Felodipine (Page 5 of 5)

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 should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). Felodipine 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; therefore, patients should have their blood pressure monitored closely during dosage adjustment of Felodipine (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Felodipine Extended-release Tablets, USP 2.5 mg, are yellow film-coated, round convex tablets, with code Y161 on one side. They are supplied as follows:

NDC 69117-0028-1 bottles of 100

NDC 69117-0028-2 bottles of 500

Felodipine Extended-release Tablets, USP 5 mg, are pink film-coated, round convex tablets, with code Y162 on one side. They are supplied as follows:

NDC 69117-0029-1 bottles of 100’s

NDC 69117-0029-2 bottles of 500’s

Felodipine Extended-release Tablets, USP 10 mg, are red film-coated, round convex tablets, with code Y163 on one side. They are supplied as follows:

NDC 69117-0030-1 bottles of 100’s

NDC 69117-0030-2 bottles of 500’s

Storage:

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

Manufacturer:

Yiling Pharmaceutical Ltd

No. 36 Zhujiang Road, Shijiazhuang, Hebei, 050035, China

Distributor:

Yiling Pharmaceutical, Inc.

5348 Vegas Drive, Las Vegas, NV 89108, USA

Revised: 07/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.5 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (500 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.5 mg (500 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (500 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (500 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (500 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (500 Tablets Bottle)
(click image for full-size original)

FELODIPINE
felodipine extended-release tablets tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0028
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
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
POLYOXYL 40 HYDROGENATED CASTOR OIL
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STEARYL FUMARATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYDEXTROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND (Convex tablets) Size 11mm
Flavor Imprint Code Y161;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69117-0028-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69117-0028-2 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210847 08/01/2019
FELODIPINE
felodipine extended-release tablets tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0029
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
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
POLYOXYL 40 HYDROGENATED CASTOR OIL
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STEARYL FUMARATE
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYDEXTROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND (Convex tablets) Size 11mm
Flavor Imprint Code Y162
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69117-0029-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69117-0029-2 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210847 08/01/2019
FELODIPINE
felodipine extended-release tablets tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0030
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
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
POLYOXYL 40 HYDROGENATED CASTOR OIL
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STEARYL FUMARATE
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYDEXTROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND (Convex tablets) Size 11mm
Flavor Imprint Code Y163
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69117-0030-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69117-0030-2 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210847 08/01/2019
Labeler — Yiling Pharmaceutical Inc. (079417422)
Registrant — Yiling Pharmaceutical Ltd (544322244)
Establishment
Name Address ID/FEI Operations
Yiling Pharmaceutical Ltd 544322244 manufacture (69117-0028), manufacture (69117-0029), manufacture (69117-0030)

Revised: 12/2020 Yiling Pharmaceutical Inc.

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