Each 5 mL of VANTIN 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 alginatebenzoate, starch, sucrose, and vegetable oil.CLINICAL PHARMACOLOGY Absorption and Excretion: Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime.Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically.
Over the recommended dosing range (100 to 400 mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours.There is minimal metabolism of cefpodoxime in vivoEffects of Food: The extent of absorption (mean AUC) and the mean peak plasma concentration increased
administered with food.Following a 200 mg tablet dose gher 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 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 increase in TProxetil Film-coated Tablets: Over the recommended dosing range (100 to 400 mg), the rate and extent of cefpodoxime absorption exhibited dose-dependency; dose-normalized C and AUC decreased by up to 32% with increasing dose.Over the recommended dosing range, the Tapproximately 2 to 3 hours and the T ranged from 2.09 to 2.84 hours.
Mean C1.4 mcg/mL for the 100 mg dose, 2.3 mcg/mL for the 200 mg dose, and 3.9 mcg/mL for the 400 mg dose.In patients with normal significant changes in other pharmacokinetic parameters were noted following multiple oral doses of up to 400 mg Q 12 hours.Tonsil Tissue:Following a single, oral 100 mg cefpodoxime proxetil film-coated maximum cefpodoxime concentration in tonsil tissue averaged 0.24 mcg/g at 4 hours post-dosing and 0.09 mcg/g at 7 hours post-dosing.Equilibrium was achieved between
No detection of cefpodoxime in hours after dosing.These results demonstrated that concentrations of cefpodoxime exceeded the MICafter dosing of 100 mg of cefpodoxime proxetil.Lung Tissue:Following a single, oral 200 mg cefpodoxime proxetil film-coated maximum cefpodoxime concentration in lung tissue averaged 0.63 mcg/g at 3 hours post-dosing, 0.52 mcg/g at 6 hours post-dosing, and 0.19 mcg/g at 12 hours post-dosing.
The results of this study indicated that cefpodoxime penetrated into lung tissue and produced sustained drug concentrations for at least 12 hours after dosing at levels that exceeded the MIC for S.pneumoniae and H.influenzae.CSF:Adequate data on CSF levels of cefpodoxime are not available.Elimination of cefpodoxime is reduced in paimpairment (50 mL/min creatinine clearance).
(See PRECAUTIONSDOSAGE AND ADMINISTRATION.) In subjects with mild impair80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours.
In subjects with moderate (30 to 49 mLimpairment (5 to 29 mL/min creatinine clearance), the half-life increased to 5.9 and 9.8 hours, respectively.Approximately 23% the body during a standard 3-hour hemodialysis procedure.irment (cirrhosis): elimination unchanged in patients with cirrhosis.
The mean cefpodoxime T and renal clearance in cirrhotic patients were y subjects.Ascites did not appear to affect values in cirrhotic subjects.No dosage adjustment is recommended in this patient Pharmacokinetics in Elderly Subjects: Elderly subjects do not require dosage adjustments unless they havePRECAUTIONS.) In healthy geriatric subjects, cefpodoxime half-life in plasma averaged 4.2 hours (vs 3.3 in younger subjects) and urinary recovery averaged 21% after a 400 mg dose was administered every 12 hours.Other pharmacokinetic parameters (C) were unchanged relative to those observed in healthy young subjects.Anaerobic Gram-positive microorganisms: SUSCEPTIBILITY TESTING Dilution Techniques:inhibitory concentrations (MICs).These MICs provide estimates of the susceptibility of microorganisms to antimicrobial compounds.
The MICs should be determined using a standardized procedure.Standardized
(broth or agar) or equivalent using standardized inoculum concentrations, and standardized concentrations of cefpodoxime from a powder of known potency.The MIC values should be interpreted according to the following criteria: For Susceptibility Testing of MIC ( (S)
4.0 Intermediate (I) 8.0 Resistant (R) For Susceptibility Testing of Haemophilus sppMIC ( (S)
The interpretive criteria for .is applicable only to broth microdilution susceptibility testing done with Haem Intermediate and Resistant categories have not been determined.For Susceptibility Testing of Neisseria gonorrhoeae.MIC ( (S)
The interpretive value for
is applicable only to agar dilution susceptibility testing done with
gonorrhoeae susceptibility test medium.
Intermediate and Resistant categories have not been determined.
For Susceptibility Testing of Streptococcus pneumoniae.MIC ( (S)
1.0 Intermediate (I) 2.0 Resistant (R)
The interpretive value for
is applicable only to broth microdilution susceptibility testing done with cation-adjusth with lysed horse blood (LHB) (25% v/v).10 mcg cefpodoxime to test the susceptibility of microorganisms to cefpodoxime
.Reports from the laboratory providing results of the standard single-
JPSBR: Volume 1, Issue 2: Sept Oct 2011 (108-112)
Sanket P et al
ABSTRACT: The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of ofloxacin and cefpodoxime proxetil in combined tablet dosage form.The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP).The first order derivative spectra was obtained in methanol and the determinations were made at 236.4 nm (ZCP of cefpodoxime proxetil) for ofloxacin
and 208.8 nm (ZCP of ofloxacin) for cefpodoxime proxetil.The linearity was obtained in the concentration range of 2-12 ofloxacin and 4-24 for cefpodoxime proxetil.
The mean recovery was 99.80
1.50 and 99.90
0.36 for ofloxacin and cefpodoxime proxetil, respectively.The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of ofloxacin and cefpodoxime proxetil in pharmaceutical tablet dosage form.The results of analysis have been validated statistically and by recovery studies.
Keywords: Ofloxacin, Cefpodoxime proxetil, First order derivative spectrophotometric method, Tablet, Validation.
Development and Validation of First Order Derivative Spectrophotometric method for simultaneous estimation of Ofloxacin and Cefpodoxime Proxetil in tablet dosage form Patel Sanket A.* Patel Satish A. Article history: Received 9 Oct 2011 Accepted 11 Oct 2011
Available online 13 Oct 2011
For Correspondence: Patel Sanket A
Center for Health Science Studies, Ganpat University, Kherva 382711, Mehsana, Gujarat, India.
Email: : Ofloxacin(OFLO) is chemically 9-Fluro-2-3 dihydro-3-methyl-10- (4-methyl 1-piperazinyl) - 7-oxo-7H- pyrido [1, 2, 3-de] 1, 4 benzoxazine-6-carboxylic acid, is a fluoroquinolone antibacterial, used in the treatment of chalmydia or chlamydophila infections including nongonococcal urethritis and in mycobacterial infections such as leprosy..It is official in IP, BP and USP.IP , BP  and USP  describe potentiometry method for its estimation.
Literature survey reveals spectofluorimetric6-7, HPLC8-9 and chemiluminescence methods for determination of OFLO in pharmaceutical dosage forms as well as in biological fluids.Literature survey also reveals spectofluorimetric, RP-HPLC and HPTLC methods for determination of OFLO with other drugs.Cefpodoxime proxetil(CEFPO) is chemically 1-(isopropoxy carbonyloxy) ) ], is a third generation cephalosporin antibiotic.It is used for infections of the respiratory tract, urinary tract and skin and soft tissues.It has greater activity against staphylococcus aureus.Cefpodoxime proxetil is official in IP and USP.
IP  and USP  describe liquid chromatography method for its estimation.
Literature survey reveals HPTLC  method for the determination of CEFPO.Literature survey also reveals RP-HPLC  and spectofluorimetric methods for determination of CEFPO with other drugs.The combined dosage forms of OFLO and CEFPO are available in the market for the prophylaxis and treatment of chronic asthma and chronic bronchitis in pediatrics.The combination of these two drugs is not official in any pharmacopoeia; hence no official
Center for Health Science Studies, Ganpat University, Kherva Mehsana, India.
Research Article JPSBR: Volume 1, Issue 2: Sept Oct 2011 (108-112)
Sanket P et al
109 method is available for the simultaneous estimation of OFLO and CEFPO in their combined dosage forms.
Literature survey does not reveal any simple spectrophotometric or other method for simultaneous estimation of OFLO and CEFPO in combined dosage forms.The present communication describes simple, sensitive, rapid, accurate and economical spectrophotometric method based on dual wavelength spectrophotometric method for simultaneous estimation of both drugs in their combined tablet dosage forms.MATERIALS AND METHODS Apparatus A double beam UV/Visible spectrophotometer (shimadzu model 1700, Japan) with spectral width of 2 nm, wavelength accuracy of 0.5 nm and a pair of 10 mm matched quartz cell was used to measure absorbance of all the solutions.Spectra were automatically obtained by UV-Probe system software.An analytical balance (Sartorius CP224S, Gottingen, Germany), an ultrasonic bath (Frontline FS 4, Mumbai, India) was used in the study.
Reagents and Materials OFLO and CEFPO bulk powder was kindly gifted by Acme Pharmaceuticals Ltd.Ahmedabad, India.The commercial fixed dose combination product was procured from the local market.Methanol AR Grade was procured from S.
D.Fine Chemicals Ltd., Mumbai, India.
Preparation of standard stock solutions An accurately weighed quantity of OFLO (10 mg) and CEFPO (10 mg) were transferred to a separate 100 ml volumetric flask and dissolved and diluted to the mark with methanol to obtain standard solution having concentration of OFLO (100 ) and CEFPO (100 ).Methodology The standard solutions of OFLO (10 g/ml) and CEFPO (10 g/ml) were scanned separately in the UV range of 200-400 nm.
The zero-order spectra thus obtained was then processed to obtain first-derivative spectra.Data were recorded at an interval of 1 nm.The two spectra were overlain and it appeared that OFLO showed zero crossing at 208.8 nm, while CEFPO showed zero crossing at 236.4 nm.At the zero crossing point (ZCP) of OFLO (208.8 nm), CEFPO showed a first-derivative absorbance, whereas at the ZCP of CEFPO (236.4 nm), OFLO showed a first-derivative absorbance.
Hence 236.4 and 208.8 nm was selected as analytical wavelengths for determination of OFLO and CEFPO, respectively.These two wavelengths can be employed for the determination of OFLO and CEFPO without any interference from the other drug in
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