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Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
DOSAGE AND ADMINISTRATION
The recommended initial dose of Lotrel is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.
It is usually appropriate to begin therapy with Lotrel only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.
The antihypertensive effect of Lotrel is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient's clinical response.
Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 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.
Dosage Adjustment In Renal Impairment
Lotrel is not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of Lotrel is required in patients with CrCl greater than 30 mL/min/1.73m² (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Lotrel may be substituted for the titrated components.
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 6 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°C–30°C (59°F–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. Revised: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/2/2015
Additional Lotrel Information
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