FLUOROMETHOLONE AND NEOMYCIN SULPHATE OPHTHALMIC SUSPENSION

DESCRIPTION

Fluorometholone belongs to a class of drugs called corticosteroids. Fluorometholone is indicated for the treatment of eye allergies, eye infections, dry eyes and other conditions following eye surgery or eye injury.

Neomycin Sulphate belongs to a class of medications known as aminoglycoside antibiotics. Neomycin Sulphate is indicated in the treatment of bacterial infection of the eye. It also helps prevent infection caused by eye injury.

COMPOSITION

Fluorometholone	USP	0.1% w/v
Neomycin Sulphate	USP
Eq. to Neomycin		0.35% w/v
Benzalkonium Chloride Solution (As Preservative)	NF	0.01% w/v
Purified Water	q.s.

PHARMACOLOGY

Fluorometholone is a glucocorticoid and has anti-inflammatory properties. It inhibits the inflammatory response (oedema, fibrin deposition, capillary dilation, and phagocytic migration) as well as capillary proliferation, deposition of collagen and scar formation. Glucocorticosteroids such as fluorometholone may increase intraocular pressure, in normal eyes and in subjects with ocular hypertension.

Neomycin Sulphate is a broad spectrum bactericidal aminoglycoside antibiotic with activity against gram-positive and gram-negative organisms. Due to extensive topical use, neomycin resistance has been reported among Pseudomonas aeruginosa, Staphylococci, and some Salmonella, Shigella, and Escherichia coli strains. Cross-resistance with kanamycin, framycetin and paromomycin occurs. The primary mechanism of action is through inhibition of protein synthesis by irreversibly binding with 30S ribosomal subunits. Pus, exudates, and bacteria growth products do not inactivate the antibiotic.

INDICATIONS

Fluorometholone–Neomycin Sulphate ophthalmic suspension (eye drops) is used to treat inflammatory conditions of the eye, infectious conjunctivitis, as well as bacterial eye infections. Fluorometholone–Neomycin Sulphate is also prescribed to treat the eye after the removal of foreign substances. It is used for the treatment of conjunctivitis (sticky eyes) due to organisms sensitive to neomycin. It can be used for the treatment of infections at the front of the eye by bacteria sensitive to the antibiotic neomycin. It can also 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.

CONTRAINDICATIONS

Do not use if you are hypersensitive (allergic) to fluorometholone or neomycin sulphate or to any of the other ingredients. If you experience an allergic reaction, please inform your doctor.

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.

DOSAGE AND ADMINISTRATION

INSTRUCTIONS FOR USE

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.

OVERDOSE

If you place accidentally too many drops in your eye, flush the eye with water or saline solution. Apply your next dose at the normal time. If by accident, anyone drinks this medicine, contact your doctor straight away. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Do not use a double dose to make up for the forgotten individual doses. Use a single dose as soon as you remember, unless it is almost time for your next dose. Then apply your next dose as usual and continue with your normal routine.

WARNING &PRECAUTIONS

If you use fluorometholone or neomycin sulphate 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 fluorometholone or neomycin sulphate.
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.
The safety and efficacy in children aged 2 years or younger has not been established.

PREGNANCY

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before using fluorometholone or neomycin sulphate.

Fluorometholone or neomycin sulphate should not be used during pregnancy and breastfeeding. It is unknown whether the active ingredients of fluorometholone or neomycin sulphate are excreted in breastmilk. fluorometholone or neomycin sulphate is therefore not recommended for mothers who are breastfeeding.

DRUG INTERACTION

It may be noted that drugs other than those listed above may also interact with Fluorometholone–Neomycin Sulphate.Usually drug interactions occur when it is used with another drug or with food. Before you use a medication for a particular ailment, you should inform the health expert about the use of any other medications including non-prescription medications, (over-the-counter medicines that may increase the effect of Fluorometholone–Neomycin Sulphate) and dietary supplements like vitamins, minerals and herbal, so that the doctor can warn you of any possible drug interactions.

Fluorometholone–Neomycin Sulphate can interact with loop diuretics and cephalosporin antibiotics.