NEGGRAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NALIDIXIC ACID

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

J01MB02

INN (International Name):

NALIDIXIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

NALIDIXIC ACID 500MG

Administration route:

ORAL

Units in package:

56

Prescription type:

Prescription

Therapeutic area:

QUINOLONES

Product summary:

Active ingredient group (AIG) number: 0107402002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2007-03-28

Summary of Product characteristics

PRESCRIBING INFORMATION
Pr
NEGGRAM

(nalidixic acid tablets USP)
URINARY ANTIBACTERIAL
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
May 9, 2006
Laval, Quebec H7L 4A8
Submission Control No. 105766
s-a Version 1.0 dated
2
NAME OF DRUG
Pr
NegGram

(nalidixic acid tablets U.S.P.)
THERAPEUTIC CLASSIFICATION
Urinary Antibacterial
ACTIONS AND CLINICAL PHARMACOLOGY
Nalidixic acid has marked antibacterial activity against gram negative
bacteria including _Proteus _
_mirabilis; P. morganii; P. vulgaris and P. rettgeri; Escherichia
coli; Enterobacter (Aerobacter) _
_and Klebsiella. Pseudomonas _strains are generally resistant to the
drug.
Nalidixic acid acts by selectively inhibiting bacterial DNA synthesis.
Nalidixic acid is
bactericidal and is effective over the enire urinary pH range.
Conventional chromosomal resistance to nalidixic acid taken in full
dosage has been reported to
emerge in approximately 2 to 14% of patients during treatment;
however, bacterial resistance to
nalidixic acid has not been shown to be transferable via R factor.
Bacterial cross-resistance between nalidixic acid and other quinolone
antimicrobials has been
observed. Even in patients treated for prolonged periods, no fungal
overgrowth has been reported
during therapy with NegGram.
INDICATIONS AND CLINICAL USE
NegGram (nalidixic acid) is indicated for the treatment of patients
with acute or chronic urinary
tract infections due to one or more species of nalidixic
acid-sensitive gram negative pathogenic
organisms, in particular Proteus species, E. coli, Aerobacter and
Klebsiella (disc sensitivity with
the 30
µ
g disc is recommended). It is useful in mixed urinary tract infection
when the nalidixic
acid-sensitive gram negative rods predominate.
When urinary tract pathogens which are resistant to other types of
antibacterial drugs are found
to be sensitive to nalidixic acid, the use of NegGram should be
considered.
CONTRAINDICATIONS
NegGram (nalidixic acid) is contraindicated in patients with known
hypersensitivity