Telmisartan 80mg 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, Cardiovascular risk reduction
Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
Pregnancy Category
Not applicable (FDA changed system, see Black Box Warning and Special Populations)
FDA Approved
Dec 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 from the pack 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, away from the 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start 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 from the pack 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, away from the 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take 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.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Monitor blood pressure regularly at home if advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For Hypertension: Initial 40 mg once daily. For Cardiovascular Risk Reduction: 80 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 effect usually achieved within 4 weeks.
cardiovascular_risk_reduction:
80 mg once daily. It is not known if doses lower than 80 mg are effective in reducing cardiovascular morbidity and mortality.
concomitant_diuretics:
Consider lower initial dose (e.g., 20 mg) if patient is volume-depleted.
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, but monitor renal function periodically. Telmisartan is not removed by hemodialysis.
Dialysis:
Not removed by hemodialysis. No specific dose adjustment needed, but monitor renal function and potassium levels.
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 it does not potentiate bradykinin-mediated effects.
Pharmacokinetics
Absorption:
Bioavailability:
42-58% (dose-dependent, 42% for 40mg, 58% for 160mg)
Tmax:
0.5-1 hour
FoodEffect:
Food slightly reduces the bioavailability (approx. 6% for 40mg, 20% for 160mg), 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:
Not available (primarily biliary/fecal excretion)
ExcretionRoute:
Primarily feces (approximately 97% of orally administered dose) via biliary excretion; negligible renal excretion.
Unchanged:
Not available (primarily excreted as glucuronide conjugate)
Pharmacodynamics
OnsetOfAction:
Within 3 hours
PeakEffect:
Within 4-8 hours
DurationOfAction:
24 hours (allows for once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
When pregnancy is detected, discontinue Telmisartan 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 (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., unusual tiredness, weakness, irregular heartbeats, nausea, tingling)
- Signs of kidney problems (e.g., decreased urination, swelling in feet/ankles, 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 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. Please 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 medications and health conditions. Never start, stop, or change the dose 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. Please 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 medications and health conditions. Never start, stop, or change the dose 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 before making any changes. Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor to avoid potential interactions.
When taking this medication for high blood pressure, be cautious with 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. Consult with your doctor before using these products.
In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, vomiting, diarrhea, or loose stools, 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 any questions or concerns, discuss them with your doctor.
If you are on a low-salt or salt-free diet, consult with your doctor before making any changes. Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor to avoid potential interactions.
When taking this medication for high blood pressure, be cautious with 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. Consult with your doctor before using these products.
In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, vomiting, diarrhea, or loose stools, 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
What to Do:
Seek immediate medical attention. Call 911 or Poison Control 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 or moderate to severe renal impairment [GFR <60 mL/min/1.73 m²])
Major Interactions
- Lithium (increased serum lithium concentrations and toxicity)
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or other agents that may increase potassium levels (e.g., heparin, trimethoprim-sulfamethoxazole) (increased risk of hyperkalemia)
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including selective COX-2 inhibitors (reduced antihypertensive effect, increased risk of renal impairment, including acute renal failure)
Moderate Interactions
- Digoxin (increased peak and trough plasma concentrations of digoxin)
- Other antihypertensive agents (additive hypotensive effect)
- Diuretics (increased risk of symptomatic hypotension, especially with initial dose)
Minor Interactions
- Not available (no specific minor interactions commonly cited as clinically significant)
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 for acute kidney injury.
Timing: Prior to initiation of therapy.
Serum Potassium (K+)
Rationale: To establish baseline and identify patients at risk for hyperkalemia (e.g., renal impairment, concomitant potassium-sparing diuretics).
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly after initiation/dose change, then monthly/quarterly once stable)
Target: <130/80 mmHg (or individualized target based on guidelines and patient comorbidities)
Action Threshold: If BP remains uncontrolled, consider dose increase or addition of other antihypertensive agents. If symptomatic hypotension occurs, consider dose reduction.
Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 6-12 months, or more frequently in patients with renal impairment or on concomitant nephrotoxic drugs)
Target: Within normal limits or stable from baseline
Action Threshold: Significant increase (>30% from baseline or progressive increase) may indicate renal impairment and warrant dose adjustment or discontinuation.
Serum Potassium (K+)
Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 6-12 months, or more frequently in patients with renal impairment, diabetes, or on concomitant potassium-increasing drugs)
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, paresthesias, fatigue, bradycardia)
- Signs of angioedema (e.g., swelling of face, lips, tongue, throat, difficulty breathing)
Special Patient Groups
Pregnancy
CONTRAINDICATED in the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is generally avoided due to potential risks, though less clearly established than later trimesters.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies show some risk. Generally, use is avoided or discontinued if pregnancy is planned or detected.
Second Trimester:
High risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure) and death.
Third Trimester:
High risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure) and death. Neonatal adverse effects include hypotension, hyperkalemia, and renal failure.
Lactation
Not recommended. It is unknown if telmisartan is excreted in human milk. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions in the breastfed infant (e.g., hypotension, hyperkalemia, renal impairment).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients (<18 years of age). Use is not recommended.
Geriatric Use
No dosage adjustment is generally necessary based on age. However, older patients may be more sensitive to the effects of telmisartan, particularly regarding blood pressure reduction and potential for renal impairment. Monitor blood pressure, 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 effect.
- Unlike ACE inhibitors, ARBs like telmisartan do not cause cough as a common side effect, making them a suitable alternative for patients who develop ACE inhibitor-induced cough.
- Telmisartan is primarily eliminated via biliary excretion, making it a good option for patients with significant renal impairment (though monitoring is still important).
- The 80 mg dose is specifically indicated for cardiovascular risk reduction in patients unable to take ACE inhibitors, independent of blood pressure control.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, Irbesartan, Candesartan, Olmesartan, Azilsartan
- Angiotensin-Converting Enzyme (ACE) Inhibitors: Lisinopril, Enalapril, Ramipril, Benazepril
- 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 ($10-$100+) 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 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 for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.