Felodipine

CLINICAL PHARMACOLOGY

Pharmacokinetics and Metabolism

Geriatric Use

Cardiovascular Effects

Renal/Endocrine Effects

FELODIPINE INDICATIONS AND USAGE

Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 felodipine.

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 1 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.

Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.

FELODIPINE CONTRAINDICATIONS

PRECAUTIONS

General

Information for Patients

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

²



Nonteratogenic Effects

<sup>**2

2






**</sup> 

Nursing Mothers

Pediatric Use

Geriatric Use

CLINICAL PHARMACOLOGY: Geriatric Use

FELODIPINE ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION

Percent of Patients with Adverse Events in Controlled Trials* of Felodipine Extended-Release Tablets (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)

Body System Adverse Events	Placebo N = 334	2.5 mg N = 255	5 mg N = 581	10 mg N = 408
* Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets.
Body as a Whole
Peripheral Edema	3.3 (0)	2 (0)	8.8 (2.2)	17.4 (2.5)
Asthenia	3.3 (0)	3.9 (0)	3.3 (0)	2.2 (0)
Warm Sensation	0 (0)	0 (0)	0.9 (0.2)	1.5 (0)
Cardiovascular
Palpitation	2.4 (0)	0.4 (0)	1.4 (0.3)	2.5 (0.5)
Digestive
Nausea	1.5 (0.9)	1.2 (0)	1.7 (0.3)	1 (0.7)
Dyspepsia	1.2 (0)	3.9 (0)	0.7 (0)	0.5 (0)
Constipation	0.9 (0)	1.2 (0)	0.3 (0)	1.5 (0.2)
Nervous
Headache	10.2 (0.9)	10.6 (0.4)	11 (1.7)	14.7 (2)
Dizziness	2.7 (0.3)	2.7 (0)	3.6 (0.5)	3.7 (0.5)
Paresthesia	1.5 (0.3)	1.6 (0)	1.2 (0)	1.2 (0.2)
Respiratory
Upper Respiratory Infection	1.8 (0)	3.9 (0)	1.9 (0)	0.7 (0)
Cough	0.3 (0)	0.8 (0)	1.2 (0)	1.7 (0)
Rhinorrhea	0 (0)	1.6 (0)	0.2 (0)	0.2 (0)
Sneezing	0 (0)	1.6 (0)	0 (0)	0 (0)
Skin
Rash	0.9 (0)	2 (0)	2 (0)	2 (0)
Flushing	0.9 (0.3)	3.9 (0)	5.3 (0.7)	6.9 (1.2)

Body as a Whole:

Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectorisarrhythmia

Digestive:

Endocrine:

Hematologic: Anemia

Metabolic:

Musculoskeletal:

Nervous/Psychiatric:

Respiratory:

Skin: Angioedema, , leukocytoclastic vasculitis

Special Senses:

Urogenital:

Gingival Hyperplasia: PRECAUTIONS: Information for Patients.)

Clinical Laboratory Test Findings



CLINICAL PHARMACOLOGY: Renal/Endocrine Effects

OVERDOSAGE

Physicians' Desk Reference (PDR)

FELODIPINE DOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism

Geriatric Use

CLINICAL PHARMACOLOGY

Patients with Impaired Liver Function
 
CLINICAL PHARMACOLOGY

HOW SUPPLIED

Felodipine Extended-Release Tablets USP, 2.5 mg






Felodipine Extended-Release Tablets USP, 5 mg





Felodipine Extended-Release Tablets USP, 10 mg






Store at

Protect from light.




Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 2.5 mg (100 Tablet Bottle)

NDC 65862-673-01
Felodipine Extended-Release
Tablets, USP
2.5 mg
Rx only                100 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 2.5 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-673-78
Felodipine Extended-Release
Tablets, USP 2.5 mg
Rx only           100 (10 x 10) Unit-dose Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 5 mg (100 Tablet Bottle)

NDC 65862-674-01
Felodipine Extended-Release
Tablets, USP
5 mg
Rx only                100 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 10 mg (100 Tablet Bottle)

NDC 65862-675-01
Felodipine Extended-Release
Tablets, USP
10 mg
Rx only                100 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 10 mg Blister Carton (10 x 10 Unit-dose)

NDC 65862-675-78
Felodipine Extended-Release
Tablets, USP 10 mg
Rx only           100 (10 x 10) Unit-dose Tablets
AUROBINDO

Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE Product Information Product Type Human prescription drug label Item Code (Source) NDC:65862-673 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELODIPINE FELODIPINE 2.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE ALUMINUM SILICATE hydroxypropyl cellulose HYPROMELLOSE 2910 (50 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) lactose monohydrate cellulose, microcrystalline polyethylene glycol 6000 POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYL GALLATE SODIUM STEARYL FUMARATE titanium dioxide FD&C BLUE NO. 2 FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape GREEN 11 mm X;15 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65862-673-90 90 in 1 BOTTLE 2 NDC:65862-673-01 100 in 1 BOTTLE 3 NDC:65862-673-99 1000 in 1 BOTTLE 4 NDC:65862-673-10 10 in 1 BLISTER PACK 5 NDC:65862-673-78 10 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203417 2013-01-17

Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE Product Information Product Type Human prescription drug label Item Code (Source) NDC:65862-674 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELODIPINE FELODIPINE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE ALUMINUM SILICATE hydroxypropyl cellulose HYPROMELLOSE 2910 (50 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) lactose monohydrate cellulose, microcrystalline polyethylene glycol 6000 POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYL GALLATE SODIUM STEARYL FUMARATE titanium dioxide ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape PINK 11 mm X;16 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65862-674-90 90 in 1 BOTTLE 2 NDC:65862-674-01 100 in 1 BOTTLE 3 NDC:65862-674-99 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203417 2013-01-17

Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE Product Information Product Type Human prescription drug label Item Code (Source) NDC:65862-675 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELODIPINE FELODIPINE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE ALUMINUM SILICATE hydroxypropyl cellulose HYPROMELLOSE 2910 (50 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) lactose monohydrate cellulose, microcrystalline polyethylene glycol 6000 POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYL GALLATE SODIUM STEARYL FUMARATE titanium dioxide ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape BROWN 11 mm X;17 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65862-675-90 90 in 1 BOTTLE 2 NDC:65862-675-01 100 in 1 BOTTLE 3 NDC:65862-675-99 1000 in 1 BOTTLE 4 NDC:65862-675-10 10 in 1 BLISTER PACK 5 NDC:65862-675-78 10 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203417 2013-01-17