Uses of Benalop: - Hypertension (high blood pressure) Oral Hypertension Adult: Amlodipine component: 2.5-10 mg once daily; benazepril component: 10-40 mg once daily. Titrate dose gradually according to response. Elderly: Initiate with 2.5 mg Amlodipine component once daily. Hepatic impairment: Initiate with 2.5 mg Amlodipine component once daily. Titrate combination slowly in severe hepatic impairment. Safety and efficacy in paediatric patients have not been established.

Combined antihypertensive preparations

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.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.

How to use Amlodipine + Benazepril Hydrochloride: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Amlodipine + Benazepril Hydrochloride may be taken with or without food, but it is better to take it at a fixed time. Administration: Additive effect when used with catecholamine depleting drugs; monitor for hypotension and/or marked bradycardia. If used with clonidine, clonidine withdrawal should occur a few days after withdrawal of the beta-blocker to prevent rebound hypertension; if replacing clonidine by beta-blocker, beta-blocker should be introduced only after clonidine administration has stopped for several days. Concurrent use with prostaglandin synthase inhibiting drugs (e.g. indomethacin) may reduce the hypotensive effects of beta-blockers. Adult Dose: Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death. Caution in elderly, renal or hepatic impairment, congestive heart failure, severe aortic stenosis, unilateral or bilateral renal artery stenosis, use during surgery or anaesthesia. Amlodipine+Benazepril can cause symptomatic hypotension, especially in patients with salt/volume depletion. ACE inhibitors (ACEi) have been associated with cholestatic jaundice and fulminant hepatic necrosis; discontinue treatment if patient develops jaundice/marked elevation of liver enzymes. Monitor renal function and serum potassium periodically. Angioedema of the face, extremities, lips, tongue, glottis, larynx and intestinal angioedema have been reported in ACEi-treated patients. As with all ACEi, may cause persistent dry cough. Lactation: Minimal amounts of benazepril enters milk, but excretion of amlodipine is not known; not recommended Renal Dose: Amlodipine is a dihydropyridine calcium antagonist. It lowers BP by relaxing the coronary vascular smooth muscles and producing coronary vasodilation; through inhibition of transmembrane Ca ion influx into vascular smooth muscle and cardiac muscle. It is also a peripheral vascular vasodilator. Benazepril and its active metabolite benazeprilat inhibit ACE, which results in decreased plasma angiotensin II and thus leading to decreased aldosterone secretion.

Patients with history of angioedema; pregnancy, lactation.

Safety and efficacy in paediatric patients have not been established.

Common - Ankle swelling - Headache - Tiredness - Palpitations - Increased potassium level in blood - Sleepiness - Cough - Taste change - Flushing (sense of warmth in the face, ears, neck and trunk) - Decreased blood pressure - Upset stomach Renal impairment: Decrease dose if CrCl <30 mL/min, severe liver impairment, or coadministered with diuretic

Pregnancy: Categories C (first trimester) and D (second and third trimesters).Nursing Mothers: Minimal amounts of unchanged benazepril and of benazeprilat are 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 and benazeprilat. It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while this combination is administered.

Precaution: Hypertension

Human overdoses with any combination of Amlodipine and Benazepril have not been reported. In scattered reports of human overdoses with Benazepril and other ACE inhibitors, there are no reports of death.

Store at 25°C, protect from moisture. Keep out of reach of children.

May be taken with or without food.

>10% Amlodipine Peripheral edema (2-15%),Pulmonary edema (7-15%) 1-10% Amlodipine Abdominal pain (1.6%),Dizziness (1.1-3.4%),Dyspepsia (1-2%),Fatigue (4.5%),Flushing (0.7-2.6%),Headache (7.3%),Male sexual dysfunction (1-2%),Muscle cramps (1-2%),Nausea (2.9%),Palpitation (0.7-4.5%),Rash (1-2%),Somnolence (1-2%),Weakness (1-2%) Benazepril ARF if renal artery stenosis Cough (1-10%),Dizziness (4%),Fatigue (2%),Headache (6%),Nausea (1%),Postural dizziness (2%),Serum creatinine increased (2%),Somnolence (2%) Potentially Fatal: Analphylactoid reactions, angioedema, Stevens-Johnson syndrome.