Cefpodoxime proxetil is an orally administered, extended-spectrum, semi-synthetic antibiotic of the cephalosporin class. Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.

Cefpodoxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Antibacterial Spectrum

Commonly Susceptible Species

Aerobic Gram Positive Organisms:

• Staphylococcus aureus (Methicillin susceptible)
• Streptococcus pyogenes

Aerobic Gram Negative Organisms:

• Haemophilus influenzae
• Moraxella catarrhalis
• Proteus mirabilis+

Species for which Acquired Resistance may be a Problem

Aerobic Gram Positive Organisms:

• Streptococcus pneumoniae

Aerobic Gram Negative Organisms:

• Citrobacter freundi
• Enterobacter cloacae
• Escherichia coli+
• Klebsiella pneumoniae
• Serratia marcescens

Inherently Resistant Organisms

Aerobic Gram Positive Organisms:

• Staphylococcus aureus (methicillin resistant)
• Enterococcus spp

Aerobic Gram Negative Organisms:

• Morganella morganii
• Pseudomonas aeruginosa

Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime.

Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. A 100 mg dose of oral suspension produced an average peak cefpodoxime concentration of approximately 1.5 mcg/mL.

When a 200 mg dose of the suspension was taken with food, the extent of absorption (mean AUC) and mean peak plasma concentration in fed subjects were not significantly different from fasted subjects, but the rate of absorption was slower with food (48% increase in Tmax). The volume of distribution is 32.3 L and peak levels of cefpodoxime occur 2 to 3 hrs after dosing. The maximum plasma concentration is 1.2 mg/L and 2.5 mg/L after doses of 100 mg and 200 mg respectively. Protein binding of cefpodoxime ranges from 22% to 33% in serum and from 21% to 29% in plasma. Concentrations of cefpodoxime in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.

As the majority of cefpodoxime is eliminated in the urine, the concentration is high. (Concentrations in 0-4, 4-8, 8-12 hr fractions after a single dose exceed MIC90 of common urinary pathogens). Good diffusion of cefpodoxime is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12 hrs after an administration of a single 200 mg dose (1.63.1μg/ g). Concentrations of cefpodoxime in the medullary and cortical tissues is similar.

Over the recommended dosing range (100–400 mg), approximately 29–33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours. There is minimal metabolism of cefpodoxime in vivo.

DGpod Tablets/Oral Suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Acute otitis media caused by Streptococcus pneumoniae, (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains).

Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes

Community-acquired pneumonia caused by Streptococcus pneumoniae or Haemophilus influenzae (including beta-lactamase-producing strains).

Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (non-beta-lactamase-producing strains only), or Moraxella catarrhalis.

Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).

Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.

Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.

Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

The tablets should be taken with food to enhance absorption.

Adults and adolescents (aged 12 years and older)

Pharyngitis and/or tonsillitis – 100 mg Q12 hours 5–10 days

Acute community-acquired pneumonia – 200 mg Q 12 hours 14 days

Acute bacterial exacerbations of chronic bronchitis – 200 mg Q 12 hours, 10 days

Skin and skin structure – 400 mg Q 12 hours, 7–14 days

Acute maxillary sinusitis – 200 mg Q 12 hours, 10 days

Uncomplicated urinary tract infection – 100 mg Q12 hours, 7 days

Granules for Oral Suspension
Oral suspension may be given without regard of food.

Infants and pediatric patients (age 2 months through 12 years)

Acute otitis media

• 10 mg/kg/day, (Max 400 mg/day)
• 5 mg/kg Q12 hours (Max 200 mg/dose) 5 days

Pharyngitis and/or tonsillitis

• 10 mg/kg/day (Max 200 mg/day)
• 5 mg/kg Q 12 hours (Max 100 mg/dose) 5–10 days

Acute maxillary sinusitis

• 10 mg/kg/day, (Max 400 mg/day)
• 5 mg/kg Q 12 hours(Max 200 mg/dose) 10 days

DGpod tablets should be swallowed whole without chewing.

DGpod Oral Suspension is provided in the form of a dry powder for reconstitution. Tap the bottle to loosen the powder. Add two-thirds of the sterile water (provided with the pack) and shake the bottle vigorously. Add more water up to the mark on the bottle and shake well. Allow the suspension to stand for 5 minutes. After mixing, the suspension should be stored in a refrigerator, 2–8°C (36–46°F). Shake well before using. Keep the container tightly closed. The mixture may be used for 14 days. Discard the unused portion after 14 days.

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

It is also contraindicated in patients with previous history of immediate and / or severe hypersensitivity reaction (anaphylaxis) to penicillin or other betalactam antibiotic.

Cefpodoxime is not a preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia due to S. pneumoniae

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures must be initiated.

Contraindications
Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels by 24–42% and the extent of absorption by 27–32%, respectively.

Probenecid
As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and a 20% increase in peak cefpodoxime plasma levels.

Oral Anticoagulants: Simultaneous administration of cefpodoxime with warfarin may augment its anticoagulant effects.

Pregnancy
Pregnancy Category B

There are no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women.

Lactation
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.

Cefpodoxime is excreted in breast milk in small amounts. Cefpodoxime may be used during breastfeeding. Continuation of breastfeeding should be questioned in case of diarrhoea or mucosal fungus infection in the breastfed infant. The possibility of sensitisation should be borne in mind.

Safety and efficacy in infants less than 2 months of age have not been established.

Dose adjustment in elderly patients with normal renal function is not necessary.

Diarrhea 7.0%

Nausea 3.3%

Vaginal Fungal Infections 1.0%

Vulvovaginal Infections 1.3%

Abdominal Pain 1.2%

Headache 1.0%

Store in a cool, dry place.

Protect from light.

DGpod-200 Tablets – Strip pack of 10 tablets

DGpod-50/DGpod-100 Oral suspension – Bottle of 30 ml