Orobac(Cefditoren pivoxil)
Therapeutic Group: Anti Bacterial
Presentation
Orobac 200 tablet: Each tablet contains Cefditoren Pivoxil INN equivalent to Cefditoren 200 mg.
Description
Cefditoren Pivoxil is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Bactericidal activity results from inhibition of cell wall synthesis. Cefditoren has antibacterial activity against gram-positive and gram-negative pathogens. It is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases. Cefditoren Pivoxil is about 14% bioavailable. It has Cmax about 1.8 g/mL, peak plasma time of 1.5-3 hours & plasma half-life of 1.2-2 hr. It is eliminated by excretion into the urine.
Indications
Cefditoren is indicated for the treatment of mild to moderate infections caused by susceptible strains of microorganisms including-
• Acute bacterial exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Pharyngitis/tonsillitis
• Uncomplicated skin and skin-structure infections
Dosage & Administration
Adult
Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg PO q-12hr for 10 days
Community-acquired pneumonia: 400 mg PO q12hr for 14 days
Pharyngitis, Tonsilitis, Uncomplicated Skin and Skin Structure Infections: 200 mg PO q12hr for 10 days
Dosage adjustment in renal impaired patients:
CrCl 30-49 mL/minute: No more than 200 mg PO q12hr
CrCl <30 mL/minute: 200 mg PO qDay
No dose adjustment necessary for mild renal impairment (CrCl 50-80 mgL/min) or mild to moderate
hepatic impairment.
Pediatric
<12 years old: Safety & efficacy not established
>12 years old: As in adults
Cefditoren should be taken with meal to enhance absorption of the drug.
Side Effects
Common adverse effects may include Diarrhea, Nausea, Headache, Abdominal pain, Dyspepsia, Vomiting, Bacterial/fungal superinfection, C. difficile colitis, Hypersensitivity, Increased bleeding time, Stevens-Johnson syndrome, Vaginal moniliasis.
Precautions
Use with caution in patients with penicillin allergy. There is a risk of carnitine deficiency in patients with renal impairment or decreased muscle mass. It may decrease prothrombin activity especially in patients with renal or hepatic impairment, poor nutritional status, prolonged antibiotic treatment or patients previously stabilized on anticoagulant therapy. Long term use may result in development of drug-resistant bacteria, or superinfection including Clostridium difficile-associated diarrhoea and pseudomembranous colitis.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy category B.
Lactation: it is not known whether Cefditoren is excreted in milk or not; Should be used with caution.
Drug Interaction
Oral bioavailability is reduced when coadministered with antacids or H2-receptor antagonists. Probenecid may increase plasma concentration and prolong half-life of Cefditoren. Cefditoren may enhance anticoagulant effect of vitamin K antagonists (e.g. warfarin).
Over Dose
As with other beta-lactam antibiotics, symptoms include nausea, vomiting, epigastric distress, diarrhoea, and convulsions. It may be removed by haemodialysis.
Storage
Do not store above 30 C. Keep away from light and out of the reach of children.
Commercial Pack
Orobac 200 tablet: Each box contains 2 blister strips of 4 tablets.
