KEFLEX- cephalexin capsule
Pragma Pharmaceuticals, LLC
KEFLEX is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
KEFLEX is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella catarrhalis.
KEFLEX is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
KEFLEX is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
KEFLEX is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis , and Klebsiella pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KEFLEX and other antibacterial drugs, KEFLEX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
The usual dose of oral KEFLEX is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.
For more severe infections larger doses of oral KEFLEX may be needed, up to 4 grams daily in two to four equally divided doses.
The recommended total daily dose of oral KEFLEX for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.
For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.
2.3 Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age with Renal Impairment
*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.
|Renal function||Dose regimen recommendation|
|Creatinine clearance ≥ 60 mL/min||No dose adjustment|
|Creatinine clearance 30 to 59 mL/min||No dose adjustment; maximum daily dose should not exceed 1 g|
|Creatinine clearance 15 to 29 mL/min||250 mg, every 8 hours or every 12 hours|
|Creatinine clearance 5 to 14 mL/min not yet on dialysis*||250 mg, every 24 hours|
|Creatinine clearance 1 to 4 mL/min not yet on dialysis*||250 mg, every 48 hours or every 60 hours|
250 mg capsules: a white to light yellow powder filled into an opaque white and opaque dark green capsule that is imprinted with KEFLEX 250 mg in edible black ink on the white body.
500 mg capsules: a white to light yellow powder filled into an opaque light green and opaque dark green capsule that is imprinted with KEFLEX 500 mg in edible black ink on the light green body.
750 mg capsules: a white to light yellow powder filled into an elongated opaque dark green and opaque dark green capsule that is imprinted KEFLEX 750 mg in edible white ink on the dark green body.
KEFLEX is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of KEFLEX. Before therapy with KEFLEX is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to KEFLEX occurs, discontinue the drug and institute appropriate treatment.
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KEFLEX, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue KEFLEX. Anticonvulsant therapy can be given if clinically indicated.
Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.
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