Drug ID: 1d00000089
Drug Name: Amlodipine and Benazepril
Generic Names: Amace- BP | Amlo-B | Lotrel
Category: Anti- Hypertensives
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: The recommended dose is one capsule containing amlodipine 2.5-10 mg and benazepril 10-40 mg- once daily.
Combination of amlodipine beslate and benazepril hydrochloride is available in the following strength 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg.
Recommended In: This combination medication is used to treat high blood pressure (hypertension). Amlodipine belongs to a class of medications called calcium channel blockers. It works by relaxing the blood vessels so the heart does not have to pump hard. Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.
Directions For Use: It comes as a capsule to take by mouth, with or without food.
Storage: Store at 25°C. Excursions permitted to 15-30°C. Protect from moisture. Dispense in tight container.
Dosage Forms: Capsule
Side Effects: Most Common - Cough, headache, dizziness, fluid retention.
Body as a Whole - Swelling of the hands, feet, ankles or lower legs, fever, chills, flu symptoms, weakness, fatigue.
Central Nervous System - Sleeplessness, nervousness, anxiety, tremor, and decreased libido.
Skin - Flushing, hot flashes, rash, yellowing of the skin or eyes, skin nodule, and skin inflammation.
Gastrointestinal - Dry mouth, nausea, abdominal pain, constipation, diarrhea, indigestion, and esophagitis.
Blood - Decrease in white blood cells.
Metabolic - Decrease in blood potassium, anemia and reduced number of platelets.
Musculoskeletal - Back pain, muscle, joint pain, and muscle cramps.
Respiratory - Throat inflammation.
Genitourinary - Sexual problems such as impotence, and increased urination.
In Case of Overdose: The most likely effect of overdose with Lotrel is vasodilation, with consequent hypotension and tachycardia. Simple repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (norepinephrine or high-dose dopamine) may be required. With abrupt return of peripheral vascular tone, overdoses of other dihydropyridine calcium channel blockers have sometimes progressed to pulmonary edema, and patients must be monitored for this complication.
Analyses of bodily fluids for concentrations of amlodipine, benazepril, or their metabolites are not widely available. Such analyses are, in any event, not known to be of value in therapy or prognosis.
No data are available to suggest physiologic maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of amlodipine, benazepril, or their metabolites. Benazeprilat is only slightly dialyzable; attempted clearance of amlodipine by hemodialysis or hemo-perfusion has not been reported, but amlodipine's high protein binding makes it unlikely that these interventions will be of value.
Avoid If: Caution should be exercised in patients with history of heart problems, blood vessel problems, blood flow problems, bone marrow problems, kidney problems, kidney transplant, vascular disease, bone marrow suppression, low blood counts, narrowing or hardening of the arteries of the brain, dehydration, low blood volume, low blood pressure, diabetes, who are receiving kidney dialysis, elderly, children, during pregnancy and breastfeeding.
It may cause dizziness, lightheadedness, or fainting, do not drive a car or operate machinery while taking this medication.
Avoid alcohol consumption.
Monitor blood potassium levels, blood pressure, and kidney function regularly while taking this medication.
Inform your doctor if you are allergic to amlodipine, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, or any other medications.
Contraindicated in patients with history of severe kidney problems, angioedema. It should not be co-administered with angiotensin receptor blockers, ACE inhibitors in patients with diabetes.
Drug Interaction: Diuretics
Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Lotrel. The possibility of hypotensive effects with Lotrel can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Lotrel.
Potassium Supplements and Potassium-Sparing Diuretics
Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, the patient's serum potassium should be monitored frequently.
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. When coadministering Lotrel and lithium, frequent monitoring of serum lithium levels is recommended.
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including benazepril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving benazepril and NSAID therapy.
The antihypertensive effect of ACE inhibitors, including benazepril, may be attenuated by NSAIDs.
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.