Curisafe Pediatric suspension 500 mg/5 ml 60 ml

Curisafe Pediatric suspension 500 mg/5 ml 60 ml

Composition:
Each 5 ml of reconstituted CURISAFE Suspension contains 500 mg of Cefadroxil activity.
Inactive Ingredients:
Microcystalline cellulose, Sodium Carboxymethyl cellulose, Polysorbate 80, Sodium benzoate , Citric acid anhydrous, Orange flavor, Pineapple flavor.
Description:
CURISAFE (Cefadroxil monohydrate) is a bactericidal first generation cephalosporin.
It exerts a bactericidal activity against both Gram-positive and Gram-negative micro-organisms by interfering with the terminal step in bacterial cell wall synthesis.
CURISAFE exhibits an outstanding effectiveness against a wide range of Gram-positive pathogens including B-lactamase and non B-lactamase producing Staphylococci, hemolytic Streptococci, Streptococcus pneumoniae and Streptococcus pyogenes.
It is also effective against several Gram-negative organisms including Escherichia coli, klebsiella pneumoniae and some strains of Proteus mirabilis, Haemophilus influenzae, Salmonella species and Shigella species.
Indications:
CURISAFE is indicated in the treatment of infections caused by Cefadroxil-susceptible strains of Gram-positive pathogens including B-lactamase and non ß-lactamase producing Staphylococci, ß-hemolytic streptococci, Streptococcus pneumoniae-and Streptococcus pyogenes.
It is also effective against several Gram-negative bacteria as follows:
- Infections of the Respiratory Tract: sinusitis, otitis media, tonsillitis, pharyngitis, laryngitis, bronchitis, bronchopneumonia, bronchiectasis, pulmonary abscess, empyema and pleurisy.
- Infections of the skin and soft tissues: cellulitis, erysipelas, pyoderma, lymphangitis, abscesses, decubitus ulcers, mastitis, furunculosis, impetigo and infected traumatic and postoperative wounds.
- Infections of the urinary Tract: pyelonephritis, cystitis, urethritis.
- Infections of the Genital Tract in Adults: prostatitis, orchitis, epididymo-orchitis, adnexitis, endometritis and other genital infections.
- Miscellaneous Infections: osteomyelitis, septic arthritis, intra-abdominal infections and dental infections.
Dosage and Administration:
CURISAFE 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 Infection: for uncomplicated lower urinary tract infection(i.e. cystitis) the usual dosage is 1 or 2 g per day in single dose or two equally divided doses.
For all other urinary tract infection the usual dosage is 2 g per day in two equally divided doses.
Skin and Skin structure infections:
For skin and skin structure infections the usual dosage is 1 g per day in a single dose or two equally divided doses.
Pharyngitis and Tonsillitis: due to group A B-hemolytic streptococcal pharyngitis and tonsillitis 1g per day in a single dose or two equally divided doses for at least ten days.
Upper and Lower respiratory tract infections:
For mild infections the usual dosage is 1g per day in two equally divided doses.
For moderate to severe infections the recommended dosage is 1 g to 2 g daily in two equally doses.
Children:
The recommended dosage 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 administrated as single dose or in two equally divided doses (every 12 hours).
CURISAFE ORAL SUSPENSION OR PEDIATRIC DROPS(dose q 12 h).
In the treatment of B-hemolytic streptococcal infections, a therapeutic dosage of CURISAFE should be administrated for at least 10 days.
For the treatment of B-hemolytic streptococcal pharyngitis or tonsillitis in both adults and children.
CURISAFE may be administrated in usual daily dose either in two divided doses or a single dose.
In patients with - renal impairment the dosage of CURISAFE 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 CURISAFE and the maintenance dose (based on the creatinine clearance rate) is 500 mg at the time intervals listed below:
Patients with creatinine clearance rates over 50ml/min/1.73m may be treated as if they were patients having normal renal function.
Reconstitution of CURISAFE Powder for Oral Suspension and Pediatric Drops:
The bottle is tapped lightly to loosen the powder.
Water is added gradually to the powder and the bottle is shaken well after each addition till the reconstituted suspension reaches the level of the mark on the bottle.
It is stable for 14 days when kept refrigerated at (2 °C - 8°C).
Contraindications:
- Hypersensitivity to Cefadroxil or other cephalosporins or to any of the excipients.
- Previous history of immediate and/or severe hypersensitivity reactions (anaphylaxis) to penicillin or other beta-lactam antibiotics.
- If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product, since it contain sucrose.
Special warnings and precautions for use:
- 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 cefadroxil as cross-allergy.
- In patients with renal impairment the dose of CURISAFE must be reduced.
Side Effects:
CURISAFE is safe and well-tolerated.
CURISAFE might cause GI disturbances including nausea, abdominal cramps and diarrhea.
Less common side effects include urticaria, skin rash, angioneurotic edema and transient leucopenia.
Pregnancy and Lactation:
Preparations containing Cephalosporins are used during pregnancy and lactation only if clearly indicated.
Storage:
Keep out of the reach of children.
Dry Powder:
Store at temperature not exceeding 30°C, in a dry place.
Reconstituted suspension:
14 days when stored in a refrigerator (2°C-8°C)
Packing:
A carton box containing a plastic bottle containing CURISAFE powder and an inner pamphlet.