PROPINE STERILE OPHTHALMIC 0.1 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIPIVEFRINE HYDROCHLORIDE

Available from:

Allergan Pharmaceuticals Ireland

INN (International Name):

DIPIVEFRINE HYDROCHLORIDE

Dosage:

0.1 %w/v

Pharmaceutical form:

Eye Drops Solution

Authorization status:

Withdrawn

Authorization date:

2007-11-15

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propine 0.1% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dipivefrine hydrochloride 0.1% w/v
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
To control intra-ocular pressure in patients with chronic open
angle glaucoma or ocular hypertensive patients with 
anterior chamber open angles.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The usual dosage is one drop in the affected eye(s) every 12
hours.
4.3 CONTRAINDICATIONS
a) Patients suffering from closed angle glaucoma
b) Hypersensitivity to any component of the formulation
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
a)
Macular oedema is a rare occurrence with adrenaline use in
aphakic patients. Prompt reversal generally follows 
discontinuance of the drug. Macular oedema with dipivefrine does present as a possibility
in the aphakic patient. 
b)
The product contains benzalkonium chloride and should
not be used by patients continuing to wear soft 
(hydrophilic) contact lenses.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None Known. 
4.6 PREGNANCY AND LACTATION
The safety of intensive or protracted use of dipivefrine during
pregnancy has not been substantiated. Caution should be 
exercised when Propine is administered to a nursing mother.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 21/10/2005_
_CRN 2015894_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None Known.
4.8 UNDESIRABLE EFFECTS
a)
Cardiovascular: tachycardia, arrhythmias and hypertension have been
reported with ocular administration of 
adrenaline, and may occur rarely with Propine the