Telmisartan 20mg Tablets

Manufacturer SOLCO HEALTHCARE Active Ingredient Telmisartan(tel mi SAR tan) Pronunciation tel mi SAR tan
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.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB)
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Pregnancy Category
Not applicable (FDA has phased out letter categories for ARBs; contraindicated in 2nd/3rd trimesters)
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FDA Approved
Nov 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Telmisartan is a medication used to lower high blood pressure and reduce the risk of heart problems like heart attack or stroke. It works by blocking a natural substance in your body that narrows blood vessels, allowing blood vessels to relax and widen, which helps blood flow more easily and lowers blood pressure.
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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 as directed, with or without food. Continue taking it even if you feel well, and take it at the same time every day.

If your medication comes in a blister pack, remove the tablet just before use by peeling back the foil. Avoid pushing the tablet through the foil, as this may cause it to break.

It's essential to drink 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 place, and away from the bathroom. Keep all medications in a safe location, 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.
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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.
  • Monitor your blood pressure regularly at home if advised by your doctor.
  • Limit sodium intake in your diet.
  • Maintain a healthy weight through diet and exercise.
  • Limit alcohol consumption.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Inform your doctor or dentist that you are taking telmisartan before any surgery or dental procedures.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg orally once daily
Dose Range: 20 - 80 mg

Condition-Specific Dosing:

hypertension: Initial dose 40 mg once daily; dose may be adjusted from 20 mg to 80 mg once daily based on blood pressure response. 20 mg may be considered for patients who require less aggressive blood pressure reduction.
cardiovascular_risk_reduction: 80 mg orally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and effectiveness not established in pediatric patients <18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary
Moderate: No dosage adjustment necessary
Severe: No dosage adjustment necessary, but monitor renal function and potassium levels closely
Dialysis: Telmisartan is not removed by hemodialysis. No dosage adjustment necessary, but monitor closely.

Hepatic Impairment:

Mild: Initial dose 20 mg orally once daily; maximum 40 mg once daily
Moderate: Initial dose 20 mg orally once daily; maximum 40 mg once daily
Severe: Contraindicated

Pharmacology

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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 aldosterone secretion, and subsequent reduction in blood pressure. It does not inhibit ACE (kininase II), thus it does not potentiate bradykinin-mediated effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 42% (for 40 mg dose), 58% (for 20 mg dose)
Tmax: 0.5 to 1 hour
FoodEffect: Food slightly reduces bioavailability (by about 6% for 40 mg dose), but this is not 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 eliminated unchanged)
ExcretionRoute: Primarily biliary/fecal (approximately 97% of dose)
Unchanged: Approximately 97% (fecal)
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Pharmacodynamics

OnsetOfAction: Within 3 hours
PeakEffect: Within 4-8 weeks for full blood pressure lowering effect
DurationOfAction: 24 hours

Safety & Warnings

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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.
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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 pass urine
+ 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (signs of low blood pressure)
  • 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)
  • Unusual tiredness or weakness
  • Muscle cramps or weakness, irregular heartbeat (signs of high potassium)
  • Decreased urination or swelling in ankles/feet (signs of kidney problems)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any 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. Please 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 the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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, stand up slowly after sitting or lying down, 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 to ensure safe use of this medication. 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.

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 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.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (low blood pressure)
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)
  • Dizziness
  • Lightheadedness

What to Do:

Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US) immediately. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Administer intravenous fluids to support blood pressure. Telmisartan is not removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes mellitus or renal impairment [GFR <60 mL/min/1.73 m2])
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • Other agents that increase serum potassium (e.g., heparin, trimethoprim-sulfamethoxazole)
  • Lithium (increased serum lithium concentrations and toxicity)
  • NSAIDs (including selective COX-2 inhibitors) - may attenuate antihypertensive effect and increase risk of renal impairment
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Moderate Interactions

  • ACE inhibitors (increased risk of hypotension, hyperkalemia, and renal impairment, especially in patients with pre-existing renal dysfunction)
  • Diuretics (increased risk of symptomatic hypotension, especially with initial dose)
  • Digoxin (slight increase in mean trough digoxin plasma concentrations)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Rationale: To assess baseline renal function, as ARBs can affect renal hemodynamics.

Timing: Prior to initiation of therapy

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ARBs can cause hyperkalemia.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: <130/80 mmHg (or individualized target based on patient comorbidities)

Action Threshold: If BP remains elevated despite maximum dose, consider adding or switching therapy. If BP is too low (symptomatic hypotension), reduce dose or discontinue.

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 patient's baseline range

Action Threshold: Significant increase (e.g., >30% from baseline or progressive increase) may indicate renal impairment; consider dose reduction or discontinuation, investigate 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 or on potassium-sparing agents)

Target: 3.5-5.0 mEq/L

Action Threshold: >5.5 mEq/L (hyperkalemia) may require dose reduction, discontinuation, or specific management.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Signs of hyperkalemia (e.g., muscle weakness, paresthesias, bradycardia)
  • Signs of angioedema (e.g., swelling of face, lips, tongue, throat)
  • Signs of renal dysfunction (e.g., decreased urine output, edema)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally not recommended due to potential risks.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal data suggest risk. Generally advised to avoid if possible.
Second Trimester: Significant risk of fetal injury (e.g., oligohydramnios, fetal skull hypoplasia, anuria, renal failure, lung hypoplasia, skeletal deformations, death).
Third Trimester: Significant risk of fetal injury (e.g., oligohydramnios, fetal skull hypoplasia, anuria, renal failure, lung hypoplasia, skeletal deformations, death).
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Lactation

Not recommended during breastfeeding. Telmisartan is excreted in the milk of lactating rats. 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 effects (e.g., hypotension, hyperkalemia, renal dysfunction) in the infant. Use of an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

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Geriatric Use

No dosage adjustment is necessary based on age. However, elderly patients may be more sensitive to the effects of telmisartan, particularly regarding blood pressure reduction and renal function. Monitor renal function and potassium levels closely.

Clinical Information

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Clinical Pearls

  • Telmisartan has the longest half-life among 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, ARBs like telmisartan do not cause cough as a common side effect because they do not affect bradykinin metabolism.
  • Telmisartan is primarily eliminated unchanged via bile/feces, making it a good option for patients with severe renal impairment (though monitoring is still crucial).
  • It is also approved for cardiovascular risk reduction in patients unable to take ACE inhibitors, based on the ONTARGET study (though not for primary prevention in low-risk patients).
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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
  • Other antihypertensives depending on patient profile and comorbidities
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.