day without work [5:<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) * 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. Incidence equal to or greater than 1% 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 LABORATORY VALUE CHANGES * Ceftibuten ORAL SUSPENSION US CLINICAL TRIALS IN PEDIATRIC PATIENTS * Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity. Incidence equal to or greater than 1% Eosinophils 3% BUN 2% Hemoglobin 1% Platelets 1% Incidence less than 1% but greater than 0.1% ALT (SGPT) AST (SGOT) Alk phosphatase Bilirubin Creatinine 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. Overdosage 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. Ceftibuten Dosage and Administration The recommended doses of Ceftibuten Oral Suspension are presented in the table below. 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): 400 mg 400 mg QD 10 days Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). (See INDICATIONS AND USAGE - 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 AND USAGE - NOTE .) PEDIATRIC PATIENTS: 400 mg 9 mg/kg QD 10 days Pharyngitis 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 AND USAGE - NOTE .) Ceftibuten ORAL SUSPENSION PEDIATRIC DOSAGE CHART CHILD'S WEIGHT 90 mg/5 mL 180 mg/5 mL Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg. 10 kg 22 lbs 1 tsp QD 1/2 tsp QD 20 kg 44 lbs 2 tsp QD 1 tsp QD 40 kg 88 lbs 4 tsp QD 2 tsp QD Renal Impairment Ceftibuten Capsules and 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 Recommended Dosing Schedules (mL/min) >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 Ceftibuten Oral Suspension DIRECTIONS FOR MIXING Ceftibuten ORAL SUSPENSION Final Concentration Bottle Size Amount of Water Directions 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. 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 mL Suspend in 28 mL of water 60 mL Suspend in 53 mL of water How is Ceftibuten Supplied Ceftibuten Capsules, containing 400 mg of Ceftibuten (as Ceftibuten dihydrate) are white, opaque capsules imprinted with the strength, are available as follows: 20 Capsules/Bottle (NDC 44183-400-22) Store the capsules between 2 and 25 C (36 and 77 F). Replace cap securely after each opening. Ceftibuten Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains Ceftibuten equivalent to 180 mg/5 mL, supplied as follows: 180 mg/5 mL 36 mg/mL 30-mL Bottle (NDC 44183-180-30) 36 mg/mL 60-mL Bottle (NDC 44183-180-02) 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). Clinical Studies Acute Bacterial Exacerbations of Chronic Bronchitis Three clinical trials (two domestic, the third abroad) have been conducted testing Ceftibuten in the treatment of acute exacerbations of chronic bronchitis (AECB). Overall, the clinical outcome among patients who had signs and symptoms of AECB, who had a gram stain showing a predominance of PMNs and few epithelial cells, and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. The bacterial eradication rates of specific pathogens are presented below. BACTERIOLOGICAL OUTCOME ACUTE BACTERIAL EXACERBATIONS OF CHRONIC BRONCHITIS Ceftibuten 400 mg QD Control Bacteriological Eradication Rates Haemophilus influenzae 45/62 (73%) 26/36 (72%) H. parainfluenzae 10/10 4/6 Moraxella catarrhalis 33/46 (72%) 32/34 (94%) Streptococcus pneumoniae 23/35 (66%) 14/20 (70%) Acute Bacterial Otitis Media Four clinical trials (three domestic, the fourth abroad) have been conducted testing Ceftibuten in the treatment of acute bacterial otitis media. Overall, the clinical outcome among patients who had signs and symptoms of acute bacterial otitis media and who were evaluated at approximately 1 to 2 weeks after completing therapy were equivalent to comparators. Tympanocentesis was performed on patients in three of the above-mentioned studies; the bacterial eradication rates of specific pathogens are presented below. BACTERIOLOGICAL OUTCOME ACUTE BACTERIAL OTITIS MEDIA Ceftibuten 9 mg/kg QD Control Bacteriological Eradication Rates Haemophilus influenzae 56/67 (81%) 29/38 (76%) Moraxella catarrhalis 20/26 (77%) 13/17 (77%) Streptococcus pneumoniae 68/105 (65%) 35/40 (88%) Streptococcus pyogenes 13/15 (87%) 5/5 REFERENCES National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA. December, 1993. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA. December, 1993. MACOVEN PHARMACEUTICALS For inquires call 1-877-622-6836 Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA Distributed by Macoven Phamaceuticals, LLC Morristown, NJ 07960, USA Rev. 03/15 35327908 PRINCIPAL DISPLAY PANEL - 400 mg Capsule Bottle Label NDC 44183-400-22 Ceftibuten Capsules 400 mg For Oral Administration Rx only 20 Capsules MACOVEN PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NDC 44183-180-02 Ceftibuten Oral Suspension 180 mg per 5 mL 60 mL (when reconstituted) Rx only MACOVEN PHARMACEUTICALS Ceftibuten Ceftibuten dihydrate capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44183-400 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ceftibuten dihydrate (Ceftibuten) Ceftibuten 400 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO GELATIN SODIUM LAURYL SULFATE TITANIUM DIOXIDE POLYSORBATE 80 BENZYL ALCOHOL SODIUM PROPIONATE EDETATE CALCIUM DISODIUM BUTYLPARABEN PROPYLPARABEN METHYLPARABEN Product Characteristics Color WHITE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 400;mg Contains Packaging # Item Code Package Description 1 NDC:44183-400-22 20 CAPSULE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050685 10/01/2013 Ceftibuten Ceftibuten dihydrate suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44183-180 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ceftibuten DIHYDRATE (Ceftibuten) Ceftibuten 180 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUCROSE 1 g in 5 mL POLYSORBATE 80 SILICON DIOXIDE SODIUM BENZOATE TITANIUM DIOXIDE XANTHAN GUM Product Characteristics Color WHITE ((off-white to cream)) Score Shape FREEFORM ((powder)) Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description 1 NDC:44183-180-30 1 BOTTLE in 1 CARTON 1 30 mL in 1 BOTTLE 2 NDC:44183-180-02 1 BOTTLE in 1 CARTON 2 60 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050686 10/01/2013 Labeler - Macoven Pharmaceuticals (832591965) Registrant - Pernix Therapeutics, LLC (004672296) Establishment Name Address ID/FEI Operations Merck Sharp & Dohme Corp. 040947439 manufacture(44183-400, 44183-180) Revised: 08/2015 Macoven Pharmaceuticals Next Interactions Print this page Add to My Med List More about ceftibuten Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 3 Reviews Add your own review/rating Drug class: third generation cephalosporins Consumer resources Ceftibuten ... +3 more Professional resources Ceftibuten (AHFS Monograph) Ceftibuten (Wolters Kluwer) Other brands: Cedax Related treatment guides Bladder Infection Bronchitis Otitis Media Pneumonia ... +3 more ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Third generation cephalosporins Related Drugs third generation cephalosporins cefdinir , ceftriaxone , Rocephin , Omnicef , cefpodoxime , cefixime Bladder Infection ciprofloxacin , amoxicillin , cephalexin , Levaquin , Keflex , More... Sinusitis prednisone , ciprofloxacin , amoxicillin , azithromycin , Augmentin , More... Strep Throat Augmentin , cefdinir , cefuroxime , erythromycin , Ceftin , clarithromycin , More... 4 more conditions... Ceftibuten Rating 3 User Reviews 9.4 /10 3 User Reviews 9.4 Rate it!} } greatest
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