trandolapril

Absorption: 70% bioavailability as trandolaprilat following oral administration.

Distribution: Crosses the placenta; enters breast milk.

Protein Binding: 80%.

Metabolism/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)

ROUTE	ONSET	PEAK	DURATION
PO	within 1–2 hr*	within 1 wk‡	up to 24 hr‡

*After single dose.

‡Chronic dosing.

Contraind./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);
Concurrent use with sacubitril/valsartan; must be a 36–hr wash-out period after switching to/from sacubitril/valsartan;
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

Use Cautiously in:

Black patients (monotherapy for hypertension less effective, may require additional therapy; higher risk of angioedema);
Surgery/anesthesia (hypotension may be exaggerated);
Renal impairment, hypovolemia, hyponatremia, and concurrent diuretic therapy (initial dose ↓ recommended);
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: Initial dose recommended in older adults.

Family history of angioedema.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

Derm: rash

Endo: hyperuricemia

F and E: hyperkalemia, hypocalcemia

GI: diarrhea, dyspepsia

GU: impaired renal function

MS: myalgia

Neuro: weakness

Resp: cough

Misc: ANGIOEDEMA

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with sacubitril↑ risk of angioedema; concurrent use contraindicated; do not administer within 36 hr of switching to/from sacubitril/valsartan.
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 blockers or aliskiren; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/min; avoid concurrent use with angiotensin II receptor blockers
NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.
↑levels and may ↑ the risk oflithium toxicity.
↑risk of angioedema with temsirolimus, sirolimus, or everolimus.

Route/Dosage ⬆ ⬇

PO (Adults ): Hypertension—1 mg once daily (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

PO (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

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

Availability ⬆ ⬇

(Generic available)

Tablets: 0.5 mg; 1 mg; 2 mg; 4 mg
In combination with: verapamil (Tarka). See Appendix [not included in this PDA edition].

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 (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing); may occur at any time during therapy. Discontinue medication and provide supportive care.
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 BUN, serum creatinine, and electrolyte levels periodically. Serum potassium, BUN and creatinine may be ↑, whereas sodium levels may be ↓. If ↑ BUN or serum creatinine concentrations occur, dose reduction or withdrawal may be required.
- 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.

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.
PO: 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 Food Sources for Specific Nutrients.
- 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 NSAIDs and 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 immediately 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 diabetic patients to monitor blood glucose closely, especially during first mo of therapy; may cause hypoglycemia.
- Advise women of reproductive potential to use contraception and notify health care professional if pregnancy is planned or suspected or if breastfeeding. 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.

Canadian Brand Names ⬆ ⬇

Pot. Nursing Diagnoses ⬆ ⬇

Decreased cardiac output(Indications)(Side Effects)
Deficient knowledge, Relate med(Patient/Family Teaching)
Noncompliance(Patient/Family Teaching)

Code ⬆

NDC Code

50090- A-S Medication Solutions
- 50090-4120- Trandolapril
  - 50090-4120-0- 30 TABLET in 1 BOTTLE (50090-4120-0)

50090- A-S Medication Solutions
- 50090-4120- Trandolapril
  - 50090-4120-1- 90 TABLET in 1 BOTTLE, PLASTIC (50090-4120-1)

50090- A-S Medication Solutions
- 50090-4128- Trandolapril
  - 50090-4128-0- 90 TABLET in 1 BOTTLE (50090-4128-0)

57237- Rising Health, LLC
- 57237-089- Trandolapril
  - 57237-089-01- 100 TABLET in 1 BOTTLE (57237-089-01)

57237- Rising Health, LLC
- 57237-090- Trandolapril
  - 57237-090-01- 100 TABLET in 1 BOTTLE (57237-090-01)

57237- Rising Health, LLC
- 57237-091- Trandolapril
  - 57237-091-01- 100 TABLET in 1 BOTTLE (57237-091-01)

63629- Bryant Ranch Prepack
- 63629-8003- Trandolapril
  - 63629-8003-1- 30 TABLET in 1 BOTTLE (63629-8003-1)

65862- Aurobindo Pharma Limited
- 65862-164- Trandolapril
  - 65862-164-01- 100 TABLET in 1 BOTTLE (65862-164-01)

65862- Aurobindo Pharma Limited
- 65862-164- Trandolapril
  - 65862-164-99- 1000 TABLET in 1 BOTTLE (65862-164-99)

65862- Aurobindo Pharma Limited
- 65862-165- Trandolapril
  - 65862-165-01- 100 TABLET in 1 BOTTLE (65862-165-01)

65862- Aurobindo Pharma Limited
- 65862-165- Trandolapril
  - 65862-165-99- 1000 TABLET in 1 BOTTLE (65862-165-99)

65862- Aurobindo Pharma Limited
- 65862-166- Trandolapril
  - 65862-166-01- 100 TABLET in 1 BOTTLE (65862-166-01)

65862- Aurobindo Pharma Limited
- 65862-166- Trandolapril
  - 65862-166-99- 1000 TABLET in 1 BOTTLE (65862-166-99)

68180- Lupin Pharmaceuticals, Inc.
- 68180-566- Trandolapril
  - 68180-566-01- 100 TABLET in 1 BOTTLE (68180-566-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-567- Trandolapril
  - 68180-567-01- 100 TABLET in 1 BOTTLE (68180-567-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-568- Trandolapril
  - 68180-568-01- 100 TABLET in 1 BOTTLE (68180-568-01)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇