TAXETIL

Cefpodoxime Proxetil USP

Composition:

Taxetil Capsule: Each capsule contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 100 mg.

Taxetil-200 Capsule: Each capsule contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 200 mg.

Taxetil Powder for Suspension: After reconstitution each 5 ml suspension contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 40 mg.

Taxetil DS Powder for Suspension: After reconstitution each 5 ml suspension contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 80 mg.

Taxetil Paediatric drops: After reconstitution each 5 ml drops contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 100 mg.

Pharmacology:

Cefpodoxime Proxetil is an orally administered prodrug that is de-esterified in the intestinal wall to release Cefpodoxime, a third generation cephalosporin. Cefpodoxime is a broad spectrum antibiotic and is active against beta lactamase producing staphylococci. Cefpodoxime binds with high affinity to penicillin-binding proteins in the bacterial cell wall, thus interfering in peptidoglycan synthesis that provides the cell wall with mechanical stability. Cefpodoxime inhibits the transpeptidase enzyme that performs the final stage in the synthesis of peptidoglycan. As a result, the bacterial cell wall is weakened, and the cell swells and then ruptures.

Indications:

• Upper respiratory tract infections
• Lower respiratory tract infections
• Urinary tract infections including gonorrhoea
• Skin and soft tissue infections
• Gynaecological infection
• Acute otitis media
• Childhood infection
• Typhoid fever of children

Dosage and administration:

Adults:

200 mg as a single dose or 100-200 mg twice daily for 5-14 days depending on the severity of the infection.

Upper respiratory tract infections (pharyngitis and tonsillitis which are recurrent, chronic, or resistant to other antibacterials): 100 mg twice daily (200 mg twice daily in sinusitis).

Lower respiratory tract infections (including bronchitis and pneumonia): 100-200 mg twice daily.

Skin and soft tissue infections: 200 mg twice daily.

Uncomplicated urinary tract infections: 100 mg twice daily (200 mg twice daily in uncomplicated upper urinary tract infections).

Uncomplicated gonorrhoea: 200 mg as a single dose.

Children:

The recommended dose is 4 mg/kg twice daily for 5-14 days according to the severity of the infection, or as follows:

15 days - 6 months : 4 mg/kg body weight 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.

Typhoid fever : 8 mg/kg body weight every 12 hours.

Side-effects:

Diarrhoea and rarely antibiotic-associated colitis, nausea and vomiting, abdominal discomfort, headache; allergic reactions including rashes, pruritus, urticaria, serum sickness-like reactions with rashes, fever and arthralgia, and anaphylaxis, erythemia multiform, toxic epidermal necrolysis reported; disturbances in liver enzymes, transient hepatitis and cholestatic jaundice; etc. Other side effects reported include eosinophilia and blood disorders, reversible interstitial nephritis, hyperactivity, nervousness, sleep disturbances, confusion, hypertonia and dizziness etc.

Contraindication:

Cefpodoxime is contraindicated in patients with a known allergy to Cefpodoxime Proxetil or to cephalosporin group of antibiotic or any inactive ingredient of the product.

Precautions:

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced because high and prolonged serum antibiotic concentration can occur in such individuals following usual doses. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics.

As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

Drug Interactions:

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminium hydroxide) or H2 blockers reduce peak levels by 24% to 42% and the extent of absorption by 27% to 32% respectively, though the rate of absorption is not altered by these concomitant medications. Oral anticholinergics delay peak plasma levels, but do not affect the extent of absorption.

Probenecid: Probenecid inhibits the excretion of Cefpodoxime.

Nephrotoxic drugs: Although nephrotoxicity has not been noted when Cefpodoxime was given alone, close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.

Use in Pregnancy and Lactation:

Pregnancy category B. There are no adequate & well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed.

Use in lactation: Cefpodoxime Proxetil is excreted in human milk. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Packaging:

Taxetil Capsule: Box containing 3x6's capsules in alu/alu blister pack.

Taxetil-200 Capsule: Box containing 2x4's capsules in alu/alu blister pack.

Taxetil Powder for Suspension: Bottle containing powder for the reconstitution of 50 ml & 100 ml suspension.

Taxetil DS Powder for Suspension: Bottle containing powder for the reconstitution of 50 ml suspension.

Taxetil Paediatric drops: Bottle containing powder for the reconstitution of 15 ml paediatric drops.