TIME Pharmaceuticals : Touching Lives, Delivering Promises
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TIME Pharmaceuticals: Thrive For Effectiveness
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:
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.
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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.
