CEPHAL-X 250 mg  

Cephalexin

Cap. 250 mg

Cefal-X^® (Cefalexin)

Description

Cefal-X^® is a semisynthetic cephalosporin antibiotic intended for oral administration.

Clinical pharmacology

Cefal-X^® is similar to cephalosporins in its bactericidal action because of their inhibition of cell-wall synthesis. Cefalexin has been shown to be active against most strains of the following microorganisms.

Antibacterial activity

Aerobes, Gram-positive:

Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis (penicillin-susceptible strains), Streptococcus pneumoniae Streptococcus pyogenes.

Aerobes, Gram-negative:

Escherichia coli, Haemophilus influenza Klebsiella pneumonia,Moraxella (Branhamella) catarrhalis, Proteus mirabilis.

Note --Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis [formerly Streptococcus faecalis  ]) are resistant to cephalosporins, including cefalexin. It is not active against most strains of Enterobacter spp, Morganella morganii and Proteus vulgaris. It has no activity against Pseudomonas spp or Acinetobacter calcoaceticus.

Pharmacokinetics

Oral absorption rapidly

Presystemic metabolism ----

Plasma half – life range 61.3 min

Volume of distribution 0.31.kg^-1

Plasma protein binding Up to 15%

Indication

1- Respiratory tract infections

2- Bone infections

3- Skin and skin structure infections

4- Otitis media

5- Genitourinary tract infections

Contraindication

Cefal-X^® is contraindicated in patients with known allergy to the cephalosporin group of antibiotics

Precaution

· If an allergic reaction to Cefalexin occurs, the drug should be discontinued and the patient treated with the usual agents (eg, epinephrine or other pressor amines, antihistamines, or corticosteroids).

· The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, cefalexin should be discontinued and appropriate therapy instituted.

· Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics.

· Cefal-X^® should be administered with caution in the presence of markedly impaired renal function.

· Indicated surgical procedures should be performed in conjunction with antibiotic therapy

· Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Pregnancy

Pregnancy category B.

Adequate and well-controlled studies in humans have not been done; this drug should be used during pregnancy only if clearly needed.

Breast feeding

Cefal-X^® is secreted in human milk. Caution should be exercised when Cefal-X^® is administered to a nursing mother.

Dosage

Usual adult and adolescent dose

· Respiratory tract infections: Oral, 500 mg every 12 hours.

· Skin/Skin Structure: 500 mg every 12 hours.

· Otitis media: 75 to 100 mg/kg/day in 4 divided doses are required.

· Uncomplicated cystitis: over 15 years of age, 500 mg every 12 hours for 7 to 14 days.

· Endocarditis, prophylaxis: oral , 2 g as a single dose one hour prior to the start of surgery.

· For all other infections:

Mild to moderate: oral, 250 mg every six hours

Severe: oral, up to 1 gram every six hours

Usual adult prescribing limits:

4 grams per day

Usual pediatric dose:

This dosage form usually is not used for children

Usual geriatric dose:

See usual adult and adolescent

Note:

· If daily doses of Cefalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

· In the treatment of (beta)-hemolytic streptococcal infections, a therapeutic dosage of Cefalexin should be administered for at least 10 days.

Patient consultation

· Consult with your physician if you have sensitivity to Cephalosporins , or any other medications

· Tell your doctor if you have or have ever had kidney disease, allergies, asthma,

· If you missed a dose, take it as soon as possible, don't take if it is almost time for next dose, don’t double dose.

· Continue medicine for full time of treatment.

· Check with your physician if condition does not improve or worsens.

Warning

· Before initiating therapy with Cefal-X^®, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Cefal-X^® should be discontinued and appropriate therapy instituted.

· pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefalexin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Interaction

· Probenecid decreases the renal tubular secretion of cefalexin. Concurrent use of amoxicillin and Probenecid may result in increased and prolonged blood levels of cefalexin.

· Cefal-X^® decrease the efficacy of estrogen-containing oral contraceptives, and recommended that additional contraceptive precautions should be used while taking , and for 7 days after stopping, a short course of any broad-spectrum antibacterial Laboratory value alteration

High urine concentrations of Cefalexin may result in false-positive reactions when testing for the presence of glucose in urine using clinitest^®, benedict's solution or fehling's solution.