Amlodipine and benazepril

The combination treats hypertension in patients not adequately controlled with amlodipine or benazepril alone. Label initiation also includes inadequate amlodipine control without tolerable edema. It is not labeled as routine initial monotherapy, an acute hypertensive-emergency drug or a universal heart-failure/angina regimen. The indication of an individual ingredient does not automatically extend to this capsule.

The selected generic is a prescription oral fixed-dose product; Lotrel is the original brand with U.S. approval 1995 under NDA020364. The retained brand label is not proof that every brand strength/package is currently sold. Component ratios and capsule identity must match the actual dispensed product.

Recommended initial combination is amlodipine 2.5 mg/benazepril 10 mg orally once daily after the labeled monotherapy conditions are met. Individualize titration, up to 10/40 mg once daily if needed. Most BP effect develops within 2 weeks; do not treat that as a mandatory increase interval for every patient. Separate titrated components may be replaced by the corresponding combination strength. Take at the same time daily, with or without food.

No adjustment is needed for mild/moderate renal impairment, but monitor renal function and potassium. Severe impairment increases benazepril exposure; the label’s recommended benazepril 5 mg component is unavailable in this fixed combination, so it is not recommended. PK identifies increased benazeprilat exposure at CrCl ≤ 30 mL/min; do not improvise a capsule split or alternate-day substitute. Older age and hepatic insufficiency increase amlodipine exposure, so consider lower individualized doses.

Verify which number belongs to each ingredient: amlodipine first, benazepril hydrochloride second. Do not add duplicate ACE-inhibitor or amlodipine products without a prescriber plan. The selected Patient Information says to take a missed dose when remembered, but if more than 12 hours have elapsed, resume the next regular dose; do not double.

Contraindicated with prior angioedema, whether or not ACE-inhibitor-related, or hypersensitivity to benazepril, another ACE inhibitor, amlodipine or capsule excipients. Do not use with aliskiren in diabetes. Neprilysin-inhibitor combination is contraindicated; allow at least 36 hours when switching to or from sacubitril/valsartan. Pregnancy has a separate fetal-toxicity boxed warning requiring prompt discontinuation when detected.

The boxed warning concerns fetal toxicity from renin-angiotensin-system blockade. Exposure can injure or kill the developing fetus; discontinue as soon as pregnancy is detected and arrange an alternative treatment plan. Angioedema and renal/potassium risks remain serious precautions although not the box’s topic.

Cough, edema, headache and dizziness are common reported effects. Adding benazepril can reduce amlodipine-associated edema in trials but does not eliminate swelling or angioedema risk. Serious events include hypotension, renal failure, hyperkalemia, angioedema and rare hepatic injury; postmarketing blood-cell and skin reactions have uncertain frequencies.

Generally avoid dual RAS blockade with another ACE inhibitor, ARB or aliskiren because hypotension, renal dysfunction and hyperkalemia increase. Aliskiren is contraindicated in diabetes and should be avoided with renal impairment GFR < 60 mL/min. Potassium supplements, potassium-sparing diuretics and potassium salt substitutes require careful review/monitoring. Sacubitril needs the 36-hour switch separation; mTOR inhibitors increase angioedema risk.

NSAIDs including COX-2 inhibitors can reduce BP benefit and worsen kidney function, especially with older age, dehydration or kidney disease; monitor renal function. Lithium exposure/toxicity can increase, requiring frequent levels. ACE inhibitors with diabetes drugs can rarely contribute to hypoglycemia; monitor symptoms/glucose as appropriate. Injectable gold has rare flushing/nausea/vomiting/hypotension reports.

Limit simvastatin to 20 mg/day with amlodipine. CYP3A inhibitors, including ritonavir, may increase amlodipine exposure; assess hypotension/edema and dose reduction. CYP3A inducers require BP monitoring because a universal numerical correction is not established. Other BP-lowering agents, including sildenafil, can add hypotension even without a demonstrated PK interaction.

Discontinue promptly when pregnancy is detected. RAS blockade in later pregnancy can impair fetal kidneys and cause oligohydramnios, lung/skull abnormalities, neonatal hypotension/renal failure or death. Discuss alternatives before conception. Exposure during pregnancy warrants specialist fetal/newborn assessment; delayed appearance of oligohydramnios does not exclude prior injury.

Small amounts of benazepril/benazeprilat enter milk, and amlodipine is present; the selected label reports an estimated median amlodipine relative infant dose 4.2% and no observed infant adverse effects in limited data. Milk-production effects are unknown. These observations do not establish safety for every neonate or combination dose; individualize treatment and feeding.

Pediatric safety/effectiveness of this combination are not established. Older adults have increased amlodipine exposure and may be more sensitive, supporting lower initial-dose consideration and BP/fall-risk assessment. Adult component approvals do not create a pediatric combination schedule.

The fixed capsule is not recommended for severe renal impairment because an appropriate low benazepril strength is unavailable. Less severe impairment still requires kidney/potassium monitoring. Hepatic insufficiency decreases amlodipine clearance; consider lower doses and reassess symptoms. Reduced renal clearance of benazeprilat differs from amlodipine’s disposition; avoid applying one component’s PK reassurance to both.

Benazepril is converted to benazeprilat, which inhibits ACE, reducing angiotensin II/aldosterone signaling. ACE also degrades bradykinin, relevant to ACE-inhibitor effects. Amlodipine blocks calcium influx predominantly in vascular smooth muscle and lowers peripheral resistance. BP effects complement one another; individual response is not guaranteed by older trial subgroup averages.

Amlodipine peaks around 6–12 hours and has a terminal half-life 30–50 hours; it is extensively hepatically metabolized. Benazepril peaks 0.5–2 hours and is converted mainly in the liver to active benazeprilat, which peaks 1.5–4 hours and is cleared mainly renally in normal kidney function. Benazeprilat’s effective elimination half-life is 10–11 hours, distinct from its longer terminal phase; steady state of both components is reached around 1 week.

Severe kidney impairment increases benazeprilat peak exposure and effective half-life. Older age and hepatic impairment decrease amlodipine clearance. The label allows food-independent administration while noting direct combination food-effect studies were not performed; avoid claiming every PK property of the fixed capsule was measured in every population.

Check BP, kidney function, potassium, volume status, pregnancy plans and prior angioedema before therapy; follow BP/orthostatic symptoms, edema/cough and renal/potassium changes. Reassess after titration or addition of NSAIDs, diuretics, potassium agents or RAS blockers. The label calls for periodic testing, not one mandatory numerical interval for everyone.

Take the prescribed capsule at the same daily time; check the strength and missed-dose instruction. Report pregnancy promptly and discuss preconception alternatives. Avoid unapproved potassium salt substitutes. Dehydration, sweating, vomiting/diarrhea or low intake can cause hypotension; contact the clinician if these occur or fainting develops. Tell dental/surgical, dialysis and allergy-treatment teams about the ACE inhibitor.

Seek emergency care for airway swelling, severe breathing difficulty or persistent/worsening chest pain. Fainting needs prompt clinician review; selected counseling says hold further treatment until consulted after syncope. Jaundice or marked hepatic abnormalities require assessment. Suspected overdose needs immediate medical help rather than extra salt/fluid or unsupervised dose changes.

Selected Avet 5/20 mg capsule is pink opaque cap/body with black imprint 922; a 100-capsule bottle is NDC 23155-922-01. This identity belongs to that generic product, not every Lotrel or generic capsule. Retain packaging and confirm appearance/NDC with the pharmacist; do not identify solely from a photo.

Oral fixed capsules contain amlodipine equivalent 2.5, 5 or 10 mg with benazepril hydrochloride 10, 20 or 40 mg in the six labeled pairs: 2.5/10, 5/10, 5/20, 5/40, 10/20 and 10/40 mg. Not every possible mathematical ratio exists. Benazepril 5 mg is absent; no injectable or liquid combination conversion is supplied.

Selected Avet capsules are stored 20–25°C, protected from moisture, heat and light, and dispensed in a tight, light-resistant container. Follow the actual dispensed product’s package instructions, keep away from children and retain its patient leaflet.