Lotrel

Lotrel is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. ( 1 )

1.1Hypertension

Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

1. Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including Lotrel in patients with diabetes. 2. Lotrel is contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, to amlodipine, or to any of the excipients of Lotrel. 3.

Lotrel is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotrel within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warnings and Precautions (5.1)] . 4. Do not coadminister aliskiren with ACE inhibitors, including Lotrel, in patients with diabetes. ( 4 ) 5. Lotrel is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine.

( 4 ) 6. Lotrel is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotrel within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan. ( 4 )

• Anaphylactoid reactions, including angioedema ( 5.2 )
• Myocardial infarction or increased angina in patients with obstructive coronary artery disease. ( 5.3 )
• Assess for hypotension and hyperkalemia. ( 5.4 , 5.6 )
• Titrate slowly in patients with impaired hepatic or severely impaired renal function. ( 5.5 , 5.7 )

5.1Fetal Toxicity

Lotrel can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.