VIGAMOX OPHTHALMIC SOLUTION 0.5%

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

MOXIFLOXACIN HCl 5.45 mg/ml EQV MOXIFLOXACIN

थमां उपलब्ध:

NOVARTIS (SINGAPORE) PTE LTD

ए.टी.सी कोड:

S01AX22

डोज़:

5 mg/ml

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

MOXIFLOXACIN HCl 5.45 mg/ml EQV MOXIFLOXACIN 5 mg/ml

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

Alcon-Couvreur NV

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2004-11-17

सूचना पत्रक

VIGAMOX
®
(MOXIFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION) 
0.5% AS BASE
DESCRIPTION: VIGAMOX
®
 (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic
solution.  It is an 8-methoxy 
fluoroquinolone anti-infective for topical ophthalmic use.
CHEMICAL NAME: 
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-
quinolinecarboxylic acid, monohydrochloride.
Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline
powder. Each mL of VIGAMOX
® 
solution contains 5.45 mg 
moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin base.
CONTAINS: ACTIVE:  Moxifloxacin 0.5% (5 mg/mL); INACTIVES:  Boric
acid, sodium chloride, and purified water.  May also contain 
hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.
VIGAMOX
®
 solution is an isotonic solution with an osmolality of approximately
290 mOsm/kg.
CLINICAL PHARMACOLOGY:
PHARMACOKINETICS:  Plasma concentrations of moxifloxacin were
measured in healthy adult male and female subjects who 
received bilateral topical ocular doses of VIGAMOX
®
 solution 3 times a day.  The mean steady-state C
max
 (2.7 ng/mL) and 
estimated daily exposure AUC (45 ng·hr/mL) values were 1,600 and
1,000 times lower than the mean C
max
 and AUC reported 
after therapeutic 400 mg oral doses of moxifloxacin.  The plasma
half-life of moxifloxacin was estimated to be 13 hours.
MICROBIOLOGY:
Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl
ring at the C7 position.  The antibacterial action of 
moxifloxacin results from inhibition of the topoisomerase II (DNA
gyrase) and topoisomerase IV.  DNA gyrase is an essential 
enzyme that is involved in the replication, transcription and repair
of bacterial DNA.  Topoisomerase IV is an enzyme known to 
play a key role in the partitioning of the chromosomal DNA during
bacterial cell division.
The mechanism of action for quinolones, including moxifloxacin, is
different from that of macrol

उत्पाद विशेषताएं

Vigamox Jul 2021.SIN
Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
VIGAMOX
®
5 mg/ml eye drops, solution
(MOXIFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION)
VIGAMOX
®
(moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic
solution. It is an 8‐
methoxy fluoroquinolone anti‐infective for topical ophthalmic use.
CHEMICAL NAME:
1‐Cyclopropyl‐6‐fluoro‐1,4‐dihydro‐8‐methoxy‐7‐[(4aS,7aS)‐octahydro‐6H‐pyrrolol[3,4‐
b]pyridin‐6‐yl]‐4‐ oxo‐3‐ quinolinecarboxylic acid,
monohydrochloride.
Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of VIGAMOX solution contains 5.45 mg moxifloxacin
hydrochloride equivalent to 5 mg
moxifloxacin base.
VIGAMOX solution is an isotonic solution with an osmolality of
approximately 290 mOsm/kg.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops (solution)
4.
CLINICAL PARTICULARS
Vigamox Jul 2021.SIN
Page 2 of 15
4.1
THERAPEUTIC INDICATIONS
VIGAMOX solution is indicated for the treatment of bacterial
conjunctivitis, blepharitis, dacryocystitis,
hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by
susceptible strains, as well as
preoperative and postoperative prophylaxis.
Susceptible strains include:
AEROBIC GRAM‐POSITIVE MICROORGANISMS:
_Corynebacterium species _
_Enterococcus faecalis* _
_Micrococcus luteus* _
_Staphylococcus aureus _
_Staphylococcus capitis* _
_Staphylococcus epidermidis _
_Staphylococcus haemolyticus _
_Staphylococcus hominis _
_Staphylococcus lugdunensis* _
_Staphylococcus warneri* _
_Streptococcus pneumoniae _
_Streptococcus viridans group _
_ _
AEROBIC GRAM‐NEGATIVE MICROORGANISMS:
_Acinetobacter lwoffii* _
_Burkholderia cepacia* _
_Haemophilus influenzae _
_Haemophilus parainfluenzae* _
_Klebsiella planticola* _
_Klebsiella pneumoniae* _
_Moraxella catarrhalis* _
_Proteus mirabilis* _
_Proteus vulgaris* _
_Pseudomonas aeruginosa* _
_Serratia liquefaciens* _
_Serratia marcescens* _
_Steno