Ceclor/Ceclor-DS

Ceclor/Ceclor-DS

cefaclor

Manufacturer:

Aspen

Distributor:

Zuellig
Full Prescribing Info
Contents
Cefaclor.
Action
Pharmacology: Pharmacokinetics: Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food. However, when it is taken with food, the peak concentration achieved is 50-75% of that observed when the drug is administered to fasting subjects and generally appears from ¾-1 hr later. Following administration of 250-mg, 500-mg and 1-g doses to fasting subjects, average peak serum levels of approximately 7, 13 and 23 mg/L, respectively, were obtained within 30-60 min. Approximately 60-85% of the drug is excreted unchanged in the urine within 8 hrs, the greater portion being excreted within the first 2 hrs. During this 8-hr period, peak urine concentrations following the 250-mg, 500-mg and 1-g doses were approximately 600, 900 and 1900 mg/L, respectively. The serum t½ in normal subjects is 0.6-0.9 hr. In patients with reduced renal function, the serum t½ of cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma t½ of the intact molecule is 2.3-2.8 hrs. Excretion pathways in patients with markedly impaired renal function have not been determined. Hemodialysis shortens the t½ by 25-30%.
Microbiology: In vitro tests demonstrate that the bactericidal action of cephalosporins results from their inhibition of cell-wall synthesis. Cefaclor is stable in the presence of bacterial β-lactamases; consequently, β-lactamase-producing organisms resistant to penicillins and some cephalosporins may be susceptible to cefaclor. Ceclor/Ceclor DS has been shown to be active against most strains of the following organisms both in vitro and in clinical infections (see Indications and Dosage & Administration):
Aerobes, Gram-Positive Organisms: Staphylococci, including coagulase-positive and coagulase-negative, and penicillinase-producing strains (when tested by in vitro methods), exhibit cross-resistance between cefaclor and methicillin; Staphylococcus aureus (including β-lactamase-producing strains), Staphylococcus epidermidis (including β-lactamase-producing strains), Staphylococcus saprophyticus; Streptococcus pneumoniae, Streptococcus pyogenes (group A streptococci).
Note: Cefaclor is inactive against methicillin-resistant staphylococci.
Aerobes, Gram-Negative Organisms: Haemophilus parainfluenzae, Haemophilus influenzae (including β-lactamase-producing strains, ampicillin-resistant strains), Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains), Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis.
Cefaclor has been shown to be active in vitro against most strains of the following organisms; however, clinical efficacy has not been established:
Gram-Negative Organisms: Citrobacter diversus, Neisseria gonorrhoeae. Anaerobic Organisms: Propionibacterium acnes, Bacteroides spp (excluding Bacteroides fragilis), Peptococci, Peptostreptococci.
Note: Pseudomonas spp, Acinetobacter calcoaceticus, most strains of enterococci, Enterobacter spp, Morganella morgani, Providencia rettgeri, indole-positive Proteus and Serratia spp are resistant to cefaclor.
Susceptibility Testing: Diffusion Techniques: Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility of bacteria to antimicrobial agents. One such standard procedure is the National Committee for Clinical Laboratory Standards (NCCLS) approved procedure. This method has been recommended for use with disks to test susceptibility of organisms to cefaclor, using the 30-mcg cefaclor disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefaclor.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30-mcg cephalothin disk should be interpreted according to the following criteria: See Table 1.

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Although the spectrum of activity of cefaclor is qualitatively similar to that of cephalothin and of the other 1st-generation cephalosporins, its activity against H. influenzae is considerably greater than that of the 1st generation cephalosporins. For this reason, a disk containing 30 mcg of cefaclor may be used to determine the susceptibility of H. influenzae using the method described by NCCLS. In the testing of H. influenzae (on Mueller-Hinton agar supplemented with hemoglobin and commercial VX supplement) or other organisms, zone diameter interpretive criteria, are identical to those used for the cephalothin disk: ≥18 mm, susceptible; 15-17 mm, moderately susceptible (intermediate for Haemophilus); and ≤14 mm, resistant.
A report of 'Susceptible' indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of 'Moderately Susceptible' suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids in which high antibiotic levels are obtained. A report of 'Resistant' indicates that achievable concentration of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 30-mcg cefaclor disk should give the following zone diameters: See Table 2.

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Dilution Techniques: Use a standardized dilution method (broth, agar, microdilution) or equivalent with cefaclor powder. The MIC values obtained should be interpreted according to the following criteria: See Table 3.

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As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard cefaclor powder should provide the following MIC values: See Table 4.

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Indications/Uses
Treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A β-hemolytic streptococci and M. catarrhalis.
Lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, H. influenzae, S. pyogenes (group A β-hemolytic streptococci), M. catarrhalis.
Upper respiratory tract infections, including pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic Streptococci) and M. catarrhalis.
Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Amoxicillin has been recommended by the American Heart Association as the standard regimen for the prophylaxis of bacterial endocarditis for dental, oral and upper respiratory tract procedures, with penicillin V a rational and acceptable alternative in the prophylaxis against α-hemolytic streptococcal bacteremia in this setting. Ceclor is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing its efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present.
Urinary tract infections, including pyelonephritis and cystitis caused by E. coli, P. mirabilis, Klebsiella spp, and coagulase-negative staphylococci.
Cefaclor has been found to be effective in both acute and chronic urinary tract infections.
Pneumonia caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains) and M. catarrhalis (including β-lactamase-producing strains).
Skin and skin structures infections caused by S. aureus (including β-lactamase-producing strains), S. pyogenes (group A β-hemolytic streptococci) and S. epidermidis (including β-lactamase-producing strains).
Uncomplicated lower urinary tract infections, including pyelonephritis, cystitis and asymptomatic bacteriuria caused by E. coli, P. mirabilis, Klebsiella spp (K. pneumoniae), S. saprophyticus and coagulase-negative staphylococci.
Sinusitis and gonococcal urethritis.
Appropriate culture, bacteriologic studies and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
Dosage/Direction for Use
Cefaclor is administered orally.
Adults: Usual Dosage: 250 mg every 8 hrs.
Bronchitis and Pneumonia: 250 mg 3 times daily.
Sinusitis: Recommended Dosage: 500 mg 3 times daily for 10 days.
More Severe Infections (eg, pneumonia or those caused by less susceptible organisms): Doses may be doubled. Doses of 4 g/day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.
Treatment of Acute Gonococcal Urethritis in Males and Females: A single dose of 3 g combined with probenecid 1 g is given.
Children: Usual Recommended Dosage: 20 mg/kg/day in divided doses every 8 hrs.
Bronchitis and Pneumonia: 20 mg/kg/day in divided doses 3 times a day.
More Serious Infections, Sinusitis, Otitis Media and Infections Caused by Less Susceptible Organisms: Recommended Dosage: 40 mg/kg/day in divided doses, with a maximum dosage of 1 g/day.
Suspension: 125 mg/5 mL: Children 18 kg: 20 mg/kg/day (1 teaspoon 3 times a day); 9 kg: 20 mg/kg/day (½ teaspoon 3 times a day) or 40 mg/kg/day (1 teaspoon twice daily).
250 mg/5 mL: 18 kg: 20 mg/kg/day (½ teaspoon 3 times a day) or 40 mg/kg/day (1 teaspoon 3 times a day); 9 kg: 40 mg/kg/day (½ teaspoon 3 times a day).
Ceclor 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 β-hemolytic streptococcal infections, a therapeutic dosage of Ceclor should be administered for at least 10 days or as prescribed by the physician.
Overdosage
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. Overdosage of cephalosporins may cause seizure.
Treatment: In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in the 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.
Contraindications
Hypersensitivity to cefaclor and other cephalosporins.
Warnings
Before therapy with Ceclor is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. If Ceclor is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity, including anaphylaxis, among β-lactam antibiotics has been clearly documented. If an allergic reaction to cefaclor occurs, Ceclor should be discontinued and, if necessary, the patient should be treated with appropriate agents eg, pressor amines, epinephrine, antihistamines or corticosteroids and other emergency measures.
Antibiotics, including Ceclor, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.
Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
Special Precautions
General: Prolonged use of 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 cefaclor 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 should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3-2.8 hrs, 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.
Antibiotics, including cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Studies have not been performed to determine potential for carcinogenicity or mutagenicity. Reproduction studies have revealed no evidence of impaired fertility.
Use in pregnancy: Reproduction studies have been performed in mice and rats at doses up to 12 times the maximum human dose and in ferrets given 3 times the maximum human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ceclor should be used during pregnancy only if clearly needed.
The effect of cefaclor on labor and delivery is unknown.
Use in lactation: No studies have been done with Ceclor DS. Small amounts of cefaclor have been detected in mother's milk following administration of single 500-mg doses. Average levels were 0.18, 0.2, 0.21 and 0.16 mcg/mL at 2, 3, 4 and 5 hrs, respectively. Trace amounts were detected at 1 hr. The effect on nursing infants is not known. Caution should be exercised when administered to a nursing woman.
Use in children: Safety and effectiveness for use in infants <1 month and children have not been established.
Use In Pregnancy & Lactation
Use in pregnancy: Reproduction studies have been performed in mice and rats at doses up to 12 times the maximum human dose and in ferrets given 3 times the maximum human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ceclor should be used during pregnancy only if clearly needed.
The effect of cefaclor on labor and delivery is unknown.
Use in lactation: No studies have been done with Ceclor DS. Small amounts of cefaclor have been detected in mother's milk following administration of single 500-mg doses. Average levels were 0.18, 0.2, 0.21 and 0.16 mcg/mL at 2, 3, 4 and 5 hrs, respectively. Trace amounts were detected at 1 hr. The effect on nursing infants is not known. Caution should be exercised when administered to a nursing woman.
Adverse Reactions
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 <1 in 200 patients.
Cases of serum sickness-like reactions have been reported with the use of 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. While further investigation is ongoing, serum sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a 2nd (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children 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 children 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 (2-3 days) based on post-marketing 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 children. 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. Anaphylaxis may be more common in patients with a history of penicillin allergy.
Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70).
Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. 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 or vaginitis, moniliasis, angioedema and rarely, thrombocytopenia or reversible interstitial nephritis.
Causal Relationship Uncertain: CNS: Rarely, reversible hyperactivity, 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 as follows to serve as alerting information for the physician.
Hepatic: Slight elevations of AST (SGOT), ALT (SGPT) or alkaline phosphatase values (1 in 40).
Hematopoietic: As has also been reported with other β-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 cefaclor and Coumadin concomitantly.
Renal: Slight elevations in BUN or serum creatinine (<1 in 500) or abnormal urinalysis (<1 in 200). 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.
Drug Interactions
Patients receiving 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 Clinitest tablets but not with Tes-Tape (Glucose enzymatic test strip, USP, Lilly).
There have been rare reports of increased anticoagulant effect when cefaclor and oral anticoagulants were administered concomitantly (see Adverse Reactions).
As with other β-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid.
Storage
Store at temperatures not exceeding 30°C.
Suspension: Protect from light. The reconstituted suspensions will retain its potency for 14 days when kept in a refrigerator at 2-8°C.
Drops: Store at temperatures not exceeding 25°C.
MIMS Class
ATC Classification
J01DC04 - cefaclor ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Ceclor: Oral susp (strawberry-flavored, red) 125 mg/5 mL x 60 mL. Oral drops 50 mg/mL (strawberry-flavored, pink) x 20 mL. Ceclor-DS: Powd for oral susp 250 mg/5 mL x 60 mL.
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