FELODIPINE (Page 4 of 4)

Clinical Laboratory Test Findings

Serum Electrolytes — No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY, Renal/Endocrine Effects).

Serum Glucose — No significant effects on fasting serum glucose were observed in patients treated with felodipine extended-release tablets in the U.S. controlled study.

Liver Enzymes -1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.

OVERDOSAGE

Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality.

In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient’s blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia.

If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5 to 1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted.

It has not been established whether felodipine can be removed from the circulation by hemodialysis.

Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.

DOSAGE AND ADMINISTRATION

The recommended starting dose is 5 mg once a day. Depending on the patient’s response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5 to 10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS). Modification of the recommended dosage is usually not required in patients with renal impairment.

Felodipine extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). Felodipine extended-release tablets should be swallowed whole and not crushed or chewed.

Geriatric Use -Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.

Patients with Impaired Liver Function -Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Felodipine Extended-Release Tablets USP, 2.5 mg, are white, film coated round convex tablets, embossed with W411 on one side and plain on other side. They are supplied as follows:

HDPE bottle of 30 tablets……………………………. 64679-411-01

HDPE bottle of 100 tablets………………………….. 64679-411-02

HDPE bottle of 500 tablets………………………….. 64679-411-04

Unit dose packages of 100 tablets ……………….. 64679-411-03

Felodipine Extended-Release Tablets USP, 5 mg, are yellow colored, film coated round convex tablets, embossed with W412 on one side and plain on other side. They are supplied as follows:

HDPE bottle of 30 tablets…………………………… 64679-412-01

HDPE bottle of 100 tablets…………………………. 64679-412-02

HDPE bottle of 500 tablets…………………………. 64679-412-04

Unit dose packages of 100 tablets……………….. 64679-412-03

Felodipine Extended-Release Tablets USP, 10 mg, are orange colored, film coated, round convex tablets, embossed with W414 on one side and plain on other side. They are supplied as follows:

HDPE bottle of 30 tablets………………………….. 64679-414-01

HDPE bottle of 100 tablets………………………… 64679-414-02

HDPE bottle of 500 tablets………………………… 64679-414-04

Unit dose packages of 100 tablets………………. 64679-414-03

Storage:

Store at 20°-25 °C (68°-77°F), [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.160810

Container Label
(click image for full-size original)

Container Label
(click image for full-size original)
Container Label
(click image for full-size original)
FELODIPINE felodipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-411
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (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 white (white) Score no score
Shape ROUND (round convex) Size 10mm
Flavor Imprint Code W411
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-411-01 30 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:55648-411-02 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:55648-411-04 500 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
4 NDC:55648-411-03 10 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55648-411-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091484 12/05/2010
FELODIPINE felodipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-412
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (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 yellow (yellow) Score no score
Shape ROUND (round convex) Size 11mm
Flavor Imprint Code W412
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-412-01 30 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:55648-412-02 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:55648-412-04 500 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
4 NDC:55648-412-03 10 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55648-412-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091484 12/05/2010
FELODIPINE felodipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-414
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (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 orange (orange) Score no score
Shape ROUND (round convex) Size 11mm
Flavor Imprint Code W414
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-414-01 30 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:55648-414-02 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:55648-414-04 500 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
4 NDC:55648-414-03 10 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (55648-414-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091484 12/05/2010
Labeler — WOCKHARDT LIMITED (650069115)

Revised: 11/2010 WOCKHARDT LIMITED

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