Classes
DEA Class; Rx
Common Brand Names; Micardis
- ARBs
Description
Angiotensin II receptor blocker (ARB)
Used for HTN and for cardiovascular risk reduction, such as stroke and MI prophylaxis, in high-risk patients unable to take ACE inhibitors
Does not inhibit ACE and accumulate bradykinin; less likely to cause cough or angioedema than ACE inhibitors
Indications
Indicated for treatment of hypertension
Indicated for cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors
Contraindications
Hypersensitivity to telmisartan or any other component of this product
Coadministration with aliskiren in patients with diabetes
Adverse Effects
- Upper respiratory tract infection (7%)
- Back pain (3%)
- Sinusitis (3%)
- Diarrhea (3%)
- Cough (1.6%)
- Pharyngitis (1%)
- 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
Warnings
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
Pregnancy and Lactation
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
There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production
Maximum Dosage
80 mg/day PO.
80 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Telmisartan
tablet
- 20mg
- 40mg
- 80mg