Drug: Ceclor

Ceclor (Cefaclor, USP) is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN304S•H2O and the molecular weight is 385.82. Each Pulvule® contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The Pulvules also contain cornstarch, F D & C Blue No. 1, F D & C Red No. 40, gelatin, magnesium stearate, silicone, titanium dioxide, and other inactive ingredients. The 500-mg Pulvule also contains iron oxide. After mixing, each 5 mL of Ceclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain cellulose, cornstarch, F D & C Red No. 40, flavors, silicone, sodium lauryl sulfate, sucrose, and xanthan gum.

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Adverse effects considered to be related to therapy with Ceclor (cefaclor) are listed below: Hypersensitivity reactions have been reported in about 1,5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients. Cases of serum-sickness-like reactions have been reported with the use of Ceclor (cefaclor) . These are characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. Occasionally, solitary symptoms may occur, but do not represent a serum-sickness-like reaction. While further investigation is ongoing, serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with Ceclor (cefaclor) . Such reactions have been reported more frequently in pediatric patients than in adults with an overall occurrence ranging from 1 in 200 (0.5%) in one focused trial to 2 in 8346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%) to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalization, usually of short duration ' (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported. More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, paresthesias, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months. Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70). Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment {see WARNINGS). Nausea and vomiting have been reported rarely. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Other effects considered related to therapy included eosinophilia (1 in 50 patients), genital pruritus, moniliasis or vaginitis ( about 1 in 50 patients), and, rarely, thrombocytopenia or reversible interstitial nephritis. Causal Relationship Uncertain - CNS - Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence have been reported. Transitory abnormalities in clinical laboratory test results have been reported. Although they were of uncertain etiology, they are listed below to serve as alerting information for the physician. Hepatic - Slight elevations of AST, ALT, or alkaline phosphatase values (1 in 40). Hematopoietic - As has also been reported with other p-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia of possible clinical significance. There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving Ceclor (cefaclor) and Coumadin® concomitantly. Renal - Slight elevations in BUN or serum creatinine (less than 1 in 500) or abnormal urinalysis (less than 1 in 200). Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, false positive test for urinary glucose, elevated bilirubin, elevated LDH, 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 (see DOSAGE AND ADMINISTRATION and OVERDOSAGE sections). Read the Ceclor (cefaclor) Side Effects Center for a complete guide to possible side effectsLearn More »

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Ceclor (cefaclor) is administered orally. Adults - The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled. Pediatric patients - The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.   Ceclor Suspension
20 mg/kg/day Weight 125 mo/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d.   18 kg 1 tsp t.i.d. 1/2 tsp t.i.d.   40 mg/kg/day 9 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 18 kg   1 tsp t.i.d. B.I.D. Treatment Option - For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.   Ceclor (cefaclor) Suspension
20 mg/kg/day
(Pharyngitis) Weight 187 ms/5 mL 375 ms/5 mL 9 kg 1/2 tsp b.i.d.   18 kg 1 tsp b.i.d. 1/2 tsp b.i.d.   40 mg/kg/day
(Otitis Media) 9 kg 1 tsp b.i.d. 1/2 tsp b.i.d. 18 kg   1 tsp b.i.d. Ceclor (cefaclor) may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS). In the treatment of p-hemolytic streptococcal infections, a therapeutic dosage of Ceclor (cefaclor) should be administered for at least 10 days.

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Drug / Laboratory Test Interactions Patients receiving Ceclor (cefaclor) may show a false-positive reaction for glucose in the urine with tests that use Benedict's and Fehling's solutions and also with Clinitesr tablets. There have been reports of increased anticoagulant effect when Ceclor (cefaclor) and oral anticoagulants were administered concomitantly. Read the Ceclor Drug Interactions Center for a complete guide to possible interactions Learn More »

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Ceclor (cefaclor) is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: (β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Ceclor (cefaclor) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Ceclor (cefaclor) in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceclor (cefaclor) and other antibacterial drugs, Ceclor (cefaclor) 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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Ceclor (cefaclor) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

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Signs and Symptoms - The toxic symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity of the epigastric distress and the diarrhea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication. Treatment - To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Unless 5 times the normal dose of cefaclor has been ingested, gastrointestinal decontamination will not be necessary. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cefaclor.

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Pulvules: 250 mg, purple and white (No. 3061) - (RxPak* of 15) NDC 0002-3061-15; (100s)
NDC 0002-3061-02; (ID †100)
NDC 0002-3061-33 500 mg, purple and gray (No. 3062) - (RxPak of 15) NDC 0002-3062-15 For Oral Suspension: 125 mg/5 mL, strawberry flavor (M-5057‡) - (150-mL size) NDC 0002-5057-68
187 mg/5 mL, strawberry flavor (M-5130‡) - (100-mL size) NDC 0002-5130-48
250 mg/5 mL, strawberry flavor (M-5058‡) - (75-mL size) NDC 0002-5058-18; (150-mL size) NDC 0002-5058-68
375 mg/5 mL, strawberry flavor (M-5132‡) - (100-mL size) NDC 0002-5132-48 *A11 RxPaks (prescription packages, Lilly) have safety closures.
†ldenti-Dose® (unit dose medication, Lilly).
‡After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] Literature revised March 28, 2003. Manufactured by: Eli Lilly Italia, S.p.A. Sesto Florentino (Firenze), Italy for Eli Lilly and Company Indianapolis, IN 46285, USA. FDA Rev date: 3/17/2004 Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

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General Prescribing Ceclor (cefaclor) 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. Prolonged use of Ceclor (cefaclor) may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. It should be recognized that a positive Coombs' test may be due to the drug, eg, in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition. Ceclor (cefaclor) should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made. As with other β-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid. Antibiotics, including cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility. Pregnancy - Teratogenic Effects - Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 12 times the human dose and in ferrets given 3 times the maximum human dose and have revealed no harm to the fetus due to Ceclor (cefaclor) . There are, however, 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 The effect of Ceclor (cefaclor) on labor and delivery is unknown. Nursing Mothers Small amounts of Ceclor (cefaclor) have been detected in mother's milk following administration of single 500-mg doses. Average levels were 0.18, 0.20, 0.21, and 0.16 µg/mL at 2, 3,4, and 5 hours respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not known. Caution should be exercised when Ceclor (cefaclor) is administered to a nursing woman. Pediatric Use Safety and effectiveness of this product for use in infants less than 1 month of age have not been established. Geriatric Use Of the 3703 patients in clinical studies of Ceclor (cefaclor) , 594 (16.0%) were 65 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney {see CLINICAL PHARMACOLOGY), and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

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