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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

General Considerations

The recommended initial dose of Lotrel is one 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 2.5-10 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.

Dosage Adjustment In Renal Impairment

Renal Impairment

Lotrel is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of Lotrel is required in patients with creatinine clearance > 30 mL/min/1.73m² (serum creatinine roughly ≤ 3 mg/dL or 265 μmol/L) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

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. Revised: December 2014

Last reviewed on RxList: 1/15/2015
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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