ATICEF 250

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COMPOSITION:

Cefadroxil monohydrate .................................... equivalent to 250 mg of cefadroxil

Excipients q.s......................................................................................... 1 sachet

(Aspartame, aerosil, sodium citrate, anhydrous citric acid, sodium benzoate, orange-flavored powder, mannitol 60, PVP K30).

DOSAGE FORM: Granules for oral suspension.

PRESENTATION: Box of 24 sachets x 1.5 g

PHARMACODYNAMICS: Aticef contains the active ingredient cefadroxil which is a semi-synthetic antibiotic classified as the first generation cephalosporin. It has bactericidal action, prevents bacterial division and development by inhibition of synthesis of the bacterial cell wall.

Gram-positive bacteria including staphylococci (penicillinase-producing and non-penicillinase-producing), haemolytic streptococci, Streptococcus pneumoniae, Streptococcus  pyogenes. Gram-negative bacteria including Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Moraxella. Haemophilus influenzae is less susceptible. 

PHARMACOKINETICS: Cefadroxil is stable in gastric acidity and well absorbed in gastrointestinal tract; it is not affected by food. About 20% of cefadroxil is reported to be bound to plasma proteins. The plasma half-life of cefadroxil is about 1.5 hrs in people with healthy renal function, and prolonged about 14 - 20 hrs in patients with impaired renal function.

Right after being absorbed, cefadroxil is widely distributed to the body tissues and fluids. It crosses the placenta and appears in breast milk.

Cefadroxil is not metabolized. More than 90% of a dose of cefadroxil is excreted unchanged in the urine within 24 hours by glomerula filtration and renal tubular secretion. Cefadroxil is highly removed by haemodialysis.

INDICATIONS:

For treatment of mild to moderate infections caused by susceptible bacteria:

* Respiratory tract infections:

- Tonsillitis, sore throat, otitis media, nasosinusitis, laryngitis.

- Bronchopneumonia, lobar pneumonia, acute and chronic bronchitis, pulmonary abscess, empyema, pleuritis.

* Urogenital infections: acute and chronic pyelonephritis, cystitis, urethritis, gynecologic infections.

* Skin and soft tissue infections: furuncles, erysipelas, lymphadenitis, abscess, cellulitis, ulcer caused by prolonged lying, mastitis.

* Other infections: musculoskeletal inflammations, osteomyelitis, septic osteoarthritis, obstetric infections.

CONTRAINDICATIONS:

Hypersensitivity to cephalosporin antibiotics.

PRECAUTIONS:

Patients with known hypersensitivity to penicillins.

Patients with renal impairment (creatinine clearance ≤ 50ml/ min).

Prolonged use of cefadroxil may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, stop using the drug. Pseudomembranous colitis has been reported by administration of broad-spectrum antibiotics. The diagnosis of pseudomembranous colitis should be cautious in patients with severe diarrhea during or after taking antibiotics. Caution should be exercised in individuals with gastrointestinal disease, particularly colitis. Experience use of cefadroxil in neonates and premature babies is still limited; cautions should be taken in these subjects.

PREGNANCY AND LACTATION:

Cefadroxil should only be used in pregnancy and lactation if really needed.

The signs of diarrhea, skin rash should be cared in breast-fed babies.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effect of cefadroxil on the ability to drive and use machines is rarely reported.

INTERACTIONS:

Cholestyramine delays the absorption of cefadroxil.

Probenecid decreases the secretion of cefadroxil.

Concomitant use of cefadroxil and furosemide, aminoglycoside increases the nephrotoxic effect.

ADVERSE EFFECTS:

Frequently: Nausea, abdominal pain, vomiting, diarrhea.

Less frequently: Eosinophilia. Urticaria, skin rash, pruritus. Reversible increases in transaminases. Testicular pain, vaginitis, candidiasis, genital itching.

Rarely: Anaphylactic reaction, serum disease, fever. Neutropenia, thrombocytopenia, hemolytic anemia, positive Coombs' tests. Pseudomembranous colitis, gastrointestinal disorders. Stevens -Johnson syndrome, Lyell's  syndrome, angioedema. Obstructive jaundice, mild elevation of AST, ALT, hepatitis. Nephrotoxicity with transient increase in urea and plasma creatinine, reversible interstitial nephritis. Convulsion (when use of high doses and in case of impaired renal function), headache, irritation. Joint pains. 

Inform your physician about any adverse effects occur during the treatment. 

OVERDOSAGE:

Symptoms of acute overdosage are mostly nausea, vomiting, diarrhea. The possibility of neuromuscular hypersensitivity and convulsions may occur, especially in patients with renal impairment.

In managing overdose, consider the posibility of multiple drug overdose, interation among drugs, and unsual drug kinetics in the patient. Artificial kidney dialysis may be useful to remove the drug from blood, but it is usually not indicated. Protect patient's airway, assist ventilation and infusion. Symptomatic treatment and supportive therapy are mainly applied after carrying out gastric lavage.

DOSAGE & ADMINISTRATION: Dissolve the drug with sufficient water (about 5 - 10 ml for 1 sachet), stir well before use.

The drug can be taken before or during a meal.

Children aged less than 1 year: 25 - 50 mg/kg of body weight/day, in 2 - 3 divided doses.

Children aged from 1 - 6 years: 250 mg (1 sachet) x 2 times/day.

Children aged more than 6 years: 500 mg (2 sachets) x 2 times/day.

Adults and children weighing > 40 kg: 500 - 1000 mg x 2 times/day.

Mild to moderate infections of respiratory tract, osteo-articulation: 500 mg twice daily. Severe cases: 1000 mg twice daily.

Skin and soft tissue infections: 1000 mg once daily.  

For patients with renal impairment:

The doses should be adjusted in patients with renal impairment whose creatinine clearance ≤ 50 ml/ minute. Initial dose: 500 - 1000 mg. Sequent doses can be adjusted as follows:

Creatinine clearance 0 - 10 ml/ minute: 500 - 1000 mg every 36 hrs.

Creatinine clearance 11 - 25 ml/ minute: 500 - 1000 mg every 24 hrs.

Creatinine clearance 26 - 50 ml/ minute: 500 - 1000 mg every 12 hrs.

The therapy should be maintained at least 5 - 10 days.

Or as directed by the physician.

Read the directions carefully before use.           Shelf-life: 36 months from the manufacturing date.

Consult the physician for more information.      Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

This drug is for prescriptions only.                        Specifications: Manufacturer's.

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