LOTENSIN HCT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LOTENSIN HCT (LOTENSIN HCT).
Lotensin HCT is a combination of benazepril, an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide, a thiazide diuretic. Benazepril inhibits ACE, reducing angiotensin II formation, leading to vasodilation and decreased aldosterone secretion. Hydrochlorothiazide increases sodium and water excretion by inhibiting the sodium-chloride symporter in the distal convoluted tubule, reducing plasma volume.
| Metabolism | Benazepril is metabolized by hepatic esterases to its active metabolite, benazeprilat. Hydrochlorothiazide is not extensively metabolized; it is eliminated unchanged in urine. |
| Excretion | Renal: ~90% (benazeprilat, benazepril, and conjugates); Biliary/fecal: ~10% |
| Half-life | Benazeprilat: 10-11 hours (effective half-life 22 hours in hypertension at steady state); Benazepril: 0.6 hours |
| Protein binding | Benazeprilat: ~89-93% (primarily albumin) |
| Volume of Distribution | Benazeprilat: ~0.7 L/kg (extensive tissue distribution) |
| Bioavailability | Oral: Benazepril ~37% (presystemic hydrolysis to benazeprilat); Food reduces absorption rate but not extent |
| Onset of Action | Oral: 1 hour (antihypertensive effect) |
| Duration of Action | Oral: 24 hours (dosing once or twice daily based on response) |
| Molecular Weight | 425.36 |
One tablet (10 mg benazepril/12.5 mg hydrochlorothiazide, 20 mg benazepril/12.5 mg hydrochlorothiazide, or 20 mg benazepril/25 mg hydrochlorothiazide) orally once daily. Dose titration: initially 10/12.5 mg, may increase to 20/12.5 mg or 20/25 mg if needed.
| Dosage form | TABLET |
| Renal impairment | For GFR 30-60 mL/min: maximum dose 20/12.5 mg daily. For GFR <30 mL/min: not recommended (use loop diuretics instead). For GFR <30 mL/min or CrCl <30 mL/min: avoid use. |
| Liver impairment | Child-Pugh A (mild): no adjustment required. Child-Pugh B (moderate): use with caution; reduce dose or consider monotherapy. Child-Pugh C (severe): contraindicated due to risk of electrolyte imbalances and hepatic encephalopathy. |
| Pediatric use | Not established for combination product. For hypertension in children ≥6 years: benazepril monotherapy starting at 0.2 mg/kg/day up to 40 mg/day; hydrochlorothiazide monotherapy starting at 1-2 mg/kg/day up to 50 mg/day. Combination not recommended due to lack of data. |
| Geriatric use | Start at lowest dose (10/12.5 mg once daily) due to increased sensitivity to hypotension and electrolyte disturbances. Monitor renal function, serum potassium, and volume status closely. Use with caution in frail elderly. |
| 1st trimester | Contraindicated due to risk of fetal renal impairment and oligohydramnios; may cause fetal hypotension and reduced renal blood flow. Avoid use. |
| 2nd trimester | Contraindicated – Drugs acting directly on the renin-angiotensin system (ACE inhibitors and ARBs) can cause fetal and neonatal morbidity and death when used during the second and third trimesters. |
| 3rd trimester | Contraindicated – Fetal toxicity includes oligohydramnios, fetal skull hypoplasia, pulmonary hypoplasia, and neonatal renal failure. Discontinue immediately if pregnancy detected. |
Clinical note
Comprehensive clinical and safety monograph for LOTENSIN HCT (LOTENSIN HCT).
| Placental transfer | Benazepril and its active metabolite benazeprilat cross the placenta; hydrochlorothiazide crosses the placenta and appears in cord blood. Evidence indicates significant placental transfer with potential fetal effects. |
| Breastfeeding |
■ FDA Black Box Warning
USE IN PREGNANCY: Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected.
| Serious Effects |
History of angioedema related to previous ACE inhibitor therapyHypersensitivity to benazepril, hydrochlorothiazide, or any sulfonamide-derived drug (hydrochlorothiazide is a sulfonamide)Anuria (due to hydrochlorothiazide component)Pregnancy (especially second and third trimesters)
| Precautions | Fetal toxicity, Hypotension in volume-depleted patients, Monitor renal function and electrolytes, Angioedema (risk higher in black patients), Monitor for signs of hypotension, hyperkalemia, and renal impairment |
| Food/Dietary | Avoid high-potassium foods (e.g., bananas, oranges, spinach, salt substitutes) as benazepril may increase potassium levels. Limit salt intake to enhance HCTZ effect. Avoid alcohol. Take with food or milk to reduce gastrointestinal upset. Avoid grapefruit juice if also taking HCTZ (rare interaction). |
Loading safety data…
| Both benazepril and hydrochlorothiazide are present in human milk in low amounts; benazeprilat (active metabolite) levels are low. Theoretical risk of hypotension and renal impairment in neonates; due to potential for serious adverse reactions, manufacturer recommends caution and considering alternative antihypertensives with more breastfeeding safety data, such as nifedipine or labetalol. |
| Lactation Rating | L3 (Moderately Safe) – Limited data; potential for adverse effects, but risk may be acceptable with monitoring. |
| Teratogenic Risk | First trimester: Possible increased risk of congenital malformations based on ACE inhibitor class; data limited. Second and third trimesters: Fetal renal dysfunction, oligohydramnios, skull ossification defects, hypotension, and anuria. Risk of fetal/neonatal death. |
| Fetal Monitoring | Monitor maternal blood pressure and renal function. Fetal ultrasound for amniotic fluid volume and fetal growth. In neonates, monitor for hypotension, hyperkalemia, and oliguria. |
| Fertility Effects | ACE inhibitors may reduce fertility by interfering with renin-angiotensin system in reproductive tissues; HCT has no known direct effect on fertility. Data limited. |
| Clinical Pearls | Lotensin HCT (benazepril/hydrochlorothiazide) is a fixed-dose combination for hypertension. Monitor serum potassium, creatinine, and BUN. Avoid in pregnancy (ACE inhibitor risk). Use caution in renal impairment (CrCl <30 mL/min). May cause angioedema; instruct patient to report swelling. Synergistic effect: HCTZ enhances benazepril's antihypertensive effect. Adjust dose in elderly or volume-depleted patients. |
| Patient Advice | Take Lotensin HCT exactly as prescribed, usually once daily. · Avoid pregnancy; notify doctor immediately if pregnant or planning pregnancy. · Report symptoms of angioedema: facial, lip, tongue, or throat swelling; difficulty breathing. · Monitor for signs of dehydration or electrolyte imbalance: excessive thirst, dry mouth, muscle cramps, weakness. · Use caution with potassium supplements, salt substitutes, or NSAIDs. · Limit alcohol intake as it may worsen hypotension. · May cause dizziness; avoid driving until you know how the medication affects you. · Do not stop abruptly without consulting your doctor. |