ATICEF 500 CAPS

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ATICEF 500 CAPS

(dark blue – light blue)

COMPOSITION:

Cefadroxil monohydrate ........................ equivalent to 500 mg of cefadroxil

Excipients q.s ........................................................................... 1 capsule

(Magnesium stearate, sodium starch glycolate, aerosil, talc).

DOSAGE FORM: Hard capsule (dark blue – light blue).

PRESENTATION:

Box of 2 blisters x 7 capsules.       Bottle 100 capsules. Bottle of 200 capsules

PHARMACODYNAMICS:

Aticef 500 caps contains the active ingredient cefadroxil which is a semi-synthetic antibiotic classified as the first generation cephalosporin. It has bactericidal action and suppresses bacterial division and development by inhibition of synthesis of the bacterial cell wall.

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

Methicillin-resistant Staphylococci or penicillin-resistant Streptococcus pneumoniae were resistant to cephalosporin antibiotics.

PHARMACOKINETICS:

Cefadroxil is acid-stable and almost completely absorbed from the GI tract. Cefadroxil is not affected when it is administered with food. Approximately 20% of cefadroxil is bound to plasma proteins. The serum half-life of cefadroxil is 1.5 hours in patients with normal renal function and is prolonged (14 - 20 hours) in patients with impaired renal function. Right after absorbed, cefadroxil is widely distributed to 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 may be excreted unchanged in the urine within 24 hours by glomerular filtration and tubular secretion. Cefadroxil may be highly removed by artificial kidney dialysis.

INDICATIONS:

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

* 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: osteomyelitis, septic osteoarthritis.

CONTRAINDICATIONS:

Hypersensitivity to cephalosporin antibiotics.

PRECAUTIONS:

Patients with a history of hypersensitivity to penicillins.

Cefadroxil should be used with caution in the presence of markedly impaired renal function. In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.

Prolonged use of cefadroxil may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, the drug should be discontinued.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics. It is important, therefore, to consider its diagnosis in patients who develop severe diarrhoea in association with the use of antibiotics. The drug should be used with caution in patients with GI diseases, particularly colitis.

Experience on cefadroxil use in newborn babies and premature infants is limited. Caution should be exercised in these patients.

PREGNANCY AND LACTATION:

Although there have been no reports of adverse effects to the fetus to date, safe use of cephaloporins during pregnancy has not been definitely established. Cefadroxil should be used during pregnancy only when clearly needed.

The excretion of cefadroxil in human milk is very low. Adverse effects on breast-fed babies have not been reported; but the baby should be concerned if diarrhoea, rash occur.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Caution should be exercised in drivers and machine users as it may induce excitement and headache.

INTERACTIONS:

Cholestyramine slows the absorption of cefadroxil. The secretion of cefadroxil is delayed by probenecid. Cefadroxil concomitantly administered with furosemide, aminoglycosides increases nephrotoxicity.

ADVERSE EFFECTS:

Frequent:  Nausea, abdominal pain, vomiting, diarrhea.

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

Rare: Anaphylactic reaction, serum sickness, fever. Neutropenia, thrombocytopenia, hemolytic anemia, positive Coombs' test. Pseudomembranous colitis, gastrointestinal disorders. Stevens - Johnson syndrome, Lyell's syndrome, angioedema. Obstructive jaundice, mild elevations of AST, ALT, hepatitis. Nephrotoxicity associated with temporary increases in blood urea and creatinine, reversible interstitial nephritis. Seizures (in patients with renal impaired function or in patients who receive high doses), headache, irritation. Joint pains. 

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

OVERDOSAGE:

Acute overdosage symptoms mostly include nausea, vomiting, and diarrhea and may be reported to cause neuromuscular hypersensitivity and seizures, particularly 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 can remove the drug from blood but usually not indicated. Protect the patient's airway and support ventilation and perfusion. Supportive and symptomatic treatment is recommended after gastric lavage.

DOSAGE & ADMINISTRATION:

Administration with food may minimize adverse GI effects.

Adults and children weighing > 40 kg: 500 - 1000 mg (1 - 2 capsules) twice daily.

Mild to moderate infections of respiratory tract, osteo-articulation: 500 mg (1 capsule) twice daily. Severe cases: 1000 mg (2 capsules) twice daily.

Skin and soft tissue infections: 1000 mg (2 capsules) once daily.  

Children aged > 6 years: 500 mg (1 capsule) twice daily.

Patients with renal impairment: Modification of usual dosage appears to be necessary in patients with creatinine clearance ≤ 50 ml/ minute. The initial dose is 500 - 1000 mg (1 - 2 capsules).

Sequent doses can be adjusted as follows:

Creatinine clearance of 0 - 10 ml/ min: 500 - 1000 mg (1 - 2 capsules) every 36 hrs.

Creatinine clearance of 11 - 25 ml/ min: 500 - 1000 mg (1 - 2 capsules) every 24 hrs.

Creatinine clearance of 26 - 50 ml/ min: 500 - 1000 mg (1 - 2 capsules) 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.                   

Consult the physician for more information.                       

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Vietnamese Pharmacopoeia IV.

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