Cefex           Film Coated Tablets

Cefadroxil monohydrate 1g

 

Usage and indications:

Cefex is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

  • Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
  • Skin and skin structure infections caused by staphylococci and/or streptococci.
  • Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).

Dosage and administration: 

Adults

  • Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e. cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).  For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).
  • Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).
  • Pharyngitis and Tonsillitis: For the treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis, 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

Children

  • For urinary tract infections:  the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours.
  • For pharyngitis, tonsillitis, and impetigo: the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours.
  • For other skin and skin structure infections: the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours.
  • In the treatment of beta-hemolytic streptococcal infections: a therapeutic dosage of Cefex should be administered for at least 10 days.

Undesirable effects:

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred.    

Hypersensitivity

Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed.

These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.

Warnings and precautions:  

Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam medicinal products because patients hypersensitive to these medicines may be hypersensitive to Cefex as well (cross- allergy).  If an allergic reaction to cefadroxil monohydrate occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefadroxil, and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicated that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis’’. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against Clostridium difficile.

Pack: box of 6 tablets.

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