Micardis

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias
  • Hypertension
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Micardis Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Telmisartan 20mg, 40mg, 80mg; tabs.

    Pharmacological Class

    Angiotensin II receptor blocker (ARB).

    How Supplied

    Tabs—3x10 (blister cards)

    How Supplied

    Micardis is supplied as:

    • white or off-white, uncoated tablets marked with the Boehringer Ingelheim company symbol on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively.
    • The 20 mg tablets are round; 40 mg and 80 mg tablets are oblong shaped.

    Storage

    Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15° C to 30° C (59° F to 86° F).

    Manufacturer

    Boehringer Ingelheim Pharmaceuticals

    Generic Availability

    YES

    Micardis Indications

    Indications

    Cardiovascular (CV) risk reduction in patients ≥55 years of age at high risk of developing major CV events who are unable to take ACE inhibitors.

    Micardis Dosage and Administration

    Adult

    80mg once daily. Monitor BP; adjustments to meds that lower BP may be needed.

    Children

    Not established.

    Micardis Contraindications

    Contraindications

    Concomitant aliskiren in patients with diabetes.

    Micardis Boxed Warnings

    Boxed Warning

    Fetal toxicity.

    Micardis Warnings/Precautions

    Warnings/Precautions

    Fetal toxicity may develop; discontinue if pregnancy is detected. Correct hypovolemia before starting therapy or monitor closely. Severe CHF. Biliary obstruction. Hepatic or renal impairment. Renal artery stenosis. Dialysis (monitor for orthostatic hypotension). Neonates. Pregnancy: avoid. Nursing mothers: not recommended.

    Warnings/Precautions

    Fetal Toxicity

    • Drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
    • Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
    • Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
    • Discontinue Micardis as soon as possible when pregnancy is detected.

    Hypotension

    • Symptomatic hypotension may occur after initiation of therapy with Micardis in those with an activated renin-angiotensin system, such as volume- or salt-depleted patients (eg, those being treated with high doses of diuretics).
    • Correct this condition prior to administration of Micardis or start treatment with a reduced dose and monitor. 
    • Patients should be placed in the supine position if hypotension does occur; if necessary, given an intravenous infusion of normal saline.
    • A transient hypotensive response is not a contraindication to further treatment, which usually can be continued once the blood pressure has stabilized.

    Hyperkalemia

    • Hyperkalemia may occur in patients on ARBs, particularly in those with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. 
    • In patients at risk, consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

    Impaired Hepatic Function

    • As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
    • Initiate telmisartan at low doses and titrate slowly in these patients.

    Impaired Renal Function

    • As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.  Initiate telmisartan at low doses and titrate slowly in these patients.
    • As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals.
    • In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with Micardis.
    • There has been no long-term use of Micardis in patients with unilateral or bilateral renal artery stenosis, but anticipate increases in serum creatinine or blood urea nitrogen, similar to that seen with ACE inhibitors.

    Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)

    • Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
    • No benefit has been associated with using two RAS inhibitors concomitantly in most patients. 
    • In general, avoid combined use of RAS inhibitors. 
    • Closely monitor blood pressure, renal function, and electrolytes in patients on Micardis and other agents that affect the RAS.
    • Avoid concomitant aliskiren with Micardis in patients with diabetes or those with renal impairment (GFR <60mL/min/1.73m2).

    Pregnancy Considerations

    Micardis can cause fetal harm when administered to a pregnant woman. Drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. 

    Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses. Discontinue Micardis as soon as possible when pregnancy is detected.

    Nursing Mother Considerations

    There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Telmisartan is present in the milk of lactating rats. 

    Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with Micardis.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Neonates with a history of in utero exposure to Micardis

    • Support blood pressure and renal perfusion if oliguria or hypotension occurs. May require exchange transfusions or dialysis to reverse hypotension and/or substituting for disordered renal function.

    Geriatric Considerations

    No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

    Hepatic Impairment Considerations

    In patients with hepatic insufficiency, plasma concentrations of telmisartan are increased, and absolute bioavailability approaches 100%.

    Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

    Micardis Pharmacokinetics

    Absorption

    Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of telmisartan is dose dependent.

    Distribution

    Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α1 - acid glycoprotein.

    Metabolism

    Telmisartan is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.

    Elimination

    Following either intravenous or oral administration of 14C-labeled telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively).

    Telmisartan shows bi-exponential decay kinetics with a terminal elimination half-life of approximately 24 hours.

    Micardis Interactions

    Interactions

    See Contraindications. Concomitant ACE inhibitors (eg, ramipril): not recommended. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt substitutes. May potentiate digoxin. Monitor lithium levels. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted.

    Micardis Adverse Reactions

    Adverse Reactions

    Back pain, upper respiratory tract infection, sinusitis, diarrhea, pharyngitis, angioedema; intermittent claudication, skin ulcer; rare: rhabdomyolysis.

    Micardis Clinical Trials

    Clinical Trials

    Two studies were conducted to support the use to reduce the risk of cardiovascular events. Both enrolled subjects age ≥55 years, at high cardiovascular risk as evidenced by coronary artery disease (75%), diabetes mellitus (27%) accompanied with end-organ damage (eg, retinopathy, left ventricular hypertrophy, and, in ONTARGET only, macro- or microalbuminuria), stroke (16%), peripheral vascular disease (13%), or transient ischemic attack (4%). 

    Patients without a history of intolerance to ACE inhibitors entered ONTARGET, and those with such a history, usually cough (90%), entered TRANSCEND, but patients with >1+ proteinuria on dipstick were excluded from TRANSCEND. For both ONTARGET and TRANSCEND trials, the primary 4-component composite endpoint was death from cardiovascular causes, myocardial infarction, stroke, and hospitalization for heart failure.  The secondary 3-component composite endpoint was death from cardiovascular causes, myocardial infarction, and stroke.

    ONTARGET was a randomized, active-controlled, multinational, double-blind study involving 25,620 patients who were randomized to telmisartan 80 mg, ramipril 10 mg, or their combination. Baseline therapy included acetylsalicylic acid (76%), lipid lowering agents (64%), beta-blockers (57%), calcium channel blockers (34%), nitrates (29%), and diuretics (28%). Mean blood pressure at randomization was 134/77 mmHg.  The mean duration of follow up was about 4 years and 6 months.  The results for the ONTARGET trial are summarized below:

    Incidence of the Primary and Secondary Outcomes

    Telmisartan (n=8542) vs. Ramipril (n=8576)

    • Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure:
      • No. of  Events Telmisartan/Ramipril =  1423 (16.7%)/1412 (16.5%); HR 97.5% CI, 1.01 (0.93-1.10)
    • Composite of CV death, myocardial infarction, or stroke:
      • No. of  Events Telmisartan/Ramipril =  1190 (13.90%)/1210 (14.1%); HR 97.5% CI, 0.99 (0.90-1.08)

    TRANSCEND randomized patients to telmisartan 80 mg (n=2954) or placebo (n=2972). Baseline therapy included acetylsalicylic acid (75%), lipid lowering agents (58%), beta-blockers (58%), calcium channel blockers (41%), nitrates (34%) and diuretics (33%). Mean blood pressure at randomization was 135/78 mmHg. The mean duration of follow up was 4 years and 8 months. The results for the TRANSCEND trial are summarized below:

    Incidence of the Primary and Secondary Outcomes

    Telmisartan (n=2954) vs. Placebo (n=2972)

    • Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure:
      • No. of  Events Telmisartan/Placebo =  465 (15.7%)/504 (17.0%); HR 95% CI, 0.92 (0.81-1.05); P =0.2129
    • Composite of CV death, myocardial infarction, or stroke:
      • No. of  Events Telmisartan/Placebo =  384 (13.0%)/440 (14.8%); HR 95% CI, 0.87 (0.76-1.00); P = 0.0483

    Individual components of the primary composite endpoint:

    • All non-fatal MI:
      • No. of  Events Telmisartan/Placebo =  114 (3.9%)/145 (4.9%); HR 95% CI, 0.79 (0.62-1.01); P = 0.0574
    • All non-fatal strokes:
      • No. of  Events Telmisartan/Placebo =  112 (3.8%)/136 (4.6%); HR 95% CI, 0.83 (0.64-1.06); P = 0.1365

     

    Although the event rates in ONTARGET were similar on telmisartan and ramipril, the results did not unequivocally rule out that Micardis may not preserve a meaningful fraction of the effect of ramipril in reducing cardiovascular events. However, the results of both ONTARGET and TRANSCEND do adequately support Micardis being more effective than placebo would be in this setting, particularly for the endpoint of time to cardiovascular death, myocardial infarction, or stroke.

    In ONTARGET, there was no evidence that combining ramipril and Micardis reduced the risk of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure greater than ramipril alone; instead, patients who received the combination of ramipril and telmisartan in ONTARGET experienced an increased incidence of clinically important renal dysfunction (eg, acute renal failure) compared to patients receiving Micardis or ramipril alone.

    Micardis Note

    Not Applicable

    Micardis Patient Counseling

    Patient Counseling

    Pregnancy

    • Advise females of childbearing age about the consequences of exposure to Micardis during pregnancy. 
    • Discuss treatment options with women planning to become pregnant. 
    • Tell patients to report pregnancies to their physicians as soon as possible.

    Lactation

    • Advise nursing women not to breastfeed during treatment with Micardis.

    Symptomatic Hypotension and Syncope

    • Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. 
    • Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. 
    • Advise patients to contact their healthcare provider if syncope occurs.

    Potassium Supplements

    • Advise patients to avoid potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider. 

    Micardis Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Telmisartan 20mg, 40mg, 80mg; tabs.

    Pharmacological Class

    Angiotensin II receptor blocker (ARB).

    How Supplied

    Tabs—3x10 (blister cards)

    How Supplied

    Micardis is supplied as:

    • white or off-white, uncoated tablets marked with the Boehringer Ingelheim company symbol on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively.
    • The 20 mg tablets are round; 40 mg and 80 mg tablets are oblong shaped.

    Storage

    Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15° C to 30° C (59° F to 86° F).

    Manufacturer

    Boehringer Ingelheim Pharmaceuticals

    Generic Availability

    YES

    Micardis Indications

    Indications

    Hypertension.

    Micardis Dosage and Administration

    Adult

    Individualized. Not volume-depleted: initially 40mg once daily; usual range 20–80mg/day. Salt/volume depleted: monitor closely or consider reduced dose. May add diuretic if insufficient response at 80mg/day.

    Children

    Not established.

    Micardis Contraindications

    Contraindications

    Concomitant aliskiren in patients with diabetes.

    Micardis Boxed Warnings

    Boxed Warning

    Fetal toxicity.

    Micardis Warnings/Precautions

    Warnings/Precautions

    Fetal toxicity may develop; discontinue if pregnancy is detected. Correct hypovolemia before starting therapy or monitor closely. Severe CHF. Biliary obstruction. Hepatic or renal impairment. Renal artery stenosis. Dialysis (monitor for orthostatic hypotension). Neonates. Pregnancy: avoid. Nursing mothers: not recommended.

    Warnings/Precautions

    Fetal Toxicity

    • Drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
    • Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
    • Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
    • Discontinue Micardis as soon as possible when pregnancy is detected.

    Hypotension

    • Symptomatic hypotension may occur after initiation of therapy with Micardis in those with an activated renin-angiotensin system, such as volume- or salt-depleted patients (eg, those being treated with high doses of diuretics).
    • Correct this condition prior to administration of Micardis or start treatment with a reduced dose and monitor. 
    • Patients should be placed in the supine position if hypotension does occur; if necessary, given an intravenous infusion of normal saline.
    • A transient hypotensive response is not a contraindication to further treatment, which usually can be continued once the blood pressure has stabilized.

    Hyperkalemia

    • Hyperkalemia may occur in patients on ARBs, particularly in those with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. 
    • In patients at risk, consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

    Impaired Hepatic Function

    • As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
    • Initiate telmisartan at low doses and titrate slowly in these patients.

    Impaired Renal Function

    • As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.  Initiate telmisartan at low doses and titrate slowly in these patients.
    • As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals.
    • In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with Micardis.
    • There has been no long-term use of Micardis in patients with unilateral or bilateral renal artery stenosis, but anticipate increases in serum creatinine or blood urea nitrogen, similar to that seen with ACE inhibitors.

    Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)

    • Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
    • No benefit has been associated with using two RAS inhibitors concomitantly in most patients. 
    • In general, avoid combined use of RAS inhibitors. 
    • Closely monitor blood pressure, renal function, and electrolytes in patients on Micardis and other agents that affect the RAS.
    • Avoid concomitant aliskiren with Micardis in patients with diabetes or those with renal impairment (GFR <60mL/min/1.73m2).

    Pregnancy Considerations

    Micardis can cause fetal harm when administered to a pregnant woman. Drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. 

    Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses. Discontinue Micardis as soon as possible when pregnancy is detected.

    Nursing Mother Considerations

    There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Telmisartan is present in the milk of lactating rats. 

    Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with Micardis.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Neonates with a history of in utero exposure to Micardis

    • Support blood pressure and renal perfusion if oliguria or hypotension occurs. May require exchange transfusions or dialysis to reverse hypotension and/or substituting for disordered renal function.

    Geriatric Considerations

    No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

    Hepatic Impairment Considerations

    In patients with hepatic insufficiency, plasma concentrations of telmisartan are increased, and absolute bioavailability approaches 100%.

    Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

    Micardis Pharmacokinetics

    Absorption

    Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of telmisartan is dose dependent.

    Distribution

    Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α1 - acid glycoprotein.

    Metabolism

    Telmisartan is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.

    Elimination

    Following either intravenous or oral administration of 14C-labeled telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively).

    Telmisartan shows bi-exponential decay kinetics with a terminal elimination half-life of approximately 24 hours.

    Micardis Interactions

    Interactions

    See Contraindications. Concomitant ACE inhibitors (eg, ramipril): not recommended. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt substitutes. May potentiate digoxin. Monitor lithium levels. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted.

    Micardis Adverse Reactions

    Adverse Reactions

    Back pain, upper respiratory tract infection, sinusitis, diarrhea, pharyngitis, angioedema; rare: rhabdomyolysis.

    Micardis Clinical Trials

    Clinical Trials

    The antihypertensive effects of Micardis was shown in 6 principal placebo-controlled clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were treated with telmisartan. After once daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure.

    Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with Micardis, blood pressure gradually returned to baseline values over a period of several days to one week. During long-term studies (without placebo control) the effect of telmisartan appeared to be maintained for up to at least one year. The antihypertensive effect of telmisartan is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients (usually a low-renin population) is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors.

    In a controlled study, telmisartan was added to hydrochlorothiazide which produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with telmisartan alone. Hydrochlorothiazide also had an added blood pressure effect when added to telmisartan.

    The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 to 80 mg doses of telmisartan was 70% to 100% for both systolic and diastolic blood pressure. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%).

    There were no changes in the heart rate of patients treated with telmisartan in controlled trials.

    Micardis Note

    Not Applicable

    Micardis Patient Counseling

    Patient Counseling

    Pregnancy

    • Advise females of childbearing age about the consequences of exposure to Micardis during pregnancy. 
    • Discuss treatment options with women planning to become pregnant. 
    • Tell patients to report pregnancies to their physicians as soon as possible.

    Lactation

    • Advise nursing women not to breastfeed during treatment with Micardis.

    Symptomatic Hypotension and Syncope

    • Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. 
    • Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. 
    • Advise patients to contact their healthcare provider if syncope occurs.

    Potassium Supplements

    • Advise patients to avoid potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider. 

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