Dosing and uses of Micardis (telmisartan)
Adult dosage forms and strengths
tablet
- 20mg
- 40mg
- 80mg
Hypertension
40 mg/day PO initially; titrated to 20-80 mgday PO, depending on response; patients with volume depletion should receive the lower dosage initially, under close supervision
Dosing considerations
- Generally, adjust dosage monthly; adjust more aggressively in high-risk patients
- Also given in combination with hydrochlorothiazide (Micardis HCT) or amlodipine (Twynsta)
Cardiovascular Risk Reduction
80 mg/day PO; whether dosages <80 mg/day reduce risk of cardiovascular morbidity or mortality is unknown
Dosing Modifications
Renal impairment: Dosage adjustment not necessary; hemodialysis (HD) patients at risk for orthostatic hypotension
Hepatic impairment: Initiate at low dosage; titrate slowly; monitor
Pediatric dosage forms and strengths
<18 years old: Safety and efficacy not established
Geriatric dosage forms and strengths
Hypertension
20 mg/day PO initially; maintenance: 20-80 mg/day
Cardiovascular Risk Reduction
80 mg/day PO
Micardis (telmisartan) adverse (side) effects
1-10%
Upper respiratory tract infection (URTI) (7%)
Back pain (3%)
Diarrhea (3%)
Myalgia (3%)
Sinusitis (3%)
Chest pain (1%)
Hypertension (1%)
Headache (1%)
Dizziness (1%)
Pharyngitis (1%)
<1%
Abnormal ECg
Anemia
Angina
Angioedema
Bradycardia
Eczema
Epistaxis
Gout
Hypercholesterolemia
Hyperkalemia
Hypoglycemia
Otitis media
Warnings
Black box warnings
Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
Contraindications
Hypersensitivity (anaphylaxis, angioedema)
Pregnancy (2nd and 3rd trimesters); significant risk of fetal or neonatal morbidity and mortality (see Black box warnings)
Bilateral renal artery stenosis
Do not coadminister with aliskiren in patients with diabetes
Cautions
Correct any volume or salt depletion before initiating therapy; observe for signs and symptoms of hypotension
Less blood pressure response in black patients than in white patients
Risk of sensitivity reactions, including anaphylactoid reactions or angioedema
Congestive heart failure (CHF); risk of renal dysfunction
Renal impairment, obstructive biliary disease, or hepatic impairment
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
Not for coadministration with aliskiren in patients with diabetes; avoid use of aliskiren with benazepril in patients with renal impairment (GFR <60 ml/min/1.73 m2)
Pregnancy and lactation
Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, d
Lactation: Not known whether drug is excreted in breast milk; avoid using
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 of Micardis (telmisartan)
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)
