Cefpodoxime

What is Cefpodoxime?

• Cefpodoxime (Banan; Vantin) is a third generation semi synthetic cephalosporin and a beta lactam antibiotic with bactericidal activity used for infections such as bronchitis (infection of the airway tubes leading to the lungs); pneumonia; gonorrhea (a sexually transmitted disease); and infections of the skin, ear, sinuses, throat, tonsils, and urinary tract.

Cefpodoxime Structual Formula V1

Cefpodoxime proxetil

Cefpodoxime

What are the uses of this medicine?

Cefpodoxime (Banan; Vantin) is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains given below:

• Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes
• Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae
• Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis
• Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains)
• Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains)
• Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes
• Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.
• Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

Limitations of use:

• The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established.
• In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents.

How does this medicine work?

• A third generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity.
• Cefpodoxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane.
• Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains.
• As a result, cefpodoxime inhibits bacterial septum and cell wall synthesis formation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a known allergy to cefpodoxime or to the cephalosporin group 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:

• antacids (Maalox, Mylanta, others)
• cimetidine
• colistimethate (Coly-Mycin M)
• diuretics ('water pills')
• famotidine (Pepcid)
• gentamicin
• kanamycin
• neomycin (Neo-Fradin)
• nizatidine (Axid)
• polymixin B
• probenecid (Probalan)
• ranitidine (Zantac)
• streptomycin
• tobramycin
• vancomycin (Vancocin)

Is this medicine FDA approved?

• It was patented in 1980 and approved for medical use in 1989.

How should this medicine be used?

Recommended dosage: FILM-COATED TABLETS:

In Adults and Adolescents (age 12 years and older):

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Pharyngitis and/or tonsillitis	200 mg	100 mg Q 12 hours	5 to 10 days
Acute community-acquired pneumonia	400 mg	200 mg Q 12 hours	14 days
Acute bacterial exacerbations of chronic bronchitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)	200 mg	single dose
Skin and skin structure	800 mg	400 mg Q 12 hours	7 to 14 days
Acute maxillary sinusitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated urinary tract infection	200 mg	100 mg Q 12 hours	7 days

GRANULES FOR ORAL SUSPENSION:

In Adults and Adolescents (age 12 years and older):

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Pharyngitis and/or tonsillitis	200 mg	100 mg Q 12 hours	5 to 10 days
Acute community-acquired pneumonia	400 mg	200 mg Q 12 hours	14 days
Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)	200 mg	single dose
Skin and skin structure	800 mg	400 mg Q 12 hours	7 to 14 days
Acute maxillary sinusitis	400 mg	200 mg Q 12 hours	10 days
Uncomplicated urinary tract infection	200 mg	100 mg Q 12 hours	7 days

Infants and Pediatric Patients (age 2 months through 12 years):

Type of Infection	Total Daily Dose	Dose Frequency	Duration
Acute otitis media	10 mg/kg/day(Max 400 mg/day)	5 mg/kg Q 12 h (Max 200 mg/dose)	5 days
Pharyngitis and/or tonsillitis	10 mg/kg/day (Max 200 mg/day)	5 mg/kg/dose Q 12 h (Max 100 mg/dose)	5 to 10 days
Acute maxillary sinusitis	10 mg/kg/day (Max 400 mg/day)	5 mg/kg Q 12 hours (Max 200 mg/dose)	10 days

Administration:

• Cefpodoxime comes as a tablet and suspension (liquid) to take by mouth.
• It is usually taken every 12 hours for 5 to 14 days depending on the condition being treated.
• A single dose is given to treat gonorrhea.
• Take the tablet with food; the suspension can be taken with or without food.
• Take cefpodoxime at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.
• Continue to take cefpodoxime until you finish the prescription even if you feel better.
• If you stop taking cefpodoxime too soon or skip doses, your infection may 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 suspension (liquid)

This medicine is available in fallowing brand namesː

• Banan; Vantin

What side effects can this medication cause?

The most common side effects of this medicine include:

• Diarrhea
• Nausea
• Vaginal Fungal Infections
• Vulvovaginal Infections
• Abdominal Pain
• Headache

Serious, but less common side effects include:

• watery or bloody stools, stomach cramps, or fever during treatment or for up to two or more months after stopping treatment
• difficulty breathing or swallowing
• wheezing
• a return of fever, sore throat, chills, or other signs of infection
• rash
• itching
• hives

What special precautions should I follow?

• Patients should be counseled that antibacterial drugs including cefpodoxime proxetil should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• When cefpodoxime proxetil is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
• 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 (with or without stomach cramps and fever) 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.
• Cefpodoxime is excreted in human milk. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced.
• Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics.
• As with other antibiotics, prolonged use of cefpodoxime proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
• If you have phenylketonuria, you should know that cefpodoxime suspension is sweetened with aspartame that forms phenylalanine.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefpodoxime proxetil, 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.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use 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?

• Safety and efficacy in infants less than 2 months of age have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• CEFPODOXIME PROXETIL

Inactive Ingredients:

• CARBOXYMETHYLCELLULOSE CALCIUM
• LACTOSE MONOHYDRATE
• HYDROXYPROPYL CELLULOSE
• SODIUM LAURYL SULFATE
• CROSPOVIDONE
• STARCH, CORN
• MAGNESIUM STEARATE
• HYPROMELLOSE 2910
• TITANIUM DIOXIDE
• PROPYLENE GLYCOL
• FD&C YELLOW NO. 6
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

Distributed by:

• Nivagen Pharmaceuticals, Inc.
• Sacramento, CA

Manufactured by:

• Novast Laboratories Ltd.
• Nantong, China

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

• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Dispense in tight, light-resistant container.
• Replace cap securely after each opening.

• Dailymed label info on Cefpodoxime
• FDA Cefpodoxime

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