C-FLOX 500 TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

JETPHARMA SDN. BHD.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Units in package:

100 Tablets

Manufactured by:

INTAS PHARMACEUTICALS LIMITED

Patient Information leaflet

(643827- K)
No. 13, Jalan Rajawali 2, Bandar Puchong Jaya, 47100
Puchong, Selangor. Tel: [phone] Fax: [phone].
Email: [e-mail]
Date: 02/08/21
The Secretary,
Generic Division,
NPRA, MOH- Malaysia.
Sub
:
Commitment Letter for submission RiMUP in Bahasa Malay
Product name
:
C flox 500mg Tablet
With reference to the above subject we are hereby commit and submit
RiMUP to PHARMACOVIGILANCE
DEPARTMENT manually for evaluation.
Kindly accept the RiMUP in Bahasa English and proceed for evaluation
of change of site variation.
Thanking you,
Regards,
Naren.V
Regulatory Affairs

Summary of Product characteristics

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory.
C-FLOX 250 & 500 TABLETS
(Ciprofloxacin tablets 250 mg & 500 mg)
C-flox (Ciprofloxacin) is a broad spectrum and potent synthetic
fluoroquinolone antibacterial agent. It is indicated in various
respiratory,
urinary and other infections caused by susceptible microorganisms.
DESCRIPTION: C-flox 250: White to off white coloured, round, biconvex,
film coated tablet plain on one side and bisecting line on other
side of the tablet.
C-flox 500: White to off white coloured, capsule shaped, biconvex,
film coated tablet with break line on one side of the tablet.
CLINICAL PHARMACOLOGY: Ciprofloxacin exhibits potent bactericidal
action by Interfering with enzyme DNA gyrase -which is needed for
the synthesis of bacterial DNA. The in vitro antimicrobial spectrum of
Ciprofloxacin includes wide range of microorganisms including
Gram-negative bacteria like campylobacter jejuni, E.coli,
Citrobacters, H.influenzae, H.parainffuenzae, Shigella, Salmonella
typhi, Vibrio cholerae,
Neisseria-gonorrhoea, N.meningitidis, Branhaemella catanrhalis,
Kleb.pneumoniae, Brucella melitensis, H.ducrayi, Proteus mirabilis,
P.vulgaris,
Pseudomonas
aeruginosa,
Providancia
rettgeri,
P.
startii,
Serratia
marcescens,
Enterobacter
cloacae,
and
Gram-positive
bacteria
like
Staphylococcus aureus, Staph. epidermidis, Staph.haemolyticus,
Streptococcus pneumoniae, Streptococcus pyogens. ..; Most strains of
Ps.
cepacia, Ps.multophilia and most anaerobic bacteria are resistant to
Ciprofloxacin.Ciprofloxacin is slightly less active at acidic pH.
Ciprofloxacin does
not cross- react with other antimicrobial agents. Synergism is
reported with aminoglycosides, clindamycin, metronidazole and
particularly
beta-lactams. Ciprofloxacin is also shown to have post antibiotic
effect (PAE) i.e. continued antibacterial effect after cessation of
drug administration.
Ciprofloxacin is rapidly and well absorbed from the gastrointestinal
tract. Oral bioavailability is about 70% and a peak plasma
concentr