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Vantin (Granule, For Suspension)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1892

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Vantin (Granule, For Suspension)
dailymed-instance:dosage
FILM-COATED TABLETS: VANTIN Tablets should be administered orally with food to enhance absorption. The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:<br/>Adults and Adolescents (age 12 years and older):<br/>GRANULES FOR ORAL SUSPENSION: VANTIN Oral Suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:<br/>Adults and Adolescents (age 12 years and older):<br/>Infants and Pediatric Patients (age 2 months through 12 years):<br/>Patients with Renal Dysfunction: For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis. When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.<br/>Patients with Cirrhosis: Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.<br/>Preparation of Suspension: After mixing, the suspension should be stored in a refrigerator, 2��to 8��C (36��to 46��F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.
dailymed-instance:descripti...
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 CHNOSand 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 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 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.
dailymed-instance:clinicalP...
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.<br/>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. 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).<br/>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 Cand AUC decreased by up to 32% with increasing dose. Over the recommended dosing range, the Twas approximately 2 to 3 hours and the Tranged from 2.09 to 2.84 hours. Mean Cwas 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.<br/>Pharmacokinetics of Cefpodoxime Proxetil Suspension: 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:<br/>Distribution: Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma.<br/>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.<br/>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 MICof S. pyogenes for at least 7 hours after dosing of 100 mg of cefpodoxime proxetil.<br/>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 MICfor S. pneumoniae and H. influenzae.<br/>CSF: Adequate data on CSF levels of cefpodoxime are not available.<br/>Effects of Decreased Renal Function: Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (<50 mL/min creatinine clearance). In subjects with mild impairment of renal function (50 to 80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours. In subjects with moderate (30 to 49 mL/min creatinine clearance) or severe renal impairment (5 to 29 mL/min creatinine clearance), the half-life increased to 5.9 and 9.8 hours, respectively. Approximately 23% of the administered dose was cleared from the body during a standard 3-hour hemodialysis procedure.<br/>Effect of Hepatic Impairment (cirrhosis): Absorption was somewhat diminished and elimination unchanged in patients with cirrhosis. The mean cefpodoxime Tand renal clearance in cirrhotic patients were similar to those derived in studies of healthy subjects. Ascites did not appear to affect values in cirrhotic subjects. No dosage adjustment is recommended in this patient population.<br/>Pharmacokinetics in Elderly Subjects: Elderly subjects do not require dosage adjustments unless they have diminished renal function. 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, AUC, and T) were unchanged relative to those observed in healthy young subjects.<br/>Microbiology: 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 in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section. Aerobic Gram-positive microorganisms:Staphylococcus aureus (including penicillinase-producing strains)NOTE: Cefpodoxime is inactive against methicillin-resistant staphylococci.Staphylococcus saprophyticusStreptococcus pneumoniae (excluding penicillin-resistant strains)Streptococcus pyogenes Aerobic Gram-negative microorganisms:Escherichia coliKlebsiella pneumoniaeProteus mirabilisHaemophilus influenzae (including beta-lactamase producing strains)Moraxella (Branhamella) catarrhalisNeisseria gonorrhoeae (including penicillinase-producing strains) The following in vitro data are available, but their clinical significance is unknown. Cefpodoxime exhibits in vitro 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. Aerobic Gram-positive microorganisms:Streptococcus agalactiaeStreptococcus spp. (Groups C, F, G)NOTE: Cefpodoxime is inactive against enterococci. Aerobic Gram-negative microorganisms:Citrobacter diversusKlebsiella oxytocaProteus vulgarisProvidencia rettgeriHaemophilus parainfluenzaeNOTE: Cefpodoxime is inactive against most strains of Pseudomonas and Enterobacter. Anaerobic Gram-positive microorganisms:Peptostreptococcus magnus
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Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
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VANTIN Tablets are available in the following strengths (cefpodoxime equivalent), colors, and sizes: 100 mg (light orange, elliptical, debossed with U3617)Bottles of 20 NDC 0009-3617-01Bottles of 100 NDC 0009-3617-02Unit dose packs of 100 NDC 0009-3617-03 200 mg (coral red, elliptical, debossed with U3618)Bottles of 20 NDC 0009-3618-01Bottles of 100 NDC 0009-3618-02Unit dose packs of 100 NDC 0009-3618-03 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 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: 50 mg/5 mL100-mL suspension NDC 0009-3531-0175-mL suspension NDC 0009-3531-0250-mL suspension NDC 0009-3531-03 100 mg/5 mL100-mL suspension NDC 0009-3615-0175-mL suspension NDC 0009-3615-0250-mL suspension NDC 0009-3615-03 Store unsuspended granules at controlled room temperature 20��to 25��C (68��to 77��F) [see USP]. Directions for mixing are included on the label. After mixing, suspension should be stored in a refrigerator, 2��to 8��C (36��to 46��F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.
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cefpodoxime proxetil
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Vantin (Granule, For Suspension)
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Clinical Trials:<br/>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 of400 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 7.0%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.Nausea 3.3%Vaginal Fungal Infections 1.0%Vulvovaginal Infections 1.3%Abdominal Pain 1.2%Headache 1.0% Incidence Less Than 1%: By body system in decreasing order: Clinical Studies Adverse events thought possibly or probably related to cefpodoxime proxetil that occurred in less than 1% of patients (N=4696) Body - fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological tests, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, localized pain. Cardiovascular - congestive heart failure, migraine, palpitations, vasodilation, hematoma, hypertension, hypotension. Digestive - vomiting, dyspepsia, dry mouth, flatulence, decreased appetite, constipation, oral moniliasis, anorexia, eructation, gastritis, mouth ulcers, gastrointestinal disorders, rectal disorders, tongue disorders, tooth disorders, increased thirst, oral lesions, tenesmus, dry throat, toothache. Hemic and Lymphatic - anemia. Metabolic and Nutritional - dehydration, gout, peripheral edema, weight increase. Musculo-skeletal - myalgia. Nervous - dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo. Respiratory - asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, sinusitis. Skin - urticaria, rash, pruritus non-application site, diaphoresis, maculopapular rash, fungal dermatitis, desquamation, dry skin non-application site, hair loss, vesiculobullous rash, sunburn. Special Senses - taste alterations, eye irritation, taste loss, tinnitus. Urogenital - hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginal pain.<br/>Granules for Oral Suspension (Multiple dose): In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly or probably related to study drug. Primarily, these discontinuations were for gastrointestinal disturbances, usually diarrhea, vomiting, or rashes. Adverse events thought possibly or probably related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials (N=2128 patients treated with cefpodoxime) were: Incidence Greater Than 1%: Diarrhea 6.0%The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%.Diaper rash/Fungal skin rash 2.0% (includes moniliasis)The incidence of diaper rash in infants and toddlers was 8.5%.Other skin rashes 1.8%Vomiting 2.3% Incidence Less Than 1%: Body: Localized abdominal pain, abdominal cramp, headache, monilia, generalized abdominal pain, asthenia, fever, fungal infection. Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis. Hemic&Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura. Metabolic&Nutritional: Increased SGPT. Musculo-Skeletal: Myalgia. Nervous: Hallucination, hyperkinesia, nervousness, somnolence. Respiratory: Epistaxis, rhinitis. Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash. Special Senses: Taste perversion.<br/>Film-coated Tablets (Single dose): In clinical trials using a single dose of cefpodoxime proxetil film-coated tablets, 509 patients were treated with the recommended dosage of cefpodoxime (200 mg). There were no deaths or permanent disabilities thought related to drug toxicity in these studies. Adverse events thought possibly or probably related to cefpodoxime in single-dose clinical trials conducted in the United States were: Incidence Greater Than 1%:Nausea 1.4%Diarrhea 1.2% Incidence Less Than 1%:Central Nervous System: Dizziness, headache, syncope.Dermatologic: Rash.Genital: Vaginitis.Gastrointestinal: Abdominal pain.Psychiatric: Anxiety.<br/>Laboratory Changes: 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: Transient increases in AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, and LDH. Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs' test, and prolonged PT, and PTT. Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia. Renal: Increases in BUN and creatinine. Most of these abnormalities were transient and not clinically significant.<br/>Post-marketing Experience: The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis. One death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.<br/>Cephalosporin Class Labeling: In addition to the adverse reactions listed above which have been observed in patients treated with cefpodoxime proxetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: Adverse Reactions and Abnormal Laboratory Tests: Renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, serum sickness-like reaction, hemorrhage, agranulocytosis, and pancytopenia. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
dailymed-instance:indicatio...
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. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION 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 is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil 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. catarrhalis. 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. influenzae. 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 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. 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 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. 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 and other antibacterial drugs, VANTIN 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.
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Vantin