OCULET® Eye Drops Solution
(and dosage form):
OCULET® Eye Drops Solution
1 mL of the sterile preservative-free solution contains 20 mg of povidone.
A32.5 Artificial tear
Povidone is a homologous linear polymer composed of 1-vinyl-2-pyrrolidone. The degree of polymerisation results in polymers of various molecular weights. The different types of Povidone are characterised by their viscosity in aqueous solution, relative to that of water, expressed as a K value. Povidone solutions exhibit a Newtonian rheological behaviour.
Further povidone exhibits a reliable rate of dissolution which makes it an effective lubricant agent for use in artificial tears.
Pharmacokinetics: Povidone reaches its target directly by topical application and has primarily a physical and no systemic effect. Therefore, no values for absorption, distribution, metabolism or excretion for this application are available. Due to its hydrophilic properties and its molecular size povidone cannot practically penetrate the cornea. A very small part enters into the nose and may reach the gastrointestinal tract. There it is practically not absorbed and the negligible part that reaches the blood is rapidly eliminated renally. Its elimination is basically due to enzymatic and cellular degradation. No pharmacokinetic drug interactions other than the physical interactions of topically applied eye drops are known.
OCULET is indicated for the sensation of dryness.
In cases of hypersensitivity to any of the ingredients.
OCULET should not be used at the same time as other ophthalmic drugs. If any other eye drops have to be used it should be waited for about 30 minutes before applying OCULET. Eye ointments should, however always be administered after the application of OCULET.
As OCULET reaches its target directly by topical application and has primarily a physical effect (wetting of the surface) and no systemic effect, no drug interactions other than the physical interactions of topically applied eye drops are significant. (See warnings).
PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
OCULET can be applied to the eye on a daily basis as often as required.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The following side effect has been reported:
Very rare <1/10 000 Eye disorders
Hypersensitivity reactions like burning or tearing have been reported which resolved when the use of OCULET was discontinued.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No cases of overdosage have been reported.
A clear solution, free from visible particulate matter.
One 10 mL white polyethylene bottle containing solution (approx. 300 drops) with a transparent polyethylene cap.
Store below 25ºC.
Do not use more than 12 weeks after opening.
Keep out of the reach of children.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF
THE CERTIFICATE OF REGISTRATION:
PHARMAFRICA (PTY) LTD
33 Hulbert Road, New Centre, Johannesburg
Private Bag X8, Rosettenville, 2130
DATE OF PUBLICATION OF THE PACKAGE INSERT:
09 October 2009
New addition to this site: May 2014
Source: Pharmaceutical Industry
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2014