Cefalex 500 (200 capsules)

INSTRUCTION FOR US

DOSAGE AND ADMINISTRATION

Administration: 

For oral use. The capsule should be taken on an empty stomach, 1 hour before meals.

Dosage:

Adults: 

- The adult dosage ranges from 1-4 g daily in divided doses

- Most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250 mg every 6 hours, or 500 mg every 12 hours. 

- For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cefalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered. 

The elderly and patients with impaired renal function: 

As for adults. Reduce dosage if renal function is markedly impaired (according to creatinin clearance)

(*) Lacking of information about dosage adjustment for patients undergoing hemodialysis.

Paediatric population: 

- The usual recommended daily dosage for children is 25-50 mg/kg (10-20 mg/lb) in divided doses. 

- For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours. 

For most infections the following schedule is suggested: 

- Children under 5 years: 125 mg every 8 hours. Granules for oral suspension is considered for correctly dose division. 

- Children 5 years and over: 250 mg every 8 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 beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.

CONTRAINDICATIONS

- Hypersensitivity to cephalexin or to any of the ingredients.

- Cefalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS AND PRECAUTIONS

Precautions for use 

- Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins or other drugs. Cefalexin should be given cautiously to penicillin-sensitive patients. There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs. 

- Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semisynthetic penicillins and cephalosporins. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken. 

- If an allergic reaction to cefalexin occurs, the drug should be discontinued and the patient treated with the appropriate agents. 

- Prolonged use of cefalexin 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. 

- Cefalexin should be administered with caution in the presence of markedly impaired renal function. Careful clinical and laboratory studies should be made because safe dosage may be lower than that usually recommended. 

- Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In haematological 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 recognised that a positive Coombs' test may be due to the drug. 

- A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets. 

- Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered. Most of these reactions occurred most likely in the first week during treatment.

Precautions with excipients

CEFALEX 250

- Product contains Ponceau 4R, which may cause allergy reactions.

CEFALEX 500

- Product contains FD&CYellow 6, which may cause allergy reactions.

SHELF-LIFE 

36 months from the manufacturing date.

Box of 01 bottle x 200 capsules.