Drug: Cedax

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-(2Amino-4-thiazolyl)-4-carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2carboxylic acid, dihydrate. Its molecular formula is C15H14N4O6S2•2H2O. 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 or 180 mg of ceftibuten per 5 mL. CEDAX (ceftibuten) 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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Clinical Trials CEDAX (ceftibuten) CAPSULES (adult patients) In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of ceftibuten capsules (400 mg per day). There were no deaths or permanent disabilities thought due to drug toxicity in any of the patients in these studies. Thirty-six of 1728 (2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea, vomiting, or nausea. Six of 1728 (0.3%) patients were discontinued due to rash or pruritus thought related to ceftibuten administration. In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten capsules in multipledose clinical trials (n = 1092 ceftibuten-treated patients). ADVERSE REACTIONS
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS (n = 1092) Incidence equal to or greater than 1% Nausea 4% Headache 3% Diarrhea 3% Dyspepsia 2% Dizziness 1% Abdominal pain 1% Vomiting 1% Incidence less than 1% but greater than 0.1% Anorexia, Constipation, Dry mouth, Dyspnea, Dysuria, Eructation, Fatigue, Flatulence, Loose stools, Moniliasis, Nasal congestion, Paresthesia, Pruritus, Rash, Somnolence, Taste perversion,Urticaria, Vaginitis   LABORATORY VALUE CHANGES*
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS Incidence equal to or greater than 1% ↑ BUN 4% ↑ Eosinophils 3% ↓ Hemoglobin 2% ↑ALT (SGPT) 1% ↑ Bilirubin 1% Incidence less than 1% but greater than 0.1% ↑ Alk phosphatase   ↑ Creatinine   ↑ Platelets   ↓Platelets   ↓ Leukocytes   ↑ AST (SCOT)   * Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity. CEDAX (ceftibuten) ORAL SUSPENSION (pediatric patients) In clinical trials, 1152 pediatric patients (772 US and 380 international), 97% of whom were younger than 12 years of age, were treated with the recommended dose of ceftibuten (9 mg/kg once daily up to a maximum dose of 400 mg per day) for 10 days. There were no deaths, life-threatening adverse events, or permanent disabilities in any of the patients in these studies. Eight of 1152 ( < 1%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily (7 out of 8) for gastrointestinal disturbances, usually diarrhea or vomiting. One patient was discontinued due to a cutaneous rash thought possibly related to ceftibuten administration. In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten oral suspension in multipledose clinical trials (n = 772 ceftibuten-treated patients). ADVERSE REACTIONS
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS (n = 772) Incidence equal to or greater than1% Diarrhea* 4% Vomiting 2% Abdominal pain 2% Loose stools 2% Incidence less than 1% but greater than 0.1% Agitation, Anorexia, Dehydration, Diaper dermatitis, Dizziness, Dyspepsia, Fever, Headache, Hematuria, Hyperkinesia, Insomnia, Irritability, Nausea, Pruritus, Rash, Rigors, Urticaria   * NOTE: The incidence of diarrhea in pediatric patients ≤ 2 years old was 8% (23/301) compared with 2% (9/471) in pediatric patients > 2 years old. LABORATORY VALUE CHANGES*
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS Incidence equal to or greater than1% ↑ Eosinophils 3% ↑ BUN 2% ↓ Hemoglobin 1% ↑ Platelets 1% Incidence less than 1% but greater than 0.1% ↑ ALT (SGPT)   ↑ AST (SCOT)   ↑ Alk phosphatase   ↑ Bilirubin   ↑ Creatinine   * Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity. In Post-marketing Experience The following adverse experiences have been reported during worldwide post-marketing surveillance: aphasia, jaundice, melena, psychosis, serum sickness-like reactions, stridor, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with ceftibuten capsules, the following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics: allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, renal dysfunction, toxic nephropathy, hepatic cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis; onset of symptoms may occur during or after antibiotic treatment (see WARNINGS). Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Read the Cedax (ceftibuten) Side Effects Center for a complete guide to possible side effectsLearn More »

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The recommended doses of CEDAX (ceftibuten) Oral Suspension are presented in the table below. CEDAX (ceftibuten) Oral Suspension must be administered at least 2 hours before or 1 hour after a meal. Type of infection (as qualified in the INDICATIONS AND USAGE section of this labeling) Daily Maximum Dose Dose and Frequency Duration ADULTS (12 years of age and older): Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzas (including β-actamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumonias (penicillin-susceptible strains only). (See INDICATIONS - NOTE.) Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS - NOTE.) 400 mg 400 mg QD 10 days PEDIATRIC PATIENTS: laryngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), and M. catarrhalis including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS - NOTE.) 400 mg 9 mg/kg QD 10 days CEFTIBUTEN ORAL SUSPENSION PEDIATRIC DOSAGE CHART CHILD'S WEIGHT 90 mg/5 mL 180 mg/5mL 10 kg 22 Ibs 1 tsp QD 1/2 tsp QD 20 kg 44 Ibs 2 tsp QD 1 tsp QD 40 kg 88 Ibs 4 tsp QD 2 tsp QD Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg. Renal Impairment CEDAX (ceftibuten) Capsules and CEDAX (ceftibuten) 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. Creatinine Clearance (mL/min) Recommended Dosing Schedules > 50 9 mg/kg or 400 mg Q24h
(normal dosing schedule) 30-49 4.5 mg/kg or 200 mg Q24h 5-29 2.25 mg/kg or 100 mg Q24h 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. Directions for Mixing CEDAX (ceftibuten) Oral Suspension DIRECTIONS FOR MIXING CEDAX (ceftibuten) ORAL SUSPENSION
Final Concentration Bottle Size Amount of Water Directions 90 mg per 5 mL 60 mL Suspend in 53 mL of water First tap the bottle to loosen powder. Then add water in two portions, shaking well after each aliquot. 90 mL Suspend in 78 mL of water 120 mL Suspend in 103 mL of water 180 mg per 5 mL 30 m Suspend in 28 mL of water 60 mL Suspend in 53 mL of water 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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Theophylline Twelve healthy male volunteers were administered one 200-mg ceftibuten capsule twice daily for 6 days. With the morning dose of ceftibuten on day 6, each volunteer received a single intravenous infusion of theophylline (4 mg/kg). The pharmacokinetics of theophylline were not altered. The effect of ceftibuten on the pharmacokinetics of theophylline administered orally has not been investigated. Antacids or H2-receptor antagonists The effect of increased gastric pH on the bioavailability of ceftibuten was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg ceftibuten capsule. A single dose of liquid antacid did not affect the Cmax or AUC of ceftibuten; however, 150 mg of ranitidine q12h for 3 days increased the ceftibuten Cmax by 23% and ceftibuten AUC by 16%. The clinical relevance of these increases is not known. Drug/Laboratory Test Interactions There have been no chemical or laboratory test interactions with ceftibuten noted to date. False-positive direct Coombs' tests have been reported during treatment with other cephalosporins. Therefore, it should be recognized that a positive Coombs' test could be due to the drug. The results of assays using red cells from healthy subjects to determine whether ceftibuten would cause direct Coombs' reactions in vitro showed no positive reaction at ceftibuten concentrations as high as 40 µg/mL. Read the Cedax Drug Interactions Center for a complete guide to possible interactions Learn More »

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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 (see DOSAGE AND ADMINISTRATION and Clinical Studies sections). Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-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 β-lactamase-producing strains), Moraxella catarrhalis (including β-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 (ceftibuten) product for the prophylaxis of subsequent rheumatic fever are not available.

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CEDAX (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation by a single hemodialysis session. Information does not exist with regard to removal of ceftibuten by peritoneal dialysis.

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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 65224-800-22) Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening. CEDAX (ceftibuten) Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains ceftibuten equivalent to 90 mg/5 mL or 180 mg/5 mL, supplied as follows: 90 mg/5 mL 18 mg/mL 60-mL Bottle (NDC 65224-802-02)
18 mg/mL 90-mL Bottle (NDC 65224-802-03)
18 mg/mL 120-mL Bottle (NDC 65224-802-04) 180 mg/5 mL 36 mg/mL 30-mL Bottle (NDC 65224-804-30)
36 mg/mL 60-mL Bottle (NDC 65224-804-02) 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). For inquires call 1-800-793-2145. Manufactured by Schering Corporation Miami Lakes, FL 33014, USA. Distributed by Pernix Therapeutics, LLC Gonzales, LA 70737, USA. Revised 04/10 Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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General As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. The dose of ceftibuten may require adjustment in patients with varying degrees of renal insufficiency, particularly in patients with creatinine clearance less than 50 mL/min or undergoing hemodialysis (see DOSAGE AND ADMINISTRATION). Ceftibuten is readily dialyzable. Dialysis patients should be monitored carefully, and administration of ceftibuten should occur immediately following dialysis. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of ceftibuten. No mutagenic effects were seen in the following studies: in vitro chromosome assay in human lymphocytes, in vivo chromosome assay in mouse bone marrow cells, Chinese Hamster Ovary (CHO) cell point mutation assay at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus, and in a bacterial reversion point mutation test (Ames). No impairment of fertility occurred when rats were administered ceftibuten orally up to 2000 mg/kg/day (approximately 43 times the human dose based on mg/m2/day). Pregnancy Teratogenic effects - Pregnancy Category B Ceftibuten was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day (approximately 8.6 times the human dose based on mg/m2/day). Ceftibuten was not teratogenic in the pregnant rabbit at oral doses up to 40 mg/kg/day (approximately 1.5 times the human dose based on mg/m2/day) and has revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies 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 Ceftibuten has not been studied for use during labor and delivery. Its use during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus. Nursing Mothers It is not known whether ceftibuten (at recommended dosages) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ceftibuten is administered to a nursing woman. Pediatric Use The safety and efficacy of ceftibuten in infants less than 6 months of age has not been established. Geriatric Patients The usual adult dosage recommendation may be followed for patients in this age group. However, these patients should be monitored closely, particularly their renal function, as dosage adjustment may be required. Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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