Amdopril Capsule

Amdopril Capsule is used for: Hypertension

Oral Hypertension Adult: Amlodipine component: 2.5-10 mg once daily; benazepril component: 10-40 mg once daily. Titrate dose gradually according to response.

Safety and efficacy in paediatric patients have not been established.

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

May be taken with or without food.

Hypersensitivity History of angioedema with or without previous ACE inhibitor therapy Hereditary or idiopathic angioedema Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan Concomitant use with Aliskiren in Patients with diabetes mellitus

Discontinue as soon as possible when pregnancy is detected; it affects the renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death. Anaphylactoid reactions, including angioedema. Myocardial infarction or increased angina in patients with obstructive coronary artery disease. Assess for hypotension and hyperkalemia. Titrate slowly in patients with impaired hepatic or severely impaired renal function. Caution in elderly, renal or hepatic impairment, congestive heart failure, severe aortic stenosis, unilateral or bilateral renal artery stenosis, use during surgery or anesthesia. 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 the patient develops jaundice/marked elevation of liver enzymes. Monitoring Parameters 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.

Pregnancy Therapy can cause fetal harm when administered to a pregnant woman; use of drugs that act on RAS during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents; When pregnancy is detected, discontinue therapy as soon as possible; the estimated background risk of major birth defects and miscarriage for indicated population is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly Reactions oligohydramnios in pregnant women who use drugs affecting renin-angiotensin system in second and third trimesters of pregnancy can result reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death Perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on week of gestation Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury If oligohydramnios is observed, consider alternative drug treatment; closely observe neonates with histories of in utero exposure to drug for hypotension, oliguria, and hyperkalemia In neonates with a history of in utero exposure to therapy, if oliguria or hypotension occurs, support blood pressure and renal perfusion Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function Lactation 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 maternal doses of benazepril and benazeprilat Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infant have been observed; there is no available information on effects of amlodipine or benazepril on milk production

Potassium supplements/potassium-sparing diuretics: hyperkalemia Lithium: Increased serum lithium levels; toxicity symptoms Injectable gold: facial flushing, nausea, vomiting, hypotension Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect Do not exceed doses greater than 20 mg daily of simvastatin mTOR inhibitors: increased risk of angioedema Dual inhibition of the renin-angiotensin system (RAS): Increased risk of renal impairment, hypotension, and hyperkalemia Neprilysin inhibitors: increased risk of angioedema Contraindicated (3) aliskiren dantrolene sacubitril/valsartan

Side effects of Amlodipine + Benazepril Hydrochloride : >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.

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.

Amdopril 5mg + 20mg Capsule manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Amlodipine + Benazepril Hydrochloride. Amdopril is availble in Bangladesh. Farmaco BD drug index information on Amdopril Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.