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Micardis (telmisartan)

BOXED WARNING

D/C when pregnancy is detected. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury/death to the developing fetus.

THERAPEUTIC CLASS

Angiotensin II receptor blocker (ARB)

DEA CLASS

RX

INDICATIONS

Treatment of HTN alone or in combination with other antihypertensives. Reduction of risk of MI, stroke, or death from cardiovascular (CV) causes in patients ≥55 yrs of age at high risk of developing major CV events who are unable to take ACE inhibitors.

ADULT DOSAGE

Hypertension

Initial: 40mg qd
Range: 40-80mg/day
May add diuretic if BP not controlled w/ 80mg

Risk Reduction of Myocardial Infarction, Stroke, Cardiovascular Death

For use in patients ≥55 years of age at high risk of developing major CV events who are unable to take ACE inhibitors 

80mg qd

DOSING CONSIDERATIONS

Hepatic Impairment
Including Biliary Obstructive Disorders:
Start at low doses and titrate slowly

ADMINISTRATION

Oral route

Take w/ or w/o food

HOW SUPPLIED

Tab: 20mg, 40mg, 80mg

CONTRAINDICATIONS

Coadministration with aliskiren in patients with diabetes.

WARNINGS/PRECAUTIONS

May develop orthostatic hypotension in patients on dialysis. Symptomatic hypotension may occur in patients with an activated RAS (eg, volume- and/or salt-depleted patients receiving high doses of diuretics); correct this condition before therapy or monitor closely. Hyperkalemia may occur, particularly in patients with advanced renal impairment, HF, and on renal replacement therapy; monitor serum electrolytes periodically. Caution in patients with hepatic impairment (eg, biliary obstructive disorders); reduced clearance may be expected. Oliguria and/or progressive azotemia and (rarely) acute renal failure and/or death may occur in patients whose renal function is dependent on the RAS (eg, severe CHF). May increase SrCr/BUN in patients with renal artery stenosis.

ADVERSE REACTIONS

URTI, back pain, sinusitis, diarrhea, intermittent claudication, skin ulcer.

DRUG INTERACTIONS

See Contraindications. Dual blockade of the RAS is associated with increased risk of hypotension, hyperkalemia, and changes in renal function (eg, acute renal failure); avoid combined use of RAS inhibitors. Closely monitor BP, renal function, and electrolytes with concomitant agents that also affect the RAS. Avoid with aliskiren in patients with renal impairment (GFR <60mL/min). Avoid with an ACE inhibitor. Coadministration with ramipril may increase ramipril/ramiprilat levels and decrease telmisartan levels; not recommended with ramipril. Hyperkalemia may occur with K+ supplements, K+-sparing diuretics, K+-containing salt substitutes, or other drugs that increase K+ levels. May increase digoxin levels; monitor digoxin levels upon initiating, adjusting, and discontinuing therapy. May increase serum lithium levels/toxicity; monitor lithium levels during concomitant use. NSAIDs, including selective COX-2 inhibitors, may attenuate antihypertensive effect and may deteriorate renal function; monitor renal function periodically.

PREGNANCY AND LACTATION

Category D, not for use in nursing.

MECHANISM OF ACTION

Angiotensin II receptor antagonist; blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues.

PHARMACOKINETICS

Absorption: Absolute bioavailability: 40mg (42%), 160mg (58%); Tmax=0.5-1 hr. Distribution: Vd=500L; plasma protein binding (>99.5%). Metabolism: Conjugation. Elimination: Feces (>97%, unchanged), urine (0.49%); T1/2=24 hrs.

ASSESSMENT

Assess for known hypersensitivity to drug, biliary obstructive disorders, CHF, renal artery stenosis, hepatic/renal impairment, volume/salt depletion, dialysis patients, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for symptomatic hypotension and other adverse reactions. Monitor BP, ECG, renal function, and serum electrolytes.

PATIENT COUNSELING

Inform women of childbearing age about the consequences of exposure to the medication during pregnancy. Discuss treatment options with women planning to become pregnant. Instruct to report pregnancies to the physician as soon as possible.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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