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trandolapril

(tran-doe-la-pril) ,

Mavik

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: ace inhibitors
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Reduction of risk of death and heart-failure-related hospitalizations in patients with left ventricular systolic dysfunction or heart failure symptoms following myocardial infarction.

Action

Angiotensin-converting enzyme (ACE) inhibitors block the conversion of angiotensin I to the vasoconstrictor angiotensin II. ACE inhibitors also prevent the degradation of bradykinin and other vasodilatory prostaglandins. ACE inhibitors also ↑ plasma renin levels and ↓ aldosterone levels. Net result is systemic vasodilation.

Therapeutic effects

Lowering of BP in hypertensive patients.
Increased survival after myocardial infarction.

Pharmacokinetics

Absorption: 70% bioavailability as trandolaprilat following oral administration.
Distribution: Crosses the placenta; enters breast milk.
Protein Binding: 80%.
Metabolism and Excretion: Converted by the liver to trandolaprilat, the active metabolite; 33% excreted in urine, 66% in feces.
Half-life: Trandolapril: 6 hr; Trandolaprilat: 22.5 hr (↑ in renal impairment).

Time/action profile (antihypertensive effect)

ROUTEONSETPEAKDURATION
POwithin 1–2 hr*within 1 wk†up to 24 hr†
*After single dose†Chronic dosing

Contraindications/Precautions

Contraindicated in: Hypersensitivity; History of angioedema with previous use of ACE inhibitors; 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: genetic implication Black patients (monotherapy for hypertension less effective, may require additional therapy; higher risk of angioedema); Surgery/anesthesia (hypotension may be exaggerated); Women of childbearing potential; Renal impairment, hypovolemia, hyponatremia, concurrent diuretic therapy, and Geriatric: Initial dose ↓ recommended; Pediatric: Safety not established.
Exercise Extreme Caution in: Family history of angioedema.

Adverse Reactions/Side Effects

Central nervous system

  • weakness

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypotension (most frequent)

Endocrinologic

  • hyperuricemia

Gastrointestinal

  • diarrhea
  • dyspepsia

Genitourinary

  • impaired renal function

Dermatologic

  • rashes

Fluid and Electrolyte

  • hyperkalemia
  • hypocalcemia

Musculoskeletal

  • myalgia

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Excessive hypotension may occur with concurrent use of diuretics.Additive hypotension with other antihypertensive agents.↑ risk of hyperkalemia with concurrent use ofpotassium supplements,potassium-containing salt substitutes, and potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of angiotensin II receptor antagonists or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minNSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.↑ levels and may ↑ the risk oflithium toxicity.

Route/Dosage

Oral (Adults) Hypertension—1 mg once dailygenetic implication (2 mg in Black patients). May be ↑ weekly up to 4 mg once daily; twice-daily dosing may be necessary in some patients (initiate therapy with 0.5 mg/day in patients receiving diuretics). Heart failure post-MI or left ventricular dysfunction post-MI—Initiate therapy at 1 mg once daily, titrate up to 4 mg once daily if possible.

Renal Impairment

Oral (Adults) CCr <30 mL/min—Initiate therapy at 0.5 mg once daily, may be slowly titrated upward (max dose = 4 mg/day).

Hepatic Impairment

Oral (Adults) Initiate therapy at 0.5 mg once daily, may be slowly titrated upward (max dose = 4 mg/day).

Availability (generic available)

Tablets: 1 mg, 2 mg, 4 mg
In combination with: verapamil (Tarka). See combination drugs.

Nursing implications

Nursing assessment

  • Hypertension: Monitor BP 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 patient for signs of angioedema (dyspnea, facial swelling).
  • Heart Failure: Monitor weight and assess patient routinely for resolution of fluid overload (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.
    • May cause hyperkalemia.
    • Monitor CBC periodically during therapy in patients with collagen vascular disease and/or renal disease. May rarely cause agranulocytosis.
    • May cause ↑ AST, ALT, alkaline phosphatase, serum bilirubin, and uric acid.

Potential Nursing Diagnoses

Decreased cardiac output (Indications,  Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
Noncompliance (Patient/Family Teaching)

Implementation

  • Due to risk for precipitous drop in BP at initiation of therapy, correct pre-existing volume depletion, if possible. Discontinuing diuretic therapy or cautiously increasing salt intake 2–3 days prior to initiation may decrease this risk. Monitor closely for at least 1 hr after BP has stabilize.
  • Oral: May be taken with or without food.

Patient/Family Teaching

  • Emphasize importance of continuing to take medication as directed at the same time each day, even if feeling well. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses. Warn patient not to discontinue ACE inhibitor therapy unless directed by health care professional.
    • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
    • Caution patient to change positions slowly to minimize orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
    • 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.
    • May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
    • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
    • Instruct patient to notify health care professional if rash; mouth sores; sore throat; fever; swelling of hands or feet; irregular heartbeat; chest pain; dry cough; hoarseness; swelling of face, eyes, lips, or tongue; or if difficulty swallowing or breathing occurs. Persistent dry cough may occur and may not subside until medication is discontinued. Consult health care professional if cough becomes bothersome. Also notify health care professional if nausea, vomiting, or diarrhea occurs and continues.
    • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected. If pregnancy is detected, discontinue medication as soon as possible.
    • Emphasize the importance of follow-up examinations to monitor effectiveness of medication.
  • Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, and stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family on correct technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes to health care professional.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of side effects.
  • Reduction of risk of death or heart-failure-related hospitalizations following myocardial infarction.

Mavik®

Trandolapril, see there.