ANDAORALFOR SUSPENSION
Approved
Jul 2007
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
9
Mechanism of Action
12.1 Mechanism of Action Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( )] . 12.3 Pharmacokinetics Absorption: Cephalexin is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and…
Indications (21)
the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( ) Otitis media ( ) Skinskin structure infections ( ) Bone infections ( ) Genitourinary tract infections ( ) To reduce the development of drug-resistant bacteriamaintain the effectiveness of Cephalexin for oral suspensionother antibacterial drugsCephalexin for oral suspensionUSP should be used only to treat infectionsstrongly suspected to be caused by bacteriarespiratory tract infections caused by susceptible isolates of Streptococcus pneumoniaeStreptococcus pyogenesotitis media caused by susceptible isolates of Streptococcus pneumoniaeHaemophilus influenzaeStaphylococcus aureusMoraxella catarrhalisskinskin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureusbone infections caused by susceptible isolates of Staphylococcus aureusProteus mirabilisgenitourinary tract infectionsincluding acute prostatitiscaused by susceptible isolates of Escherichia coliKlebsiella pneumoniae
Clinical Trials (5)
A Study of Cephalexin Liquid in Healthy Participants
Started Jul 2015
28 enrolled
Healthy
A Study of Cephalexin Suspension in Healthy Participants
Started May 2014
28 enrolled
Healthy Volunteers
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Started May 2014
28 enrolled
Healthy Volunteers
A Study of Cephalexin Capsules in Healthy Participants
Started Apr 2014
28 enrolled
Healthy Volunteers
A Study of Cephalexin in Healthy Participants
Started Apr 2014
28 enrolled
Healthy Volunteers