Each capsule contains Cephalexin monohydrate equivalent to 500 mg of Cephalexin.
Excipients/Inactive Ingredients: Lactose monohydrate, Colloidal Silicon Dioxide, Magnesium stearate.
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms.
1. Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin in the subsequent prevention of rheumatic fever are not available at present).
2. Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis.
3. Skin and skin structure infections caused by staphylococci and/or streptococci.
4. Bone infections caused by staphylococci and/or P. mirabilis.
5. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.
Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
Cephalexin is administered orally.
Adults: The adult dosage ranges from 1 to 4 g daily in divided doses.
The usual adult dose is 250 mg every 6 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 organisms, larger doses may be needed. If daily doses of Cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients: The 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 severe infections, the dosage may be doubled.
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 β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Before cephalexin therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins and penicillin.
Cephalosporin c derivatives should be given cautiously to penicillin-sensitive patients.
Serious acute hypersensitivity reactions may require epinephrine and other emergency measures.
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to Cephalexin.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients which diarrhea subsequent to the administration of antibacterial agent.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated colitis.
After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
General: Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Cephalexin 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 Cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.
Cephalexin should be administered with caution in the presence of markedly impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
As a result of administration of Cephalexin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions and also with Clinitest tablets.
As with other β-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.
Use in pregnancy: Safety of this product for use during pregnancy has not been established.
Pregnancy: Pregnancy Category B - The daily oral administration of cephalexin to rats in doses of 250 or 500 mg/kg prior to and during pregnancy, or to rats and mice during the period of organogenesis only had no adverse effect on fertility, fetal viability, fetal weight, or litter size. Note that the safety of cephalexin during pregnancy in humans has not been established.
Cephalexin showed no enhanced toxicity in weanling and newborn rats as compared with adult animals. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cephalexin should be used during pregnancy only if clearly needed.
Nursing mothers: The excretion of cephalexin in the milk increased up to 4 hours after a 500-mg dose; the drug reached a maximum level of 4 μg/mL, then decreased gradually, and had disappeared 8 hours after administration. Caution should be exercised when cephalexin is administered to a nursing woman.
Gastrointestinal: Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side effect has been diarrhea. It was very rarely severe enough to warrant cessation of therapy.
Abdominal pain, gastritis, and dyspepsia have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.
Hypersensitivity: Allergic reactions in the form of rash, urticaria, angioedema, and rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. In some of these reactions, supportive therapy may be necessary.
Anaphylaxis has also been reported.
Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Eosinophilia neutropenia, thrombocytopenia, slight elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported.
Concurrent administration of Probenecid inhibits excretion of cephalexin and increases the serum levels by 50-100%.
J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Cap 500 mg (dark grey-caramel coloured, No "0" hard capsule, "STADA" and "500" imprinted on body and cap containing white to off-white powder) x 100's.