Țară: Tanzania
Limbă: engleză
Sursă: Tanzania Medicinces & Medical Devices Authority
Cefpodoxime Proxetile
Hetero Laboratories Limited, INDIA
Cephalosporins
Cefpodoxime Proxetile
200 mg
Tablets
Hetero Labs Limited, Unit - I, INDIA
Physical description: Orange coloured capsules, shaped film coated tablets debossed with "c" and "3" on one side and plain on the other side; Local technical representative: SURYA PHARMA LIMITED (29253)
Registered/Compliant
2021-03-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT INN NAME: PODOXAL 200 (Cefpodoxime Proxetil Tablets USP 200 mg) TRADE NAME: PODOXAL 200 STRENGTH: 200 mg PHARMACEUTICAL FORM: Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 200 mg. Excipients: Each 200 mg tablet contains 91.00 mg of Lactose monohydrate. 3. PHARMACEUTICAL FORM DOSAGE FORM: Tablets DESCRIPTION: Orange coloured oval shaped film coated tablets debossed with ‘C’ and ‘3’ on one side and plain on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. ACUTE OTITIS MEDIA caused by Streptococcus pneumoniae (excluding penicillin resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). PHARYNGITIS AND/OR TONSILLITIS caused by Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available. COMMUNITY-ACQUIRED PNEUMONIA caused by S. pneumoniae or H. Influenzae (including beta- lactamase-producing strains). ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chroni Citiți documentul complet