Dosing & Uses
Dosage Forms & Strengths
tablet
- 20mg
- 40mg
- 80mg
Hypertension
Indicated for treatment of hypertension
Dosage must be individualized
40 mg/day PO initially; titrated to 20-80 mg/day PO, depending on response; patients with volume depletion should receive the lower dosage initially, under close supervision
Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks
When additional blood pressure reduction is required after the 80-mg dose, a diuretic may be added
Cardiovascular risk reduction
Indicated for cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors
80 mg PO qDay
Unknown whether doses lower than 80 mg are effective in reducing the risk of cardiovascular morbidity and mortality
Dosage Modifications
Renal impairment: No dosage adjustment necessary; hemodialysis (HD) patients at risk for orthostatic hypotension
Hepatic impairment
- In patients with hepatic insufficiency, plasma concentrations of telmisartan increased, and absolute bioavailability approached 100%
- Monitor carefully and titrate up slowly in patients with biliary obstructive disorders or hepatic insufficiency
Dosing Considerations
Use of telmisartan with an ACE inhibitor is not recommended
<18 years old: Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
1-10%
Upper respiratory tract infection (7%)
Back pain (3%)
Sinusitis (3%)
Diarrhea (3%)
Cough (1.6%)
Influenza-like symptoms (≥1%)
Dyspepsia (≥1%)
Myalgia (≥1%)
Urinary tract infection (≥1%)
Abdominal pain ≥1%)
Headache (≥1%)
Dizziness (≥1%)
Pain (≥1%)
Fatigue (≥1%)
Coughing (≥1%)
Hypertension (≥1%)
Chest pain (≥1%)
Nausea (≥1%)
Peripheral edema (≥1%)
Pharyngitis (1%)
Frequency Not Defined
Autonomic nervous system: Impotence, increased sweating, flushing
Body as a whole: Allergy, fever, leg pain, malaise
Cardiovascular: Palpitations, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG
Central nervous system: Insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia
Gastrointestinal: Flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, nonspecific gastrointestinal disorders
Metabolic: Gout, hypercholesterolemia, diabetes mellitus
Musculoskeletal: Arthritis, arthralgia, leg cramps
Psychiatric: Anxiety, depression, nervousness
Resistance mechanism: Infection, fungal infection, abscess, otitis media
Respiratory: Asthma, bronchitis, rhinitis, dyspnea, epistaxis
Skin: Dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis;
Vascular: Cerebrovascular disorder
Special senses: Abnormal vision, conjunctivitis, tinnitus, earache
Postmarketing Reports
Most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome)
Rare cases of rhabdomyolysis have been reported
Warnings
Black Box Warnings
Fetal toxicity
- 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
Contraindications
Hypersensitivity to telmisartan or any other component of this product
Coadministration with aliskiren in patients with diabetes
Cautions
Use of 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
Hyperkalemia may occur in patients on ARBs, particularly in patients 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 level
As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduce clearance
Pregnancy (2nd and 3rd trimesters); significant risk of fetal or neonatal morbidity and mortality (see Black Box Warnings)
Dual blockade of the renin-angiotensin system with angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy
Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function and electrolytes in patients on benazepril and other agents that affect the RAS
Drug interaction overview
- Not for coadministration with aliskiren in patients with diabetes; avoid use of aliskiren with telmisartan in patients with renal impairment (GFR <60 ml/min/1.73 m2)
- When coadministered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed; monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan
Pregnancy & Lactation
Pregnancy
May cause fetal harm when administered to a pregnant woman
Use of 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
When pregnancy is detected, discontinue as soon as possible
Animal data
- Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses
Clinical considerations
-
Disease-associated maternal and/or embryo/fetal risk
- Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
- Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
- Carefully monitor pregnant women with hypertension and managed accordingly
-
Fetal/neonatal adverse reactions
- Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
- During pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment
- Fetal testing may be appropriate, based on the week of gestation
- If oligohydramnios is observed, discontinue telmisartan, unless it is considered lifesaving for the mother
- Note: Oligohydramnios may not appear until after the fetus has sustained irreversible injury
- Closely observe infants with histories of in utero exposure to telmisartan for hypotension, oliguria, and hyperkalemia
- If oliguria or hypotension occurs, support blood pressure and renal perfusion
- May require transfusions or dialysis as a means of reversing hypotension and/or substituting for disordered renal function
Lactation
There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production
Present in the milk of lactating rats
Advise a nursing woman not to breastfeed during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Angiotensin II receptor blocker; inhibits vasoconstrictor and aldosterone-secreting effects of angiotensin II
Absorption
Onset: 1-2 hr
Duration: <24 hr
Peak plasma time: 0.5-1 hr
Distribution
Protein bound: >99.5%
Vd: 500 L
Metabolism
Metabolized in liver to inactive metabolite
Elimination
Half-life: 24 hr
Dialyzable: No (HD)
Excretion: Feces (>97%), urine (small amount)
Administration
Oral Administration
Take with or without food
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Tablets should not be removed from blisters until immediately before administration
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Patient Handout
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