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PYRFLOX
Caplet
COMPOSITION  :
Each  film coated caplet contains Norfloxacin 400 mg

DESCRIPTION  :
Pyrflox is a bacterial gyrase blocker with a broad antibacterial spectrum. The mode of action is by inhibition of DNA gyrase
activity. Pyrflox is bactericidal at very low concentrations.
Resistance is rare. Plasmid mediated resistance has not been reported and, due to the mode of action, is not likely to occur.

The common bacterial pathogens causing urinary tract infections–Escherichia coli, Proteus mirabilis, Staphylococcus
saprophyticus and those species inherently resistant to antibiotics-Enterobacter spp., Klebsiella spp., Serratia spp.,
indolpositive Proteus, Acinetobacter, Pseudomonas aeruginosa and Streptococcus faecalis – are sensitive to Pyrflox. Aerobic
bacteria causing gastroenteritis such as Shigella spp is sensitive.
Both non-penicillinase – and penicillinase producing N. gonorrhoeae are highly sensitive. Anaerobes are not sensitive.

Pyrflox is rapidly absorbed following oral administration. Peak serum levels in the order of 0.8 ml/l after 200 mg and 1.5 ml /l
after 400 mg are obtained after 1-2 hours. One third of a given dose is excreted in the urine ; 80 % as unchanged drug, 15 %
as metabolite less active than norfloxacin, and less than 5 % as inactive metabolites. Peak urinary concentrations are found 2
hours after the dose administration and bactericidal concentrations remain for 12 hours.
The extent of protein binding is low, 10-15 %. The serum half-life is 3-5 hours. In patients with impaired renal function,
creatinine clearance less than 30 ml/min, the renal elimination of norfloxacin decreases and the half-life is 6 – 7 hours.
Hemodialysis does not affect the half-life.

INDICATIONS :
Infections caused by bacteria sensitive to Pyrflox such as urinary tract infections, specific infection in gastrointestinal caused by
shigella, gonorrhoeae.

DOSAGE  :
Urinary tract infections  :
Acute uncomplicated UTI               :  200 mg twice daily
Complicated UTI                             :  400 mg twice daily
Gastrointestinal infections                :  400 mg, 2–3 times daily
Acute uncomplicated gonorrhoeae :  600 mg, twice daily or 800 mg in a single dose

PRECAUTIONS  :
Pyrflox should not be given to pregnant / nursing women or prepubertal children as safety data is not available. In patients
with moderate renal impairment, i.e. creatinine clearance 10 – 30 ml/min, the dose should be limited to 400 mg daily and the
patient carefully followed.

ADVERSE  REACTIONS  :
Pyrflox is very well tolerated. Gastrointestinal  reactions such as nausea and abdominal pain may occur. Vomiting and diarrhea
are rare. Dizziness, headache and a few cases of skin reactions have been reported. Hypersensitivity reactions are rare.

CAUTION  :
This medication may cause tendinitis and tendon rupture.
Consult Physician before use.

CONTRAINDICATIONS  :
Hypersensitivity to norfloxacin and chemically related substances. Severe renal insufficiency, i.e. creatinine clearance less than
10 ml/min.

PACKING  :
Box of 5x10’s.   Reg.No.DKL9521009109A1.

On medical prescription only.



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High Standard
Pyridam is Certified in  Good
Manufacturing Practices
(GMP).

Our Products have met the
International Level and
Requirement.

How to contact us
for more information

email: info@pyridam.com
Phone: +62-21-536-90112
Fax     : +62-21-532-9049