1. Name Of The Medicinal Product
OpticromTM Aqueous Eye Drops
2. Qualitative And Quantitative Composition
Sodium cromoglicate 2.0% w/v.
3. Pharmaceutical Form
A clear colourless to pale yellow solution for administration to the eye.
4. Clinical Particulars
4.1 Therapeutic Indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
4.2 Posology And Method Of Administration
Adults and children: one or two drops into each eye four times daily or as indicated by the doctor.
Elderly: no current evidence for alteration of the dose.
Route of administration: topical ophthalmic.
4.3 Contraindications
The product is contraindicated in patients who have shown hypersensitivity to Sodium cromoglicate, Benzalkonium chloride or Disodium edetate.
4.4 Special Warnings And Precautions For Use
Discard any remaining contents four weeks after opening the bottle.
As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with Sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear clinical need.
It is not known whether Sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of Sodium cromoglicate has any undesirable effects on the baby.
4.7 Effects On Ability To Drive And Use Machines
As with all eye drops, instillation of Opticrom may cause a transient blurring of vision.
4.8 Undesirable Effects
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.
4.9 Overdose
No action other than medical observation should be necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
In vitro and in vivo animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
5.2 Pharmacokinetic Properties
Sodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of Sodium cromoglicate is absorbed following administration to the eye.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Benzalkonium chloride, Disodium edetate, Purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
The eye drops should be used within 4 weeks of opening the container. Any remaining after this time should be discarded.
6.4 Special Precautions For Storage
Store below 30oC.
Protect from direct sunlight.
6.5 Nature And Contents Of Container
Low density polyethylene bottle and plug with a polypropylene cap with a shrink type security seat containing 13.5 ml.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. Marketing Authorisation Number(S)
PL 04425/0324
9. Date Of First Authorisation/Renewal Of The Authorisation
28 February 2003
10. Date Of Revision Of The Text
December 2006
11 LEGAL CLASSIFICATION
POM
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