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Lotrel

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Lotrel

Indications
Dosage
How Supplied

INDICATIONS

Hypertension

Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

DOSAGE AND ADMINISTRATION

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.

The antihypertensive effect of Lotrel is largely attained within 2 weeks.

It is usually appropriate to begin therapy with Lotrel only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

Renal Impairment: Regimens of therapy with Lotrel need not take account of renal function as long as the patient's creatinine clearance is > 30 mL/min/1.73m² (serum creatinine roughly ≤ 3 mg/dL or 265 μmol/L). Lotrel is not recommended in patients with more severe renal impairment.

Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

Add-on Therapy

A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Lotrel.

In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

Replacement Therapy

Lotrel may be substituted for the titrated components.

HOW SUPPLIED

Dosage Forms And Strengths

Lotrel (amlodipine/benazepril) capsules are available as follows:

2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg, and 10/40 mg.

Storage And Handling

Lotrel is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. All six strengths are packaged in bottles of 100 capsules.

Capsules are imprinted with “Lotrel” and appropriate code.

Dose Capsule Color/Code NDC Code Bottle of 100
2.5/10 mg
white with 2 gold bands/2255
NDC 0078-0404-05
5/10 mg
light brown with 2 white bands/2260
NDC 0078-0405-05
5/20 mg
pink with 2 white bands/2265
NDC 0078-0406-05
5/40 mg
light blue with 2 white bands/0384
NDC 0078-0384-05
10/20 mg
purple (amethyst) with 2 white bands/0364
NDC 0078-0364-05
10/40 mg
dark blue with 2 white bands/0379
NDC 0078-0379-05

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936.

Last reviewed on RxList: 1/27/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Lotrel - User Reviews

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Hypertension

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