Micardis


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telmisartan

Micardis

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

FDA Box Warning

Drugs that act directly on the renin-angiotensin system can cause injury to or death of a developing fetus. Discontinue drug as soon as possible when pregnancy is detected.

Action

Inhibits vasoconstricting effects and blocks aldosterone-producing effects of angiotensin II at various receptor sites, including vascular smooth muscle and adrenal glands

Availability

Tablets: 20 mg, 40 mg, 80 mg

Indications and dosages

Hypertension

Adults: 40 mg P.O. daily, titrated up or down within range of 20 to 80 mg daily based on response and tolerance

Cardiovascular risk reduction

Adults: 80 mg P.O. daily in patients unable to take angiotensin-converting enzyme (ACE) inhibitors

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• heart failure, impaired renal function secondary to primary renal disease or renal stenosis, obstructive biliary disorders, hepatic impairment, volume or sodium depletion

• patients receiving high-dose diuretics

• concomitant use of ACE inhibitors and angiotensin receptor blockers (avoid use)

• pregnant or breastfeeding patients

• children younger than age 18 (safety not established).

Administration

• Don't remove tablet from blister pack until just before giving.

• Know that drug may be used alone or with other antihypertensives.

Adverse reactions

CNS: dizziness, headache, fatigue

CV: chest pain, peripheral edema, hypertension, intermittent claudication

EENT: sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, dyspepsia, abdominal pain

GU: urinary tract infection

Musculoskeletal: myalgia, back and leg pain

Respiratory: cough, upper respiratory infection

Skin: ulcer

Other: pain, flu or flulike symptoms, hypersensitivity

Interactions

Drug-drug. Antihypertensives, diuretics: increased risk of hypotension

Ace inhibitors (ramipril): increased ramipril steady-state Cmax and area under the curve (AUC), decreased telmisartan Cmax and AUC

Digoxin: increased digoxin blood level

Lithium: increased serum lithium concentration and toxicity

Nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors): deterioration of renal function, including possible acute renal failure in elderly patients, volume-depleted patients (including those on diuretic therapy), or with compromised renal function; attenuated telmisartan antihypertensive effect

Drug-diagnostic tests. Creatinine: slight elevation

Drug-food. Any food: slightly reduced drug bioavailability

Patient monitoring

• Monitor blood pressure frequently and watch for signs and symptoms of hypotension.

• Closely monitor patient with impaired hepatic or renal function. Correct volume deficits as appropriate before therapy starts. Monitor fluid intake and output and creatinine level during therapy.

Patient teaching

• Tell patient to take 1 hour before or 2 hours after meals.

• Caution patient not to remove tablet from blister pack until just before taking.

• Advise patient to report swelling or chest pain.

• Teach patient to measure blood pressure regularly and report significant changes.

• Tell patient to report suspected pregnancy to prescriber. Caution her not to breastfeed.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

telmisartan

(tel-mi-sar-tan) ,

Micardis

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: angiotensin ii receptor antagonists
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Reduction of risk of myocardial infarction, stroke, or cardiovascular death in patients ≥55 yr who are at high risk for cardiovascular events and are unable to take ACE inhibitors.

Action

Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites, including vascular smooth muscle and the adrenal glands.

Therapeutic effects

Lowering of BP in hypertensive patients.

Pharmacokinetics

Absorption: 42–58% absorbed following oral administration (bioavailability increased in patients with hepatic impairment).
Distribution: Crosses the placenta.
Protein Binding: 99.5%.
Metabolism and Excretion: Excreted mostly unchanged in feces via biliary excretion.
Half-life: 24 hr.

Time/action profile (antihypertensive effect)

ROUTEONSETPEAKDURATION
POwithin 3 hr*4 wks†24 hr†
*After single dose†Chronic dosing

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Bilateral renal artery stenosis; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula.
Use Cautiously in: Volume- or salt-depleted patients or patients receiving large doses of diuretics (correct deficits before initiating therapy); genetic implication Black patients (may not be as effective); Impaired renal function caused by primary renal disease or heart failure (may worsen renal function); Obstructive biliary disorders or hepatic impairment; Women of childbearing potential; Pediatric: Safety not established for children <18 yr.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache

Cardiovascular

  • hypotension

Ear, Eye, Nose, Throat

  • sinusitis

Fluid and Electrolyte

  • hyperkalemia

Gastrointestinal

  • abdominal pain
  • diarrhea
  • dyspepsia

Genitourinary

  • impaired renal function

Musculoskeletal

  • back pain
  • myalgia

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Additive hypotensive effects with other antihypertensives.Excessive hypotension may occur with concurrent use of diuretics.↑ risk of hyperkalemia with concurrent use of potassium supplements,potassium-containing salt substitutes, or potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minMay ↑ serum digoxin levels.NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.↑ risk of renal dysfunction when used with ramipril ; concurrent use not recommended.

Route/Dosage

Hypertension

Oral (Adults) 40 mg once daily (volume-depleted patients should start with 20 mg); may be titrated up to 80 mg/day.

Cardiovascular Risk Reduction

Oral (Adults) 80 mg once daily.

Availability

Tablets: 20 mg, 40 mg, 80 mg
In combination with: hydrochlorothiazide (Micardis HCT); amlodipine (Twynsta); seecombination drugs.

Nursing implications

Nursing assessment

  • Assess BP (lying, sitting, standing) and pulse frequently during initial dose adjustment and periodically during therapy. Notify health care professional of significant changes.
  • Monitor frequency of prescription refills to determine compliance.
  • Assess patients for signs of angioedema (dyspnea, facial swelling).
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.
    • May cause hyperkalemia.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Noncompliance (Patient/Family Teaching)

Implementation

  • Volume depletion should be corrected, if possible, before initiation of therapy.

Patient/Family Teaching

  • Emphasize the importance of continuing to take as directed, even if feeling well. Take missed doses as soon as remembered if not almost time for next dose; do not double doses. Instruct patient to take medication at the same time each day. Warn patient not to discontinue therapy unless directed by health care professional. Advise patient to read Patient Information prior to starting therapy and with each refill in case of changes.
  • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
  • Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
  • Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.
  • Caution patient to avoid sudden changes in position to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially cough, cold, or allergy remedies.
  • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
  • Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
  • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects.
  • Decreased risk of myocardial infarction, stroke, or cardiovascular death.

Micardis®

Telmisartan, see there.
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They also claimed that Micardis protected patients from early morning strokes and heart attacks and that Combivent could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease.
Telmisartan, an angiotensin-II receptor blocker (ARB) marketed as Micardis, is manufactured by Boehringer Ingelheim Pharmaceuticals.
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4 mg, Mirapex (pramipexole dihydrochloride) tablets, Aggrenox (aspirin/extended-release dipyridamole) 25 mg/200 mg capsules, Micardis (telmisartan) tablets, and Micardis HCT (telmisartan/hydrochlorothiazide) 40 mg/12.
7 billion yen due to brisk sales of such mainstay products as hypertension drug Micardis, cholesterol-fighting drug Lipitor and immunosuppressant Prograf.
Tokyo, Japan, July 5, 2006 - (JCN) - Astellas Pharma and Nippon Boehringer Ingelheim have filed a joint application for an additional indication of Micardis, an angiotensin II receptor blocker, with the Ministry of Health, Labor and Welfare.
Combination drugs include Aldoril, Atacand HCT, Avalide, Benicar HCT, Diovan HCT, Dyazide, Hyzaar, Lotensin HCT, Maxzide, Micardis HCT.
BIPI) for alleged off-label marketing and deceptive practices used to promote four prescription drugs: Micardis, Aggrenox, Atrovent, and Combivent.
Telmisartan tablets USP, 20 Watson Micardis tablets
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