LOTREL

The rate and extent of absorption of benazepril and amlodipine from Lotrel are the same as when administered as individual tablets. Absorption from the individual tablets is not influenced by the presence of food in the gastrointestinal tract; food effects on absorption from Lotrel have not been studied. Absorption: Following oral administration of Lotrel, peak plasma concentrations of amlodipine are reached in 6 to 12 hours. Absolute bioavailability has been calculated as between 64% and 90%. F...

Over 950 patients received Lotrel once-daily in 6 double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours, with peak reductions achieved 2 to 8 hours after dosing. Once-daily doses of benazepril/amlodipine using benazepril doses of 10 to 20 mg and amlodipine doses of 2.5 to 10 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 10–25/6–13 mmHg. In 2 studies in patients not adequately controlled on either benazepril 40 mg alone (n = 329) or amlodipine 10 mg alone (n = 812) once-daily doses of Lotrel 10/40 mg furt...

Discontinuation because of adverse reactions occurred in 4% of Lotrel-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with Lotrel were cough and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates ob...

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 e...

• 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 ) 5.1 Fetal 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 ...

7 DRUG INTERACTIONS

• Potassium supplements/potassium-sparing diuretics: hyperkalemia ( 7.1 )
• Lithium: Increased serum lithium levels; toxicity symptoms ( 7.1 )
• Injectable gold: facial flushing, nausea, vomiting, hypotension ( 7.1 )
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect ( 7.1 )
• Do not exceed doses greater than 20 mg daily ...