Cefadroxil

Cefadroxil is an oral antibiotic in the cephalosporin family of drugs, a family that includes cephalexin (Keflex), cefaclor (Ceclor), cefuroxime (Zinacef), cefpodoxime (Vantin), cefixime (Suprax), and many other injectable antibiotics. Cephalosporins stop bacteria from multiplying by preventing bacteria from forming the walls that surround them. The walls are necessary to protect bacteria from their environment and to keep the contents of the bacterial cell together. Bacteria cannot survive without a cell wall. Cephalosporins are most effective when bacteria are actively multiplying and forming cell walls. Cefadroxil is active against many bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Moraxella catarrhalis, E. coli, Klebsiella, and Proteus mirabilis. The FDA approved cefadroxil in 1977.

GENERIC AVAILABLE: Yes

Tablets: 1 g. Capsules: 500 mg. Powder for suspension: 125, 250, and 500 mg/teaspoon (5 ml).

Cefadroxil should be stored at room temperature, 15 C - 30 C (59 F - 86 F). Once mixed, the suspension should be refrigerated and discarded after 14 days.

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 (cefadroxil) " 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® (cefadroxil) 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® (cefadroxil) for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

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

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

Manufactured by Bristol-Myers Squibb Co. Princeton, NJ 08543. For Warner Chilcott Company, Inc. Fajardo, PR 00738. Marketed by Warner Chilcott (US), Inc. Rockaway, NJ 07866. Revised April 2007. FDA Rev date: 6/5/2007

Do not take this medication if you are allergic to cefadroxil or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);

• cefazolin (Ancef);

• cefdinir (Omnicef);

• cefditoren (Spectracef);

• cefpodoxime (Vantin);

• cefprozil (Cefzil);

• ceftibuten (Cedax);

• cefuroxime (Ceftin);

• cephalexin (Keflex); or

• cephradine (Velosef); and others.

Before taking cefadroxil, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

• kidney disease; or

• a history of intestinal problems, such as colitis.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cefadroxil.

The cefadroxil suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefadroxil if you have diabetes.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cefadroxil may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefadroxil will not treat a viral infection such as the common cold or flu.

Cefadroxil can be taken on an empty stomach or with food or milk if it causes stomach upset.

Shake the liquid form of cefadroxil well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefadroxil.

Store the tablets and capsules at room temperature away from moisture and heat.

Store cefadroxil oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci).100 120 121 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.100 120 121

AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;111 116 117 119 other anti-infectives (e.g., oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.116 117 119

If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).116 117 119

Skin and Skin Structure Infections

Treatment of mild to moderate skin and skin structure infections caused by susceptible staphylococci or streptococci.100 120 121

Urinary Tract Infections (UTIs)

Treatment of mild to moderate UTIs, including acute prostatitis, caused by susceptible Escherichia coli, Klebsiella, or Proteus mirabilis.100 120 121

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis† in penicillin-allergic individuals undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk.115 119 Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).115 119

When selecting anti-infectives for prophylaxis of bacterial endocarditis, consult most recent AHA recommendations for specific information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis.115

In the U.S.

• Duricef

Available Dosage Forms:

• Powder for Suspension
• Tablet
• Capsule

Therapeutic Class: Antibiotic

Pharmacologic Class: 1st Generation Cephalosporin

If your symptoms or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefadroxil may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you or your child have any medical tests, tell the medical doctor in charge that you are using cefadroxil. The results of some tests may be affected by cefadroxil.

Cefadroxil Tablets, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to off-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as (6 R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. It has the following structural formula:

C16H17N3O5S·H2O      M.W.381.40

Cefadroxil oral tablets available in 1 g strength contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.

NDC 68289-006-01
Cefadroxil Tablets
USP
1 Gram
100 Film coated Tablets
Rx Only

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption

Rapid and well absorbed from GI tract

Distribution

Vd: 0.31 L/kg

Excretion

Urine (>90% as unchanged drug within 24 hours)

Time to Peak

Serum: Within 70 to 90 minutes

Half-Life Elimination

1 to 2 hours; 20 to 24 hours in renal failure

Protein Binding

20%

Hypersensitivity to cefadroxil, any component of the formulation, or other cephalosporins

Refer to adult dosing.

Pharyngitis: Children and Adolescents: Oral:

Manufacturer’s labeling: 30 mg/kg/day in a single dose or divided every 12 hours

Alternate dosing: Refer to adult dosing

Skin and skin structure infections: Children and Adolescents: Oral: 30 mg/kg/day in divided doses every 12 hours. For impetigo: 30 mg/kg/day in a single dose or divided every 12 hours.

Tonsillitis: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or divided every 12 hours

Urinary tract infections: Children and Adolescents: Oral: 30 mg/kg/day in divided doses every 12 hours

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), chills, pharyngitis, seizures, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Consult your pharmacist.

Applies to cefadroxil: oral capsule, oral powder for suspension, oral tablet

Along with its needed effects, cefadroxil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cefadroxil:

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chills
• clay-colored stools
• cough or hoarseness
• dark-colored urine
• diarrhea
• difficulty with moving
• feeling of discomfort
• fever
• fever with or without chills
• flushing or redness of the skin
• general feeling of tiredness or weakness
• headache
• inflammation of the joints
• itching
• joint or muscle pain
• light-colored stools
• lower back or side pain
• muscle aches
• muscle pain or stiffness
• painful or difficult urination
• pinpoint red spots on the skin
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swollen lymph glands
• unusual bleeding or bruising
• unusually warm skin
• vomiting
• yellow eyes or skin

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• bloating
• chest pain
• coughing up blood
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing or swallowing
• dizziness
• fast heartbeat
• general body swelling
• high fever
• hives
• increased menstrual flow or vaginal bleeding
• increased thirst
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea
• nosebleeds
• pain
• pale skin
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shortness of breath
• sudden decrease in the amount of urine
• swollen or painful glands
• tightness in the chest
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight loss
• vomiting of blood
• wheezing

Some side effects of cefadroxil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

• Hives or welts
• itching of the vagina or genital area
• itching or pain of the genital area
• pain during sexual intercourse
• redness of the skin
• thick, white vaginal discharge with no odor or with a mild odor

Uncomplicated: 1 g orally every 12 hours for 14 days

1 month or older: 15 mg/kg orally every 12 hours, not to exceed 2 g per 24 hours

Cefadroxil is moderately dialyzable.

Following a single 1 gram oral dose to six lactating women, peak milk cefadroxil levels were observed at six to seven hours, averaging 1.83 mcg per mL. These levels are low and are not expected to cause adverse effects in nursing infants.

Cefadroxil is excreted into human milk in small amounts. However, no adverse effects in nursing infants have been reported. Cefadroxil is considered compatible with breast-feeding by the American Academy of Pediatrics.