Katerzia

KATERZIA- amlodipine benzoate suspension
Azurity Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Hypertension

KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

KATERZIA may be used alone or in combination with other antihypertensive agents.

1.2 Coronary Artery Disease (CAD)

Chronic Stable Angina
KATERZIA is indicated for the symptomatic treatment of chronic stable angina. KATERZIA may be used alone or in combination with other antianginal agents.

Vasospastic Angina (Prinzmetal’s or Variant Angina)
KATERZIA is indicated for the treatment of confirmed or suspected vasospastic angina. KATERZIA may be used as monotherapy or in combination with other antianginal agents.

Angiographically Documented CADIn patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, KATERZIA is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.

2 DOSAGE AND ADMINISTRATION

2.1 Adults

The usual initial antihypertensive oral dose of KATERZIA is 5 mg orally once daily, and the maximum dose is 10 mg once daily.

Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding KATERZIA to other antihypertensive therapy [see Use in Specific Populations (8.6)].

Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg once daily for adequate effect.

Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg once daily [see Clinical Studies (14.4)].

2.2 Children

The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3), Clinical Studies (14.1)].

3 DOSAGE FORMS AND STRENGTHS

KATERZIA oral suspension contains 1 mg/mL of amlodipine (equivalent to 1.30 mg of amlodipine benzoate) in an aqueous, white to off-white, liquid suspension.

4 CONTRAINDICATIONS

KATERZIA is contraindicated in patients with known sensitivity to amlodipine.

5 WARNINGS AND PRECAUTIONS

5.1 Hypotension

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

5.2 Increased Angina or Myocardial Infarction

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of KATERZIA, particularly in patients with severe obstructive coronary artery disease.

5.3 Patients with Hepatic Failure

Because KATERZIA is extensively metabolized by the liver and the plasma elimination half-life (t1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering KATERZIA to patients with severe hepatic impairment.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in about 1.5% of patients and was not different from placebo (about 1%). The most commonly reported adverse reactions more frequent than placebo are reflected in the table below. The incidence (%) of adverse reactions that occurred in a dose related manner are as follows:

Table 1: Most Common Dose-Related Adverse Events Compared to Placebo

Amlodipine

Placebo

2.5 mg

5 mg

10 mg

N=520

N=275

N=296

N=268

Edema

1.8

3.0

10.8

0.6

Dizziness

1.1

3.4

3.4

1.5

Flushing

0.7

1.4

2.6

0.0

Palpitation

0.7

1.4

4.5

0.6

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials included the following:

Table 2: Other Adverse Events with a Reported Incidence Greater Than 1%

Amlodipine (%)

Placebo (%)

(N=1730)

(N=1250)

Fatigue

4.5

2.8

Nausea

2.9

1.9

Abdominal Pain

1.6

0.3

Somnolence

1.4

0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

Table 3: Comparison of Drug and Dose-Related Adverse Events Reported by Men and Women

Amlodipine

Placebo

Male=%

Female=%

Male=%

Female=%

(N=1218)

(N=512)

(N=914)

(N=336)

Edema

5.6

14.6

1.4

5.1

Flushing

1.5

4.5

0.3

0.9

Palpitations

1.4

3.3

0.9

0.9

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