Benazepril / Hydrochlorothiazide Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg

Reference Brands: Lotensin HCT (USA), Cibadrex (EU/UK)

Category: Heart Disorder

Benazepril and hydrochlorothiazide tablets in 10/12.5 mg, 20/12.5 mg and 20/25 mg, an ACE inhibitor and thiazide combination for hypertension, for importers, distributors and hospital buyers.

Product Description:

This fixed-dose tablet pairs benazepril, an ACE inhibitor, with hydrochlorothiazide, a thiazide diuretic. Benazepril is converted in the liver to benazeprilat, which blocks formation of angiotensin II, relaxes arteries and lowers aldosterone. Hydrochlorothiazide increases sodium and water loss in the distal tubule. The ACE inhibitor also partly offsets the potassium loss caused by the diuretic. The strengths listed are 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg, allowing a step-up once the right dose of each component is known.

It is used for hypertension not controlled by one drug, or to replace two separate tablets in a stable patient; it is not generally the first treatment. One tablet is taken once daily. ACE inhibitors can cause angioedema and a dry cough, and the combination is contraindicated in pregnancy. Pharmacists check potassium, sodium and creatinine, and watch lithium, NSAIDs and potassium supplements. Thiazides can raise uric acid and blood glucose, and European labels warn of non-melanoma skin cancer with long-term hydrochlorothiazide. Anuria rules it out.

Sourcing notes. Check which strengths are registered in your market, because the range differs between labels and some include a 5 mg/6.25 mg tablet. Expect a CTD or ACTD dossier with bioequivalence against the reference combination and stability for your climatic zone, including zone IVb for hot humid markets. Moisture-protective blisters are normal and there is no cold chain. Ask for a CoA per batch covering both actives, the GMP certificate, a CoPP and a nitrosamine risk assessment. It is prescription-only. Specify strengths, pack size and labelling language.