Dexadrox 500 mg

Indonesia • Dexa Medica

Indication

Cefadroxil are 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, 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).

Note:

  • Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever.
  • Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
  • Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

Composition

Each capsule contains:
Cefadroxil monohydrate equivalent to cefadroxil 500 mg.

Package

Box, 10 strips x 10 capsules

Dosage Forms

Capsule

ATC Classification

J01D

Warning

Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Consult Your Doctor
Safety of this item for use during pregnancy has not been established. Please consult your doctor.
Lactation
Consult Your Doctor
Safety of this item for use during lactation has not been established. Please consult your doctor.
Precaution
  • Before therapy with cefadroxil is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefadroxil, cephalosporins, penicillins, or other drugs.
  • Caution should be exercised to penicillin-sensitive patients because of the possibility of cross-sensitivity among beta-lactam antibiotic.
  • If an allergic reaction to cefadroxil 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.
  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefadroxil, and may range in severity from mild diarrhea to fatal colitis.
  • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile that produces toxins A and B which contribute to the development of CDAD. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile (i.e., oral metronidazole or vancomycin), and surgical evaluation should be instituted as clinically indicated.

Dosage

Adults
Urinary tract infections:

  • For uncomplicated lower urinary tract infections (i.e., cystitis): 1-2 g per day given in single or 2 divided doses.
  • For all other urinary tract infections: 2 g per day given in 2 divided doses.

Skin and soft tissue infections:
1 g per day in single or 2 divided dose.

Pharyngitis and tonsillitis:
Treatment of group A beta-hemolytic streptococcal: 1 g per day given in single or 2 divided doses for 10 days.

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

* For detailed product information, see package insert.
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