Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: 4′ - [1(1,4′ - Dimethyl - 2′ - propyl[2,6′ - bi - 1H - benzimidazol] - 1′ - yl)methyl] - [1,1′ - biphenyl] - 2 - carboxylic acid
Molecular Formula: C33H30N4O2
CAS Number: 144701-48-4
Brands: Micardis, Micardis HCT
May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 2 49 50 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue as soon as possible.1 2 50
Introduction
Angiotensin II receptor (AT1) antagonist.1 2 3 16
Uses for Telmisartan
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 17 19
One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.43
Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.43
Diabetic Nephropathy
A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.
CHF
A second-line agent in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.
Telmisartan Dosage and Administration
General
Hypertension
Fixed-combination telmisartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.2
Administration
Oral Administration
Administer orally once daily without regard to meals.1 2
Dosage
Adults
Hypertension
Monotherapy
Oral
Initially, 40 mg once daily in adults without intravascular volume depletion.1 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.43
Usual dosage: 20–80 mg once daily; no additional therapeutic benefit with higher dosages.1
Combination Therapy
Oral
If BP is not adequately controlled by monotherapy with telmisartan 80 mg daily, can switch to fixed-combination tablets (telmisartan 80 mg and hydrochlorothiazide 12.5 mg; then telmisartan 160 mg and hydrochlorothiazide 25 mg), administered once daily.2
If BP is not adequately controlled by monotherapy with hydrochlorothiazide 25 mg or if BP is controlled but hypokalemia is problematic at this dosage, can use fixed-combination tablets containing telmisartan 80 mg and hydrochlorothiazide 12.5 mg, administered once daily.2 Can increase dosage to telmisartan 160 mg and hydrochlorothiazide 25 mg, if needed, to control BP.2
Special Populations
Hepatic Impairment
Initiate therapy under close medical supervision in patients with obstructive biliary disease or hepatic impairment.1
If fixed-combination tablets are used in patients with obstructive biliary disease or hepatic impairment, recommended initial dosage is telmisartan 40 mg and hydrochlorothiazide 12.5 mg daily.2 Use of fixed combination not recommended in those with severe hepatic impairment.2
Renal Impairment
No initial dosage adjustments necessary in patients with Clcr >30 mL/minute.1 2 Manufacturer makes no specific recommendations regarding telmisartan monotherapy in those with Clcr ≤30 mL/minute.1
Telmisartan/hydrochlorothiazide fixed combination not recommended in patients with Clcr <30 mL/minute.2
Geriatric Patients
No initial dosage adjustments necessary.1 2
Volume- and/or Salt-Depleted Patients
Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.1 2
Cautions for Telmisartan
Contraindications
Known hypersensitivity to telmisartan or any ingredient in the formulation.1 2 7
Warnings/Precautions
Warnings
Hypotension
Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).1 2 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)
Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 2
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 2 50 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.50
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.49 50
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.49 50 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13
Malignancies
In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126
Sensitivity Reactions
Anaphylactoid reactions and/or angioedema possible;1 2 7 14 not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.b
General Precautions
Renal Effects
Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.1 2
Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 2
Use of Fixed Combinations
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.2
Specific Populations
Pregnancy
Category C (1st trimester); Category D (2nd and 3rd trimesters).1 2 (See Boxed Warning.)
Lactation
Distributed into milk in rats; not known whether distributed into human milk.1 2 Discontinue nursing or the drug.1 2
Pediatric Use
Safety and efficacy not established in children <18 years of age.1 2 21
Geriatric Use
No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 2
Hepatic Impairment
Plasma telmisartan concentrations may be increased in patients with obstructive biliary disease or hepatic impairment.1 2 (See Special Populations under Absorption, in Pharmacokinetics.) Dosage adjustments may be necessary.2 (See Hepatic Impairment under Dosage and Administration.)
Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with severe hepatic impairment.2
Renal Impairment
Deterioration of renal function may occur.1 2 (See Renal Effects under Cautions.)
Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr <30 mL/minute.2
Blacks
BP reduction may be smaller in black patients compared with non-black patients; use in combination with a diuretic.1 43
Common Adverse Effects
Upper respiratory tract infection, sinusitis, pharyngitis, back pain, diarrhea.1
Interactions for Telmisartan
Not metabolized by CYP isoenzymes; has no effect on CYP isoenzymes except for some inhibition of CYP2C19 in vitro.1 2
Specific Drugs
Drug | Interaction | Comment |
|---|---|---|
Acetaminophen | Interactions unlikely1 2 | |
Amlodipine | Interactions unlikely1 2 | |
Digoxin | Increased plasma digoxin concentrations1 2 | Monitor serum digoxin concentrations when telmisartan therapy is initiated, adjusted, or discontinued in patients stabilized on digoxin1 2 3 21 |
Glyburide | Interactions unlikely1 2 | |
Hydrochlorothiazide | Additive hypotensive effects1 2 | |
Ibuprofen | Interactions unlikely1 2 | |
Simvastatin | Interactions unlikely1 2 | |
Warfarin | Possible decreased plasma warfarin concentrations; INR not affected1 2 |
Telmisartan Pharmacokinetics
Absorption
Bioavailability
Absolute bioavailability is dose dependent: 42% at 40 mg, 58% at 160 mg.1 2
Peak plasma concentration generally reached at 0.5–1 hour following oral administration.1 2
Onset
Antihypertensive effect evident within 2 weeks, with maximum BP reduction after 4 weeks.1
Food
Food slightly reduces bioavailability.1 2
Special Populations
In patients with hepatic insufficiency, plasma telmisartan concentrations are increased and absolute bioavailability approaches 100%.1 2
Distribution
Extent
Crosses the placenta and is distributed in the fetus in animals.1 2
Distributed into milk in rats; not known whether distributed into human milk.1 2
Plasma Protein Binding
>99.5% (principally albumin and α1-acid glycoprotein).1 2
Elimination
Metabolism
Metabolized in liver (via conjugation) to inactive metabolite.1 2
Not metabolized by CYP isoenzymes.1 2
Elimination Route
Eliminated mainly (>97%) as unchanged drug in feces (via bile); small amounts (<1%) eliminated in urine.1 2
Half-life
Biphasic; terminal half-life is approximately 24 hours.1 2
Special Populations
Not removed from blood by hemofiltration.1 2
Stability
Storage
Oral
Tablets
25°C (may be exposed to 15–30°C).1 2 Do not remove tablets from blisters until immediately before administration.1 2
Actions
Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 2
Does not interfere with response to bradykinins and substance P.1 2
Does not share the ACE inhibitor common adverse effect of dry cough.1 2 33
Advice to Patients
Risks of use during pregnancy.1 2 49 50
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 2
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2
Importance of informing patients of other important precautionary information.1 2 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 20 mg | Micardis (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) |
40 mg | Micardis (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) | ||
80 mg | Micardis (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 40 mg with Hydrochlorothiazide 12.5 mg | Micardis HCT (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) |
80 mg with Hydrochlorothiazide 12.5 mg | Micardis HCT (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) | ||
80 mg with Hydrochlorothiazide 25 mg | Micardis HCT (with povidone) | Boehringer Ingelheim, (also promoted by Abbott) |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Micardis 20MG Tablets (BOEHRINGER INGELHEIM): 30/$123.19 or 90/$337.09
Micardis 40MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$355.97
Micardis 80MG Tablets (BOEHRINGER INGELHEIM): 30/$122.99 or 90/$325.95
Micardis HCT 40-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$339.96
Micardis HCT 80-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$122.00 or 90/$331.99
Micardis HCT 80-25MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$349.97
Twynsta 80-5MG Tablets (BOEHRINGER INGELHEIM): 30/$129.99 or 90/$365.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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More Telmisartan resources
- Telmisartan Side Effects (in more detail)
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