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Cephalexin

AXCEL CEPHALEXIN-250 CAPSULES COMPOSITION
Each capsule contains
Cephalexin Monohydrate
equivalent to Cephalexin 250mg

PRESENTATION
Pink / ruby red hard gelatin capsule, size 2.

AXCEL CEPHALEXIN-500 CAPSULES COMPOSITION
Each capsule contains
Cephalexin Monohydrate
equivalent to Cephalexin 500mg

PRESENTATION
Pink / purple hard gelatin capsule, size 0.

INDICATIONS
Treatment of infections caused by susceptible bacteria:
Respiratory tract infection: acute and chronic bronchitis and infected bronchiectasis. Ear, nose and throat infections: otitis media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis. Urinary tract infections: acute and chronic pyelonephritis, cystitis and protatitis. Prophylaxis of recurrent urinary tract infection. Gynaecological and obstetric infections. Skin, soft-tissue and bone infections. Gonorrhoea (when Penicillin is not suitable). Dental procedures: treatment of dental infections. As prophylaxis treatment for patients with heart disease undergoing dental treatment as an alternative to penicillin.

PHARMACOLOGY
Cephalexin is almost completely absorbed from the gastrointestinal tract. If cephalexin is taken with food, absorption may be delayed, but the total amount absorbed is not appreciably altered. It is widely distributed in the body but does not enter the cerebrospinal fluids in significant quantities. It is not metabolised. About 80% or more of a dose is excreted unchanged in the urine.

DOSAGE AND ADMINISTRATION
For oral administration only.
Adult
Many infections in adults will respond to oral dosage of 1 gram to 2 grams per day in divided doses; however, for most infections, the following simple scheme will be found satisfactory:

Adult and children over 12 years: 500mg three times daily.
To aid compliance, especially in ambulatory patients, the daily dosage may be given in two equal doses, e.g. 1g twice daily in adults with urinary tract infections.

For severe or deep seated infections, especially when less sensitive organisms are involves, the dosage should be increased to g three times daily or 1.5g four times daily.

Children
Normal recommended dose for children: 25 - 60mg/kg/day.
For chronic, severe or deep seated infections, this should be increased to 100mg/kg/day (maximum 4g/day).
0 to 1 year : 25 to 60mg/kg/day
1 to 2 years : 62.5 to 125mg four times daily or 125 to 250mg twice daily.
3 to 6 years : 125 to 250mg four times daily or 250 to 500mg twice daily.
7 to 12 years: 250 to 500mg four times daily or 500mg to 1g twice daily.
It is recommended to take Axcel Cephalexin-125 Suspension for dosage below 250mg.

Duration of treatment
For most acute infections, treatment should continue for at least two days after signs have returned to normal and symptoms have subsided, but in chronic, recurrent or complicated urinary tract infections, treatment for two weeks (giving 500mg four times daily) is recommended.

The standard recommended dosage should be halved for patients with severe renal impairment (creatinine clearance < 10ml/min). The maximum recommended dosages (i.e. adults 6g / day, children 4g/day) should be reduced by 50% in mild, 75% in moderate and 87.5% in severe renal failure. Adult patients receiving intermittent dialysis should be given an additional 500mg cephalexin after each dialysis, i.e. total dosage up to g on that day. Children should receive an additional 8mg per day.

CONTRAINDICATION
Contraindicated in patient hypersensitive to cephalosporin.

PRECAUTION
Cephalexin should be used with caution for patient with penicillin sensitivity. False positive urinary glucose and false positive Combs' test have been found during the treatment of Cephalexin. Patients with renal impairment should be given with caution.

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 with diarrhea subsequent to the administration of cephalexin.

 

Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patients is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Use in Pregnancy and Lactation
Cephalexin is widely distributed in the body. It crosses the placenta and small quantities are found in the milk of nursing mother. Caution should be taken while given to pregnant women and nursing mothers.

SIDE EFFECTS
The most common side effects of cephalexin are generally gastrointestinal disturbances and hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness and anaphylaxis.

DRUG INTERACTIONS
Cephalexin decreases the efficacy of oestrogen containing oral contraceptives. The concomitant use of probenecid will reduce the excretion of cephalexin; nephrotoxic drug such as aminoglycoside antibiotic-gentamicin may increase the risk of kidney damage with cephalexin. Concomitant use with loop diuretic-frusemide may enhance nephrotoxicity.

OVERDOSAGE AND TREATMENT
No undesirable side effects are expected due to overdosage when taken orally. These can be removed by haemodialysis or peritoneal dialysis.

STORAGE
Keep container well closed. Store below 30C. Protect from light.

PACK QUANTITIES
Axcel Cephalexin - 250 Capsule: Available in blister pack of 10 x 10's.
Axcel Cephalexin - 500 Capsule: Available in blister pack of 10 x 10's.

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