Product Code : AB-07B
Dosage Form : TABLET
INFORMATION FOR THE USER
Cefpodoxime 200mg Tablets
Read all of this information carefully before you start taking this medicine because it contains important information for you.
- Keep this information. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
1. COMPOSITION:
Each tablet contains:
Cefpodoxime – 200mg
For oral use only.
2. DESCRIPTION:
Cefpodoxime is an anti-biotic that is very useful to treat a wide variety of infections. It belongs to the class of drugs known as cephalosporins.
3. PHARMACOLOGICAL ACTION:
Cefpodoxime is an orally administered extended-spectrum semi-synthetic antibiotic of the cephalosporin class. It is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. It has activity in the presence of some beta-lactamases both penicillinases & cephalosporinases of Gram-negative & Gram-positive bacteria.
4. CLINICAL PHARMACOKINETICS:
Cefpodoxime proxetil is a prodrug that is absorbed from the GI tract & de-esterified to its active metabolite cefpodoxime. Following oral administration approx. 50% of the dose was absorbed systemically & produced an average peak concentration of approx. 1.5 mcg/mL. The extent of absorption (mean AUC) & mean peak plasma conc. 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 & peak levels occur 2-3 hrs after dosing. The maximum plasma concentration is 1.2 mg/L & 2.5 mg/L after doses of 100 mg & 200 mg resp. Protein binding ranges from 22-33% in serum & from 21-29% in plasma. Conc. in excess of the minimum inhibitory levels (MIC) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid & prostate tissue. As the majority is eliminated in the urine the concentration is high. Good diffusion is also seen into renal tissue, with concentrations above MIC90 of the common urinary pathogens, 3-12 hrs. Conc. of cefpodoxime in the medullary & cortical tissues is similar. Studies in healthy volunteers show median concentrations in the total ejaculate 6-12 hrs following administration to be above the MIC90 of N. gonorrhoeae. The main route of excretion is renal, 80% is excreted unchanged in the urine, with an elimination half-life of approx. 2.4 hours. Over the recommended dosing range approx. 29–33% of dose was excreted unchanged in urine in 12 hours. There is minimal metabolism of cefpodoxime in vivo.
5. INDICATIONS:
Cefpodoxime is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
- Acute otitis media
- Pharyngitis and/or tonsillitis
- Community-acquired pneumonia
- Acute bacterial exacerbation of chronic bronchitis
- Acute, uncomplicated urethral & cervical gonorrhea
- Acute, uncomplicated ano-rectal infections in women
- Uncomplicated skin & skin structure infections
- Acute maxillary sinusitis
- Uncomplicated urinary tract infections (cystitis)
6. CONTRAINDICATIONS:
Cefpodoxime tablets are contraindicated in the following cases:
- In patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics or to any of the excipients.
- Previous history of immediate and/or severe hypersensitivity reaction (anaphylaxis) to penicillin/other betalactam antibiotic.
7. WARNINGS AND PRECAUTIONS:
Not preferred for the treatment of staphylococcal pneumonia & should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia.
Serious & occasionally fatal hypersensitivity reactions have been reported.
A detailed inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefpodoxime, other cephalosporins, penicillins, or other drugs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of Cefpodoxime.
In patients with transient/persistent reduction in urinary output due to renal impairment, the total daily dose of cefpodoxime should be reduced because high & prolonged serum antibiotic concentrations can occur in such individuals following usual doses.
Should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis.
Neutropenia and more rarely agranulocytosis may develop particularly during extended treatment.
May be absorbed onto the surface of red cell membranes & react with antibodies directed against the drug. This can produce a positive Coomb’s test and very rarely, haemolytic anaemia.
Changes in renal function have been observed particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potential diuretics.
Prolonged use may result in the overgrowth of non-susceptible organisms.Prescribing in the absence of a proven/strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient & increases the risk of the development of drug-resistant bacteria.
8. ADVERSE EFFECTS:
Common side effects include:
- Nausea
- Abdominal pain
- Headache
- Vomiting
- Dyspepsia
- Dry mouth
- Myalgia
- Dizziness
- Insomnia
- Hypersensitivity reactions
9. DRUG INTERACTIONS:
Antacids: Concomitant administration of high doses of antacids or H2 blockers reduces peak plasma levels by 24–42% & the extent of absorption by 27–32%, respectively. The rate of absorption is not altered by these concomitant medications.
Probenecid: Renal excretion was inhibited by probenecid & resulted in an approximately 31% increase in AUC & a 20% increase in peak plasma levels.
Nephrotoxic Drugs: Close monitoring of renal function is advised when administered concomitantly with compounds of known nephrotoxic potential.
Oral Anticoagulants: Simultaneous administration with warfarin may augment its anticoagulant effects.
Bioavailability is decreased by approx. 30% when administered with drugs which neutralise gastric pH/inhibit acid secretions.
Potentially enhance the anticoagulant effect of coumarins & reduces contraceptive effect of oestrogens.
9. DOSAGE:
Adults: 1-2 tablets a day depending on the type and severity of infection.
10. ADMINISTRATION:
The tablets need to be swallowed with a glass of liquid. Do not crush or break the tablet as it will destroy the film coating.
11. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
12. MANUFACTURED BY:
13. MARKETED BY:
Last revised on May 2019.