Amlobenz (Amlodipine Besylate / Benazepril Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

{template}

Hypertension

Amlodipine besylate and benazepril hydrochloride capsules are 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 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg 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. 

The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. 

It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules 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 amlodipine besylate and benazepril hydrochloride capsules need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.73 m² (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). Amlodipine besylate and benazepril hydrochloride capsules are 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 amlodipine besylate and benazepril hydrochloride capsules.

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

Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

DOSAGE FORMS AND STRENGTHS

Amlodipine besylate and benazepril hydrochloride capsules are available as follows:

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

HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. 

Amlodipine besylate and benazepril hydrochloride capsules, 2.5 mg/10 mg contain white to off-white powder and size "4" hard gelatin capsules of ivory color cap and ivory color body, filled in size "1" hard gelatin capsule with bluish green color cap and ivory color body, imprinted "RDY"on cap and "338"on body with black ink and are supplied in bottles of 30, 100 and 500. 

Bottles of 30                                                               NDC 55111-338-30

Bottles of 100                                                              NDC 55111-338-01

Bottles of 500                                                              NDC 55111-338-05 

Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/10 mg contain white to off-white powder and size "4" hard gelatin capsules of ivory color cap and ivory color body, filled in size "1" hard gelatin capsule with yellow color cap and ivory color body, imprinted "RDY"on cap and "339" on body with black ink and are supplied in bottles of 30, 100 and 500. 

Bottles of 30                                                               NDC 55111-339-30

Bottles of 100                                                             NDC 55111-339-01

Bottles of 500                                                             NDC 55111-339-05 

Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/20 mg contain white to off-white powder and size "4" hard gelatin capsules of flesh color cap and flesh color body, filled in size "1" hard gelatin capsule with medium orange color cap and ivory color body, imprinted "RDY" on cap and "340" on body with black ink and are supplied in bottles of 30, 100 and 500.   

Bottles of 30                                                               NDC 55111-340-30

Bottles of 100                                                             NDC 55111-340-01

Bottles of 500                                                             NDC 55111-340-05  

Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size "4" hard gelatin capsules of flesh color cap and flesh color body, filled in size "1" hard gelatin capsule with light grey color cap and ivory color body, imprinted "RDY" on cap and "341" on body with black ink and are supplied in bottles of 30, 100 and 500. 

Bottles of 30                                                               NDC 55111-341-30

Bottles of 100                                                             NDC 55111-341-01

Bottles of 500                                                             NDC 55111-341-05 

Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP).