Cefadroxil (Page 3 of 3)

OVERDOSAGE

A study of children under six years of age suggested that ingestion of less than 250 mg/ kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.

In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6–8 hour hemodialysis session.

DOSAGE AND ADMINISTRATION

Cefadroxil capsules are acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

Adults

Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).

Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis— 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

Children

For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil monohydrate should be administered for at least 10 days.

Renal Impairment

In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M ]) is 500 mg at the time intervals listed below.

Creatinine Clearance	Dosage Interval
0-10 mL/min	36 hours
10-25 mL/min	24 hours
25-50 mL/min	12 hours

Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

HOW SUPPLIED

Cefadroxil Capsules USP, 500 mg are size ‘0’ capsules with maroon cap and white body, imprinted with “LU” (in black edible ink) on cap and with “F11” (in black edible ink) on body, containing white to off-white powder supplied as follows:

NDC 68180-180-08 Bottle of 50

NDC 68180-180-01 Bottle of 100

Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature].

REFERENCES

1. National Committee for Clinical Laboratory Standards, Approved Standard,Performance Standards for Antimicrobial Disk Susceptibility Test , 4th Edition, Vol. 10 (7): M2-A4, Villanova, PA, April, 1990.
2. National Committee for Clinical Laboratory Standards, Approved Standard:Methods for Dilution Antimicrobial Susceptibility Tests forBacteria that Grow Aerobically , 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990.

Manufactured by:

Lupin Limited

Mandideep 462 046

INDIA

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

May 2012 ID#225464

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cefadroxil Capsules USP, 500 mg

Rx Only

Package Label – Bottle of 100s

NDC 68180-180-01

CEFADROXIL cefadroxil capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-180 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFADROXIL (CEFADROXIL ANHYDROUS) CEFADROXIL ANHYDROUS 500 mg

Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE SHELLAC POTASSIUM HYDROXIDE MAGNESIUM STEARATE PROPYLENE GLYCOL TITANIUM DIOXIDE FERROSOFERRIC OXIDE

Product Characteristics Color RED (Maroon Cap) , WHITE (White Body) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code LU;F11 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-180-08 50 CAPSULE in 1 BOTTLE None 2 NDC:57297-180-01 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065392 04/23/2008

Labeler — LUPIN LIMITED (675923163)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		725504448	manufacture (57297-180), pack (57297-180)

Revised: 05/2016 LUPIN LIMITED