CEDROX 500 (cap)
-
Chemical Name:
Cefadroxil -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin (First Generation) -
Pharmaceutical Form:
Capsules -
Composition:
Cefadroxil ( as Monohydrate ) 500mg
CEDROX
Capsules, Dry Powder for Oral Suspension
Cefadroxil Monohydrate
1.PROPERTIES:
CEDROX (Cefadroxil) is a semisynthetic first generation cephalosporin antibiotic intended for oral administration. In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of bacterial cell wall synthesis. CEDROX has been shown to be active against the following organisms in vitro: Beta-hemolytic Streptococci, Streptococcus (Diplococcus) pneumonia, Staphylococci including penicillinase-producing strains, Escherichia coli, Proteus mirabilis, Klebsiella species, Moraxella (Branhamella) catarrhalis, Bacteroides species (excluding Bacteroids fragillis), other strains of sensitive gram-negative organisms include some strains of Haemophilus influenzae, Salmonella species and Shigella species.
2.PHARMACOKINETICS:
CEDROX (Cefadroxil) is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 µg/ml, respectively. Measurable levels were present 12 hours after administration. Over 90 % of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 µg/ml during the period following a single 500-mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil urinary concentration. The urine antibiotic concentration, following a 1 gram dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.
3.INDICATIONS:
CEDROX is indicated in the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
- Upper and lower respiratory infections.
- Skin and skin structure infections.
- Genitourinary tract infections.
- Other infections: Osteomyelitis and septic arthritis.
4.CONTRA-INDICATIONS:
CEDROX (Cefadroxil) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
5.PRECAUTIONS:
- Before therapy with CEDROX is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to CEDROX, other cephalosporins, penicillins or to other drugs.
- Pseudomembranous colitis has been reported with the use of cephalosporin (and other broad spectrum antibiotics); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use. Treatment with broad spectrum antibiotics alters normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.
Mild cases of colitis may respond to drug discontinuation alone. Moderate to severe cases should be managed with fluid, electrolyte and protein supplementation as indicated.
When the colitis is not relieved by drug discontinuation or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile.
- CEDROX should be prescribed with caution in individuals with history of gastrointestinal diseases, particularly colitis.
- Pregnancy & Nursing Mothers: Cefadroxil should be used during pregnancy only if clearly needed. Cefadroxil is distributed into breast milk; therefore, this drug should be used with caution in nursing women.
6.ADVERSE REACTIONS:
As for the other cephalosprins CEDROX may rarely cause diarrhea, nausea, and vomiting.
It may very rarely cause genital pruritus, vaginal fungal infection, transient hyponeutrophilia, rash, pruritus and angioedema.
All these reactions disappear as soon as treatment is stopped.
7.DRUG INTERACTIONS:
- Probenecid delays the excretion of Cefadroxil.
- Caution should be taken when CEDROX is taken with potent diuretics and/or aminoglycosides. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics and/or potent diuretics such as furosemide.
8.DOSAGE & ADMINISTRATION:
CEDROX (cefadroxil) is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Adults:
Urinary tract infections: For uncomplicated lower urinary tract infections (i.e. cystitis) the usual dosage is 1 or 2 g per day in single (q.d.) or in two equally divided doses (b.i.d).
For all other urinary tract infections the usual dosage is 2 g per day in two equally 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 a single dose (q.d.) or in two equally divided doses (b.i.d.).
Pharyngitis and tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis 1 g per day in single dose (q.d.) or in two equally divided doses (b.i.d.) for at least 10 days.
Upper and lower respiratory tract infections : For mild infections, the usual dosage is 1 g per day in two equally divided doses (500 mg twice a day).
For moderate to severe infections, the recommended dosage is 1 g to 2 g daily in two equally divided doses (500 mg to 1 g every 12 hours).
Children:
The recommended dosage for children is 25 to 50 mg/kg/day in two equally divided doses (every 12 hours) as indicated. For pharyngitis, tonsillitis, and impetigo the recommended daily dosage may be administered as a single dose or in two equally divided doses (every 12 hours).
| CEDROX Oral Suspension | ||
| Child’s weight (Kg) | Dose (q 12 h) | |
| 125 mg/5 ml (25 mg/ml) | 250 mg/5 ml (50 mg/ml) | |
| 5 | 2.5 – 5 ml | - |
| 10 | 5 – 10 ml | 2.5 – 5 ml |
| 15 | 7.5 –15 ml | 3.75 – 7.5 ml |
| 20 | 10 – 20 ml | 5 – 10 ml |
| 25 | 12.5 – 25 ml | 6.25 – 12.5 ml |
In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of CEDROX should be administered for at least 10 days.
In patients with renal impairment, the dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1 g of CEDROX (Cefadroxil) and the maintenance dose (based on the creatinine clearance rate) is 500 mg at the time intervals listed below:
| Creatinine Clearance mL/min | Dosage Intervals |
| 0 –10 | 36 hours |
| 10 – 25 | 24 hours |
| 25 – 50 | 12 hours |
Patients with creatinine clearance rates over 50 ml/min may be treated as if they were patients having normal renal function.
*Reconstitution the dry powder for oral suspension:
For 60 mL bottles containing powder for oral suspension at strengths of 125 mg/5ml and 250 mg/5ml: Shake the bottle to loosen the powder. Add water to the bottle until the reconstituted suspension is at level with the mark on the label. Invert and shake it well after each addition. Each teaspoonful (5 ml) of suspension contains 125 mg or 250 mg of CEDROX activity as the monohydrate, depending upon the concentration of the formulation. Constituted CEDROX for oral suspension is stable for 14 days when stored under refrigeration at temperature between (2-8)°C. Shake bottle well before using. Keep bottle tightly closed. Discard unused portion after 14 days under refrigeration.
9.PACKAGING & COMPOSITION:
- CEDROX 250 - Capsules: A pack of 12 capsules in blister. Each capsule contains Cefadroxil Monohydrate equivalent to 250 mg Cefadroxil.
- CEDROX 500 - Capsules: A pack of 12 Capsules in blister. Each capsule contains Cefadroxil Monohydrate equivalent to 500 mg Cefadroxil.
- CEDROX 125 - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 5 mL contains Cefadroxil Monohydrate equivalent to 125 mg Cefadroxil.
- CEDROX 250 - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 5 mL contains Cefadroxil Monohydrate equivalent to 250 mg Cefadroxil.
10.STORAGE CONDITIONS:
Store CEDROX – Capsules and Dry Powder for Oral Suspension at temperature between (15-30)°C.
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