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SPECTRATIL (Cefpodoxime proxetil Tablets & Suspension)


Cefpodoxime proxetil is an extended spectrum third generation oral cephalosporin.

It is a prodrug of cefpodoxime. Cefpodoxime proxetil is chemically designated as (RS)-1- (isopropoxycarbonyloxy) ethyl (+) - (6R, 7R)-7-(2-(2-amino-4-thiozolyl)-2-((z) methoxyimono) acetamido) - 3- methoxy methyl -8-oxo-5-thia-1-azabicyclo (4.2.0.) oct-2-ene-2-carboxylate.


Pharmacology:
The antibacterial action of cefpodoxime is through the inhibition of bacterial cell wall synthesis by acylation of membrane bound transpeptidase enzymes; this prevents cross linkage of Peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity.
Antimicrobial Activity:
Cefpodoxime proxetil is active against a wide range of Gram positive and Gram-negative bacteria including Beta lactamase producing strains. Cefpodoxime is highly stable in the presence of Beta lactamase hence organisms resistant to penicillins and other cephalosporins may be susceptible to Cefpodoxime.


Antibacterial Spectrum includes:

Gram-positive aerobes:
Staphylococcus aureus (including Beta lactamase producing strains), Staphylococcus saprophyticus,
Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp (Groups C, F, G).

Gram-negative aerobes:
Escherichia coli, Haemophilus influenzae (including Beta lactamase producing strains), Klebsiella pneumoniae,
Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including Beta lactamase producing strains),
Proteus mirabilis, Citrobacter diversus, Haemophilus parainfluenzae, Proteus vulgaris, Providencia rettgeri.

Anaerobes:
Peptostreptococcus magnus.

Following organisms are not susceptible to cefpodoxime proxetil:
Pseudomonas aeruginosa, Enterococcus faecalis, Methicillin resistant Staphylococcus aureus, Enterobacter spp.

Compositions:

Spectratil Tablets 100 mg
Each film-coated tablet contains Cefpodoxime proxetil equivalent to Cefpodoxime 100 mg
Spectratil Tablets 200 mg
Each film-coated tablet contains Cefpodoxime proxetil equivalent to Cefpodoxime 200 mg
Spectratil Oral Suspension 100 mg/5 ml
Each 5 ml of the constituted suspension contains Cefpodoxime proxetil equivalent to Cefpodoxime 100 mg.

Interactions:
Upper respiratory tract infections:
Acute Maxillary sinusitis, acute otitis media, tonsillitis and pharyngitis.

Lower respiratory tract infections:
Acute bacterial exacerbation of chronic bronchitis and community acquired pneumonia.

Uncomplicated skin and skin structure infections:
Abscesses, wound infections, cellulites, furuncle, subcutaneous abcesses.

Genito-urinary tract infections:
Acute uncomplicated urethral and cervical gonorrhoea, acute uncomplicated ano-rectal infections, complicated pyelonephritis and complicated cystitis.

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

Side Effects:
The side effects are mild and transient. GI side effects are nausea, diarrhoea, vomiting, abdominal pain and colitis. Occasionally, headache, dizziness, allergic reactions like hypersensitivity, mucocutaneous reactions, skin rashes and pruritis, hemolytic disorders like thrombocytosis, thrombocytopenia, leucopenia ad eosinophilla occur.

Precautions:
Cefpodoxime proxetil tablets should be used with caution in patients with previous history of GI disorders like pseudomembranous colitis.. The presence of Clostridium difficile should be investigated. During extended therapy (more than 10 days),blood count should be monitored and treatment should be discontinued if neutropenia is found.

Warnings:
Cefpodoxime proxetil tablets should not be given to patients with anaphylactic response to penicillins. Care should be taken incase of patients with previous history of hypersensitivity to Cephalosporins. It should not be used for the treatment of atypical pneumonia caused by organisms such as Legionella,Mycoplasma and Chlamydia

Drug Interactions:
When administered along with histamine (H-receptor) blockers or antacids, approximately 30% plasma concentration of cefpodoxime decrease due to increase in pH. When administered with probenecid, plasma levels of cefpodoxime increases. When administered with compounds of known nephrotoxic potential, close monitoring of renal function is advised.

Drug/inter laboratory test interactions:
Cephalosporin induce positive direct Coomb's test.

Pregnancy:
The results of animal studies in different species indicated that the drug is not having teratogenic or fetotoxic effects. Since the safety of the drug in pregnancy was not established, it should be administered with caution during pregnancy.

Lactation:
The drug is excreted in human milk. Thus it is recommended that breast-feeding or treatment of mother with cefpodoxime should be stopped.

Dosage:

Adults (>=12 years)
Acute exacerbation of chronic bronchitis 200 mg 12 hourly for 10 days
Community acquired pneumonia 200 mg 12 hourly for 4 days
Pharyngitis/tonsillitis 100 mg 12 hourly for 5-10 days
Urinary tract infections 100 mg 12 hourly for 7-10 days
Skin and skin structure infections 400 mg 12 hourly for 7-14 days
Acute uncomplicated gonorrhea 200 mg single dose
Acute Maxillary sinusitis 200 mg 12 hourly for 10 days
Children (2 months—12 years)
Acute otitis media 10 mg/kg/day (max. 400 mg/day in two divided doses) for 5 days
Pharyngitis and tonsillitis 10 mg/kg/day (max. 200 mg/day in two divided doses) for 5—10 days
Acute Maxillary Sinusitis 200 mg 12 hourly for 10 days

Renal impairment (Adults):

Creatinine clearance Dose and Frequency
Less than 30 ml/min  200 mg every 24 hours
Less than 10 ml/min 200 mg every 48 hours
Haemodialysis patients 200 mg thrice a week after dialysis

Elderly subjects do not require dosage adjustments unless they have diminished renal function.

Spectratil is provided as a dry powder for constitution. Add sufficient boiled and cooled water up to the mark on the label. Keep the constituted suspension in a refrigerator at 2° C to 8° C. Constituted suspension should be consumed within 14 days. Shake well before use.

Presentation:

Spectratil Tablets 100 mg - Strip of 4's
Spectratil Tablets 200 mg - Strip of 4's
Spectratil Oral Suspension 100 mg/5 ml


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