Zeporin

Zeporin

cefalexin

Manufacturer:

Drugmaker's Lab

Distributor:

Pharma Dynamic
Full Prescribing Info
Contents
Cefalexin monohydrate.
Description
Capsule: Each capsule contains: Cefalexin (as monohydrate) 500 mg.
Powder for Suspension: Each 5 mL contains: Cefalexin (as monohydrate) 250 mg.
Oral Drops: When reconstituted each 1 mL contains: Cefalexin (as monohydrate) 100 mg.
Action
Pharmacology: Cefalexin is a bactericidal and has antimicrobial activity against both Gram-positive and Gram-negative organisms.
Pharmacokinetics: Cefalexin is completely absorbed after oral administration either with or without food and rapidly excreted in the urine. Recovery in the urine of 70-100% of the drug given orally indicates virtually complete absorption. After an oral dose of 250 mg, Cefalexin (Zeporin) achieves the therapeutic urine concentrations. Therefore, increased doses are not required unless high plasma levels are considered necessary. It provides more than adequate antibacterial activity in body fluids and tissues. Taken orally, the serum concentration of this drug is found to be equal or greater than those resulting from comparable intramuscular doses of cephalotin or cephaloridine. It allows a wider margin of safety. Doses of 250-500 mg administered every 6 hours do not produce evidence of accumulation of the drug or signs of toxicity.
Microbiology: In vitro tests demonstrate that the cephalosporins are bactericidal because they inhibit cell wall synthesis. Cefalexin is active against the following organisms in vitro beta hemolytic Streptococci, including coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella sp., Neiserria catarrhalis, some strains of Haemophilus influenzae. Note: Most strains of Enterococci (Streptococcus faecalis) and a few strains of Staphylococci are resistant to cefalexin. It is not active against most strains of Enterobacter sp., Pr. morganil and Pr. vulgaris. It has no activity against Pseudomonas or Herella species. When tested by in vitro methods, staphylococci exhibit cross resistance between cefalexin and methicillin type antibiotics.
Indications/Uses
Infections caused by susceptible organisms in the respiratory and urinary tracts, and in skin and soft tissues. Infections which commonly respond well to treatment with cefalexin include cellulitis. Subcutaneous abscesses and wound infections due to Staphylococci, Pneumonia and broncho-pneumonia due to Diplococcus pneumoniae and in acute and chronic infections of the urinary tract, e.g. cystitis, pyelonephiritis, and bacteriuria due to susceptible organisms, especially strains of Escherichia coli, Proteus mirabilis and species of Klebsiella.
Dosage/Direction for Use
Capsule: Cefalexin is administered orally. The usual dose for adults is 1 to 2 g daily given in divided doses at 6-, 8- or 12- hourly intervals; in severe or deep-seated infections the dose can be increased up to 6 daily but when high doses are required the use of parenteral cephalosporin should be considered. For streptococcal pharyngitis or tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections: 500 mg may be administered every 12 hours. Children may be given 25 to 100 mg per kg body-weight daily in divided doses to a maximum of 4 g daily. For streptococcal pharyngitis or tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections, the total daily dose may be divided and administered every 12 hours.
Doses may need to be reduced in severe renal impairment.
Powder for Suspension: Usual adult dose: 250 mg every 6 hours. For streptococcal pharyngitis or tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections: 500 mg may be administered every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses greater than 6 g are required, parental cephalosporins, in appropriate doses should be considered. Children: Usual recommended daily dose: 25-100 mg/kg body weight to a maximum of 4 g daily in divided doses. For streptococcal pharyngitis and tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections, the total daily dose may be divided and administered every 12 hours.
Child's Weight: 10 kg: 1/2 to 1 teaspoonful (2.5 to 5 mL); 20 kg: 1 to 2 teaspoonfuls (5 to 10 mL); 40 kg: 2 to 4 teaspoonfuls (10 to 20 mL).
(To be taken 4 times a day or as prescribed by the physician) or,
10 kg: 1 to 2 teaspoonfuls (5 to 10 mL); 20 kg: 2 to 4 teaspoonfuls (10 to 20 mL); 40 kg: 4 to 8 teaspoonfuls (20 to 40 mL).
(To be taken 2 times a day or as prescribed by the physician.)
In severe infections, The dosage may be doubled. In the therapy of otitis media, Clinical studies have shown that a dosage of 75-100 mg/kg/day in 4 divided doses is required. In the treatment of beta-hemolytic streptococcal infections a therapeutic dose should be administered for at least 10 days. Dosage upon the discretion of the physician may also be administered.
Oral Drops: Cefalexin is administered orally. Usual adult dose: 250 mg every 6 hours. For streptococcal pharyngitis or tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue infections: 500 mg may be administered every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses greater than 6 g are required, parental cephalosporins, in appropriate doses should be considered. Children: Usual recommended daily dose: 25-100 mg/kg body weight to a maximum of 4 g daily in divided doses. For streptococcal pharyngitis and tonsillitis, mild uncomplicated urinary tract infections, and skin and soft tissue 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 75-100 mg/kg/day in divided doses is required. In the treatment of beta-hemolytic streptococcal infections a therapeutic dose should be administered for at least 10 days.
Contraindications
Hypersensitivity to cephalosporin antibiotics.
Warnings
Before cefalexin therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporin and penicillin. Cephalosporin C derivatives should be given cautiously in penicillin-sensitive patients. There is some evidence of partial cross allergenicity of the penicillin and cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Special Precautions
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergenic reaction occurs the drug should be discontinued and the patient treated. Prolonged use may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coomb's tests have been reported during treatment with cephalosporin antibiotics. In haematological studies or in transfusion cross matching procedures when antiglobulin tests are performed on the minor side or in Coomb's testing of newborns whose mothers have received cephalosporins antibiotics before parturition, it should be recognized that a positive Coomb's test may be due to the drug. Cefalexin 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. Indicate surgical procedures should be performed in conjunction with antibiotic therapy. As a result of administration of cefalexin, a false positive reaction of glucose in the urine may occur. This has been observed with Benedict and Fehlings solutions and also with Clinitest tablets, but not with Test-Tape. The quantitative determination of urinary protein using strong acids is misleading during therapy as precipitation of cefalexin in the urine may occur.
Use In Pregnancy & Lactation
Use in Pregnancy: Safety of Zeporin for use during pregnancy has not been established.
Adverse Reactions
Gastrointestinal: The most frequent side effect has been diarrhea. It was rarely severe enough to warrant cessation of therapy. Nausea, vomiting, dyspepsia and abdominal pain have also occurred. As with other broad spectrum antibiotics, colitis including rare instances of Pseudomembraneous colitis has been reported in conjunction with cefalexin therapy.
Hypersensitivity: Allergies in the form of rash, urticaria and angioedema have been observed, this reactions usually subsides during discontinuation of the drug. Anaphylaxis has also been reported.
Others: Other reactions include genital and anal pruritus, genital moniliasis, vaginitis vaginal discharge, dizziness, fatigue, and headache. Eosinophilia, neutropenia and slight elevations in AST and ALT have been reported.
Caution For Usage
Directions for Reconstitution: Shake the bottle to loosen the powder prior to reconstitution.
Shake well before using.
Powder for Suspension: To reconstitute add 47 mL of water. Invert and shake until all powders are evenly suspended. Following reconstitution, the oral suspension is stable for 7 days at room temperature (30°C) or 14 days under refrigeration (2°C-8°C).
Oral Drops: To reconstitute add 7 mL of water. Invert and shake until all powders are evenly suspended. Following reconstitution, the oral drops is stable for 7 days at room temperature (30°C) or 14 days under refrigeration (2°C-8°C). Shake well before using.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 500 mg x 50's. Oral suspension 250 mg/5 mL x 60 mL. Oral drops 100 mg/mL x 10 mL.
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