Generic Name

Composition

Therapeutic Category

Division

Cefadroxil

Cefadroxil 250mg DT

Cefadroxil 500mg Capsules

Cefadroxil 125mg/5ml Dry Syrup

Cephalosporin Antibiotic

COSMO

    BRAND COMPOSITION DESCRIPTION
    FEDROX 250

    Each dispersible tablet contains:

    Cefadroxil Monohydrate IP eq. to Anhydrous Cefadroxil       250mg

    Light yellow, circular flat tablet with breakline on one side.
    FEDROX 500

    Each capsule contains:

    Cefadroxil Monohydrate IP eq. to Anhydrous Cefadroxil      500mg

    Size '0' plain hard gelatin capsule with yellow body and red cap filled with white blend of granular powder.

    FEDROX DS

    Each 5ml of dry syrup contains:

    Cefadroxil Monohydrate IP eq. to Anhydrous Cefadroxil      125mg

    White opaque HDPE bottle with circular mark for 60 ml on the outerside filled with slight white blend of granular powder.

     

     

    PATIENT INFORMATION

    Administration:

    • FEDROX may be taken with or without food. In case of gastrointestinal disturbance it may be administered with food.
    • After reconstitution use the FEDROX dry syrup within 10days.
    • Complete the full course of medication as prescribed even if the symptoms disappear after few days.

    Pregnancy: Category B

    Nursing Mother: FEDROX is present in low concentration in breast milk.

    Storage: Store tablets at room temperature (25°C) away from direct heat and light; Protect from moisture; Keep out of reach of children.

    Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not take extra medicine to make up the missed dose.

     

    PHARMACOLOGY

    Pharmacotherapeutic Group: beta-lactam antibiotic; First generation cephalosporins.

     

    Pharmacodynamic properties: FEDROX (Cefadroxil) binds to penicillin-binding protein (PBPs) and inhibits the transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly. This causes formation of a defective cell wall that is osmotically unstable, resulting in bacterial cell death.

     

    Pharmacokinetic properties:

    Absorption: Well absorbed from the GI tract (oral); Time to peak plasma concentrations: 1.5-2 hr.

    Distribution: Body tissues and fluids (wide); Crosses the placenta and enters breast milk; Does not penetrate CSF; Protein-binding: 20%.

    Metabolism: Not metabolized.

    Excretion: Via urine (90% of drug excreted as unchanged); Elimination half life: 1.5 hr, prolonged in renal impairment.

     

    INDICATIONS

    Urinary tract infection; Otitis media; Bone and Join Infections; Respiratory tract infection; Skin and soft tissue infection; Surgical Prophylaxis

     

    DOSE

    Uncomplicated urinary tract infections: 1-2 g daily as a single or 2 divided doses.

    SSTI: 1 g/day in single or divided doses. 

    Pharyngitis and Tonsillitis: 1 g/day in single or divided doses for 10 days. 

    Child: 30 mg/kg/day in 2 divided dose.

     CONTRAINDICATIONS

    Hypersensitivity

     SPECIAL PRECAUTIONS

    Impaired renal function; History of severe allergy or asthma; Pregnancy and lactation

     ADVERSE DRUG REACTIONS

    Nausea, vomiting, diarrhoea, abdominal discomfort; skin rash, angioedema; elevated liver enzyme values; superinfection with resistant organisms especially candida.

    Potentially Fatal: Anaphylactic reaction; pseudomembranous colitis.

     DRUG INTERACTIONS

    Prothrombin time prolonged; bleeding may occur when taken with anticoagulants; Decreased elimination with probenecid; Combination with aminoglycoside antibiotics, poylmyxin B, colistin or high dose loop ceiling diuretic can potentiate neprotoxic effect.

    PRESENTATION

    FEDROX 250: Each box contains 10 strip packs of 10 tablets per strip.

    FEDROX 500: Each box contains 10strip pack of 10 capsules per strip.

    FEDROX DS: Each bottle contains 30g per 60ml dry syrup.