Safexin 125
SAFEXIN-125
Cephalexin 125 mg BP
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COMPOSITION
Each 5 ml. when reconstituted with water contains:
Cephalexln BP equivalent to Cephalexin anhydrous base : 125 mg
Excipients: Q.S.
Colour: Tartrazine & Brilliant Blue FCF
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INDICATIONS & USAGE
- Respiratory tract infections caused by S.pneumoniae S.pyogense.
- Otitis Media due to S.pneumoniae, H.influenzae, Streptococcia, and M.catarrhalis.
- Skin & Skin structure Infection caused by Staphylococci and streptococci.
- Bone infections caused by Stephylococci, P.mirabillis.
- Genitourinary tract infections including acute prostatitis caused by E.coli, P.mirabillis and K.pneumoniae
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CONTRAINDICATIONS
Cephalexin is contraindicated in patients with known allergy to cephalosporins. Care is necessary in treating patients with a history of sensitivity to penicillins or with a known history of allergy.
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PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following dose of 250 mg,500mg. and 1g, average peak werum levels of approximately 9,18 and 32 ug/ml respectively were obtained at 1 hour. Measurable levels were present 6 hour after administration.
Cephalexin is excreted in the urine by glomerular filtration 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 1g dose were approximately 1,000, 2,200 and 5000 ug/ml respectively.
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PHARMACOKINETICS
Cephalexin is almost completely absorbed from the gastrointestinal track and produce a pick plasma concentration of about 18 ug per ml. One hour after a 500mg oral dose, doubling the dose doubles the peak concentration.
If cephalexin is taken with food, absorption may be delayed, but the total amount absorbed is not appreciably altered. Up to 15% of a dose is bound to plasma proteins. The plasma half-life is about 1 hour, it increases with reduced renal function.
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TOXICOLOGY
Nephrotoxicity has been reported with cephalexin although it is less toxic than cephaloridine. Acute renal tubular necrosis has followed excessive dosage and has also been associated with its use in older patients of those with pre-existing renal impairment, or with the concomitant administration of nephrotoxic drugs such as aminoglycoside antibiotics.
Acute intersititial nephritis is also a possibility as a manifestation of hypersensitivity.
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DOSAGE & ADMINISTRATION
Children: 5-15 years:
25-50 mg/kg body weight daily in divided dosage.Direction for reconstitution:
Add freshly boiled & cooled water up to the mark. Shake vigorously. Adjust the volume with water up to the mark if required.The reconstituted suspension should be stored in refrigerator at a temperature between 2? to 8?C and used within one weak constitution.
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STORAGE
Store below 25?C.
Protect from light. -
NAFDAC REG. NO.
04-8980