Medicase - Benadip 5/20 - Capsule - 5mg+20mg - Amlodipine + Benazepril Hydrochloride

Benadip 5/205mg+20mg

Type:Capsule

Generic Name:Amlodipine + Benazepril Hydrochloride

Manufacturer:Incepta Pharmaceuticals Ltd.

Price:৳8.00

Indication

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.

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.

Contraindication

Safety and efficacy in paediatric patients have not been established.

Mode of Action

May be taken with or without food.

Precaution

Hypertension

Side Effect

Renal impairment: Decrease dose if CrCl <30 mL/min, severe liver impairment, or coadministered with diuretic

Pregnancy Category Note

>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.