Pataday® Sterile Ophthalmic Solution 0.2%

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Olopatadine Hydrochloride 0.222% eqv Olopatadine base

Prieinama:

NOVARTIS (SINGAPORE) PTE LTD

ATC kodas:

S01GX09

Dozė:

0.2% w/v

Vaisto forma:

SOLUTION, STERILE

Sudėtis:

Olopatadine Hydrochloride 0.222% eqv Olopatadine base 0.2% w/v

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

Prescription Only

Pagaminta:

Alcon-Couvreur NV

Autorizacija statusas:

ACTIVE

Leidimo data:

2011-05-24

Pakuotės lapelis

PATADAY
®

Olopatadine Ophthalmic Solution 0.2%
DESCRIPTION
PATADAY
®
 Olopatadine Ophthalmic Solution 0.2% is a sterile ophthalmic
solution containing olopatadine for 
topical administration to the eyes.
Olopatadine hydrochloride is a white, crystalline, water-soluble
powder with a molecular weight of 373.88 and a molecular formula of 
C
21
H
23
NO
3 
• HCl.  The chemical structure is presented below:

CHEMICAL NAME: 11-[(Z)-3-(Dimethylamino)
propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic
acid, hydrochloride.
Each mL of PATADAY
®
 solution contains: ACTIVE: 2.22 mg olopatadine hydrochloride
equivalent to 2 mg olopatadine.
INACTIVES: povidone; dibasic sodium phosphate; sodium chloride;
edetate disodium; benzalkonium chloride 0.01% (PRESERVATIVE) 
hydrochloric acid / sodium hydroxide (adjust pH); and purified water.
It has a pH of approximately 7 and an osmolality of approximately 300
mOsm/kg.
CLINICAL PHARMACOLOGY
Olopatadine is a relatively selective histamine H
1
 antagonist and an inhibitor of the release of histamine from the
mast cells.  
Decreased chemotaxis and inhibition of eosinophil activation has also
been demonstrated.  Olopatadine is devoid of effects on 
alpha-adrenergic, dopaminergic, and muscarinic type 1 and 2
receptors.
Systemic bioavailability data upon topical ocular administration of
PATADAY
®
 solution are not available.  Following topical ocular 
administration of olopatadine 0.15% ophthalmic solution in
man, olopatadine was shown to have a low systemic exposure. Two 
studies in normal volunteers (totaling 24 subjects) dosed bilaterally
with olopatadine 0.15% ophthalmic solution once every 12 hours 
for 2 weeks demonstrated plasma concentrations to be generally below
the quantitation limit of the assay (< 0.5 ng/mL).  Samples in 
which olopatadine was quantifiable were typically found within 2 hours
of dosing and ranged from 0.5 to 1.3 ng/mL.  The elimination 
half-life in plasma following oral dosing was 8 to 12 hours, and eli

Prekės savybės

Pataday Jul 2020.SINv1
Page 1 of 9
1. NAME OF THE MEDICINAL PRODUCT
PATADAY®
OLOPATADINE OPHTHALMIC SOLUTION 0.2%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PATADAY* Olopatadine Ophthalmic Solution 0.2% is a sterile ophthalmic
solution containing
olopatadine for topical administration to the eyes.
Olopatadine hydrochloride is a white, crystalline, water-soluble water
with a molecular weight of 373.88
and a molecular formula of C
21
H
23
NO
3
•HCl. The chemical structure is presented below:
CHEMICAL NAME: 11-[(Z)-3-(Dimethylamino)
propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid,
hydrochloride.
Active ingredients: 2.22 mg of olopatadine hydrochloride in one mL
solution (0.2%)
3. PHARMACEUTICAL FORM
Eye Drops, solution
Colorless to light yellow solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of ocular itching associated with allergic conjunctivitis.
Results from clinical studies up to 12 weeks duration demonstrate that
PATADAY solution when dosed
once a day is effective in the treatment of the ocular signs and
symptoms of allergic conjunctivitis and
rhinoconjunctivitis, and the nasal symptoms of allergic
rhinoconjunctivitis. Conjunctival allergen
challenge studies demonstrated that PATADAY solution is significantly
more effective than its vehicle
within 3 minutes after antigen challenge and up to 24 hours after
dosing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
Pataday Jul 2020.SINv1
Page 2 of 9
_Adults _
One drop in each affected eye once daily.
_Elderly _
No dosage adjustment in elderly patients is necessary in patients of
65 years of age or above.
_Pediatric population (below 18 years) _
Safety and effectiveness in pediatric patients below the age of 3
years have not been established.
Special populations
RENAL IMPAIRMENT
No studies have been performed in patients with renal impairment. No
dosage regimen adjustment is
required for patients with renal impairment.
HEPATIC IMPAIRMENT
No studies have been performed in patients with hepatic impairment. No
dosage regimen