Flumelone N Ophthalmic Solution

This ophthalmic solution is used for the treatment of conjunctivitis (sticky eyes) due to organisms sensitive to neomycin. This may be used for the treatment of infections at the front of the eye by bacteria sensitive to the antibiotic neomycin. This  can be used following removal of something from your eye, as well as before and after surgery, where there is a possibility of infection with susceptible organisms.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Their primary target is the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes.

Like other aminoglycoside antibiotic drugs, neomycin inhibits bacterial ribosomes by binding to the 30S ribosomal subunit of susceptible bacteria and disrupting the translational machinery of bacterial protein synthesis. Bacterial translation is normally initiated by the mRNA binding to the 30S ribosomal subunit and subsequent binding with 50S subunit for elongation.

The usual dose for adults is one to two drops in eye two to four times a day. During the first 24 to 48 hours, the dose may be safely increased to one drop every hour or as directed by physician.

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. Apply your eye drops in the following way:

• Wash your hands. Shake the bottle well before use. Tilt your head back and look at the ceiling.
• Gently pull the lower eyelid down until there is a small pocket.
• Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
• Let go of the lower lid, and close your eye. Press your finger against the corner of your eye (the side where your eye meets your nose) for one minute.

Do not use this ophthalmic solution:

• If you are hypersensitive (allergic) to fluorometholone or neomycin sulfate or to any of the other ingredients of this preparation.
• If you have an eye infection (with pus) caused by micro-organisms not sensitive to the antibiotic neomycin;
• If you have an active viral or fungal infection of the eye;
• If you have tuberculosis of the eye;
• If you have glaucoma;
• If you are pregnant or breastfeeding.

The following side effects may occur: Increased eye pressure (glaucoma), loss of part of the usual field of vision, blurred vision, cataracts (cloudy lens), eye irritation, red eye, eye pain, foreign body sensation, eyelid or eye swelling, itchy or watery eye, ulcers on the surface of the eye, secondary eye infections from fungi or viruses, skin rash, allergic reactions, change in your sense of taste.

This ophthalmic solution should not be used during pregnancy and breastfeeding. It is unknown whether the active ingredients of this preparation are excreted in breast milk. Therefore it is not recommended for mothers who are breast feeding.

If you use this ophthalmic solution for a long period of time:

• It may cause the pressure inside your eye (intraocular pressure) to increase which can lead to glaucoma. The pressure in your eye should be regularly measured.
• It may cause cataracts (cloudy lens), lack of clearness of vision, or a delay in wound healing of the eye.
• Damage to the front part of the eye (due to a fungal infection), may occur during or after the use of this ophthalmic solution.
• It may increase the risk of corneal damage, cause thinning of the cornea or small ulcerations in the surface of your eye.
• It may also suppress the body’s immune response which leads to secondary eye infections.

Ophthalmic steroid - antibiotic combined preparations

The safety and efficacy in children aged 2 years or younger has not been established.

Store at or below 25°C. Do not freeze. Do not use 30 days after first opening the bottle, even if there is still some liquid remaining.