# Brand Name Generic & Strenght Dosage Form Pack Size
1 Xepodox GS Cefpodoxime 40 mg / 5ml Granules for Suspension 50 ml
2 Xepodox GPD Cefpodoxime 200mg / 1ml Granules for Paediatric drops 15 ml

Xepodox®

Capsule/Suspension

 COMPOSITION

XepodoxÒ100 Capsule :  Each capsule contains Cefpodoxime Proxetil INN equivalent to Cefpodoxime 100 mg. 

XepodoxÒ200 Capsule :  Each capsule contains Cefpodoxime Proxetil INN equivalent to Cefpodoxime 200 mg.

XepodoxÒGranules for Suspension: After reconstitution each 5 ml suspension contains Cefpodoxime Proxetil INN equivalent to Cefpodoxime 40 mg. 

XepodoxÒDS Suspension: After reconstitution each 5 ml suspension contains Cefpodoxime Proxetil INN equivalent to Cefpodoxime 80 mg.

XepodoxÒGranules for Paediatric Drops: After reconstitution each 1 ml suspension contains Cefpodoxime Proxetil INN equivalent to Cefpodoxime 20 mg.

 

DESCRIPTION

Cefpodoxime Proxetilis an orally administered extended spectrum, semi-synthetic 3rd generation antibiotic of cephalosporin class. Like other b-lactam antibiotics it is a bactericidal drug that acts by inhibition of bacterial cell wall synthesis. 

 

INDICATIONS

Cefpodoxime is indicated for the treatment of patients infected with susceptible strains of micro-organisms which include a wide range of gram-positive & gram-negative bacteria. As it is highly stable in presence of b-lactamase enzyme, so it is more effective against gram-positive bacteria than other 3rd generation oral Cephalosporins. 

The susceptible organisms include gram-positive bacteria eg. S. aureus(including penicillinase producing strains), S. saprophyticusS. pneumoniae, S. pyogenes, S. Agalactiae, P. magnusand gram-negative bacteria eg. E. coli, K. pneumoniae, H. influenzae(including b-lactamase producer & Ampicillin resistant strains) M. catarrhalis, N. gonorrhoeae(including penicillinase producing strains), P. mirabillis, C. diversus, H. parainfluenzae, K. oxytoca, P. vulgaris, P. rettgeri.

 

Cefpodoxime is indicated in the following diseases:-

1. Lower respiratory tract infection: Acute community-acquired pneumonia, Acute bacterial exacerbation of chronic bronchitis; (2) Upper respiratory tract infection: Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsillitis; (3) Sexually transmitted diseases: Acute uncomplicated urethral & cervical gonorrhea, Acute ano-rectal infection in woman caused by N. gonorrhoeae; (4) Uncomplicated urinary tract infection: Cystitis, Pyuria; (5) Skin & soft tissue infections: Furuncle, Cellulitis, Subcutaneous abscess, infectious atheroma & periproctal abscess. 

 

DOSAGE AND ADMINISTRATION 

Cefpodoxime capsule should be administered orally with food to enhance absorption. Cefpodoxime suspension may be given without regard to food. 

The recommended doses, duration of treatment, applicable patient population is as below:

Adults (including age 13 years & older):

Type of infection

Total daily dose

Dose Frequency

Duration

Acute community-acquired pneumonia 

Acute bacterial exacerbation of chronic bronchitis

Uncomplicated gonorrhea (men/women)

Rectal gonococcal infection in women

Skin & soft tissue infection

Pharyngitis and/or tonsillitis 

Uncomplicated urinary tract infection 

Acute maxillary sinusitis

400mg

400 mg

200 mg

200 mg

800 mg

200 mg

200 mg 

400 mg 

200 mg 12 hourly

200 mg 12 hourly

200 mg12 hourly

200 mg12 hourly

400 mg 12 hourly

100 mg 12 hourly

100 mg 12 hourly

200 mg 12 hourly

14 days

10 days

Single dose 

Single dose 

(7 to 14) days

(5 to 10) days

 7 days

10 days

 

Child :

15 days -  6 months: 4 mg/kg every 12 hours

6 months - 2 years               : 40 mg every 12 hours

3 - 8 years                             : 80 mg every 12 hours 

over 9 years                          : 100 mg every 12 hours

 

Patients with renal dysfunction: For patients with severe renal impairment (creatinine clearance < 30 ml/min) the dosing intervals should be increased to 24 hourly.

Patients with liver cirrhosis: Cefpodocime proextil pharmacokinetics in cirrhotic patients are similar to those in healthy subjects. Dose adjustment is not necessary in this population. 

 

SIDE EFFECTS 

Cefpodoxime has very few side effects. The side effects include diarrhea, nausea, skin & vaginal fungal infection, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, cough etc. In children incidence of fungal skin rash is more than adults. 

 

PRECAUTION

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other broad spectrum antibiotics, prolonged use of cefpodoxime proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. 

 

CONTRAINDICATION

Cefpodoxime proxetil is contraindicated in patients with a known allergy to Cefpodoxime or to the cephalosporin group of antibiotics.

 

USE IN PREGANCY AND LACTATION 

Cefpodoxime was neither teratogenic nor embryocidal in animal trial. There is, however, no adequate and well-controlled study of cefpodoxime proxetil use in pregnant woman. The drug should be used during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue the drug. 

DRUG INTERACTIONS

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H-blockers reduce plasma level by 24% to 42% and the extent of absorption by 27% to 32% respectively. 

Probenecid: Renal excretion of Cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC. 

Nephrotoxic drugs: Close monitoring of renal function advised when Cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.

 

OVERDOSAGE

Overdosage may cause toxic reaction. Toxic symptoms include nausea, vomiting, epigastric distress, diarrhoea

 

PACKAGING

XepodoxÒ100 Capsule : Box containing 3 x 4’s, 4 x 4’s, 5 x 4’s capsule in alu-pvc / alu-alu pack.

 

XepodoxÒ200 Capsule : Box containing 2 x 4’s, 3 x 4’s, 4 x 4’s capsule in alu-pvc / alu-alu pack.

 

XepodoxÒGranules for Suspension: Bottle containing 100 ml or 50 ml suspension.

 

XepodoxÒDS Suspension:Bottle containing 100 ml or 50 ml suspension.

 

XepodoxÒGranules for Paediatric Drops:Bottle containing 15 ml or 30 ml suspension.

 

 

 

Manufactured By

Rangs Pharmaceuticals Ltd.

Tejgaon, Dhaka, Bangladesh

 

®Registered Trade Mark