Amlozep5 mg+10 mg

Amlozep is a fixed-dose combination indicated for the treatment of hypertension (high blood pressure).

• Established/FDA-approved use: Treatment of hypertension in patients whose blood pressure is not adequately controlled with either amlodipine or benazepril monotherapy alone, or as a substitution therapy in patients already controlled on the individual components given concurrently in similar proportions.
• Not recommended as initial therapy for hypertension; it is intended for patients who require combination treatment after monotherapy has proven insufficient.

Amlozep is not indicated for initial treatment of hypertension and is not indicated in patients whose blood pressure can be controlled with a single agent.

Each capsule of Amlodipine + Benazepril Hydrochloride contains amlodipine (as amlodipine besylate) and benazepril hydrochloride in fixed-dose combinations, commonly available as 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg (amlodipine/benazepril) capsules.

Amlozep is a fixed-dose combination antihypertensive medicine that pairs a dihydropyridine calcium channel blocker (amlodipine) with an angiotensin-converting enzyme (ACE) inhibitor (benazepril hydrochloride). The combination is designed for patients whose blood pressure is not adequately controlled on either component alone, providing complementary mechanisms of blood pressure lowering.

Amlozep is administered orally, once daily, and is available in several fixed-dose strengths to allow individualized titration.

Amlozep belongs to the therapeutic class of combination antihypertensive agents, combining a calcium channel blocker (dihydropyridine class) with an ACE inhibitor.

Amlodipine + Benazepril Hydrochloride combines two complementary antihypertensive mechanisms:

• Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing relaxation of arterial smooth muscle and a resultant decrease in peripheral vascular resistance and blood pressure.
• Benazepril hydrochloride is a prodrug hydrolyzed to benazeprilat, an ACE inhibitor that blocks conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, and reduces aldosterone secretion. This decreases peripheral arterial resistance and blood pressure without causing significant reflex tachycardia.

Used together, Amlodipine + Benazepril Hydrochloride produces additive antihypertensive effects through complementary vasodilatory pathways.

Amlozep is given orally, once daily, with or without food, swallowed whole with a glass of water. Doses should not be crushed or chewed unless specifically directed by a physician.

Amlozep has the following clinically significant drug interactions:

• Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium: increased risk of hyperkalemia due to the benazepril component.
• Lithium: ACE inhibitors can increase serum lithium levels and the risk of lithium toxicity; monitor lithium levels closely.
• NSAIDs (including selective COX-2 inhibitors): may reduce the antihypertensive effect and increase risk of renal impairment, particularly in volume-depleted or elderly patients.
• Dual blockade of the renin-angiotensin system (e.g., concurrent ARBs, aliskiren): increased risk of hypotension, hyperkalemia, and renal impairment; concomitant use with aliskiren is contraindicated in patients with diabetes (see Contraindications).
• Neprilysin inhibitors (e.g., sacubitril): increased risk of angioedema; do not administer within 36 hours of switching between benazepril and a neprilysin inhibitor.
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus): increased risk of angioedema.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may increase amlodipine plasma concentrations, raising the risk of hypotension and edema.
• Simvastatin: amlodipine increases simvastatin exposure; limit simvastatin dose to 20 mg daily when co-administered.

Common side effects of Amlozep include:

• Dry, persistent cough (a known ACE inhibitor class effect)
• Headache
• Dizziness
• Peripheral (ankle/leg) edema, a dose-dependent amlodipine class effect
• Fatigue/asthenia
• Flushing

Serious but less common effects include angioedema (swelling of the face, lips, tongue, or throat, which can be life-threatening if it involves the airway and requires immediate discontinuation and emergency evaluation), symptomatic hypotension (especially after the first dose or in volume-depleted patients), hyperkalemia, and rarely, hepatic dysfunction or hepatitis. Rare postmarketing reports include Stevens-Johnson syndrome, pancreatitis, and blood dyscrasias (e.g., thrombocytopenia, hemolytic anemia).

Boxed Warning: Amlozep can cause fetal injury and death when administered during the second and third trimesters of pregnancy. When pregnancy is detected, discontinue Amlozep as soon as possible. Use of ACE inhibitors during pregnancy is associated with oligohydramnios, fetal renal failure, skull hypoplasia, and other fetal/neonatal injury.

Amlozep should not be used during pregnancy. In women of childbearing potential, use is only appropriate if reliable contraception is in place, and only if clearly needed and no suitable alternative exists; consult a physician immediately if pregnancy is suspected or confirmed.

Lactation: It is not known whether benazepril or amlodipine are excreted in human milk in clinically significant amounts. Because of the potential for serious adverse effects in a nursing infant, breastfeeding is generally not recommended during treatment with Amlozep unless a physician determines the benefit clearly outweighs the risk.

Use Amlozep with caution in the following situations:

• Hypotension/volume depletion: Excessive hypotension, particularly after the first dose, may occur in patients who are volume- or salt-depleted (e.g., from diuretic therapy). Correct volume depletion before starting therapy or start under close medical supervision.
• Renal impairment/bilateral renal artery stenosis: ACE inhibitors can cause deterioration of renal function, particularly in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; monitor renal function.
• Hyperkalemia: Benazepril can raise serum potassium; use caution with potassium supplements, potassium-sparing diuretics, or in renal impairment.
• Angioedema: If swelling of the face, lips, tongue, throat, or extremities occurs, discontinue Amlozep immediately and seek emergency medical care, especially if there is any airway involvement.
• Cough: A persistent dry cough is a recognized class effect of ACE inhibitors and usually resolves after discontinuation.
• Hepatic impairment: Amlodipine clearance is reduced; a rare ACE-inhibitor-associated cholestatic hepatitis/hepatic failure syndrome has been reported - discontinue and seek prompt medical attention if jaundice or marked liver enzyme elevation occurs.
• Aortic stenosis/severe heart failure: Use amlodipine-containing products cautiously in patients with severe obstructive coronary artery disease or significant aortic stenosis.
• Surgery/anesthesia: ACE inhibitors may contribute to hypotension during major surgery or anesthesia.

Overdose of Amlozep may cause excessive peripheral vasodilation with marked and prolonged hypotension, reflex tachycardia, and shock. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services without delay. Management is generally supportive and may include cardiovascular monitoring, elevation of the extremities, and careful administration of intravenous fluids under medical supervision; specific antidotes are not available, and treatment should only be undertaken by qualified medical personnel in a hospital setting.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: Use a lower starting dose (amlodipine 2.5 mg component) due to reduced clearance of amlodipine; monitor blood pressure and renal function closely.

Renal impairment: No dosage adjustment is generally required in mild-to-moderate renal impairment; use in severe renal impairment is generally not recommended for this fixed-dose combination, and individual component titration is preferred with close monitoring of renal function and potassium.

Hepatic impairment: Amlodipine clearance is reduced in hepatic impairment; start with the lowest available dose and titrate slowly.

Pregnancy and lactation: See Pregnancy and Lactation section - contraindicated in pregnancy.

Pediatric patients: See Pediatric Uses.

Amlozep is generally used long-term for chronic management of hypertension, as directed by a physician. Blood pressure control should be periodically reassessed, and treatment should not be stopped abruptly without medical advice.

Calcium channel blocker (dihydropyridine) + Angiotensin-converting enzyme (ACE) inhibitor combination.

Amlodipine + Benazepril Hydrochloride lowers blood pressure through two complementary mechanisms: amlodipine blocks calcium influx into vascular smooth muscle, causing arterial vasodilation, while benazepril (via its active metabolite benazeprilat) inhibits angiotensin-converting enzyme, reducing angiotensin II formation and aldosterone secretion, which further reduces vascular resistance and blood pressure.

D (Category C in first trimester; Category D in second and third trimesters)

Safety and efficacy of Amlozep in pediatric patients have not been established. This fixed-dose combination is not recommended for use in children, and treatment of pediatric hypertension should follow physician guidance using individually titrated, age-appropriate agents.