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Amlodipine Besylate / Benazepril Hydrochloride
Amlodipine Besylate / Benazepril Hydrochloride is a Calcium channel blocker / ACE inhibitor combination Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently FDA-approved for Hypertension. Also known as: Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril, Hydrochloride Capsules).
This combination drug lowers blood pressure by relaxing blood vessels (amlodipine) and reducing angiotensin II production (benazepril).
This combination drug lowers blood pressure by relaxing blood vessels (amlodipine) and reducing angiotensin II production (benazepril). Used for Hypertension.
At a glance
| Generic name | Amlodipine Besylate / Benazepril Hydrochloride |
|---|---|
| Also known as | Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril, Hydrochloride Capsules) |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Drug class | Calcium channel blocker / ACE inhibitor combination |
| Target | L-type calcium channels; Angiotensin-converting enzyme (ACE) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Amlodipine is a calcium channel blocker that prevents calcium from entering vascular smooth muscle cells, causing vasodilation. Benazepril is an ACE inhibitor that blocks the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby reducing peripheral vascular resistance and blood pressure. Together, these complementary mechanisms provide additive antihypertensive effects.
Approved indications
- Hypertension
Common side effects
- Headache
- Dizziness
- Fatigue
- Peripheral edema
- Cough
- Hyperkalemia
- Angioedema
Key clinical trials
- Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets (PHASE1)
- Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (PHASE3)
- Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions (PHASE1)
- Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions (PHASE1)
- Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension (PHASE4)
- Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus (PHASE4)
- ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria (PHASE4)
- Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amlodipine Besylate / Benazepril Hydrochloride CI brief — competitive landscape report
- Amlodipine Besylate / Benazepril Hydrochloride updates RSS · CI watch RSS
- Dr. Reddy's Laboratories Limited portfolio CI
Frequently asked questions about Amlodipine Besylate / Benazepril Hydrochloride
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Related
- Drug class: All Calcium channel blocker / ACE inhibitor combination drugs
- Target: All drugs targeting L-type calcium channels; Angiotensin-converting enzyme (ACE)
- Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Also known as: Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril, Hydrochloride Capsules)
- Compare: Amlodipine Besylate / Benazepril Hydrochloride vs similar drugs
- Pricing: Amlodipine Besylate / Benazepril Hydrochloride cost, discount & access