Benadip
Benazepril plus Amlodipine

Presentation
Benadip 10/2.5 capsule: Each capsule contains Benazepril HCl USP 10 mg and Amlodipine besylate BP equivalent to Amlodipine 2.5 mg
Benadip 10/5 capsule: Each capsule contains Benazepril HCl USP 10 mg and Amlodipine besylate BP equivalent to Amlodipine 5 mg
Benadip 20/5 capsule: Each capsule contains Benazepril HCl 20 mg and Amlodipine besylate BP equivalent to Amlodipine 5 mg

Description
Benazepril inhibits angiotensin-converting enzyme (ACE). ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and aldosterone secretion. Mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension.

Amlodipine is a dihydropyridine calcium antagonist which inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It has greater effect on vascular smooth muscle cells than on cardiac muscle cells; Amlodipine is a peripheral arterial vasodilator that causes reduction in peripheral vascular resistance and reduction in blood pressure. Serum calcium concentration is not affected by Amlodipine.

Indications and Uses
Benadip is indicated for the treatment of hypertension.

Contraindications
Amlodipine besylate and Benazepril hydrochloride combination is contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine.

Dosage And Administration
Usual dose: once daily. Amlodipine and Benazepril combination therapy using Amlodipine doses of 2.5-10 mg and Benazepril doses of 10-20 mg, the antihypertensive effect is increased with increasing dose of Amlodipine in all patient groups, and the effect is increased with increasing dose of Benazepril. All patient groups benefited from the reduction in Amlodipine-induced edema.

Precautions
Impaired Renal Function: When the renin-angiotensin-aldosterone system is inhibited by Benazepril, changes in renal function may be anticipated in severe renal disease.
Treatment with Benazepril was associated with increases in blood urea and serum creatinine in hypertensive patients with unilateral or bilateral renal artery stenosis,
Hyperkalemia: Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.
Patients with Congestive Heart Failure: In general, all calcium channel blockers should be used with caution in patients with heart failure. In patients with severe congestive heart failure, whose renal function may depend on the activity of the renin Angiotensin-aldosterone system, treatment with ACE inhibitors (including Benazepril) may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure.
Patients with Hepatic Failure: Since amlodipine is extensively metabolized by the liver, caution should be exercised when administering Amlodipine and Benazepril to patients with severe hepatic impairment.
Cough: Persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy

Side Effects
Cough Headache, Dizziness, and Edema. Other side effects considered possibly or probably related to the drug are: Angioedema, Asthenia and fatigue, Insomnia, nervousness, anxiety, tremor, and decreased libido, Dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, and esophagitis, Hypokalemia, Back pain, musculoskeletal pain, cramps, impotence, polyuria etc.

Use in pregnancy & lactation
Pregnancy Categories C (first trimester) and D (second and third trimesters). Minimal amounts of unchanged Benazepril is excreted into the breast milk of lactating women treated with Benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1 % of the maternal doses of Benazepril. It is not known whether amlodipine is excreted in human milk. So, it is recommended that nursing should be discontinued while Amlodipine and Benazepril are administered.
Use in children
Safety and effectiveness in paediatric patients have not been established.

Overdosage
The most likely effect of overdose with Amlodipine and Benazepril is vasodilation, with consequent hypotension and tachycardia. Simple repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (nor epinephrine or high-dose dopamine) may be required. Benazepril is only slightly dialyzable; attempted clearance of amlodipine by haemodialysis or hemo-perfusion has not been reported.

Commercial Pack
Benadip 10/2.5: Each box contains 5 blister strips of 4 capsules.
Benadip 10/5: Each box contains 5 blister strips of 4 capsules.
Benadip 20/5: Each box contains 5 blister strips of 4 capsules.
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