Micardis 80mg 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
Category D/X
FDA Approved
Nov 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Telmisartan is a medication used to treat high blood pressure and to reduce the risk of heart attack, stroke, or death from heart problems in certain high-risk patients. It works by relaxing blood vessels, allowing blood to flow more easily and lowering blood pressure.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
If your medication comes in a blister pack, remove the tablet just before use. To do this, peel back the foil on the blister pack, but avoid pushing the tablet through the foil, as this may cause it to break.
It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature, in a dry location, and away from the bathroom. Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you're feeling well. Establish a routine by taking your medication at the same time every day.
If your medication comes in a blister pack, remove the tablet just before use. To do this, peel back the foil on the blister pack, but avoid pushing the tablet through the foil, as this may cause it to break.
It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature, in a dry location, and away from the bathroom. Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take medication consistently, ideally at the same time each day.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Follow a low-sodium diet as recommended by your doctor or dietitian.
- Engage in regular physical activity.
- Limit alcohol intake.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically 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 dose 40 mg once daily; dose can be increased to a maximum of 80 mg once daily if needed. Full antihypertensive effect usually achieved within 4 weeks.
cardiovascular_risk_reduction:
80 mg once daily. It is not known if doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity and mortality.
heart_failure:
Not FDA approved for heart failure, but may be used off-label in some cases, typically 40-80 mg once daily, often in combination with other agents.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness not established in pediatric patients <18 years of age)
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients <18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary. However, monitor renal function periodically.
Dialysis:
Telmisartan is not removed by hemodialysis. No dosage adjustment necessary, but monitor renal function and potassium.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
Initial dose 20 mg once daily. Maximum dose 40 mg once daily. Use with caution.
Severe:
Contraindicated in patients with severe hepatic impairment (e.g., cholestasis or biliary obstruction).
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 vasoconstrictor 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 it does not potentiate bradykinin-mediated effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 42-58% (dose-dependent, 40 mg dose is ~50%)
Tmax:
0.5-1 hour
FoodEffect:
Food slightly reduces bioavailability (by ~6% for 40 mg dose), but this is not considered clinically significant, and telmisartan may 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:
Approximately 900 mL/min (total plasma clearance)
ExcretionRoute:
Biliary/fecal (primarily as unchanged drug and its glucuronide conjugate)
Unchanged:
Approximately 98% (fecal)
Pharmacodynamics
OnsetOfAction:
Within 3 hours
PeakEffect:
Within 4-8 weeks (for full antihypertensive effect)
DurationOfAction:
24 hours (due to long half-life and tight receptor binding)
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:
- Severe dizziness or fainting (signs of low blood pressure)
- Unusual tiredness or weakness
- Swelling of the face, lips, tongue, or throat (signs of angioedema - seek immediate medical attention)
- Difficulty breathing or swallowing (signs of angioedema - seek immediate medical attention)
- Yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting (signs of liver problems)
- Muscle weakness, irregular heartbeat (signs of high potassium)
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 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 discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following 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 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 discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, 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 on a low-salt or salt-free diet, consult with your doctor to discuss any necessary adjustments.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. Additionally, if you have high blood pressure and are taking this medication, consult with 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 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 on a low-salt or salt-free diet, consult with your doctor to discuss any necessary adjustments.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. Additionally, if you have high blood pressure and are taking this medication, consult with 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 heart rate)
- Bradycardia (slow heart rate)
- Dizziness
- Fainting
- Acute renal failure (rare)
What to Do:
Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. Treatment is symptomatic and supportive. If ingestion was recent, gastric lavage may be considered. Hemodialysis is not effective for removing telmisartan.
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 (Non-Steroidal Anti-Inflammatory Drugs, including selective COX-2 inhibitors)
- Lithium
- Digoxin (increased plasma concentrations of digoxin)
Moderate Interactions
- Diuretics (e.g., thiazide diuretics, loop diuretics - risk of excessive blood pressure reduction)
- Other antihypertensive agents (additive hypotensive effect)
- Corticosteroids (may reduce antihypertensive effect)
- Baclofen (increased antihypertensive effect)
- Amifostine (increased hypotensive effect)
Minor Interactions
- Alcohol (may enhance hypotensive effect)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.
Timing: Prior to initiation
Serum Potassium (K+)
Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Persistent elevation above target, or symptomatic hypotension
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Periodically (e.g., 1-2 weeks after initiation or dose change, then every 3-6 months, or as clinically indicated)
Target: Within normal limits, or stable from baseline
Action Threshold: Significant increase (>30% from baseline or rapid rise), especially if accompanied by hyperkalemia
Serum Potassium (K+)
Frequency: Periodically (e.g., 1-2 weeks after initiation or dose change, then every 3-6 months, or as clinically indicated)
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L (consider dose reduction or discontinuation), or symptomatic hyperkalemia
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
- Fatigue or weakness
- Muscle cramps or weakness (may indicate hyperkalemia)
- Swelling of face, lips, tongue, or throat (rare, but indicative of angioedema)
- Difficulty breathing or swallowing (rare, but indicative of angioedema)
- Persistent dry cough (less common than with ACE inhibitors, but possible)
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks, though less severe than later trimesters.
Trimester-Specific Risks:
First Trimester:
Category D. Limited human data suggest potential risk, but less severe than later trimesters. Still, generally avoided if alternatives exist.
Second Trimester:
Category X. Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
Third Trimester:
Category X. Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
Lactation
Use is generally not recommended during breastfeeding. Telmisartan is excreted in the milk of lactating rats, and it is unknown if it 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.
Infant Risk:
Moderate risk (L3). Potential for hypotension, hyperkalemia, and renal effects in the infant. Monitor infant for adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 18 years of age. Use is not recommended.
Geriatric Use
No dosage adjustment is generally necessary based on age alone. However, elderly patients may be more sensitive to the effects of telmisartan, particularly hypotension. Initiate therapy at the lower end of the dosing range (e.g., 20 mg) and titrate carefully. Monitor renal function and electrolytes closely.
Clinical Information
Clinical Pearls
- Telmisartan has the longest half-life among commonly used ARBs (approximately 24 hours), allowing for consistent 24-hour blood pressure control with once-daily dosing.
- It is highly lipophilic, which may contribute to its tissue penetration and sustained receptor blockade.
- Unlike ACE inhibitors, telmisartan (and other ARBs) does not cause a dry cough, making it a suitable alternative for patients who develop cough with ACE inhibitors.
- Telmisartan is also indicated for cardiovascular risk reduction in patients unable to take ACE inhibitors, due to its proven efficacy in the ONTARGET study.
- Caution is advised when combining telmisartan with NSAIDs, especially in elderly, volume-depleted, or renally impaired patients, due to increased risk of renal dysfunction and hyperkalemia.
- Dual blockade of the RAAS (e.g., ARB + ACEI, or ARB + aliskiren) is generally not recommended due to increased risk of adverse events without significant additional benefit, particularly in patients with diabetes or renal impairment.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Valsartan, Losartan, Irbesartan, Olmesartan, Candesartan, 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 antihypertensives depending on patient comorbidities and indications.
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 30 tablets (generic 80mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.