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FELODIPINE

WOCKHARDT USA LLC

Felodipine Extended-Release Tablets, USP Rx only

FULL PRESCRIBING INFORMATION: CONTENTS*

FELODIPINE DESCRIPTION
CLINICAL PHARMACOLOGY
Clinical Studies
FELODIPINE INDICATIONS AND USAGE
FELODIPINE CONTRAINDICATIONS
PRECAUTIONS
FELODIPINE ADVERSE REACTIONS
- Clinical Laboratory Test Findings
OVERDOSAGE
FELODIPINE DOSAGE AND ADMINISTRATION
HOW SUPPLIED

FULL PRESCRIBING INFORMATION

FELODIPINE DESCRIPTION

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CLINICAL PHARMACOLOGY

Mechanism of Action

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In vitroin vitro

Pharmacokinetics and Metabolism

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Geriatric Use

Hepatic Dysfunction

Cardiovascular Effects

Renal/Endocrine Effects

Clinical Studies

MEAN REDUCTIONS IN BLOOD PRESSURE (mmHg)*
Dose	N	Systolic/Diastolic Mean Peak Response	Mean Trough Response	Trough/Peak Ratios (%s)
Study 1 (8 weeks)
2.5 mg	68	9.4/4.7	2.7/2.5	29/53
5 mg	69	9.5/6.3	2.4/3.7	25/59
10 mg	67	18.0/10.8	10.0/6.0	56/56
Study 2 (4 weeks)
10 mg	50	5.3/7.2	1.5/3.2	33/40**
20 mg	50	11.3/10.2	4.5/3.2	43/34**

FELODIPINE INDICATIONS AND USAGE

FELODIPINE CONTRAINDICATIONS

PRECAUTIONS

General

Hypotension-

Heart Failure

Patients with Impaired Liver Function

Peripheral Edema-

Information for Patients

Drug Interactions

CYP3A4 Inhibitors

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Erythromycin_max

Grapefruit juice_max

Cimetidine_max

Beta-Blocking Agents_max

Digoxin

Anticonvulsants

Tacrolimus

Other Concomitant Therapy

Interaction with Food

Carcinogenesis, Mutagenesis, Impairment of Fertility

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Pregnancy

Teratogenic Effects^**²

Nonteratogenic Effects^**²

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Nursing Mothers

Pediatric Use

Geriatric Use:

FELODIPINE ADVERSE REACTIONS

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
Body as a Whole
Peripheral Edema	3.3 (0.0)	2.0 (0.0)	8.8 (2.2)	17.4 (2.5)
Asthenia	3.3 (0.0)	3.9 (0.0)	3.3 (0.0)	2.2 (0.0)
Warm Sensation	0.0 (0.0)	0.0 (0.0)	0.9 (0.2)	1.5 (0.0)

Cardiovascular
Palpitation	2.4 (0.0)	0.4 (0.0)	1.4 (0.3)	2.5 (0.5)

Digestive
Nausea	1.5 (0.9)	1.2 (0.0)	1.7 (0.3)	1.0 (0.7)
Dyspepsia	1.2 (0.0)	3.9 (0.0)	0.7 (0.0)	0.5 (0.0)
Constipation	0.9 (0.0)	1.2 (0.0)	0.3 (0.0)	1.5 (0.2)

Nervous
Headache	10.2 (0.9)	10.6 (0.4)	11.0 (1.7)	14.7 (2.0)
Dizziness	2.7 (0.3)	2.7 (0.0)	3.6 (0.5)	3.7 (0.5)
Paresthesia	1.5 (0.3)	1.6 (0.0)	1.2 (0.0)	1.2 (0.2)

Respiratory
Upper Respiratory Infection	1.8 (0.0)	3.9 (0.0)	1.9 (0.0)	0.7 (0.0)
Cough	0.3 (0.0)	0.8 (0.0)	1.2 (0.0)	1.7 (0.0)
Rhinorrhea	0.0 (0.0)	1.6 (0.0)	0.2 (0.0)	0.2 (0.0)
Sneezing	0.0 (0.0)	1.6 (0.0)	0.0 (0.0)	0.0 (0.0)

Skin
Rash	0.9 (0.0)	2.0 (0.0)	0.2 (0.0)	0.2 (0.0)
Flushing	0.9 (0.3)	3.9 (0.0)	5.3 (0.7)	6.9 (1.2)

Body as a Whole: Cardiovascular: Myocardial infarction, hypotensionsyncope, angina pectoris, arrhythmia Digestive: Endocrine: Hematologic: Anemia; Metabolic: Musculoskeletal: Nervous/Psychiatric: Respiratory: Skin: Angioedemaleukocytoclastic vasculitis Special Senses: Urogenital:

Gingival Hyperplasia

Clinical Laboratory Test Findings

Serum Electrolytes

Serum Glucose

Liver Enzymes

OVERDOSAGE

Physicians' Desk Reference (PDR)

FELODIPINE DOSAGE AND ADMINISTRATION

Geriatric Use

Patients with Impaired Liver Function

HOW SUPPLIED

Storage:

Manufactured by:

Distributed by:

FELODIPINE

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE

Product Information
Product Type	Human prescription drug label	Item Code (Source)	NDC:64679-411
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
POLYOXYL 40 HYDROGENATED CASTOR OIL
hydroxypropyl cellulose
HYPROMELLOSES
cellulose, microcrystalline
lactose monohydrate
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
titanium dioxide
polyethylene glycol

Product Characteristics
Color	Size	Imprint Code	Shape
white (white)	10 mm	W411	ROUND

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC:64679-411-01	30 in 1 BOTTLE
2	NDC:64679-411-02	100 in 1 BOTTLE
3	NDC:64679-411-04	500 in 1 BOTTLE
4		10 in 1 BLISTER PACK
5	NDC:64679-411-03	10 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091484	2010-12-05

FELODIPINE

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE

Product Information
Product Type	Human prescription drug label	Item Code (Source)	NDC:64679-412
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
POLYOXYL 40 HYDROGENATED CASTOR OIL
hydroxypropyl cellulose
HYPROMELLOSES
cellulose, microcrystalline
lactose monohydrate
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
titanium dioxide
polyethylene glycol
D&C YELLOW NO. 10
FD&C YELLOW NO. 6

Product Characteristics
Color	Size	Imprint Code	Shape
yellow (yellow)	11 mm	W412	ROUND

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC:64679-412-01	30 in 1 BOTTLE
2	NDC:64679-412-02	100 in 1 BOTTLE
3	NDC:64679-412-04	500 in 1 BOTTLE
4		10 in 1 BLISTER PACK
5	NDC:64679-412-03	10 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091484	2010-12-05

FELODIPINE

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE

Product Information
Product Type	Human prescription drug label	Item Code (Source)	NDC:64679-414
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
POLYOXYL 40 HYDROGENATED CASTOR OIL
hydroxypropyl cellulose
HYPROMELLOSES
cellulose, microcrystalline
lactose monohydrate
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
titanium dioxide
polyethylene glycol
D&C YELLOW NO. 10
FD&C YELLOW NO. 6

Product Characteristics
Color	Size	Imprint Code	Shape
orange (orange)	11 mm	W414	ROUND

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC:64679-414-01	30 in 1 BOTTLE
2	NDC:64679-414-02	100 in 1 BOTTLE
3	NDC:64679-414-04	500 in 1 BOTTLE
4		10 in 1 BLISTER PACK
5	NDC:64679-414-03	10 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091484	2010-12-05

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!

FELODIPINE description, usages, side effects, indications, overdosage, supplying and lots more!

FELODIPINE

Felodipine Extended-Release Tablets, USP Rx only

FULL PRESCRIBING INFORMATION: CONTENTS*

FULL PRESCRIBING INFORMATION

FELODIPINE DESCRIPTION

CLINICAL PHARMACOLOGY

Mechanism of Action

Pharmacokinetics and Metabolism

Cardiovascular Effects

Renal/Endocrine Effects

Clinical Studies

FELODIPINE INDICATIONS AND USAGE

FELODIPINE CONTRAINDICATIONS

PRECAUTIONS

General

Information for Patients

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use:

FELODIPINE ADVERSE REACTIONS

Clinical Laboratory Test Findings

OVERDOSAGE

FELODIPINE DOSAGE AND ADMINISTRATION

HOW SUPPLIED

FELODIPINE

Product Information

Active Ingredient/Active Moiety

Inactive Ingredients

Product Characteristics

Packaging

Marketing Information

FELODIPINE

Product Information

Active Ingredient/Active Moiety

Inactive Ingredients

Product Characteristics

Packaging

Marketing Information

FELODIPINE

Product Information

Active Ingredient/Active Moiety

Inactive Ingredients

Product Characteristics

Packaging

Marketing Information