PODOXAL 100 Tablets 100 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Cefpodoxime Proxetile

Available from:

Hetero Laboratories Limited, INDIA

ATC code:

Cephalosporins

INN (International Name):

Cefpodoxime Proxetile

Dosage:

100 mg

Pharmaceutical form:

Tablets

Manufactured by:

Hetero Labs Limited, Unit - I, INDIA

Product summary:

Physical description: Orange coloured oval shaped film coated tablets debossed with 'C' and '4' on one side and plain on the other side; Local technical representative: SURYA PHARMA LIMITED (29253)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

Page 1 of 21
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.
Page 2 of 21
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 bacteri