Active ingredients: Fluorometolone
FLUATON 0.1% eye drops, suspension
Fluaton package inserts are available for pack sizes:- FLUATON 0.1% eye drops, suspension
- FLUATON 0.1% ophthalmic ointment
Indications Why is Fluaton used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Anti-inflammatory
THERAPEUTIC INDICATIONS
Fluaton is indicated in acute and subacute inflammatory forms of the anterior segment of the eye.
Contraindications When Fluaton should not be used
- Intracular hypertension;
- acute herpes simplex and most of the other corneal virus diseases in the acute ulcerative phase, except in association with specific chemotherapeutic agents for the herpetic virus, conjunctivitis with ulcerative keratitis also in the initial phase (fluorescein + test);
- tuberculosis of the eye;
- mycosis of the eye;
- acute purulent ophthalmias, purulent and herpetic conjunctivitis which can be masked or aggravated by corticosteroids;
- sty.
In viral herpetic keratitis, its use is not recommended and may possibly be permitted under the strict supervision of the ophthalmologist.
Hypersensitivity to the active substance or to any of the excipients.
Generally contraindicated in pregnancy and lactation: contraindicated in children under two years (see Special warnings).
Precautions for use What you need to know before taking Fluaton
Steroid therapy in the treatment of stromal herpes simplex requires great care; frequent slit lamp monitoring is required.
During prolonged treatments it is advisable to carry out frequent checks of the ocular tone. Prolonged use can give rise to problems: uninterrupted application for over a month is not recommended.
Prolonged use could cause glaucoma, optic nerve damage, acuity and visual field defects, posterior subcapsular cataract formation, or help stabilize secondary ocular infections from pathogens released from ocular tissue.
In diseases that result in thinning of the cornea or sclera, perforation is known to occur due to topical steroids.
Corneal infections are particularly prone to develop in conjunction with prolonged steroid applications; therefore this possibility should be considered in any type of corneal ulcer where a steroid is in use or has been used. In any case, in case of infections it is necessary to institute an "adequate cover therapy.
Interactions Which drugs or foods can modify the effect of Fluaton
No particular interactions and incompatibilities with other drugs were found.
Warnings It is important to know that:
Safety and efficacy have not been demonstrated in children under two years of age.
The eye drops in the single-dose container, not containing preservatives, must be used for a single dressing and in a single patient and therefore the bottle must be disposed of even if there is residual medication in it.
The multidose bottle contains benzalkonium chloride: do not apply while wearing contact lenses. In the case of contact lens wearers wear the same only 15 minutes after using the product.
Pregnancy and breastfeeding
Corticosteroids showed teratogenic activity in experimental animals. There are no safety studies in pregnant women, therefore use in pregnancy can only be carried out after careful evaluation by the physician of the risk / benefit ratio.
Effects on ability to drive and use machines
Fluaton does not change alertness and can therefore also be administered to patients who have to drive cars.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Fluaton: Posology
Instill in the eye, after shaking the bottle vigorously, 2 drops 2 to 4 times a day, according to medical prescription.
Instructions for Use
Fluaton 0.1% in single-dose container
Before use, make sure that the single-dose container is intact.
Detach the single-dose container from the strip
Open by turning the top without pulling
Avoid letting the tip of the container come into contact with the eye or any other surface.
Side Effects What are the side effects of Fluaton
Occasionally, burning sensations, irritation, phenomena of individual hypersensitivity of different types towards the product may occur locally, where this happens it is necessary to stop the treatment and consult the doctor.
Prolonged use could cause glaucoma, damage to the optic nerves, defects in acuity and visual field, posterior subcapsular cataract formation, or the establishment of secondary ocular infections from pathogens released from ocular tissue.
In diseases that result in thinning of the cornea or sclera, perforation of the globe is known to occur (see also Precautions for use).
Compliance with the instructions given in this leaflet reduces the risk of undesirable effects.
The patient should report any undesirable effects to the treating physician or pharmacist if found.
Expiry and Retention
This date is intended for the product in intact packaging, properly stored.
Warning: Do not use the medicine after the expiry date indicated on the package.
Eye drops in 5 ml bottle: the shelf life of the medicine after the first opening of the container is 28 days
Eye drops in single-dose container: The product does not contain preservatives: after opening the container, the product must be administered and the single-dose bottle must be disposed of even if only partially used.
Deadline "> Other information
COMPOSITION
Fluaton 0.1% eye drops, suspension - bottle of 5 ml
- Active ingredient: 0.1 g fluorometolone
- Excipients: polyvinyl alcohol, benzalkonium chloride, sodium edetate, sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water.
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
- Active ingredient: 0.1 g fluorometolone
- Excipients: polyvinyl alcohol, sodium edetate, sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water.
PHARMACEUTICAL FORM AND CONTENT
Eye drops, suspension.
Box of 1 bottle of 5 ml; Box of 20 single-dose containers of 0.4 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
FLUATON 0.1% EYE DROPS, SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml of Fluaton eye drops contain
Active ingredient: Fluorometolone 0.1 g.
For the full list of excipients, see sections 6.1.
03.0 PHARMACEUTICAL FORM -
Eye drops, suspension.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Fluaton is indicated in acute and subacute inflammatory forms of the anterior segment of the eye.
04.2 Posology and method of administration -
Instill in the eye, after shaking the bottle vigorously, 2 drops 2 to 4 times a day according to medical prescription.
04.3 Contraindications -
a) intraocular hypertension;
b) acute herpes simplex and most of the other corneal virus diseases in the acute ulcerative phase, except in association with specific chemotherapeutic agents for the herpetic virus, conjunctivitis with ulcerative keratitis also in the initial phase (Fluorescein + test);
c) tuberculosis of the eye;
d) mycosis of the eye;
e) acute purulent ophthalmias, purulent and herpetic conjunctivitis which can be masked or aggravated by corticosteroids;
f) sty.
In viral herpetic keratitis, its use is not recommended and may possibly be permitted under the strict supervision of the ophthalmologist.
Hypersensitivity to the active substance or to any of the excipients.
Generally contraindicated in pregnancy and lactation (see par. 4.6); contraindicated in children under two years (see par.4.4)
04.4 Special warnings and appropriate precautions for use -
Steroid therapy in the treatment of stromal herpes simplex requires great care; frequent slit lamp monitoring is required.
During prolonged treatments it is advisable to carry out frequent checks of the ocular tone. Prolonged use can give rise to problems: uninterrupted application for over a month is not recommended.
Prolonged use could cause glaucoma, optic nerve damage, acuity and visual field defects, posterior subcapsular cataract formation, or help stabilize secondary ocular infections from pathogens released from ocular tissue.
In diseases that result in thinning of the cornea or sclera, perforation is known to occur due to topical steroids.
Corneal infections are particularly prone to develop in conjunction with prolonged steroid applications; therefore this possibility should be considered in any type of corneal ulcer where a steroid is in use or has been used.
In any case, in case of infections it is necessary to institute an "adequate cover therapy.
Safety and efficacy have not been demonstrated in children younger than two years of age.
The eye drops in the single-dose container, not containing preservatives, must be used for a single dressing and in a single patient and therefore the bottle must be disposed of even if there is residual medication in it.
The multidose bottle contains benzalkonium chloride: do not apply while wearing contact lenses.
In the case of contact lens wearers wear the same only 15 minutes after using the product.
04.5 Interactions with other medicinal products and other forms of interaction -
No particular interactions and incompatibilities with other drugs have been reported.
04.6 Pregnancy and breastfeeding -
Corticosteroids showed teratogenic activity in experimental animals.
There are no safety studies in pregnant women, therefore use in pregnancy can only be carried out after careful evaluation by the physician of the risk / benefit ratio.
04.7 Effects on ability to drive and use machines -
Fluaton does not change alertness and can therefore also be administered to patients who have to drive cars.
04.8 Undesirable effects -
Occasionally, burning sensations, irritation, phenomena of individual hypersensitivity of different types towards the product may occur locally, where this happens it is necessary to stop the treatment and consult the doctor.
Prolonged use could cause glaucoma, damage to the optic nerves, defects in acuity and visual field, posterior subcapsular cataract formation, or the establishment of secondary ocular infections from pathogens released from the ocular tissue.
In diseases that cause thinning of the cornea and sclera, perforation of the globe is known to occur (see also section 4.4).
04.9 Overdose -
The very low toxicity of the product observed in both animals and humans lead us not to consider the need for specific interventions even in cases of accidental ingestion.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
The numerous clinical literature on the product highlights its remarkable efficacy in the therapy of inflammatory forms of the anterior segment of the eye, both severe and mild; in any case, a significant increase in intraocular pressure has never been shown even with prolonged treatments ( over 30 days).
In recent clinical studies, the use of 0.1% fluorometholone has been shown to have a valid anti-inflammatory activity useful for the treatment of inflammations resulting from laser therapy. The preventive effect on the appearance of anterior synechiae that limit its effectiveness was evident. hypotensive of laser trabeculoplasty.
The presence of polyvinyl alcohol (PVA) in Fluaton eye drops has shown in a comparative clinical trial with a formulation without PVA to significantly improve the symptoms linked to the instability of the tear film.
S01BA07.
Ophthalmological - anti-inflammatory.
Fluorometolone is a corticosteroid that has a remarkable local anti-inflammatory activity (40 times that of cortisone). This activity is carried out through the reduction of the number of inflammatory cells and the production of fibrin. Fluorometolone, like other steroids, reduces the ability to "heal. Fluorometholone has shown a reduced ability" to induce clinically significant changes in intraocular pressure.
The Fluaton also contains PVA.
This substance, performing the function of stabilizing the tear film, is able to prevent disorders related to the condition of dry eye concomitant with the inflammatory state.
This symptomatology (burning, sensation of a foreign body and dry eyes), which in the active phase is confused with the specific one of the disease, becomes predominant when this is in the process of recovery.
The PVA, forming a tenacious protective film on the corneal epithelium, prevents or limits the manifestation of said symptoms.
It also allows to further improve the local tolerability of the eye drops.
05.2 "Pharmacokinetic properties -
The drug is equally well absorbed with both intact and damaged cornea. Systemic absorption is completely irrelevant and has never been a clinical problem.
05.3 Preclinical safety data -
The active principle has an LD50 equal to 2450 mg / kg intraperitoneally in rats, a dose considerably higher than that used in the clinic.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Fluaton 0.1% eye drops, suspension - bottle of 5 ml
Polyvinyl alcohol, benzalkonium chloride, sodium edetate, sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water.
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
Polyvinyl alcohol, sodium edetate, sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
Fluaton 0.1% eye drops, suspension - bottle of 5 ml
3 years.
Validity after first opening: 28 days.
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
24 months.
The product does not contain preservatives: after opening the container, the product must be administered and the single-dose bottle must be disposed of even if only partially used.
06.4 Special precautions for storage -
Fluaton 0.1% eye drops, suspension - bottle of 5 ml
No special storage precautions.
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Fluaton 0.1% eye drops, suspension - bottle of 5 ml
Plastic bottle complete with dropper and cap with screw closure.
The material used for the production of the bottles and droppers is in low density polyethylene, that of the polystyrene caps. Pack of 1 bottle.
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
Single-dose bottle in low density polyethylene. The bottles are assembled in strips of 10 units, each strip is protected by a heat-sealed aluminum casing. Pack of 20 single-dose containers.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Bausch & Lomb - IOM S.p.A. - Viale Martesana, 12 - 20090 Vimodrone (MI)
08.0 MARKETING AUTHORIZATION NUMBER -
Fluaton 0.1% eye drops, suspension - 5 ml bottle AIC N ° 023503028
Fluaton 0.1% eye drops, suspension - 0.4 ml single-dose containers
AIC N ° 023503030
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Multi-dose eye drops
Date of first authorization: October 1976
Renewal of the authorization: June 2010
Single-dose eye drops
Date of first authorization: March 2005
Renewal of the authorization: June 2010
10.0 DATE OF REVISION OF THE TEXT -
September 2016