SWOT Analysis of cefuroxime axetil

Md: Jabiur Rahaman

Daffodil International University,Bangladesh

Dept. of Pharmacy

Introduction

CEFTIN (cefuroxime axetil) Tablets andCEFTIN (cefuroxime axetil) for OralSuspension contain cefuroxime ascefuroxime axetil. CEFTIN (cefuroximeaxetil) is a semisynthetic, broad-spectrumcephalosporin antibiotic for oraladministration.

Its molecular formula is C20H22N4O10S, andit has a molecular weight of 510.48.

Cefuroxime axetil is in the amorphous form and has the following structural formula:

CEFTIN (cefuroxime axetil) Tablets are film-coated and contain the equivalent of 250 or500 mg of cefuroxime as cefuroxime axetil.CEFTIN (cefuroxime axetil) Tablets containthe inactive ingredients colloidal silicondioxide, croscarmellose sodium,hydrogenated vegetable oil, hypromellose,methylparaben, microcrystalline cellulose,propylene glycol, propylparaben, sodiumbenzoate, sodium lauryl sulfate, andtitanium dioxide.

Strength

Cefuroxime Axetil - Clinical Pharmacology:• Absorption and Metabolism: After oral administration,

Cefuroxime Axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.

• Indications and Usage for Cefuroxime Axetil:• Pharyngitis/Tonsillitis: caused byStreptococcus

pyogenes.• Acute Bacterial Otitis Media: caused byStreptococcus

pneumoniae,Haemophilus influenzae(including beta-lactamase–producing strains),Moraxellacatarrhalis(including beta-lactamase–producing strains), orStreptococcus pyogenes.

• Acute Bacterial Maxillary Sinusitis: caused byStreptococcus pneumoniaeorHaemophilus

• Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary BacterialInfections of Acute Bronchitis: caused byStreptococcuspneumoniae,Haemophilus influenza.

• Uncomplicated Skin and Skin-Structure Infections: caused byStaphylococcus aureus(including beta-lactamase–producing strains) orStreptococcuspyogenes.

Pregnancy: Category B. The safety of cefuroxime axetil in pregnancy has not been established. The use of cefuroximeaxetil in pregnant women requires that the likely benefit from the drug be weighed against the possible risk to the mother and fetus.

In present lots of pharmaceutical industry commercially Manufacturing cefuroximeaxetil categories drug shown in table 1…

• Orion Pharma Ltd.

• 125mg x 20s pack: 300.00 MRP; 250mg x 20s pack: 500.00 MRP; 500mg x 12s pack: 540.00 MRP

• AXET

• Cefuroxime axetil 125mg/5ml suspension

• Suspension

• Orion Pharma Ltd.

• 70ml bot: 215.00 MRP

• AXET

• Cefuroxime (as sodium salt) 250mg & 750mg/vial

• Injection (IV/IM)

• Orion Pharma Ltd.

• 250mg vial x 1s pack: 60.00 MRP; 750mg vial x 1s pack: 125.00 MRP

• AXETIL

• Cefuroxime axetil 125mg, 250mg & 500mg/tablet

• Tablet (Film Coated)

• Alco Pharma Ltd.

• 125mg x 12s pack: 144.00 MRP; 250mg x 8s pack: 176.00 MRP; 500mg x 8s pack: 320.00 MRP

• AXETIL• Cefuroxime axetil 125mg/5ml suspension• Suspension• Alco Pharma Ltd.• 70ml bot: 190.00 MRP• AXIM• Cefuroxime axetil 125mg, 250mg & 500mg/tablet• Tablet (Film Coated)• Aristopharma Ltd.• 125mg x 10s pack: 150.00 MRP; 250mg x 20s pack: 500.00 MRP; 500mg x 10s pack:

450.00 MRP• AXIM• Cefuroxime axetil 125mg/5ml suspension• Suspension• Aristopharma Ltd.• 70ml bot: 198.00 MRP• AXIM• Cefuroxime (as sodium salt) 750mg/vial• Injection (IV/IM)• Aristopharma Ltd.• 1 vial pack: 125.00 MRP• CEBAC-A• Cefuroxime axetil 125mg/tablet• Tablet (Film Coated)• Seema Pharmaceuticals Ltd.• 125mg x 8s pack: 120.00 MRP

• CEFOTIL• Cefuroxime axetil 125mg, 250mg & 500mg/tablet• Tablet (Film Coated)• Square Pharmaceuticals Ltd.• 125mg x 20s pack: 300.00 MRP; 250mg x 20s pack: 500.00 MRP; 500mg x 6s pack: 270.00 MRP• CEFOTIL• Cefuroxime axetil 125mg, 250mg & 500mg/tablet• Tablet (Film Coated)• Square Pharmaceuticals Ltd.• 125mg x 20s pack: 300.00 MRP; 250mg x 20s pack: 500.00 MRP; 500mg x 6s pack: 270.00 MRP• CEFOTIL• Cefuroxime axetil 125mg/5ml suspension• Suspension• Square Pharmaceuticals Ltd.• 70ml bot: 198.00 MRP• CEFOTIL 1.5 IV• Cefuroxime (as sodium salt) 1.5gm/vial• Injection (IV)• Square Pharmaceuticals Ltd.• 1.5gm vial x 1s pack: 200.00 MRP• CEFOTIL 750• Cefuroxime (as sodium salt) 750mg/vial• Injection (IV/IM)• Square Pharmaceuticals Ltd.• 750mg vial x 1s pack: 125.00 MRP

Weakness

• side effects of cefuroxime (Ceftin):Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;• fever, chills, body aches, flu symptoms;• chest pain, fast or pounding heartbeats;• unusual bleeding;• blood in your urine;• seizure (convulsions);• pale or yellowed skin, dark colored urine, fever,

confusion or weakness;• jaundice yellowing of the skin.

• Adverse Reactions:

Cefuroxime Axetil Tablets in Clinical Trials: Multiple-Dose Dosing Regimens: 7 to 10 Days Dosing Using multiple doses of Cefuroxime Axetil tablets, 912 patients were treated with CefuroximeAxetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity.

• Abdominal pain• Abdominal cramps• Flatulence• Indigestion• Headache• Vaginitis• Rash• Hives• Itch• Dysuria• Chills• Chest pain• Shortness of breath• Mouth ulcers• Swollen tongue• Sleepiness

• precautions when taking cefuroximeaxetil (Ceftin):

Before taking cefuroxime, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (e.g., cephalexin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Opportunity

• Pseudomembranous colitis has been reported to be associated with the use of cefuroximeaxetil and other broad-spectrum antibiotics. Therefore, it is important to consider its diagnosis in patients administered cefuroximeaxetil who develop diarrhea. Treatment with broad-spectrum antibiotics, including cefuroxime axetil, alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis. Mild cases of colitis may respond to drug discontinuance alone.

Moderate to severe cases should be managed with fluid, electrolyte, and protein supplementation as indicated. When the colitis is severe or not relieved by discontinuance of cefuroxime axetiladministration, consideration should be given to the administration of oral vancomycin or other suitable therapy. Other possible causes of colitis should also be considered.

Threat

• In present time cefruoxime axetil in Bangladesh lots of pharmaceutical produce this types of drug and doctors should be prescribed this drug too much for the treatment. cefroxime axetil is a second generation drug for this condition it should be prevented many microbial agent.Many pharmaceutical industry produce this categoris drug so that they uses lots of API that’s vary the price of this drug for example:

CEFOBAC 1.5 IV

Cefuroxime (as sodium salt) 1.5gm/vial

Injection (IV)

Popular Pharmaceuticals Ltd.

1 vial pack: 200.00 MRP

On the other hand

AXIM

Cefuroxime (as sodium salt) 750mg/vial

Injection (IV/IM)

Aristopharma Ltd.

1 vial pack: 125.00 MRP

In this list we make little difference between two companies product.price make a fact to compare with two pharmaceutical industries product.