-
Therapeutic Category
- BETA-LACTAM ANTIBIOTICS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Capsules
- Composition : Cephalexin ( Monohydrate ) 250 mg / Cap
- Active Substance : Cephalexin
PROPERTIES:
Keflixine (Cephalexin) is a semisynthetic cephalosporin antibiotic intended for oral administration.
Clinical Pharmacology:
Keflixine is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 μg/mL respectively were obtained at 1 hour. Cephalexin is excreted in the urine by glomerular ltration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations
following the 250 mg, 500 mg, and 1 g doses were approximately 1,000, 2,200, and 5,000 μg/mL respectively
Microbiology:
-In vitro tests demonstrate that the cephalosporin is bactericidal because of their inhibition of cell-wall synthesis. Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the indications and usage section.
Aerobic Gram-positive microorganisms:
Staphylococcus aureus (including penicillinase-producing strains)
Staphylococcus epidermidis (penicillin-susceptible strains)
Streptococcus pneumoniae
Streptococcus pyogenes
Aerobic Gram-negative microorganisms:
Escherichia coli
Haemophilus inuenzae
Klebsiella pneumoniae
Moraxella (Branhamella) catarrhalis
Proteus mirabilis
Note -Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis [formerly Streptococcus faecalis]) are resistant to cephalosporins, including cephalexin. It is not active against most strains of Enterobacter spp, Morganella morganii, and Proteus vulgaris. It has no activity against Pseudomonas spp
INDICATIONS AND USAGE:
Keflixine is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections, Otitis media, Skin and skin structure infections, Bone infections, genitourinary tract infections.
Note -Culture and susceptibility tests should be initiated prior to and during therapy.
Renal function studies should be performed when indicated.
CONTRAINDICATIONS:
Keflixine is contraindicated in patients with known allergy to the cephalosporin group of antibiotics
WARNINGS:
*Before cephalexin therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins and penicillin.
*Cephalosporin derivatives should be given cautiously to penicillin-sensitive patients
*Serious acute hypersensitivity reactions may require epinephrine and other emergency measures.
*Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously
*Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening. erefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents.
*Treatment with antibacterial agents alters the normal ora of the colon and may permit overgrowth of clostridia .
*After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated.
In moderate to severe cases, consideration should be given to management with uids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically eective against Clostridium dicile colitis.
PRECAUTIONS:
General -Patients should be followed carefully so that any side eects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Keixine occurs, the drug should be discontinued and the patient treated with the usual agents (eg, epinephrine or other pressor amines, antihistamines, or corticosteroids )
*Prolonged use of Keixine may result in the overgrowth of nonsusceptible organisms.
Careful observation of the patient is essential.
*Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics
*Keixine should be administered with caution in the presence of markedly impaired renal function
*As a result of administration of Keixine, a false-positive reaction for glucose in the
urine may occur. is has been observed with Benedict’s and Fehling’s solutions
*As with other (beta)-lactams, the renal excretion of cephalexin is inhibited by probenecid.
*Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Usage in Pregnancy: Safety of this product for use during pregnancy has not been
established.
Nursing Mothers: Caution should be exercised when Keixine is administered to a nursing woman.
Pediatric Use: Safety and eectiveness of this product for use in infants less than 1
month of age have not been established.
ADVERSE REACTIONS:
Gastrointestinal : Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely.
most frequent side eect has been diarrhea
Hypersensitivity : Allergic reactions in the form of rash, urticaria, angioedema, and these reactions usually subsided upon discontinuation of the drug over dosage
Over dosage: (Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary.
Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more eective than emesis or lavage.
DOSAGE AND ADMINISTRATION :
Adults: usual adult dose is 250 mg every 6 hours or 500 mg every 12 hours.
For the following infections, a dosage of 500 mg may be administered every 12 hours:
Streptococcal pharyngitis, skin and skin structure infections and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days.
For more severe infections or those caused by less susceptible organism.
Pediatric patients: usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of (beta)-hemolytic streptococcal infections, a therapeutic dosage of Keixine should be administered for at least 10 days.
STORAGE CONDITION :
CAPSULES : Store below 25 C
PACKING:
Keflixine 250 capsule: Box of 20 capsules
Keflixine 500 capsule: Box of 20 capsules.