LOXIP 250 ciprofloxacin (as hydrochloride) 250 mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

ciprofloxacin hydrochloride, Quantity: 294.586 mg (Equivalent: ciprofloxacin, Qty 250 mg)

Verfügbar ab:

Strides Pharma Science Pty Ltd

INN (Internationale Bezeichnung):

ciprofloxacin hydrochloride

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type A; povidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Verabreichungsweg:

Oral

Einheiten im Paket:

28, 60, 14

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections; Gonorrhoeal urethritis and cervicitis; Gastroenteritis; Bronchial Infections; Skin and skin structure infections; Bone and joint infections; Chronic bacterial prostatitis of mild to moderate severity. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note: Typhoid and Paratyphoid infections and infections due to multi-resistant Staphylococcus aureus are excluded from the above due to insufficient data. Because Gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with Ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

Produktbesonderheiten:

Visual Identification: White to off-white, round, film coated tablets, with a score line on one side & debossed with F & 23 with a score line in between on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2011-12-16

Gebrauchsinformation

LOXIP™ 250, 500 & 750
CONSUMER MEDICINE INFORMATION
Ciprofloxacin hydrochloride 250 mg, 500 mg and 1000 mg film-coated
tablets
WHAT IS IN THIS LEAFLET
The leaflet answers some common questions about LOXIP tablets. It does
not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking LOXIP
tablets against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LOXIP IS USED FOR
LOXIP tablets are used for the treatment of infections of the lungs,
skin, bones, joints, kidneys,
bladder, prostate and bowel. LOXIP is also used to treat inhalation
anthrax (an infection caused by
breathing in the spores of bacteria).
LOXIP tablets contain the active ingredient, CIPROFLOXACIN, which is
an antibiotic belonging to a
group of medicines
called
quinolones (pronounced kwin-o-lones). These antibiotics work by
killing the bacteria that are causing your infection.
LOXIP will not work against infections caused by viruses such as colds
or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it for another reason.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LOXIP IF YOU HAVE AN ALLERGY TO:

ciprofloxacin, the active ingredient in LOXIP;

any of the ingredients listed at the end of this leaflet; or

other medicines belonging to the quinolone chemical family (e.g.
moxifloxacin, norfloxacin,
nalidixic acid).
Some of the symptoms of an allergic reaction may include:

shortness of breath;

wheezing or difficulty breathing;

swelling of the face, lips, tongue or other parts of the body; or

rash, itching or hives on the skin.
DO NOT TAKE LOXIP IS YOU ARE ALSO TAKING A MEDICINE CALLED TIZANIDINE,
A MUSCLE RELAXANT
USED TO TREAT SPASTICITY

Fachinformation

Page 1 of 18
PRODUCT INFORMATION
LOXIP™ 250, 500 & 750
FILM-COATED TABLETS
NAME OF THE MEDICINE
Active ingredient:
Ciprofloxacin hydrochloride
Chemical name:
1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-
dihydroquinoline-3-
carboxylic acid hydrochloride
CAS number:
86393-32-0
Molecular weight:
367.8
Molecular formula:
C
17
H
19
ClFN
3
O
3,
_x_H
2
O
Chemical structure:
DESCRIPTION
Ciprofloxacin hydrochloride is a pale yellow crystalline powder,
slightly hygroscopic. It is
soluble in water, slightly soluble in methanol, very slightly soluble
in anhydrous ethanol,
practically insoluble in acetone, in ethyl acetate and in methylene
chloride.
LOXIP is available as tablets containing 250 mg, 500 mg & 750 mg
ciprofloxacin (as
hydrochloride).
LOXIP
tablets
contain
the
following
inactive
ingredients:
Microcrystalline
cellulose,
sodium
starch
glycollate
type
A,
povidone,
colloidal
anhydrous
silica,
magnesium
stearate, hypromellose, macrogol 400 & titanium dioxide.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS (MICROBIOLOGY)
Ciprofloxacin has_ in vitro_ activity against a wide range of
Gram-negative and Gram-
positive
organisms.
The
bactericidal
action
of
ciprofloxacin
appears
to
result
from
interference with the enzyme, DNA gyrase. Ciprofloxacin is usually
active against the
following organisms_ in vitro_.
Page 2 of 18
Gram-Negative:
_Escherichia coli; Klebsiella _species (including _Klebsiella
pneumoniae _and_ Klebsiella _
_oxytoca); Enterobacter _ species_; Citrobacter _ species_; Salmonella
_ species_; Shigella _
species_; _
_Proteus _
_mirabilis; _
_Proteus _
_vulgaris; _
_Providencia _
_stuartii; _
_Providencia _
_rettgeri (formerly Proteus rettgeri); Morganella morganii (formerly
Proteus morganii); _
_Serratia_
species_* _
(_including _
_Serratia _
_marcescens), _
_Pseudomonas _
_aeruginosa, _
_Pseudomonas _
_fluorescens, _
_Campylobacter _
species_, _
_Haemophilus _
_influenzae, _
_Moraxella (Branhamella) catarrhalis. _
_ _
Gram-Positive*:
_Staphylococcus aureus _ (including methicillin-susceptible and
methicillin-r