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

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Felodipine

Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FELODIPINE DESCRIPTION


181924
Felodipine


aluminium silicateFD&C blue #2

CLINICAL PHARMACOLOGY


Mechanism of Action

++

In vitro in vitro

Cardiovascular Effects

Pharmacokinetics and Metabolism




1/2

1/2 50

50 Cardiovascular Effects DOSAGE AND ADMINISTRATION



14



max

Geriatric Use










Cardiovascular Effects








PRECAUTIONS

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)
* Placebo response subtracted
** Different number of patients available for peak and trough measurements
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
18/10.8
10/6
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 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




ADVERSE REACTIONS







CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION



Information for Patients




Drug Interactions






Itraconazole

max

Erythromycin

max

Grapefruit Juice

max

Cimetidine

max

Beta-Blocking Agents

max

Digoxin



Anticonvulsants



Tacrolimus



Other Concomitant Therapy



Interaction with Food
 
CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism.

Carcinogenesis, Mutagenesis, Impairment of Fertility


**2 **2



**2

in vitro in vivo **2in vitro

**2


**

Pregnancy




Teratogenic Effects

** 2



Nonteratogenic Effects

**2

2






** 

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
Felodipine

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

Felodipine

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
Felodipine

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
Felodipine

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

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


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