Telmisartan 40mg Tablets
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It 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
D (1st Trimester), X (2nd and 3rd Trimesters)
FDA Approved
Nov 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
Keep your medication in its original container and store it at room temperature in a dry place. Avoid storing it in a bathroom. Make sure to keep all medications in a safe 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 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
Keep your medication in its original container and store it at room temperature in a dry place. Avoid storing it in a bathroom. Make sure to keep all medications in a safe 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
- Take the medication exactly as prescribed, usually once a day, with or without food.
- Do not stop taking telmisartan without talking to your doctor, even if you feel well.
- Continue to follow a low-sodium diet as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit alcohol intake.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Monitor your blood pressure regularly at home if advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
40 mg orally once daily
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
hypertension:
Initial dose 40 mg orally 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 4-8 weeks.
cardiovascular_risk_reduction:
80 mg orally once daily. It is not known whether doses lower than 80 mg 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 required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required, but monitor renal function and potassium levels closely.
Dialysis:
Telmisartan is not removed by hemodialysis. No dose adjustment required, but monitor.
Hepatic Impairment:
Mild:
Maximum dose of 40 mg orally once daily.
Moderate:
Maximum dose of 40 mg orally 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 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:
Approximately 42-58% (dose-dependent, 42% for 40 mg, 58% for 160 mg).
Tmax:
0.5-1 hour (plasma peak concentrations).
FoodEffect:
Food slightly reduces the bioavailability (AUC by 6% for 40 mg, 20% for 160 mg), 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 excretion).
ExcretionRoute:
Primarily biliary/fecal excretion (>97% of dose).
Unchanged:
>97% (excreted unchanged in feces).
Pharmacodynamics
OnsetOfAction:
Within 3 hours (for blood pressure reduction).
PeakEffect:
Full antihypertensive effect is usually achieved within 4-8 weeks of initiating therapy.
DurationOfAction:
24 hours (due to long half-life and tight receptor binding).
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., muscle weakness, slow or irregular heartbeat)
- Signs of kidney problems (e.g., little or no urination, swelling in your feet or ankles, feeling tired or short of breath)
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 for you 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 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 for you 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, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions you have with your doctor.
If you are following a low-salt or salt-free diet, consult with your doctor. Additionally, if you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor to avoid potential interactions.
If you have high blood pressure and are taking this medication, 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 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, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
As directed by your healthcare provider, regularly monitor your blood pressure and undergo blood tests. Discuss any concerns or questions you have with your doctor.
If you are following a low-salt or salt-free diet, consult with your doctor. Additionally, if you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor to avoid potential interactions.
If you have high blood pressure and are taking this medication, 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 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
- Fainting
- Acute renal failure
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic. Hemodialysis is not effective for removing telmisartan.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or moderate to severe renal impairment (eGFR < 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.
- NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, including COX-2 inhibitors) - may attenuate antihypertensive effect, increased risk of renal impairment and hyperkalemia.
- Lithium - increased serum lithium concentrations and toxicity.
- Digoxin - increased plasma digoxin concentrations.
- ACE inhibitors (e.g., enalapril, lisinopril) - dual blockade of the RAS increases risk of hypotension, hyperkalemia, and renal impairment; generally avoid concomitant use.
Moderate Interactions
- Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses.
- Other antihypertensive agents - additive hypotensive effect.
- Corticosteroids (systemic) - may reduce the antihypertensive 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, as telmisartan can cause hyperkalemia, especially 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 for first few weeks, then monthly or as clinically indicated) until target BP is achieved, then periodically.
Target: <130/80 mmHg or as per individual patient goals and guidelines.
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 or dose change, then every 3-6 months, or as clinically indicated), especially in patients with renal impairment, heart failure, or on concomitant NSAIDs.
Target: Within patient's baseline range or acceptable limits.
Action Threshold: Significant increase (e.g., >30% above baseline or progressive increase) may indicate renal dysfunction; consider dose reduction, discontinuation, or investigation of underlying cause.
Serum Potassium (K+)
Frequency: Periodically (e.g., 1-2 weeks after initiation or dose change, then every 3-6 months, or as clinically indicated), especially in patients with renal impairment, diabetes, or on concomitant potassium-sparing agents.
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, difficulty breathing)
- Symptoms of renal impairment (e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Telmisartan is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. It should be discontinued as soon as pregnancy is detected. Exposure during the first trimester should also be avoided if possible, as there is growing evidence of risk.
Trimester-Specific Risks:
First Trimester:
Category D. While risks are lower than in later trimesters, exposure should be avoided if possible. Observational studies suggest a potential increased risk of major congenital malformations following first trimester exposure to ARBs.
Second Trimester:
Category X. Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal death.
Third Trimester:
Category X. Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal death.
Lactation
Telmisartan is not recommended during breastfeeding. It is unknown if telmisartan is excreted in human milk, but due to the potential for serious adverse effects in 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:
Potential for serious adverse effects (e.g., hypotension, hyperkalemia, renal impairment) in the breastfed infant. L3 (Moderately Safe) or L4 (Potentially Hazardous) depending on source, but generally advised against.
Pediatric Use
Safety and effectiveness of telmisartan in pediatric patients have not been established. Use is not recommended.
Geriatric Use
No dosage adjustment is generally necessary in elderly patients. However, greater sensitivity of some older individuals cannot be ruled out. Monitor renal function and potassium levels, as elderly patients may be more susceptible to hyperkalemia and renal impairment.
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 has a high lipophilicity, which may contribute to its tissue penetration and sustained receptor blockade.
- Unlike ACE inhibitors, telmisartan does not cause cough as it does not affect bradykinin metabolism.
- It is primarily eliminated via biliary excretion, making it a suitable option for patients with significant renal impairment (though monitoring is still crucial).
- Telmisartan is also indicated for cardiovascular risk reduction in patients unable to take ACE inhibitors, due to its proven efficacy in the ONTARGET study.
Alternative Therapies
- Other Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, 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
- Direct Renin Inhibitors: Aliskiren (limited use)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.