Dofixim® - Cefpodoxime proxetil USP - Antibacterial

Description:
Cefpodoxime proxetil is an orally administered prodrug that is de-esterified in the intestinal wall to release cefpodoxime a broad spectrum, semisynthetic 3rd generation cephalosporin antibiotic. Like other -lactam antibiotics it is bactericidal and acts by inhibiting cell wall synthesis. It is more active than other oral cephalosporin against respiratory bacterial pathogens.

Composition:
Dofixim®Capsule : Each capsule contains Cefpodoxime proxetil USP equivalent to 100 mg Cefpodoxime.
Dofixim®Tablet : Each Tablet contains Cefpodoxime proxetil USP equivalent to 200 mg Cefpodoxime.
Dfixim®Dry Suspension : Each 5 ml reconstituted suspension contains Cefpodoxime proxetil USP equivalent to 40 mg Cefpodoxime.

Indication:

Upper respiratory tract infection : Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsilitis.
Lower respiratory tract infection : Acute community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis.
Uncomplicated urinary tract infection : Cystitis, Pyuria. Skin and soft tissue infection : Furuncle, Cellulitis, Subcutaneous abscess, infectious atheroma.
Sexually transmitted disease : Acute uncomplicated urethral and cervical gonorrhoea.
Gastrointestinal Tract Infection : Typhoid fever

Drug interaction:

Antacids : Concomitant administration of high doses of antacids or H2- Blocker reduces peak plasma level by 24% to 42% and the extent of absorption by 27% to 30% respectively.

Probenecid : It inhibits the excretion of Cefpodoxime.
Nephrotoxic drugs : Close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.

Dosage and administration:
Dofixim®capsule should be administered only with food to enhance absorption but suspension may be given without regard to food.

Adults (Age 13 years and older)

Types of infection	Dosage	Duration
Upper respiratory tract infection including tonsillitis and pharyngitis.	100 mg	12 hourly for 5-10 days
Acute exacerbation of chronic bronchitis	200 mg	12 hourly for 10 days
Acute community acquired pneumonia	200 mg	12 hourly for 14 days
Uncomplicated gonorrhoea	200 mg	Single dose
Uncomplicated urinary tract infection	100 mg	12 hourly for 7 days
Skin and soft tissue infection	200-400 mg	12 hourly for 7-14 days
Acute maxillary sinusitis	200 mg	12 hourly for 10 days

Children (Age 15 days to 9 years)

Age of children	Dosage	Duration
15 days-6 months 6 months-2 years 3 years-8 years Over 9 years	4 mg/kg every 40 mg every 80 mg every 100 mg every	12 hours 12 hours 12 hours 12 hours

Side effects:
Dofixim®has very few side effects. Diarrhoea and rarely antibiotic associated with colitis, nausea, vomiting, abdominal discomfort etc. may occur. Other side effects include rashes, pruritus, urticaria, serum sickness, chest pain, myalgia, dyspepsia, dizziness, vertigo, fungal and vaginal infection.

Use in pregnancy and lactation:
There is no well-controlled and sufficient study of Cefpodoxime proxetil regarding its use in pregnancy. It was neither teratogenic nor embryocidal in animal trial. This drug should be given during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made whether to discontinue brest feeding or to discontinue the drug.

Contraindication:
Dofixim®is contraindicated in patient with known hypersensitivity to it or to other cephalosporin antibiotics.

How supplied:
Dofixim® Capsule : Box contains 2 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Tablet : Box contains 3 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Dry Suspension: Bottle contains dry powder for 50 ml & 100 ml suspension.

 Manufacturer’s Source: IBN SINA