Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2176
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Cedax (Capsule)
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The recommended doses of CEDAX Oral Suspension are presented in the table below. CEDAX Oral Suspension must be administered at least 2 hours before or 1 hour after a meal. Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.<br/>Renal Impairment: CEDAX Capsules and CEDAX Oral Suspension may be administered at normal doses in the presence of impaired renal function with creatinine clearance of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency are presented in the following table.<br/>Hemodialysis Patients: In patients undergoing hemodialysis two or three times weekly, a single 400-mg dose of ceftibuten capsules or a single dose of 9 mg/kg (maximum of 400 mg of ceftibuten) oral suspension may be administered at the end of each hemodialysis session.<br/>Directions for Mixing CEDAX Oral Suspension: After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator. Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.
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CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, dihydrate. Its molecular formula is CHNOS���2HO. Its molecular weight is 446.43 as the dihydrate. Ceftibuten dihydrate has the following structural formula: CEDAX Capsules contain ceftibuten dihydrate equivalent to 400 mg of ceftibuten. Inactive ingredients contained in the capsule formulation include: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell and/or band contains gelatin, sodium lauryl sulfate, titanium dioxide, and polysorbate 80. The capsule shell may also contain benzyl alcohol, sodium propionate, edetate calcium disodium, butylparaben, propylparaben, and methylparaben. CEDAX Oral Suspension after reconstitution contains ceftibuten dihydrate equivalent to 90 mg of ceftibuten per 5 mL. CEDAX Oral Suspension is cherry flavored and contains the inactive ingredients: cherry flavoring, polysorbate 80, silicon dioxide, simethicone, sodium benzoate, sucrose (approximately 1 g/5 mL), titanium dioxide, and xanthan gum.
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PHARMACOKINETICS:<br/>Absorption:<br/>Distribution:<br/>Protein Binding: Ceftibuten is 65% bound to plasma proteins. The protein binding is independent of plasma ceftibuten concentration.<br/>Tissue Penetration:<br/>Metabolism and Excretion: A study with radiolabeled ceftibuten administered to 6 healthy adult male volunteers demonstrated that cis-ceftibuten is the predominant component in both plasma and urine. About 10% of ceftibuten is converted to the trans-isomer. The trans-isomer is approximately���as antimicrobially potent as the cis-isomer. Ceftibuten is excreted in the urine; 95% of the administered radioactivity was recovered either in urine or feces. In 6 healthy adult male volunteers, approximately 56% of the administered dose of ceftibuten was recovered from urine and 39% from the feces within 24 hours. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment .<br/>Food Effect on Absorption: Food affects the bioavailability of ceftibuten from CEDAX Capsules and CEDAX Oral Suspension. The effect of food on the bioavailability of CEDAX Capsules was evaluated in 26 healthy adult male volunteers who ingested 400 mg of CEDAX Capsules after an overnight fast or immediately after a standardized breakfast. Results showed that food delays the time of Cby 1.75 hours, decreases the Cby 18%, and decreases the extent of absorption (AUC) by 8%. The effect of food on the bioavailability of CEDAX Oral Suspension was evaluated in 18 healthy adult male volunteers who ingested 400 mg of CEDAX Oral Suspension after an overnight fast or immediately after a standardized breakfast. Results obtained demonstrated a decrease in Cof 26% and an AUC of 17% when CEDAX Oral Suspension was administered with a high-fat breakfast, and a decrease in Cof 17% and in AUC of 12% when CEDAX Oral Suspension was administered with a low-calorie nonfat breakfast .<br/>Bioequivalence of Dosage Formulations: A study in 18 healthy adult male volunteers demonstrated that a 400-mg dose of CEDAX Capsules produced equivalent concentrations to a 400-mg dose of CEDAX Oral Suspension. Average Cvalues were 15.6 (3.1)��g/mL for the capsule and 17.0 (3.2)��g/mL for the suspension. Average AUC values were 80.1 (14.4)��g���hr/mL for the capsule and 87.0 (12.2)��g���hr/mL for the suspension.<br/>Special Populations:<br/>Microbiology: Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis. Ceftibuten is stable in the presence of most plasmid-mediated beta-lactamases, but it is not stable in the presence of chromosomally-mediated cephalosporinases produced in organisms such as Bacteroides, Citrobacter, Enterobacter, Morganella, and Serratia. Like other beta-lactam agents, ceftibuten should not be used against strains resistant to beta-lactams due to general mechanisms such as permeability or penicillin-binding protein changes like penicillin-resistant S. pneumoniae. Ceftibuten has been shown to be active against most strains of the following organisms both in vitro and in clinical infections : Gram-positive aerobes:Streptococcus pneumoniae (penicillin-susceptible strains only)Streptococcus pyogenes Gram-negative aerobes:Haemophilus influenzae (including��-lactamase-producing strains)Moraxella catarrhalis (including��-lactamase-producing strains) There are no known organisms which are potential pathogens in the indications approved for ceftibuten for which ceftibuten exhibits in vitro activity but for which the safety and efficacy of ceftibuten in treating clinical infections due to these organisms, have not been established in adequate and well-controlled trials. NOTE: Ceftibuten is INACTIVE in vitro against Acinetobacter, Bordetella, Campylobacter, Enterobacter, Enterococcus, Flavobacterium, Hafnia, Listeria, Pseudomonas, Staphylococcus, and Streptococcus (except pneumoniae and pyogenes) species. In addition, it shows little in vitro activity against most anaerobes, including most species of Bacteroides.<br/>Susceptibility testing:
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CEDAX (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
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CEDAX Capsules, containing 400 mg of ceftibuten (as ceftibuten dihydrate) are white, opaque capsules imprinted with the product name and strength, are available as follows: 20 Capsules/Bottle (NDC 45809-401-20) Store the capsules between 2��and 25��C (36��and 77��F). Replace cap securely after each opening. CEDAX Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains ceftibuten equivalent to 90 mg/5 mL, supplied as follows: 90 mg/5 mL18 mg/mL 30-mL Bottle (NDC 45809-801-30)18 mg/mL 60-mL Bottle (NDC 45809-801-60)18 mg/mL 90-mL Bottle (NDC 45809-801-90)18 mg/mL 120-mL Bottle (NDC 45809-801-12) Prior to reconstitution, the powder must be stored between 2��and 25��C (36��and 77��F). Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2��and 8��C (36��and 46��F).
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dailymed-ingredient:benzyl_alcohol,
dailymed-ingredient:butylparaben,
dailymed-ingredient:edetate_calcium_disodium,
dailymed-ingredient:gelatin,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:methylparaben,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polysorbate_80,
dailymed-ingredient:propylparaben,
dailymed-ingredient:sodium_lauryl_sulfate,
dailymed-ingredient:sodium_propionate,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:titanium_dioxide
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ceftibuten dihydrate
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Cedax (Capsule)
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CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below . Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including��-lactamase-producing strains), Moraxella catarrhalis (including��-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control. Acute Bacterial Otitis Media due to Haemophilus influenzae (including��-lactamase-producing strains), Moraxella catarrhalis (including��-lactamase-producing strains), or Streptococcus pyogenes. NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered. Pharyngitis and Tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.
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Cedax
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