Product Description.:
West- Ward, 986
capsule , gray purple , oblong oblong
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceclor and other antibacterial drugs, Ceclor should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DRUG DESCRIPTION
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.
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.
INDICATIONS
Ceclor 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 is generally effective in the eradication of streptococci from the nasopharynx however, substantial data establishing the efficacy of Ceclor 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 and other antibacterial drugs, Ceclor 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.
SIDE EFFECTS
Adverse effects considered to be related to therapy with Ceclor 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. 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. 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%
