Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Cefaclor (UNII: 69K7K19H4L) (Cefaclor Anhydrous - UNII:3Z6FS3IK0K)
Carlsbad Technology, Inc.
Cefaclor
Cefaclor Anhydrous 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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. Cefac
Cefaclor Oral Suspension, USP, is supplied in bottles with child-resistant caps as: 125 mg/5 mL strawberry flavor: NDC 61442-173-02 (75-mL size) NDC 61442-173-01 (150-mL size) 187 mg/5 mL strawberry flavor NDC 61442-174-02 (50-mL size) NDC 61442-174-01 (100-mL size) 250 mg/5 mL strawberry flavor NDC 61442-175-02 (75-mL size) NDC 61442-175-01 (150-mL size) 375 mg/5 mL strawberry flavor NDC 61442-176-02 (50-mL size) NDC 61442-176-01 (100-mL size) 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 dry powder at 20∘to 25℃ (68∘to 77℉). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CEFACLOR- CEFACLOR SUSPENSION CARLSBAD TECHNOLOGY, INC. ---------- CEFACLOR FOR ORAL SUSPENSION, USP Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor for Oral Suspension, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION 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 C H ClN O S•H O and the molecular weight is 385.82. After mixing, each 5 mL of Cefaclor 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 methylcellulose, sodium lauryl sulfate, sucrose, and xanthan gum, FD&C Red No. 40, strawberry flavor. The color of drug powder in the dry powder state is white to off-white. After reconstitution, it turns to a red suspension. CLINICAL PHARMACOLOGY 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% to 75% of that observed when the drug is administered to fasting subjects and generally appears from three fourths to 1 hour 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 mcg/mL, respectively, were obtained within 30 to 60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations following the 250 mg, 500 mg and 1 g doses were approximately 600, 900 and 1,900 mcg/mL, respectively. The ser Leggi il documento completo