Duricef

There are no adequate studies of cefadroxil in pregnant women.

Cefadroxil is secreted in breast milk.

Serious side effects have been reported with cefadroxil. See the "Cefadroxil Precautions" section.

Common side effects of cefadroxil include:

• nausea
• vomiting
• diarrhea
• mild rash
• dyspepsia (indigestion)

This is not a complete list of cefadroxil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Cefadroxil is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefadroxil is used to treat many different types of infections caused by bacteria.

Cefadroxil may also be used for purposes other than those listed in this medication guide.

Antibacterial; β-lactam antibiotic; first generation cephalosporin.a

Storage

Oral

20–25°C in tight container.100

20–25°C.121 After reconstitution, refrigerate in a tight container; discard after 14 days.121

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You or your child may take this medicine with or without food.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  • For infections:
    • Adults and teenagers—1000 to 2000 milligrams (mg) per day, taken as a single dose or divided and taken twice a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose or divided and taken every 12 hours.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days.

Duricef is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate[6R-[6α,7β(R*)]]-. It has the formula C16H17N3O5S • H2O and the molecular weight of 381.40. It has the following structural formula:

Duricef film-coated tablets, 1 g, contain the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, simethicone emulsion, and titanium dioxide.

Duricef for Oral Suspension contains the following inactive ingredients: FD&C Yellow No. 6, flavors (natural and artificial), polysorbate 80, sodium benzoate, sucrose, and xanthan gum.

Duricef capsules contain the following inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

Duricef is 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 tonsillitis1 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 Duricef should be administered for at least 10 days.

See chart for total daily dosage for children.

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 Duricef and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M2]) is 500 mg at the time intervals listed below.

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

Duricef® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with “PPP’’ and “784’’ on one end and with “Duricef’’ and “500 mg’’ on the other end.

Capsules are supplied as follows:

N 0430-0780-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

Duricef® 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with “PPP’’ on one side of the bisect and “785’’ on the other side of the bisect. Tablets are supplied as follows:

N 0430-0781-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

Duricef® for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

250 mg/5 mL N 0430-2782-15  50 mL Bottle

N 0430-2782-17 100 mL Bottle

500 mg/5 mL N 0430-2783-16  75 mL Bottle

N 0430-2783-17 100 mL Bottle

Prior to reconstitution: Store at controlled room temperature 15°–30° C (59°–86° F).

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 for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990.

Manufactured by Bristol-Myers Squibb Co.

Princeton, NJ 08543

For Warner Chilcott Company, Inc.

Fajardo, PR 00738

Marketed by Warner Chilcott, Inc.

Rockaway, NJ 07866

2782G073

Revised April 2007