Prescription Drug Information: Fenofibrate (Page 4 of 4)

OVERDOSAGE

There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

DOSAGE AND ADMINISTRATION

Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.

For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.

For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.

Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 200 mg per day.

Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 67 mg/day.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

HOW SUPPLIED

Fenofibrate capsules, USP (micronized), 67 mg are hard gelatin capsule shells with pink opaque cap and pink opaque body imprinted IG and 470 with black ink. They are supplied as follows:

NDC 69097-894-02 Bottles of 30 capsules
NDC 69097-894-07 Bottles of 100 capsules
NDC 69097-894-15 Bottles of 1,000 capsules

Fenofibrate capsules, USP (micronized), 134 mg are hard gelatin capsule shells with blue opaque cap and blue opaque body imprinted IG and 471 with black ink. They are supplied as follows:

NDC 69097-895-02 Bottles of 30 capsules
NDC 69097-895-07 Bottles of 100 capsules
NDC 69097-895-12 Bottles of 500 capsules

Fenofibrate capsules, USP (micronized), 200 mg are hard gelatin capsule shells with orange opaque cap and orange opaque body imprinted IG and 472 with black ink. They are supplied as follows:

NDC 69097-896-02 Bottles of 30 capsules
NDC 69097-896-07 Bottles of 100 capsules
NDC 69097-896-12 Bottles of 500 capsules

STORAGE

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

REFERENCES

1.GOLDBERG AC, et al. Fenofibrate for the Treatment of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter US Study. Clinical Therapeutics, 11, pp. 69-83, 1989.2.NIKKILA EA. Familial Lipoprotein Lipase Deficiency and Related Disorders of Chylomicron Metabolism. In Stanbury J.B., et al. (eds.): The Metabolic Basis of Inherited Disease, 5th edition, McGraw-Hill, 1983, Chap. 30, pp. 622-642.3.BROWN WV, et al. Effects of Fenofibrate on Plasma Lipids: Double-Blind, Multicenter Study In Patients with Type IIA or IIB Hyperlipidemia. Arteriosclerosis. 6, pp. 670-678, 1986.

Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788

Manufactured for:
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059

Revised: 05/2020

PRINCIPAL DISPLAY PANEL — 67 mg

NDC 69097-894-07 Rx Only

Fenofibrate
Capsules, USP
67 mg 100 Capsules

Cipla

PRINCIPAL DISPLAY PANEL — 134 mg

NDC 69097-895-07 Rx Only

Fenofibrate
Capsules, USP
134 mg 100 Capsules

Cipla

PRINCIPAL DISPLAY PANEL — 200 mg

NDC 69097-896-07 Rx Only

Fenofibrate
Capsules, USP
200 mg 100 Capsules

Cipla

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-894 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 67 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SILICON DIOXIDE MAGNESIUM STEARATE FD&C BLUE NO. 1 FD&C RED NO. 3 D&C YELLOW NO. 10 TITANIUM DIOXIDE GELATIN, UNSPECIFIED

Product Characteristics Color PINK (Pink opaque cap) , PINK (Pink opaque body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code IG;470 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-894-02 30 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:69097-894-07 100 CAPSULE in 1 BOTTLE, PLASTIC None 3 NDC:69097-894-15 1000 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207378 03/30/2017

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-895 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 134 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SILICON DIOXIDE MAGNESIUM STEARATE FD&C BLUE NO. 1 D&C RED NO. 28 TITANIUM DIOXIDE GELATIN, UNSPECIFIED

Product Characteristics Color BLUE (Blue opaque cap) , BLUE (Blue opaque body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code IG;471 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-895-02 30 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:69097-895-07 100 CAPSULE in 1 BOTTLE, PLASTIC None 3 NDC:69097-895-12 500 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207378 03/30/2017

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-896 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 200 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SILICON DIOXIDE MAGNESIUM STEARATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 TITANIUM DIOXIDE GELATIN, UNSPECIFIED

Product Characteristics Color ORANGE (Orange opaque cap) , ORANGE (Orange opaque body) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code IG;472 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-896-02 30 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:69097-896-07 100 CAPSULE in 1 BOTTLE, PLASTIC None 3 NDC:69097-896-12 500 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207378 03/30/2017

Labeler — Cipla USA Inc., (078719707)

Registrant — Cipla USA Inc., (078719707)

Establishment
Name	Address	ID/FEI	Operations
InvaGen Pharmaceuticals Inc.		165104469	manufacture (69097-894), manufacture (69097-895), manufacture (69097-896), analysis (69097-894), analysis (69097-895), analysis (69097-896)

Establishment
Name	Address	ID/FEI	Operations
InvaGen Pharmaceuticals Inc.		080334903	analysis (69097-894), analysis (69097-895), analysis (69097-896), pack (69097-894), pack (69097-895), pack (69097-896)

Revised: 01/2023 Cipla USA Inc.,