Curisafe-Cefaddroxil monohydrate-Broad spectrum antibiotic

Curisafe pamphlet

 500 mg capsules , 1 g tablets , 125 mg / 5 ml , 250 mg / 5 ml , 500 mg / 5 ml powder for oral suspension. And 100 mg / ml pediatric drops.

Pharmaceutical forms : curisafe tablets : each curisafe tablet contains 1 g of cefadroxil activity .

Curisafe capsules : each curisafe capsule contains 500 mg of cefadroxil activity .

Curisafe powder for oral suspension : each 5 ml of reconstituted curisafe suspension contains 125 mg or 250 mg or 500 mg of cefadroxil activity .

Curisafe pediatric drops : each 1 ml of reconstituted curisafe pediatric drops contains 100 mg of cefadroxil activity .

Properties : curisafe ( cefadroxil monohydrate ) is a bactericidal first-generation cephalosporin . it exerts a bactericidal activity against both Gram-positive and Gram-negative microorganisms by interfering with the terminal step in bacterial cell wall synthesis .

Cefadroxil is markedly resistant to hydrolysis by  -lactamase therefore its spectrum covers both –lactamase and non –lactamase producing bacteria.

Pharmacokinetics : following oral administration of curisafe formulations, cefadroxil is well absorbed from the gastrointestinal tract and its absorption is not affected by food. Cefadroxil is widely distributed in body tissues and fluids. 20% of the drug is bound to plasma proteins. Peak plasma concentrations are achieved within 1.5 to 2 hours and measurable levels are present 12 hours after oral adminidtration. Most of cefadroxil dose ( more than 90% ) is excreted unchanged in the urine within 24 hours. The plasma half-life of cefadroxil is about 1.5 hours and is prolonged in patients with impaired renal function. Cefadroxil concentration is maintained well above the MICs of susceptible urinary pathogens throughout the dosing interval ( 12 hours ). The drug crosses the placenta and small amounts appear in breast milk.

Bactericidal spectrum : curisafe exhibits outstanding effectiveness against a wide range of Gram-posirive pathogens including β-lactamase and non-β-lactamase producing staphylococci , haemolytic 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 β-lactamase and non-β-lactamase producing staphylococci , β haemolytic 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, pyodermia, 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 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 gram per day in a single dose or two equally divided doses. For all other urinary tract infections the usual dosage is 2 gram per day in two equally divided doses.

Skin and skin structure infections: for skin and skin structure infections the usual dosage is 1 gram per day in a single dose or two equally doses.

Pharyngitis and tonsillitis : due to group A beta-hemolytic streptococcal pharyngitis and tonsillitis – 1 gram 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 1 g per day in two equally divided doses. Moderate to severe infections the recommended dosage is 1 g to 2 g daily in two equally divided doses.

Children: the recommended dosage for children is 25 to 50 mg/kg/dayin two equally divided doses (every 12 hours) as indicated. For pharyngitis, tonsillitis and impetigo the recommended daily dosage may be administered as single dose or in two equally divided doses (every 12 hours).

In the treatment of beta-hemolytic streptococcal infections , a therapeutic dosage of curisafe should be administered for at least ten days. For the treatment of beta-hemolytic streptococcal pharyngitis or tonsillitis in both adults and children curisafe may be administered in usual daily dose either in two divided doses or a single dose.

In patients eith 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 curisafe and the maintenance dose (based on creatinine clearance rate) is 500 mg at the time intervals listed below.

Creatinine clearance (ml/min/1.73m²)	Dosage interval
0 – 10                               10 – 25                               25 - 50	36 hours                                     24 hours                                     12 hours

Patients with creatinine clearance rates over 50 ml/min/1.73m² may be treated as if they were patients having normal renal functions. In five adult anuric patients it was demonstrated that an average of 63% of a 1 g oral  dose is extracted from the body during a 6 to 8 hour hemodialysis session.

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 additiont till the reconstituted suspension reaches the level of the mark on the bottle. The resultant suspension provides cefadroxil activity of 125 mg or 250 mg per 5 ml of oral suspension or of 100 mg per ml of reconstituted curisafe pediatric drops. It is stable for 14 days when kept refrigerated at (4°C) or for 7 days when stored at room temperature (15°C - 30°C).

Contraindications: hypersensitivity to cephalosporins and penicillins.

Precautions: in patients with renal impairment, the dose of curisafe must be reduced. Caution is recommended when curisafe is administered to patients with a history of penicillin allergy as cross-allergenicity between penicillins and cephalosporins is encountered.

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.

Drug interactions: probenecid reduces renal excretion of cefadroxil. Aminoglycosides may increase the risk of nephrotoxicity. Anticoagulant effect of warfarin is increased by cefadroxil. Interference with laboratory tests: during cephalosporins treatment, false positive results may be obtained for urinary glucose if determined by reduction methods. Cefadroxil may cause false positive reaction for ketones in the urine when tested using nitroprusside. Direct coomb's test may give false positive results.

Overdosage and treatment: accidental ingestion of high doses of cefadroxil containing preparations causes diarrhea, abdominal pain, nausea and vomiting. Treatment includes gastric lavage, activated charcoal intake, hemodialysis and treatment of symptoms.

Packing: A box containing 8 curisafe tablets, each of 1 g cefadroxil activity. A box containing 8 curisafe capsules, each of 500 mg cefadroxil activity. A bottle containing curisafe powder for suspension to provide 125 mg or 250 mg or 500 mg of cefadroxil activity per 5 ml of the reconstituted suspension. A bottle containing curisafe powder for pediatric drops to provide 100 mg cefadroxil activity per 1 ml of the reconstituted pediatric drops.

Storage: keep at room temperature (15 - 30°C) away from moisture.

Keep out of the reach of children.

Do not use the drug after the expiry date printed on the box.