FELODIPINEEXTENDED-RELEASE TABLETS (Page 5 of 5)

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 (0.5-1 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.

To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the 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 — 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

No.3584 — Felodipine extended-release tablets, 2.5 mg, are sage green, round convex tablets, with code 450 on one side and PLENDIL on the other. They are supplied as follows:

NDC 63304-435-01 bottles of 100

No.3585 — Felodipine extended-release tablets, 5 mg, are light red-brown, round convex tablets, with code 451 on one side and PLENDIL on the other. They are supplied as follows:

NDC 63304-436-01 bottles of 100

No.3586 — Felodipine extended-release tablets, 10 mg, are red-brown, round convex tablets, with code 452 on one side and PLENDIL on the other. They are supplied as follows:

NDC 63304-437-01 bottles of 100

Storage

Store below 30°C (86°F). Keep container tightly closed. Protect from light.

PLENDIL is a trademark of the Astrazeneca group of companies

© Astrazeneca 2008

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257, USA

By: Merck & Co., Inc

Whitehouse Station, NJ, 08889, USA

9874900

31427-00 Rev. 07/08

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

100''s_bottle_label
(click image for full-size original)

2.5 mg_- 100’S BOTTLE LABEL

100's_bottle_label
(click image for full-size original)

5 mg — 100’S BOTTLE LABEL

100's_bottlle_label
(click image for full-size original)

10 mg — 100’S BOTTLE LABEL

FELODIPINEEXTENDED-RELEASE TABLETS
felodipine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-435
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
HYDROXYPROPYL CELLULOSE
TITANIUM DIOXIDE
LACTOSE
FD&C BLUE NO. 2
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
Product Characteristics
Color green (sage green) Score no score
Shape ROUND (Convex) Size 11mm
Flavor Imprint Code 450;PLENDIL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-435-01 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019834 09/10/2008
FELODIPINEEXTENDED-RELEASE TABLETS
felodipine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-436
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
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
LACTOSE
SODIUM STEARYL FUMARATE
Product Characteristics
Color red (light red brown) Score no score
Shape ROUND (convex) Size 11mm
Flavor Imprint Code 451;PLENDIL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-436-01 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019834 09/10/2008
FELODIPINEEXTENDED-RELEASE TABLETS
felodipine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-437
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
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
LACTOSE
SODIUM STEARYL FUMARATE
Product Characteristics
Color red (red-brown) Score no score
Shape ROUND (convex) Size 11mm
Flavor Imprint Code 452;PLENDIL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-437-01 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019834 09/10/2008
Labeler — Ranbaxy Pharmaceuticals Inc (937890044)
Registrant — Astrazeneca Limited Partnership (785395237)
Establishment
Name Address ID/FEI Operations
Ranbaxy Pharmaceuticals Inc 937890044 relabel
Establishment
Name Address ID/FEI Operations
Merck & Co Inc 001317064 manufacture

Revised: 09/2009 Ranbaxy Pharmaceuticals Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.