back the foil on the blister pack, but do not push the tablet through the foil, as this may cause it to break.
It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it in its original container at room temperature, in a dry place. Avoid storing it in a bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location.
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 one.
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 to feel better. To establish a routine, take your medication at the same time every day.
If your medication comes in a blister pack, remove the tablet just before taking it. To do this, peel back the foil on the blister pack, but do not push the tablet through the foil, as this may cause it to break.
It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it in its original container at room temperature, in a dry place. Avoid storing it in a bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location.
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 one.
Lifestyle & Tips
- Take medication exactly as prescribed, usually once daily, with or without food.
- Continue to follow a low-sodium diet as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake.
- Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
- Inform your doctor or dentist that you are taking telmisartan before any surgery or dental procedures.
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 40 mg once daily; dose may be increased to a maximum of 80 mg once daily if needed to achieve blood pressure goal. Full antihypertensive effect is usually achieved within 4 to 8 weeks.
cardiovascular_risk_reduction:
80 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary, but monitor blood pressure and renal function closely.
Dialysis:
Not removed by hemodialysis. No dosage adjustment necessary, but monitor blood pressure and renal function closely.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
Maximum dose of 40 mg once daily
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Telmisartan 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 vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral vascular resistance, and reduced blood pressure. It does not inhibit ACE (kininase II), thus avoiding the potential for increased bradykinin-mediated side effects like cough.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 42% (40 mg dose), 58% (80 mg dose)
Tmax:
0.5 to 1 hour
FoodEffect:
Food slightly reduces the bioavailability (AUC) of telmisartan, but this is not considered clinically significant, and it can be taken with or without food.
Distribution:
Vd:
Approximately 500 L
ProteinBinding:
>99.5% (primarily to plasma albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 24 hours
Clearance:
Not available (primarily biliary excretion)
ExcretionRoute:
Primarily biliary/fecal (>97%), with a small amount excreted renally.
Unchanged:
>97% (excreted unchanged in feces)
Pharmacodynamics
OnsetOfAction:
Within 3 hours (for blood pressure lowering)
PeakEffect:
Full antihypertensive effect is usually achieved within 4 to 8 weeks of starting therapy.
DurationOfAction:
24 hours (allowing for once-daily dosing)
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
+ Trouble 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
+ Trouble 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:
- Sudden swelling of the face, lips, tongue, or throat (signs of angioedema) - seek immediate medical attention.
- Difficulty breathing or swallowing - seek immediate medical attention.
- Severe dizziness or fainting.
- Unusual tiredness or weakness.
- Muscle cramps or weakness, irregular heartbeat (signs of high potassium).
- Decreased urination or swelling in your feet or 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently dehydrated or have electrolyte imbalances.
If you are 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 inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
* Any health problems you have
Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently dehydrated or have electrolyte imbalances.
If you are 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 inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
* Any health problems you have
Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 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 specific dietary restrictions, such as a low-salt or salt-free diet, discuss this with your doctor.
Additionally, if you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. If you have high blood pressure and are taking this medication, talk to your doctor before using over-the-counter (OTC) products that may increase blood pressure, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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 symptoms 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 specific dietary restrictions, such as a low-salt or salt-free diet, discuss this with your doctor.
Additionally, if you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. If you have high blood pressure and are taking this medication, talk to your doctor before using over-the-counter (OTC) products that may increase blood pressure, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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 symptoms 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 heart rate)
- Bradycardia (slow heart rate)
- Dizziness
- Lightheadedness
- Syncope (fainting)
What to Do:
If overdose is suspected, seek emergency medical attention or call the Poison Control Center at 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
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
- Potassium supplements - increased risk of hyperkalemia
- Lithium - increased serum lithium concentrations and lithium toxicity
- Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors - reduced antihypertensive effect, increased risk of renal impairment (including acute renal failure) in patients who are volume-depleted or have compromised renal function
Moderate Interactions
- Digoxin - increased plasma concentrations of digoxin (monitor digoxin levels upon initiation, adjustment, and discontinuation of telmisartan)
- Other antihypertensive agents - additive hypotensive effect
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, especially important in patients with pre-existing renal impairment or those at risk.
Timing: Prior to initiation of therapy
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, especially important in patients with renal impairment, diabetes, or those on potassium-sparing diuretics/supplements.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, typically weekly to monthly until stable, then every 3-6 months or as clinically indicated.
Target: <130/80 mmHg or individualized target based on patient comorbidities.
Action Threshold: If BP remains above target, 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, especially during dose titration, or if renal function is compromised. Typically 1-2 weeks after initiation/dose change, then every 3-12 months.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant increase (e.g., >30% from baseline or progressive increase) may indicate renal impairment and require dose reduction or discontinuation.
Serum Potassium (K+)
Frequency: Periodically, especially in patients at risk for hyperkalemia (e.g., renal impairment, diabetes, concomitant use of potassium-sparing diuretics/supplements). Typically 1-2 weeks after initiation/dose change, then every 3-12 months.
Target: 3.5-5.0 mEq/L
Action Threshold: K+ > 5.5 mEq/L may require dose reduction, discontinuation, or management of hyperkalemia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat)
- Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
Special Patient Groups
Pregnancy
Telmisartan can cause fetal harm or death when administered to a pregnant woman. Discontinue as soon as possible when pregnancy is detected. There are no adequate and well-controlled studies of telmisartan in pregnant women.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies have shown adverse effects. Risk of major birth defects is not well-established, but exposure should be avoided.
Second Trimester:
Increased risk of fetal and neonatal morbidity and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and anuria leading to renal failure and death.
Third Trimester:
Increased risk of fetal and neonatal morbidity and death, including oligohydramnios, fetal lung hypoplasia, skeletal deformations, and anuria leading to renal failure and death.
Lactation
It is not known whether telmisartan is excreted in human milk. Telmisartan is excreted in the milk of lactating rats. Because of 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:
Unknown, but potential for serious adverse reactions in breastfed infants. Not recommended.
Pediatric Use
Safety and effectiveness 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, and monitoring of renal function is particularly important.
Clinical Information
Clinical Pearls
- Telmisartan has the longest half-life among commonly used ARBs (approximately 24 hours), supporting its once-daily dosing and providing consistent 24-hour blood pressure control.
- It is highly lipophilic, which may contribute to its tissue penetration and sustained AT1 receptor blockade.
- Telmisartan is primarily eliminated via biliary excretion, making it a suitable option for patients with significant renal impairment (though monitoring is still advised).
- It is a good alternative for patients who develop cough with ACE inhibitors, as it does not affect bradykinin metabolism.
- Beyond hypertension, telmisartan is also indicated for cardiovascular risk reduction in patients unable to take ACE inhibitors, due to its proven efficacy in reducing the risk of MI, stroke, or cardiovascular death in high-risk patients.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, 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
- Other antihypertensive classes depending on patient comorbidities and indications.
Cost & Coverage
Average Cost:
Varies widely per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic telmisartan); Tier 3 or higher (for brand Micardis)
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 substance taken, the amount, and the time it occurred.