POLI-CIFLOXIN 250 TABLET 250 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CIPROFLOXACIN HCl MONOHYDRATE EQV CIPROFLOXACIN

Available from:

MD PHARMACEUTICALS PTE. LTD.

ATC code:

J01MA02

Dosage:

250 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

CIPROFLOXACIN HCl MONOHYDRATE EQV CIPROFLOXACIN 250 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

POLIPHARM CO LTD

Authorization status:

ACTIVE

Authorization date:

1998-10-23

Summary of Product characteristics

POLI-CIFLOXIN 250
Composition:
Each tablet contains
Ciprofloxacin HCl monohydrate equivalent to
Ciprofloxacin 250 mg
Properties:
Ciprofloxacin is a fluoroquinone bactericidal and acts by inhibiting
the A subunit of DNA
gyrase (topoisomerase) which is essential in the reproduction of
bacterial DNA. It has a wide
spectrum of activity including Enterobacteriaceae, _ Pseudomonas
aeruginosa_, _ Haemophilus_,
and _Neisseria_ spp. and also against staphylococci and some other
Gram-positive bacteria.
Indications:
For treatment of infections caused by sensitive to Ciprofloxacin gram
positive and gram
negative pathogens in respiratory tract, ear, sinuses, kidneys,
urinary tract and etc.
Dosage:
The usual dose is 250-500 mg twice daily or as prescribed by a
physician. A single dose of
250 mg for the treatment of gonorrhoea.
Warnings and precautions:
Cardiac disorders
Caution should be taken when using fluoroquinolones, including
ciprofloxacin, in patients with
known risk factors for prolongation of the QT interval such as, for
example:
- congenital long QT syndrome
- concomitant use of drugs that are known to prolong the QT interval
(e.g. Class IA and III
anti-arrhythmics, tricyclic antidepressants, macrolides,
antipsychotics)
- uncorrected electrolyte imbalance (e.g. hypokalaemia,
hypomagnesaemia)
- elderly
- cardiac disease (e.g. heart failure, myocardial infarction,
bradycardia)
Peripheral Neuropathy
Cases of sensory or sensorimotor axonal polyneuropathy affecting small
and/or large axons
resulting in paresthesias, hypoesthesias, dysesthesias and weakness
have been reported in
patients receiving fluoroquinolones, including Poli-Cifloxin 250.
Symptoms may occur soon
after initiation of Poli-Cifloxin 250 and may be irreversible.
Poli-Cifloxin 250 should be
discontinued immediately if the patient experiences
symptoms of peripheral neuropathy
including pain, burning, tingling, numbness, and/or weakness or other
alterations of sensation
including light touch, pain, temperature, position sense, and
vibratory sensation.
Vision