Vantin Information
Vantin (Cefpodoxime proxetil)
Vantin (Cefpodoxime proxetil) Description
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4- thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.
Its empirical formula is CHNOS and its structural formula is represented below:
The molecular weight of cefpodoxime proxetil is 557,6.
Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied both as film-coated tablets and as flavored granules for oral suspension.
Vantin (Cefpodoxime proxetil) Tablets contain cefpodoxime proxetil equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxymethylcellulose calcium, carnauba wax, FD&C Yellow No. 6, hydroxypropylcellulose, hypromellose, lactose hydrous, magnesium stearate, propylene glycol, sodium lauryl sulfate and titanium dioxide. In addition, the 100 mg film-coated tablets contain D&C Yellow No. 10 and the 200 mg film-coated tablets contain FD&C Red No. 40.
Each 5 mL of Vantin (Cefpodoxime proxetil) Oral Suspension contains cefpodoxime proxetil equivalent to 50 mg or 100 mg of cefpodoxime activity after constitution and the following inactive ingredients: artificial flavorings, butylated hydroxy anisole (BHA), carboxymethylcellulose sodium, microcrystalline cellulose, carrageenan, citric acid, colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, lactose, maltodextrin, natural flavorings, propylene glycol alginate, sodium citrate, sodium benzoate, starch, sucrose, and vegetable oil.
Vantin (Cefpodoxime proxetil) Clinical Pharmacology
The extent of absorption (mean AUC) and the mean peak plasma concentration increased when film-coated tablets were administered with food. Following a 200 mg tablet dose taken with food, the AUC was 21 to 33% higher than under fasting conditions, and the peak plasma concentration averaged 3.1 mcg/mL in fed subjects versus 2.6 mcg/mL in fasted subjects. Time to peak concentration was not significantly different between fed and fasted subjects.
When a 200 mg dose of the suspension was taken with food, the extent of absorption (mean AUC) and mean peak plasma concentration in fed subjects were not significantly different from fasted subjects, but the rate of absorption was slower with food (48% increase in T).
In adult subjects, a 100 mg dose of oral suspension produced an average peak cefpodoxime concentration of approximately 1.5 mcg/mL (range: 1.1 to 2.1 mcg/mL), which is equivalent to that reported following administration of the 100 mg tablet. Time to peak plasma concentration and area under the plasma concentration-time curve (AUC) for the oral suspension were also equivalent to those produced with film-coated tablets in adults following a 100 mg oral dose.
The pharmacokinetics of cefpodoxime were investigated in 29 patients aged 1 to 17 years. Each patient received a single, oral, 5 mg/kg dose of cefpodoxime oral suspension. Plasma and urine samples were collected for 12 hours after dosing. The plasma levels reported from this study are as follows:
Cefpodoxime is active against a wide spectrum of Gram-positive and Gram-negative bacteria. Cefpodoxime is stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and cephalosporins, due to their production of beta-lactamase, may be susceptible to cefpodoxime. Cefpodoxime is inactivated by certain extended spectrum beta-lactamases.
The bactericidal activity of cefpodoxime results from its inhibition of cell wall synthesis.
Cefpodoxime has been shown to be active against most strains of the following microorganisms, both and in clinical infections, as described in the section.
The following data are available, but their clinical significance is unknown. Cefpodoxime exhibits minimum inhibitory concentrations (MICs) of ≤ 2.0 mcg/mL against most (≥90%) of isolates of the following microorganisms. However, the safety and efficacy of cefpodoxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Vantin (Cefpodoxime proxetil) Susceptibility Testing
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 10 mcg cefpodoxime disk should provide the following zone diameters with the quality control strains listed below:
ATCC is a registered trademark of the American Type Culture Collection.
Vantin (Cefpodoxime proxetil) Indications And Usage
Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vantin (Cefpodoxime proxetil) and other antibacterial drugs, Vantin (Cefpodoxime proxetil) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Vantin (Cefpodoxime proxetil) Contraindications
Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
Vantin (Cefpodoxime proxetil) Warnings
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
A concerted effort to monitor for in cefpodoxime-treated patients with diarrhea was undertaken because of an increased incidence of diarrhea associated with in early trials in normal subjects. organisms or toxin was reported in 10% of the cefpodoxime-treated adult patients with diarrhea; however, no specific diagnosis of pseudomembranous colitis was made in these patients.
In post-marketing experience outside the United States, reports of pseudomembranous colitis associated with the use of cefpodoxime proxetil have been received.
Vantin (Cefpodoxime proxetil) Precautions
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced because high and prolonged serum antibiotic concentrations can occur in such individuals following usual doses. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. (See .)
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.
Prescribing Vantin (Cefpodoxime proxetil) 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.
Patients should be counseled that antibacterial drugs including Vantin (Cefpodoxime proxetil) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vantin (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. 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 Vantin (Cefpodoxime proxetil) 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 (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.
Of the 3338 patients in multiple-dose clinical studies of cefpodoxime proxetil film-coated tablets, 521 (16%) were 65 and over, while 214 (6%) were 75 and over. No overall differences in effectiveness or safety were observed between the elderly and younger patients. In healthy geriatric subjects with normal renal function, cefpodoxime half-life in plasma averaged 4.2 hours and urinary recovery averaged 21% after a 400 mg dose was given every 12 hours for 15 days. Other pharmacokinetic parameters were unchanged relative to those observed in healthy younger subjects.
Dose adjustment in elderly patients with normal renal function is not necessary.
Vantin (Cefpodoxime proxetil) Adverse Reactions
Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were:
Hepatic
Hematologic
Serum Chemistry
Renal:
Most of these abnormalities were transient and not clinically significant.
Vantin (Cefpodoxime proxetil) Overdosage
In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects.
In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised.
The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea.
Vantin (Cefpodoxime proxetil) Dosage And Administration
(See for indicated pathogens.)
Vantin (Cefpodoxime proxetil) Tablets should be administered orally with food to enhance absorption. (See )
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
Vantin (Cefpodoxime proxetil) How Supplied
Vantin (Cefpodoxime proxetil) Tablets are available in the following strengths (cefpodoxime equivalent), colors, and sizes:
Store tablets at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Replace cap securely after each opening. Protect unit dose packs from excessive moisture.
Vantin (Cefpodoxime proxetil) Oral Suspension provides the equivalent of 50 mg or 100 mg cefpodoxime per 5 mL suspension (when constituted as directed) and is available in lemon creme flavor in the following sizes:
Vantin (Cefpodoxime proxetil) Clinical Trials
In two double-blind, 2:1 randomized, comparative trials performed in adults in the United States, cefpodoxime proxetil was compared to other beta-lactam antibiotics. In these studies, the following bacterial eradication rates were obtained at 5 to 9 days after therapy:
In these studies, clinical cure rates and bacterial eradication rates for cefpodoxime proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis.
Vantin (Cefpodoxime proxetil)
Vantin (Cefpodoxime proxetil) Principal Display Panel - Mg Per Ml Bottle Label
NDC 0009-3531-01
Equivalent to 50 mg per 5 mLcefpodoxime when constituted
100 mL (when mixed)
Vantin (Cefpodoxime proxetil) Principal Display Panel - Mg Per Ml Bottle Label
NDC 0009-3615-01
Equivalent to 100 mg per 5 mLcefpodoxime when constituted
100 mL (when mixed)
Vantin (Cefpodoxime proxetil) Principal Display Panel - Mg Tablet Bottle Label
NDC 0009-3617-026505-01-368-2867
100 Tablets
Vantin (Cefpodoxime proxetil) Principal Display Panel - Mg Tablet Bottle Label
NDC 0009-3618-026505-01-368-2870
100 Tablets
