Cefprozil

What is Cefprozil?

• Cefprozil (Cefzil) is a semi-synthetic broad-spectrum cephalosporin antibiotic used to treat certain infections caused by bacteria, such as bronchitis; and infections of the skin, ears, sinuses, throat, and tonsils.

Cefprozil

What are the uses of this medicine?

Cefprozil (Cefzil) is used for the treatment of patients with mild to moderate infections as fallows:

• Pharyngitis/tonsillitis
• Otitis Media
• Acute Sinusitis
• Acute Bacterial Exacerbation of Chronic Bronchitis
• Uncomplicated Skin and Skin-Structure Infections

How does this medicine work?

• Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic.
• The bactericidal action of cefprozil results from inhibition of cell-wall synthesis.

• Cefprozil has been shown to be active against most strains of the following microorganisms:

Aerobic gram-positive microorganisms:

• Staphylococcus aureus (including β-lactamase-producing strains)
• Streptococcus pneumoniae
• Streptococcus pyogenes

NOTE: Cefprozil is inactive against methicillin-resistant staphylococci.

Aerobic gram-negative microorganisms:

• Haemophilus influenzae (including β-lactamase-producing strains)
• Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains)

Who Should Not Use this medicine ?

• This medicine cannot be used in patients:

with known allergy to the cephalosporins class of antibiotics.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amikacin, diuretics ('water pills'), gentamicin, kanamycin, neomycin (Neo-Fradin), probenecid (Probalan), streptomycin, and tobramycin.

Is this medicine FDA approved?

• Originally discovered in 1983, and approved in 1992,it was sold under the tradename Cefzil by Bristol Meyers Squibb until 2010 when the brand name version was discontinued.
• It continues to be available from various companies in its generic form.

How should this medicine be used?

Recommended dosage: In ADULTS (13 years and older):

• In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.

Pharyngitis/Tonsillitis:

• 500mg every 24h for 10 days.

Acute Sinusitis:

• 250mg every 12h or 500mg every 12h for 10 days.
• For moderate to severe infections, the higher dose should be used.

Acute Bacterial Exacerbation of Chronic Bronchitis:

• 500mg every 12h for 10 days.

Uncomplicated Skin and Skin Structure Infections:

• 250mg every 12h or 500mg every 24h or 500mg every 12h for 10 days.

In CHILDREN (2 years to 12 years):

Pharyngitis/Tonsillitis:

• 7.5 mg/kg every 12h for 10 days.

Uncomplicated Skin and Skin Structure Infections:

• 20 mg/kg every 24h for 10 days.

In INFANTS & CHILDREN (6 months to 12 years): Otitis Media:

• 15 mg/kg every 12h for 10 days.

Acute Sinusitis:

• 7.5 mg/kg every 12h or 15 mg/kg every 12h for 10 days.

Administration:

• Cefprozil comes as a tablet and a suspension to take by mouth.
• It is usually taken with or without food every 12 or 24 hours for 10 days.
• Take cefprozil at around the same time every day.
• Shake the suspension well before each use to mix the medication evenly.
• You should begin to feel better during the first few days of treatment with cefprozil.
• If your symptoms do not improve or get worse, call your doctor.
• Take cefprozil until you finish the prescription, even if you feel better.
• If you stop cefprozil too soon or skip doses, your infection not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and a suspension

This medicine is available in fallowing brand namesː

• Cefzil

What side effects can this medication cause?

The most common side effects of this medicine include:

• Gastrointestinal: Diarrhea, nausea, vomiting, and abdominal pain.
• Hepatobiliary: Elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, and bilirubin values. As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.
• Hypersensitivity: Rash, urticaria.
• CNS: Dizziness, hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely.
• Hematopoietic: Decreased leukocyte count, eosinophilia.
• Renal: Elevated BUN, serum creatinine.
• Other: Diaper rash and superinfection, genital pruritus and vaginitis

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefprozil tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Prescribing cefprozil tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Cephalosporins, including cefprozil, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.
• Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.
• Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
• Patients should be counseled that antibacterial drugs including cefprozil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefprozil tablets or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with copper reduction tests (Benedict’s or Fehling’s solution or with Clinitest tablets), but not with enzyme-based tests for glycosuria (e.g., Clinistix).
• Caution should be exercised when cefprozil is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.
• If you have phenylketonuria, you should know that cefuroxime suspension is sweetened with aspartame that forms phenylalanine.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• diarrhea and loss of appetite

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Cefprozil is eliminated primarily by the kidneys.
• In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of cefprozil from the body.

Can this medicine be used in pregnancy?

• Pregnancy category B.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years.
• The safety and effectiveness of cefprozil in the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years.
• The safety and effectiveness of cefprozil in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years.
• Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis, or below the age of 2 years for the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin structure infections.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CEFPROZIL

Inactive ingredients:

• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOL 400
• POLYSORBATE 80
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TITANIUM DIOXIDE
• D&C YELLOW NO. 10 ALUMINUM LAKE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6

Who manufactures and distributes this medicine?

Manufactured By:

• Teva Pharmaceuticals USA, Inc.
• North Wales, PA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

• Dailymed label info on Cefprozil
• FDA Cefprozil

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