CEFPROX (Cefpodoxime proxetil.)

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PRESENTATION: Film-Coated tab 100 mg x 1 x 10's. Oral Susp 40 mg/5 mL x 50 ml.
ACTIONS: Cefpodoxime proxetil is an orally administered, extended spectrum, semisynthetic antibiotic of the cephalosporin class. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime.
Microbiology: Cefpodoxime is active in vitro against a wide range of gram-positive and gram-negative bacteria. Cefpodoxime is highly stable in the presence of ß-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins, due to the presence of p-lactamases, may be susceptible to cefpodoxime. The bactericidal activity of cefpodoxime results from its inhibition of cell wall synthesis. Cefpodoxime is usually active against the following organisms in vitro and in clinical infections: Gram-positive Aerobes: Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus saprophyticus. Streptococcus pyogenes, Streptococcus pneumonia (excluding penicillin-resistant strains). Gram-Negative Aerobes: Escherlchia coli, Haemophilus influenzae (including ß-lactamase-producing strains), Klebsiella pneumoniae, Moraxella (Branhameila) catarrhalis, Neisseria gonorrhoeae (including penicillinase-producing strains), Proteus mirabilis.
Note: Cefpodoxime is inactive against most strains of Enterococcus, Pseudomonas and Enterobacter.
INDICATIONS: Treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Lower Respiratory Tract lnfections: Community-acquired pneumonia caused by S. pneumonia or H. influenzae (including B-lactamase producing strains). Acute bacterial exacerbation of chronic bronchitis caused by S. preumoniae, H. influenzae (non ß-lactamase-producing strains only) or M. catarrhalis. Sexually-Transmitted Diseases: Acute, uncomplicated urethral and cervical gonorrhoea, and ano-rectal infections caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
Skin and Skin Structure: Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes.
Upper Respiratory Tract lnfections: Acute otitis media caused by Streptococcus pneumoniae, Haemophilus infIuenzae (including B-lactamase producing strains) or (Moraxella (Branhamella) catarrhalis. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes. Urinary Tract infections: Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli. Klebsiella pneumoniae, Proteus mirabilis or StaphyIococcus saprophyticus.
DOSAGE & ADMINISTBATION: Film-Coated Tablet Cefprox tablet should be administered orally with food to enhance absorption (see Table 1). Oral Suspension: For administration of suspension, use the calibrated dosier where the dosier cone has the calibrated marks in kg (from 5-25 kg) corresponds to the child's weight e.g., the calibration mark “1 3” corresponds to the quantity (dose) to be administered to a “13” kg child twice daily. Cefprox suspension is recommended to be administered during meals (see Table 2).
Renal impairment: For patients with severe renal impairment (creatinine clearance <30 ml/min), the dosing intervals should be increased to every 24 hrs. ln patients maintained on haemodialysis, the dose frequency should be 3 times weekly after haemodialysis.
OVERDOSAGE: ln the event of serious toxic reaction from overdosage, haemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised.
CONTRAINDICATIONS: Known allergy to cefpodoxime or to any of the antibiotics in the cephalosporin group.
WARNINGS: Before therapy with Cefprox is instituted, careful inquiry should be made to determine whether the patient has previous hypersensitivity reactions to cefpodoxime, other cephalosporins, penicillins or other drugs. lf cefpodoxime is to be administered to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to '10% of patients with a history of penicillin allergy. lf an allergic reaction to Cefprox occurs, discontinue use. Serious acule hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, lV fluids and antihistamine, and airway management, as clinically indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefpodoxime and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
PRECAUTIONS: Carcinogenicity: Long-term animal carcinogenesis studies of celpodoxime proxetil have not been performed.
Mutagenicity: Mutagenesis studies of cefpodoxime were all negative.
Use in pregnancy: There are no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women; Cefprox should be used during pregnancy only if clearly needed.
Labor and Delivery: Celprox has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Use in lactation: Cefpodoxime 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.
Use  in children: Safety and efficacy in infants under 5 months have not been established.
ADVERSE REACTIONS: Film-Coated Tablets (Multiple Dose): ln clinical trials using multiple doses of cefpodoxime proxetil film-coated tablets, 3338 patients were treated with the recommended dosages of cefpodoxime (100-400 mg every 12 hrs). Adverse events thought possibly or probably related to celpodoxime in multiple-dose clinical trials were incidence >1 %: Diarrhoea7.2%, nausea 3.8%, vaginal lungal infections 3.1%, abdominal pain 1.6%,rash1.4%, headache 1.1%, vomiting 1.1%. lncidence <'l%: Cardiovascular: Chest pain, hypotension.
Dermatologic: Fungal skin infection, skin scaling/ peeling. Endocrine: Menstrual irregularity.
Genital: Pruritus.
Gastrointestinal: Flatulence, decreased salivation, candidiasis, pseudomembranous colitis.
Hypersensitivity: Anaphylactic shock.
Metabolic: Decreased appetite.
Miscellaneous: Malaise. Fever.
Central Nervous System: Dizziness, fatigue, anxiety, insomnia, flushing, nightmares, weakness.
Respiratory: Cough epistaxis. Special Senses: Altered taste, eye itching, tinnitus.
Oral Suspension (Multiple Dose): ln clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 1586 paediatric patients (90% of whom were <12 years) were treated with the recommended dosage of celpodoxime (10 mg/kg/ day every 24 hrs or divided evey 12 hrs to maximum equivalent adult dose). Adverse events thought possible or probably related to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials were: lncidence >1%: Diarrhoea 7.2%, diaper/fungal skin rash 2.3%, other skin rashes 1.8%, vomiting 2.1%.
lncidence <1%: Central Neruous System: Headache, itritability.
Dermatologic: Exacerbation of acne, exfoliative dermatitis.
Genital: Pruritus or vaginitis.
Gastrointestinal: Nausea, abdominal pain, candidiasis, decreased salivation, pseudomembranous colitis.
Metabolic: Decreased appetite.
Miscellaneous: Fever.
Psychiatric: Hyperactivity/nervousness.
Respiratory: Epistaxis, rhinitis.
Laboratory Changes: Significant laboratory changes that have been reported in clinical trials of cefpodoxime proxetil, without regard to drug relationship were: Hepatic: Transient increased AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin and LDH.
Haematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased haemoglobin, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, positive Coombs'test and prolonged PT and PTT.
Serum Chemistry: lncreased glucose, decreased glucose, decreased serum albumin, decreased serum total protein.
Renal: lncreased BUN and creatinine levels. Most of these abnormalities were transient and not
clinically significant.
INTERACTIONS: Antacids: Concomitant administration 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 βß-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid, and resulted in an approximately 31 % increase in AUC and 20% increase in peak cefpodoxime plasma levels respectively.
Drug/Laboratory Test interactions: Cephalosporins, including cefpodoxime proxetil are known to occasionally induce a positive direct Coombs'test.

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