ORACEF 100 (susp)
-
Chemical Name:
Cefpodoxime (Proxetil) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin (Third Generation) -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Cefpodoxime (Proxetil) 100mg
ORACEF
Film Coated Tablets, Dry Powder for Oral Suspension
Cefpodoxime (Proxetil)
1.CLINICAL PHARMACOLOGY:
Cefpodoxime is a broad spectrum antibiotic, semi-synthetic, orally administered. Belonging to the third generation cephalosporins.
The bactericidal activity of Cefpodoxime results from its inhibition of the bacterial cell wall synthesis.
Cefpodoxime has a high degree of stability in the presence of beta lactamase (penicillinase and cephalosporinase), that are produced by gram-negative and gram-positive bacteria.
Cefpodoxime has been shown to be active against most of the following microorganisms:
Gram-positive: Staphylococcus Aureus (including penicillinase producing strains), Staphylococcus Saprophyticus, Streptococcus (Diplococcus) Pneumonia and its various types (A, B, C, F and G), Propionibacterium Acnes, Corynebacterium Diphteriae.
Gram-negative: Citrobacter Diversus, Escherichia Coli, Haemophilus Influenza, Haemophilus Para Influenza, Klebsiella pneumonia, Klebsiella Oxytoca, Moraxella (Branhamella) Catarrhalis, Neisseria Meningitidis, Neisseria Gonorrhoeae, Pasteurella Multocida, Peptostreptococcus Magnus, Proteus Mirabilis, Proteus Vulgaris, Providence spp., Salmonella spp., Shinella spp.
2.INDICATIONS:
ORACEF is recommended in the treatment of the following infections:
Tonsillitis, pharyngitis, sinusitis, otitis media, community acquired pneumonia, acute purulent bronchitis, acute bacterial exacerbation of chronic obstructive bronchitis, acute uncomplicated urethral and cervical gonorrhea caused by (Neisseria gonorrhea), acute uncomplicated rectum and anus infections caused by (Neisseria gonorrhea), uncomplicated urinary tract infections (cystitis), skin and soft tissues infections.
3.CONTRAINDICATIONS:
Hypersensitivity to Cefpodoxime or to the Cephalosporins group.
4.SIDE EFFECTS:
Cefpodoxime may cause in some patients: Diarrhoea, abdominal pain, nausea, vomiting, vaginal fungal infection, rash, headache, rarely pseudomembranous colitis and positive direct coomb’s test.
5.DRUG INTERACTIONS:
- Antacids (aluminium hydroxide, sodium carbonate) and H2 receptor antagonists (ranitidine), reduces peak plasma levels and the extent of the absorption of the cefpodoxime.
- Pentagastrine reduces the gastric pH causing an increase of the biodisponsibility of the Cefpodoxime.
- Probenecid delays the excretion of Cefpodoxime.
6.PRECAUTIONS:
- ORACEF should be prescribed with caution in patients with renal impairment.
- ORACEF should be prescribed with caution in individuals with previous history of allergy to beta lactams or in patients receiving concurrent treatment with potent diuretics.
- ORACEF should not be used during pregnancy only if clearly needed.
- ORACEF is distributed into breast milk; therefore, this drug should be used with caution during lactation.
7.DOSAGE & ADMINISTRATION:
Adults:
- In acute sinusitis, acute and chronic purulent bronchitis, acute community-acquired bacterial pneumonia, acute bacterial exacerbation of chronic obstructive bronchopneumonia: 400 mg administered daily with meals in two equally divided doses.
- In tonsillitis, pharyngitis, and uncomplicated urinary tract infections: 200 mg administered daily with meals in two equally divided doses.
- In uncomplicated gonorrhea (men and women) and rectal gonococcal infections (Women): 200 mg administered as a single dose.
- In skin and soft tissue infections: 800 mg administered daily with meal in two equally divided doses.
Dosage in renal impairment:
In patients with renal impairment (creatinine clearance < 30 mL/min) the dosage should be adjusted accordingly, to prevent drug accumulation. A dosage of ORACEF 100 mg administered daily, as a single dose is sufficient.
Children:
10 mg/kg daily should be administered with meals in two equally divided doses in the following infections:
Acute otitis media: (maximum to 200 mg daily).
Pharyngitis and tonsillitis: (maximum to 100 mg daily).
According to physician’s prescription the recommended duration of treatment varies from 7 to 14 days.
Reconstitution directions for oral suspension:
Shake the bottle to loosen the powder. Add pre-boiling cold water until the reconstituted suspension is at level with the mark on the label.
8.PACKAGING & COMPOSITION:
- ORACEF 100 - F.C.Tablets: A pack of 10 film coated tablets in blister. Each f.c.tablet contains Cefpodoxime (Proxetil) 100 mg.
- ORACEF 200 - F.C.Tablets: A pack of 10 film coated tablets in blister. Each f.c.tablet contains Cefpodoxime (Proxetil) 200 mg.
- ORACEF 50 - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 5 mL of the suspension contains Cefpodoxime (Proxetil) 50 mg.
- ORACEF 100 - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 5 mL of the suspension contains Cefpodoxime (Proxetil) 100 mg.
9.STORAGE CONDITIONS:
Store ORACEF - F.C.Tablets and Dry Powder for Oral Suspension at temperature between(15-30)°C.
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