PATANOL STERILE OPHTHALMIC SOLUTION 0.1%

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

OLOPATADINE HCl 11.1 mg/ml EQV OLOPATADINE

Հասանելի է:

NOVARTIS (SINGAPORE) PTE LTD

ATC կոդը:

S01GX09

Դոզան:

1mg/ml

Դեղագործական ձեւ:

SOLUTION

Կազմը:

OLOPATADINE HCl 11.1 mg/ml EQV OLOPATADINE 1mg/ml

Կառավարման երթուղին:

OPHTHALMIC

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

ALCON-COUVREUR NV

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

1998-12-02

Տեղեկատվական թերթիկ

DESCRIPTION
PATANOL Eye Drops, Solution, are supplied as a sterile aqueous solution containing olopatadine, 
a relatively selective H
1
-receptor antagonist and inhibitor of histamine release from the mast cell 
for topical administration to the eyes.
CONTAINS
Each ml of PATANOL Eye Drops, Solution contains:
ACTIVE: 1.11 mg olopatadine hydrochloride equivalent to 1 mg
olopatadine.
PRESERVATIVE: benzalkonium chloride 0.01%.
INACTIVES: disodium phosphate dodecahydrate; sodium chloride; hydrochloric acid/sodium 
hydroxide (adjust pH); and purified water.
CLINICAL PHARMACOLOGY
Olopatadine is a multiple-action molecule: an inhibitor of the release of histamine from the 
mast cell and a relatively selective histamine H
1
-antagonist that inhibits the _in vivo_ and _in vitro_ 
type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects 
on human conjunctival epithelial cells and an inhibitor of cytokine secretion. Olopatadine is 
devoid  of  effects  on  alphaadrenergic,  dopamine,  muscarinic  Type  1  and  2,  and  serotonin 
receptors.
Following topical ocular administration in man, olopatadine was shown to have low systemic 
exposure.  Two  studies  in  normal  volunteers  (totalling  24  subjects)  dosed  bilaterally  with 
olopatadine 0.15% eye drops 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 half-life in plasma was
approximately 3 hours, and elimina-
tion was predominantly through renal excretion.
Approximately 60 - 70% of the dose was recovered in the urine as parent drug. Two metabo-
lites, the mono-desmethyl

Ապրանքի հատկությունները

Patanol Jul 2020.SINv1
Page 1 of 7
1. NAME OF THE MEDICINAL PRODUCT
PATANOL
®
0
.1% EYE DROPS, SOLUTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 1 mg olopatadine (equivalent to 1.11 mg
olopatadine hydrochloride).
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to pale yellow sterile solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PATANOL eye drops is indicated for the treatment of the signs and
symptoms of allergic conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose is 1 drop in each affected eye 2 times per day.
Use in children
Safety and effectiveness in paediatric patients below the age of 3
years have not been established.
Use in patients with renal impairment
No studies have been performed in patients with renal impairment. No
dosage regimen adjustment is
required for patients with renal impairment.
Use in patients with hepatic impairment
No studies have been performed in patients with hepatic impairment. No
dosage regimen adjustment is
required for patients with hepatic impairment.
Use in patients 65 years of age or above
No dosage regimen adjustment is required in patients 65 years of age
or above.
METHOD OF ADMINISTRATION
For ocular use.
After cap is removed, if tamper evident snap collar is loose, snap
collar should be removed before using
product.
To avoid contamination, the dropper tip should not touch any surface.
The dropper tip should also not come
into contact with the eye as this may cause injury to the eye. The
bottle should be kept tightly closed when
Patanol Jul 2020.SINv1
Page 2 of 7
not in use.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is reduced.
This may result in a decrease in systemic side effect and increase in
local activity.
If more than one topical ophthalmic product is being used, the
products must be administered at least 5
minutes apart. Eye ointments should be administered last.Patients
should be advised not to wear a contact
lens if t