1. Name Of The Medicinal Product
RapitilTM Eye Drops
2. Qualitative And Quantitative Composition
Nedocromil sodium 2.0% w/v.
3. Pharmaceutical Form
Presented as a 5 ml sterile, preserved, aqueous solution containing 2% nedocromil sodium in a dropper bottle for administration to the eye.
4. Clinical Particulars
4.1 Therapeutic Indications
For the prevention, relief and treatment of allergic conjunctivitis, including seasonal allergic conjunctivitis, allergic conjunctivitis and vernal-kerato conjunctivitis.
4.2 Posology And Method Of Administration
Adults (including the elderly) and children aged 6 years and over:
In seasonal allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily. In seasonal allergic conjunctivitis therapy should be restricted to 12 weeks.
In vernal kerato-conjunctivitis: one drop into each eye four times daily.
Adults (including the elderly):
In perennial allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily.
Rapitil should be used regularly to ensure optimum control of symptoms.
There is only limited clinical trial evidence with Rapitil in children aged below 6 years, therefore use in this age range cannot be recommended.
4.3 Contraindications
Contraindicated in patients with known hypersensitivity to any constituent of the formulation.
4.4 Special Warnings And Precautions For Use
Patients who use soft contact lenses should be advised not to wear them during the treatment period. In patients who continue to use hard or gas-permeable contact lenses during treatment with the eye drops, the lenses should be taken out of the eye prior to instillation and not inserted again for at least 10 minutes.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None has been reported.
4.6 Pregnancy And Lactation
Studies in pregnant and lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all medications caution should be exercised during pregnancy (especially during the first trimester) and whilst breast feeding.
On the basis of animal studies and its physicochemical properties it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no information to suggest that the use of nedocromil sodium by nursing mothers has any undesirable effects upon the baby.
4.7 Effects On Ability To Drive And Use Machines
No sedative effects have been reported.
4.8 Undesirable Effects
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely. Some patients have reported a distinctive taste.
4.9 Overdose
Animal studies have not shown evidence of toxic effects of nedocromil sodium even at high dosage, nor have extended human studies revealed any safety hazard with the drug. Overdosage is unlikely, therefore, to cause problems. However, if suspected, treatment should be supportive and directed to the control of the relevant symptoms.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Decongestant and other antiallergics
ATC code: S01G X04
Rapitil, the ophthalmic preparation of nedocromil sodium, displays specific anti-allergic and anti-inflammatory properties. Nedocromil sodium has been shown to prevent the release of inflammatory mediators from a range of inflammatory cell types.
5.2 Pharmacokinetic Properties
Following topical ophthalmic administration, less than 4% of the dose is absorbed following multiple dosing. Absorption occurs primarily through the nasal mucosa as approximately 80% of the ophthalmic dose drains into the nose via the naso-lachrymal duct, although 1-2% of the dose may be absorbed orally.
Nedocromil sodium is reversibly bound to plasma proteins and is not metabolised, but is excreted unchanged in bile and urine. The drug is rapidly cleared from the plasma (plasma clearance 10.2 + 1.3 ml/min/kg - elimination half-life 5.3 + 0.9 min) and accumulation does not occur.
5.3 Preclinical Safety Data
Animal studies have failed to reveal toxic effects with nedocromil sodium even at high doses.
6. Pharmaceutical Particulars
6.1 List Of Excipients
benzalkonium chloride,
sodium chloride,
disodium edetate.
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 25°C, away from direct sunlight. Discard any remaining contents four weeks after opening the bottle.
6.5 Nature And Contents Of Container
A plastic dropper bottle containing 5ml of sterile, aqueous solution for administration to the eye.
6.6 Special Precautions For Disposal And Other Handling
Please refer to enclosed package insert.
7. Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. Marketing Authorisation Number(S)
PL 04425/0285
9. Date Of First Authorisation/Renewal Of The Authorisation
26 February 2004
10. Date Of Revision Of The Text
22 July 2010
Legal category
POM
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