trandolapril

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.

Exercise Extreme Caution in:

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.

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].

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).

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.

Classifications ⬆ ⬇

Therapeutic Classification: antihypertensives

Pharmacologic Classification: ace inhibitors

Pharmacokinetics ⬆ ⬇

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).

Canadian Brand Names ⬆ ⬇

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.

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.

Pronunciation ⬆ ⬇

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)

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Indications ⬇

Contraind./Precautions ⬆ ⬇