HumanFeed & Digestive Products

Cefadroxil Monohydrate

Composition

Arocef® 500 Capsule: Each capsule contains Cefadroxil Monohydrate BP equivalent to Cefadroxil 500 mg.

Arocef®Powder for Suspension: Each 5 ml suspension contains Cefadroxil Monohydrate BP equivalent to Cefadroxil 125 mg.

Description

Arocef® is the preparation of Cefadroxil. Cefadroxil is an orally active first generation cephalosporin. It is bactericidal in vitro against both Gram-positive and Gram-negative microorganisms. Sensitive Gram-positive organisms include: penicillinase and non-penicillinase producing Staphylococci, β-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: Tonsillitis, 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.

Dosage & 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 the following table:

0-10 mL/min/1.73 m2: 1000 mg - 500 mg - 36 hrs

11-25 mL/min/1.73 m2: 1000 mg - 500 mg - 24 hrs

26-50 mL/min/1.73 m2: 1000 mg - 500 mg - 12 hrs

Contraindications

Arocef® is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any other cephalosporins.

Side Effects

The most commonly reported side-effects are gastrointestinal disturbances and hypersensitive phenomena. Rash, pruritus, urticaria, angioneurotico edema 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.

Pregnancy & 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. Cefadroxil is excreted in breast milk and should be used with caution in lactating mothers.

Precautions & Warnings

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.