Azor (Amlodipine Besylate / Olmesartan Medoxomil) - Indications and Dosage

1   INDICATIONS AND USAGE

Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents.

Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.

Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies ] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.

Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg at Week 8 With LOCF

Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg at Week 8 With LOCF

Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg at Week 8 With LOCF

Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg at Week 8 With LOCF

The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg.

For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.

2   DOSAGE AND ADMINISTRATION

General Considerations

The side effects of olmesartan medoxomil are generally rare and apparently independent of dose. Those of amlodipine are generally dose-dependent (mostly edema).

Maximum antihypertensive effects are attained within 2 weeks after a change in dose.

Azor may be taken with or without food.

Azor may be administered with other antihypertensive agents.

Dosage may be increased after 2 weeks. The maximum recommended dose of Azor is 10/40 mg.

Replacement Therapy

Azor may be substituted for its individually titrated components.

When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on Therapy

Azor may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with olmesartan medoxomil (or another angiotensin receptor blocker) alone.

Initial Therapy

The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [See Clinical Studies ].

Initial therapy with Azor is not recommended in patients ≥75 years old or with hepatic impairment [See Warnings and Precautions and Use in Specific Populations (8.5, 8.6 )].

3   DOSAGE FORMS AND STRENGTHS

Azor tablets are formulated for oral administration in the following strength combinations:

	5/20	5/40	10/20	10/40
Amlodipine equivalent (mg)	5	5	10	10
Olmesartan medoxomil (mg)	20	40	20	40

16   HOW SUPPLIED/STORAGE AND HANDLING

Azor tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.

Azor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Azor tablets are supplied for oral administration in the following strength and package configurations:

Tablet Strength (amlodipine equivalent/ olmesartan medoxomil) mg	Package Configuration	NDC#	Product Code	Tablet Color
5/20 mg	Bottle of 30	65597-110-30	C73	White
	Bottle of 90	65597-110-90
	10 blisters of 10	65597-110-10
	Bottle of 1000	65597-110-11
10/20 mg	Bottle of 30	65597-111-30	C74	Grayish Orange
	Bottle of 90	65597-111-90
	10 blisters of 10	65597-111-10
	Bottle of 1000	65597-111-11
5/40 mg	Bottle of 30	65597-112-30	C75	Cream
	Bottle of 90	65597-112-90
	10 blisters of 10	65597-112-10
	Bottle of 1000	65597-112-11
10/40 mg	Bottle of 30	65597-113-30	C77	Brownish Red
	Bottle of 90	65597-113-90
	10 blisters of 10	65597-113-10
	Bottle of 1000	65597-113-11

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].