Buy Lotensin Online

Benazepril (benazepril hydrochloride)

BOXED WARNING

D/C when pregnancy is detected. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury/death to the developing fetus.

OTHER BRAND NAMES

Lotensin

THERAPEUTIC CLASS

ACE inhibitor

DEA CLASS

RX

INDICATIONS

Treatment of HTN alone or in combination w/ thiazide diuretics.

ADULT DOSAGE

Hypertension

Not Receiving a Diuretic:
Initial: 10mg qd
Maint: 20-40mg/day as single dose or in 2 equally divided doses
Adjust dose based on measurement of peak (2-6 hrs after dosing) and trough responses
Max: 80mg/day
May add diuretic if BP is not controlled

PEDIATRIC DOSAGE

Hypertension

≥6 Years:
Initial: 0.2mg/kg qd
Max: 0.6mg/kg (or 40mg/day)

DOSING CONSIDERATIONS

Concomitant Medications
Concomitant Diuretics:
Initial: 5mg qd
If possible, d/c diuretic 2-3 days prior to therapy to avoid hypotension. If BP is not controlled w/ benazepril alone, diuretic therapy should be resumed

Renal Impairment
CrCl <30mL/min (SrCr >3mg/dL):
Initial: 5mg qd
Titrate: May increase until BP is controlled
Max: 40mg/day

ADMINISTRATION

Oral route

Preparation of Sus (for 150mL of a 2mg/mL Sus):
1. Add 75mL of Ora-Plus oral suspending vehicle to an amber polyethylene terephthalate bottle containing 15 benazepril 20mg tablets, and shake for at least 2 min
2. Allow the sus to stand for a minimum of 1 hr
3. After the standing time, shake the sus for a minimum of 1 additional min
4. Add 75mL of Ora-Sweet oral syrup vehicle to the bottle and shake the sus to disperse the ingredients
5. Shake the sus before each use

HOW SUPPLIED

Tab: 5mg, 10mg; (Lotensin) 20mg, 40mg

CONTRAINDICATIONS

History of angioedema. Coadministration w/ aliskiren in patients w/ diabetes.

WARNINGS/PRECAUTIONS

Not recommended in pediatric patients w/ GFR <30mL/min. Head/neck angioedema reported; d/c and institute appropriate therapy immediately. Higher incidence of angioedema in blacks than nonblacks. Intestinal angioedema reported; monitor for abdominal pain. Anaphylactoid reactions reported during desensitization w/ hymenoptera venom, dialysis w/ high-flux membranes, and LDL apheresis w/ dextran sulfate absorption. Symptomatic hypotension may occur, most likely in patients w/ volume and/or salt depletion; correct depletion before initiating therapy. Excessive hypotension, which may be associated w/ oliguria or azotemia and, rarely, w/ acute renal failure and death, may occur in patients w/ CHF; monitor closely during first 2 weeks of therapy and whenever dose is increased. Associated w/ syndrome that starts w/ cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death (rare); d/c if jaundice or marked hepatic enzyme elevations develop. May cause changes in renal function. Increases in BUN and SrCr reported in patients w/ renal artery stenosis or w/ no preexisting renal vascular disease; monitor renal function during the 1st few weeks of therapy, and reduce dose and/or d/c the diuretic if needed. Hyperkalemia and persistent nonproductive cough reported. Hypotension may occur w/ surgery or during anesthesia. Caution in elderly.

ADVERSE REACTIONS

Headache, dizziness.

DRUG INTERACTIONS

See Contraindications. Hypotension risk and increased BUN and SrCr w/ diuretics. Increased risk of hyperkalemia w/ K+-sparing diuretics, K+-containing salt substitutes, or K+ supplements; use w/ caution and periodically monitor K+. Increased lithium levels and symptoms of lithium toxicity reported; monitor lithium levels. Nitritoid reactions reported w/ injectable gold. Hypoglycemia may develop w/ insulin or oral antidiabetics. NSAIDs, including selective COX-2 inhibitors, may attenuate antihypertensive effect and may cause deterioration of renal function. Dual blockade of the RAS is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure); avoid combined use and closely monitor BP, renal function, and electrolytes w/ concomitant agents that also affect the RAS. Avoid w/ aliskiren in patients w/ renal impairment (GFR <60mL/min).

PREGNANCY AND LACTATION

Category D, safety not known in nursing.

MECHANISM OF ACTION

ACE inhibitor; decreases plasma angiotensin II, which leads to decreased vasopressor activity and aldosterone secretion.

PHARMACOKINETICS

Absorption: Tmax=0.5-1 hr, 1-2 hrs (benazeprilat, fasting), 2-4 hrs (benazeprilat, nonfasting). Distribution: Plasma protein binding (96.7%, 95.3% benazeprilat); crosses placenta; found in breast milk. Metabolism: Liver, cleavage of ester group; benazeprilat (active metabolite). Elimination: Urine (trace amounts, unchanged; 20%, benazeprilat), bile (11-12%, benazeprilat); T1/2=10-11 hrs (benazeprilat, adults), 5 hrs (benazeprilat, pediatric patients).

ASSESSMENT

Assess for history of angioedema, diabetes, volume/salt depletion, CHF, renal artery stenosis, risk factors for hyperkalemia, renal impairment, drug hypersensitivity, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for angioedema, anaphylactoid reactions, hyperkalemia, and other adverse reactions. Monitor BP, LFTs, and renal function.

PATIENT COUNSELING

Inform about fetal risks if taken during pregnancy and discuss treatment options in women planning to become pregnant; instruct to report pregnancy as soon as possible. Instruct to d/c therapy and to immediately report signs/symptoms of angioedema. Instruct to report lightheadedness, especially during the 1st days of therapy; advise to d/c and consult w/ a physician if syncope occurs. Inform that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting may lead to excessive fall in BP, w/ the same consequences of lightheadedness and possible syncope. Advise not to use K+ supplements or salt substitutes containing K+ w/o consulting physician. Advise to promptly report any indication of infection.

STORAGE

20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture. (Lotensin) ≤30°C (86°F). Protect from moisture. (Sus) 2-8°C (36-46°F) for up to 30 days.

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