| DESCRIPTION |
Lodiben®, is a combination of Calcium Channel Blocker Amlodipine Besilate and ACE Inhibitor Benazepril Hydrochloride. Benazepril and benazeprilat (the active metabolite of Benazepril) inhibit 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 to decreased aldosterone secretion. Mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensinaldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. |
| INDICATIONS |
| Lodiben® is indicated for the treatment of hypertension. This fixed dose combination drug is not indicated for the initial therapy of hypertension. |
| DOSAGE & ADMINISTRATION |
Usual dose is once daily. Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while Benazepril is effective in doses of 10-80 mg.In clinical trials of Amlodipine/Benazepril combination therapy using Amlodipine doses of 2.5-10 mg and Benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of Amlodipine in all patient groups, and the effects increased with increasing dose of Benazepril in nonblack groups. All patient groups benefited from the reduction in Amlodipine-induced edema.Safety and effectiveness in paediatric patients have not been established |
| CONTRAINDICATIONS |
| Amlodipine Besilate and Benazepril Hydrochloride combination is contraindicated in patients who are hypersensitive to Benazepril, to any other ACE inhibitor, or to Amlodipine. |
| PRECAUTIONS |
| Impaired Renal Function: This combination should be used with caution in patients with severe renal disease. When the renin-angiotensin-aldosterone system is inhibited by Benazepril, changes in renal function may be anticipated in susceptible individuals. Treatment with Benazepril is associated with increases in blood urea nitrogen and serum creatinine in hypertensive patients with unilateral or bilateral renal artery stenosis. When such patients are treated with this combination, renal function should be monitored during the first few week of therapy. |
| SIDE-EFFECTS |
| Reported side effects were generally mild and transient, and there was no relationship between side effects and age sex, race, or duration of therapy. The most common side effects are cough and edema. Other side effects include angioedema, fatigue, insomnia, nervousness, decreased libido, dry mouth, nausea, hypokalemia. |
| DRUG INTERACTIONS |
Diuretics: Diuretics: Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with this combination. The possibility of hypotensive effects with the combination can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with the ombination. Potassium Supplements and Potassium-Sparing Diuretics: Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently.
Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. This combination and lithium should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. Other: Benazepril has been used concomitantly with oral anticoagulants, betaadrenergic-blocking agents, calcium-blocking agents, cimetidine, diuretics, digoxin, hydralazine, and naproxen without evidence of clinically important adverse interactions. In clinical trials, Amlodipine has been safely administered with thiazide diuretics,beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics and oral hypoglycemic drugs. |
| USE IN PREGNANCY AND LACTATION |
Pregnancy Category D. ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, this combination should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis. Minimal amounts of unchanged Benazepril and benazeprilat at 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 isrecommended that nursing be discontinued while this medication is administered.
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| PHARMACEUTICAL PRECAUTIONS |
| Store in a cool and dry place, away from light. Keep out of reach of children. |
| PACKAGING |
Lodiben® 2.5/10 capsules: Box containing 6 strips of 6 capsules each. Each capsule contains Amlodipine Besilate BP equivalent to Amlodipine 2.5 mg and Benazepril Hydrochloride USP 10 mg. Lodiben® 5/10 capsules: Box containing 4 strips of 6 capsules each. Each capsule contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Benazepril Hydrochloride USP 10 mg.
Lodiben® 5/20 capsules: Box containing 4 strips of 4 capsules each. Each capsule contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Benazepril Hydrochloride USP 20 mg.
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