| DESCRIPTION |
Arocef is the preparation of cefadroxil monohydrate. Cefadroxil is an orally active first generation cephalosporin. It is bactericidal in vitro against a wide range of Gram-positive and Gram-negative microorganisms. Sensitive Gram-positive organisms include: penicillinase and non-penicillinase producing Staphylococci, ß-haemolytic Streptococci, Streptococcus pneumoniae and Streptococcus pyogenes. Sensitive Gram-negative organisms include Escherichia coli, Klebsiella species, Proteus mirabilis, Moraxella catarrhalis and Bacteroides spp. and some strains of Haemophilus influenzae. |
| INDICATIONS |
Respiratory tract infections: Tonsilitis, pharyngitis, lobar and bronchopneumonia, acute and chronic bronchitis, pulmonary abscess, empyema, pleurisy, sinusitis, laryngitis.
Skin and soft tissue infections: Lymphadenitis, abscess, cellulitis, decubitus ulcers, mastitis, furunculosis, erysipelas.
Genitourinary tract infections: Pyelonephritis, cystitis, urethritis, gynecological infection.
Other infections: Osteomyelitis, septic arthritis.
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| DOSAGE AND ADMINISTRATION |
Adults: 500 mg - 1 g in single or divided doses, depending upon the severity of infection.
Children:
Under one year : 25 mg / kg daily in divided doses.
1-6 years : 250 mg twice daily.
Over 6 years : 500 mg twice daily
Elderly: Same as adult dose. No specific dosage recommendations or precautions for use in the elderly except to monitor those patients with impaired renal function.
Renal impairment: In patient with renal impairment doses may be administered according to thefollowing table:
Creatinine clearance
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Initial dose
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Maintenance dose
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Dose interval
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0-10 ml/min/1.73 m2
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1000 mg
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500 mg
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36 hrs
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11-25 ml/min/1.73 m2
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1000 mg
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500 mg
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24 hrs
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26-50ml/min/1.73 m2
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1000 mg
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500 mg
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12 hrs
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| CONTRAINDICATIONS |
Arocef is contraindicated in the patients with a history of hypersensitivity to cefadroxil or any other cephalosporins.
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| USE IN PREGNANCY AND LACTATION |
Although animal studies and clinical experiments have not shown any evidence of teratogenicity, the safe use of Arocef during pregnancy has not been established. Arocef is excreted in breast milk and should be used with caution in lactating mothers.
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| PRECAUTIONS |
In patients with a history of penicillin allergy, Arocef should be used with caution. There is evidence of partial cross - allergenicity between the penicillins and the cephalosporins. If an allergic reaction to Arocef occurs, the drug should be discontinued and patient should be treated with the usual agents (pressor amines, corticosteroids or antihistamines), depending on the severity of the reaction. Cefadroxil can be removed from the body by haemodialysis. As experiment in premature infants and neonates is limited, the use of Arocef in these patients should only be undertaken with caution. As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms.
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| SIDE EFFECTS |
The most commonly reported side-effects are gastrointestinal disturbances and hypersensitive phenomena. Rash, pruritus, urticaria, angioneurotic oedema have been observed infrequently. Serum sickness, vomiting, diarrhoea, dyspepsia, abdominal discomfort, fever, dizziness, headache, arthralgia and genital candidiasis may also occur. Reversible neutropenia may occur rarely, as may leucopenia, thrombocytopenia, agranulocytosis & minor elevation in serum transaminase & Stevens-Johnson Syndrome. Colitis, including rare instances of pseudo- membraneous colitis, has been reported. |
| PHARMACEUTICAL PRECAUTION |
Store in a cool (below 30°C) and dry place, away from light. Keep out of reach of children.
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| PACKAGING |
Arocef capsule : Box containing 6 strips of 4 capsules each. Each capsule contains cefadroxil monohydrate BP equivalent to 500 mg cefadroxil.
Arocef suspension : Bottle containing powder for the preparation of 100 ml suspension. After reconstitution each 5 ml suspension contains cefadroxil monohydrate BP equivalent to 125 mg cefadroxil.
Arocef paediatric drops : Bottle containing powder for the preparation of 15 ml suspension. After reconstitution each 1.25 ml suspension contains cefadroxil monohydrate BP equivalent to 125 mg cefadroxil.

Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK
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