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The molecular weight of Cefpodoxime Proxetil USP is 557.6. Cefpodoxime Proxetil USP is a prodrug; its active metabolite is cefpodoxime. All doses of Cefpodoxime Proxetil USP in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime Proxetil tablets USP 100 mg contain FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No.
6 as color additives. Cefpodoxime Proxetil tablets USP 200 mg contain color additives including FD&C Yellow No. Cefpodoxime Proxetil tablets USP contain Cefpodoxime Proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxymethylcellulose calcium, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and opadry orange.
The constituents of opadry orange 03H53614 (used in 100 mg strength) are hypromellose, titanium dioxide, propylene glycol, FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. The constituents of opadry orange 03H53615 (used in 200 mg strength) are hypromellose, titanium dioxide, propylene glycol, FD&C Yellow No.
6 and FD&C Red No. Slideshow Cefpodoxime Proxetil - 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 vivo. Effects of Food: 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. Pharmacokinetics of Cefpodoxime Proxetil 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 max and AUC decreased by up to 32% with increasing dose.
Over the recommended dosing range, the Tmax was approximately 2 to 3 hours and the T1/2 ranged from 2.09 to 2.84 hours. Mean Cmax was 1.4 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 renal function, neither accumulation nor significant changes in other pharmacokinetic parameters were noted following multiple oral doses of up to 400 mg Q 12 hours. CEFPODOXIME PLASMA LEVELS (mcg/mL) IN FASTED ADULTS AFTER FILM-COATED TABLET ADMINISTRATION (Single Dose) Dose Time after oral ingestion (cefpodoxime equivalents) 1 hr 2 hr 3 hr 4 hr 6 hr 8 hr 12 hr 100 mg 0.98 1.4 1.3 1 0.59 0.29 0.08 200 mg 1.5 2.2 2.2 1.8 1.2 0.62 0.18 400 mg 2.2 3.7 3.8 3.3 2.3 1.3 0.38 Distribution: Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma. Skin Blister: Following multiple-dose administration every 12 hours for 5 days of 200 mg or 400 mg Cefpodoxime Proxetil, the mean maximum cefpodoxime concentration in skin blister fluid averaged 1.6 and 2.8 mcg/mL, respectively. Skin blister fluid cefpodoxime levels at 12 hours after dosing averaged 0.2 and 0.4 mcg/mL for the 200 mg and 400 mg multiple-dose regimens, respectively.
Tonsil Tissue: Following a single, oral 100 mg Cefpodoxime Proxetil film-coated tablet, the mean 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 plasma and tonsil tissue within 4 hours of dosing. No detection of cefpodoxime in tonsillar tissue was reported 12 hours after dosing. These results demonstrated that concentrations of cefpodoxime exceeded the MIC 90 of S. Pyogenes for at least 7 hours after dosing of 100 mg of Cefpodoxime Proxetil.
Lung Tissue: Following a single, oral 200 mg Cefpodoxime Proxetil film-coated tablet, the mean 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 90 for S. Pneumoniae and H. CSF: Adequate data on CSF levels of cefpodoxime are not available. Effects of Decreased Renal Function: Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (. Susceptibility Test Interpretive Criteria for Cefpodoxime 2.
Pathogen Minimum Inhibitory Concentrations (mcg / mL) Disk Diffusion Diameters (mm) S I R S I R Enterobacteriaceae ≤ 2 4 ≥ 8 ≥ 21 18 to 20 ≤ 17 Haemophilus influenzae a ≤ 2 -≥ 21 -Streptococcus pneumoniae ≤ 0.5 1 ≥ 2 -Neisseria gonorrhoeae a ≤ 0.5 -≥ 29 -Susceptibility of staphylococci to cefpodoxime may be deduced from testing only penicillin and either cefoxitin or oxacillin. A = The current absence of resistant isolates precludes defining any results other than 'Susceptible'. Isolates yielding MIC results other than 'Susceptible' should be submitted to a reference laboratory for further testing. A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration at the infection site necessary to inhibit growth of the pathogen. A report of Intermediate indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation.
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A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected. Quality Control: Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test 1,2,3.
Standard cefpodoxime powder should provide the following range of MIC values noted in Table 2. For the diffusion technique using the 10 mcg disk, the criteria in Table 2 should be achieved. Acceptable Quality Control Ranges for Cefpodoxime QC Strains Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion Zone diameters (mm) Escherichia coli ATCC 25922 0.25 to 1 23 to 28 Haemophilus influenzae ATCC 49247 0.25 to 1 25 to 31 Streptococcus pneumoniae ATCC 49619 0.03 to 0.12 28 to 34 Neisseria gonorrhoeae ATCC 49226 0.03 to 0.12 35 to 43 Staphylococcus aureus ATCC 25923 - 19 to 25 Staphylococcus aureus ATCC 29213 1 to 8 - ATCC ® is a registered trademark of the American Type Culture Collection. Indications and Usage for Cefpodoxime Proxetil Cefpodoxime Proxetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta- lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta- lactamase-producing strains). Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime Proxetil tablets are generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of Cefpodoxime Proxetil tablets for the prophylaxis of subsequent rheumatic fever are not available.
Community-acquired pneumonia caused by S. Pneumoniae or H. Influenzae (including beta-lactamase-producing strains). Acute bacterial exacerbation of chronic bronchitis caused by S. Pneumoniae, H. Influenzae (non-beta-lactamase-producing strains only), or M.
Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. 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). NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. Gonorrhoeae has not been established. Data do not support the use of Cefpodoxime Proxetil tablets in the treatment of pharyngeal infections due to N.
Gonorrhoeae in men or women. Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated. NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related.
The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See.) 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. NOTE: In considering the use of Cefpodoxime Proxetil tablets 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. (See section.) 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 Cefpodoxime Proxetil tablets and other antibacterial drugs, Cefpodoxime Proxetil tablets 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. Contraindications Cefpodoxime Proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
Warnings BEFORE THERAPY WITH Cefpodoxime Proxetil IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Cefpodoxime Proxetil OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. 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 produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. Difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. 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. A concerted effort to monitor for C. Difficile in cefpodoxime-treated patients with diarrhea was undertaken because of an increased incidence of diarrhea associated with C.
Difficile in early trials in normal subjects. Difficile 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. Precautions Warning: This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.
5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. General: 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 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. Information for Patients: 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.
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 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. Drug Interactions: Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels by 24% to 42% and the extent of absorption by 27% to 32%, respectively.
The rate of absorption is not altered by these concomitant medications. Oral anti-cholinergics (e.g., propantheline) delay peak plasma levels (47% increase in Tmax), but do not affect the extent of absorption (AUC). Probenecid: As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and 20% increase in peak cefpodoxime plasma levels. Nephrotoxic drugs: Although nephrotoxicity has not been noted when Cefpodoxime Proxetil was given alone, close monitoring of renal function is advised when Cefpodoxime Proxetil is administered concomitantly with compounds of known nephrotoxic potential. Drug/Laboratory Test Interactions: Cephalosporins, including Cefpodoxime Proxetil, are known to occasionally induce a positive direct Coombs' test.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal carcinogenesis studies of Cefpodoxime Proxetil have not been performed. Mutagenesis studies of cefpodoxime, including the Ames test both with and without metabolic activation, the chromosome aberration test, the unscheduled DNA synthesis assay, mitotic recombination and gene conversion, the forward gene mutation assay and the in vivo micronucleus test, were all negative. No untoward effects on fertility or reproduction were noted when 100 mg/kg/day or less (2 times the human dose based on mg/m2) was administered orally to rats. Pregnancy Teratogenic Effects: Pregnancy Category B Cefpodoxime Proxetil was neither teratogenic nor embryocidal when administered to rats during organogenesis at doses up to 100 mg/kg/day (2 times the human dose based on mg/m2) or to rabbits at doses up to 30 mg/kg/day (1 to 2 times the human dose based on mg/m 2). 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. Labor and Delivery: Cefpodoxime Proxetil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Nursing Mothers: Cefpodoxime is excreted in human milk. In a study of 3 lactating women, levels of cefpodoxime in human milk were 0%, 2% and 6% of concomitant serum levels at 4 hours following a 200 mg oral dose of Cefpodoxime Proxetil. At 6 hours post-dosing, levels were 0%, 9% and 16% of concomitant serum levels.
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. Pediatric Use: Safety and efficacy in infants less than 2 months of age have not been established. Geriatric Use: 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. Adverse Reactions Clinical Trials: Film-coated Tablets (Multiple dose): In clinical trials using multiple doses of Cefpodoxime Proxetil film-coated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One- hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity.
Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. The percentage of Cefpodoxime Proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. Adverse events thought possibly or probably related to cefpodoxime in multiple-dose clinical trials (N=4696 cefpodoxime-treated patients) were: Incidence Greater Than 1%: Diarrhea 7% Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. Difficile organism or toxin in the stool. Pathogen Cefpodoxime Comparator E. Coli 200/243 (82%) 99/123 (80%) Other pathogens 34/42 (81%) 23/28 (82%) K.
Pneumoniae P. Saprophyticus TOTAL 234/285 (82%) 122/151 (81%) 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.
Acute Otitis Media Studies In controlled studies of acute otitis media performed in the United States, where significant rates of beta-lactamase-producing organisms were found, Cefpodoxime Proxetil was compared to cefixime. In these studies, using very strict evaluability criteria and microbiologic and clinical response criteria at the 4 to 21 day post-therapy follow-up, the following presumptive bacterial eradication/clinical success outcomes (cured and improved) were obtained. Cefpodoxime Proxetil Cefixime Pathogen 5 mg/kg Q 12 h x 5 d S. Pneumoniae 88/122 (72%) 72/124 (58%) H.
Influenzae 50/76 (66%) 61/81 (75%) M. Catarrhalis 22/39 (56%) 23/41 (56%) S. Pyogenes 20/25 (80%) 13/23 (57%) Clinical success rate 171/254 (67%) 165/258 (64%) Manufactured for: OrchidPharma, Inc. Princeton, NJ 08540, USA Manufactured by: Hospira Healthcare India Pvt.Ltd., At Irungattukottai – 602 105, India On behalf of: Orchid Healthcare (A Division of Orchid Pharma Ltd.) At Irungattukottai – 602 105, India R01/16 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL OrchidPharma NDC 42043-120-20 Cefpodoxime Proxetil Tablets, USP 100 mg.
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20 Tablets Rx only.