Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:
Fluorometholone USP…………………1mg

For a full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Eye drops, suspension.

A white, microfine suspension.

CLINICAL PARTICULARS

4.1 Therapeutic indications

For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

4.2 Posology and method of administration

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is for topical ophthalmic use only, applied as drops into the conjuctival sac. Shake Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma well before use.

Instil 1 – 2 drops into the conjunctival sac 2 – 4 times daily. During the first 24 to 48 hours of treatment, the dose may be safely increased to 2 drops at one hour intervals.

The treatment should not be withdrawn too early.

In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

Paediatric population

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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, as well as mycobacterial and untreated bacterial infection of the eye and fungal diseases of ocular structures, and any undiagnosed ‘red eye’ as this may indicate a viral infection.

4.4 Special warnings and precautions for use

Eye drops containing corticosteroids should not be used for longer than a week except under an eye specialist’s careful surveillance combined with regular measurement of intraocular pressure.

Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) with possible development of glaucoma and infrequent damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, and delayed wound healing. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.

Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex keratitis requires great caution. Frequent follow-ups including slit lamp microscopy is recommended.

To prevent eye injury or contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection.

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is used and wait for at least 15 minutes before reinsertion.

Concomitant ocular medication should be administered 5 minutes prior to the installation of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of fluorometholone in pregnant women.

Studies in animals have shown reproductive toxicity.

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is not recommended during pregnancy.

Lactation

It is unknown whether fluorometholone is excreted in human milk. Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma has no influence on the ability to drive or use machines. However, instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring to subside before driving or operating machinery or taking part in any activity where this could put themselves or others at risk.

4.8 Undesirable effects

Class effects:

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

The following undesirable effects have been reported since Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma was marketed.

Frequency:

Common: affecting >1/100 and <1/10 patients

Not known: the incidence cannot be determined from available information.

Immune system disorders

Not known: Hypersensitivity

Eye disorders

Common: Intraocular pressure increased

Not known: Eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, blurred vision*, eye discharge, eye pruritis, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including subcapsular)*, ulcerative keratitis, ocular infection (including bacterial, fungal*, and viral* infections), visual field defect, punctate keratitis.

Gastrointestinal disorders

Not known: Dysgeusia

Skin and subcutaneous tissue disorders

Not known: Rash

*See section 4.4 for further information

Adverse reactions reported in phosphate containing eye drops

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important

4.9 Overdose

Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.

If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, plain

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation.

Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.

Although topical corticosteroid treatment often increases intraocular pressure both in normal eyes and in the eyes of a patient with increased intraocular pressure, fluorometholone increases intraocular pressure less than, for example, dexamethasone. A study showed that fluorometholone after six weeks’ treatment increased intraocular pressure statistically significantly less than dexamethasone (mean change dexamethasone: 9 mmHg, mean change fluorometholone: 3 mmHg).

5.2 Pharmacokinetic properties

When tritium-labelled 0.1 % fluorometholone suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after administration. A rapidly forming metabolite occurred at high concentrations both in aqueous humour and corneal extracts, which shows that fluorometholone is metabolised to a certain extent while penetrating the cornea and aqueous humour.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose ocular toxicity and repeated dose systemic toxicity.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polyvinyl alcohol, Benzalkonium chloride, Edetate disodium, Sodium chloride, Disodium phosphate, heptahydrate, Sodium dihydrogen phosphate, monohydrate, Polysorbate 80, Sodium hydroxide (for pH adjustment), Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

Discard 28 days after first opening.

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze.

6.5 Nature and contents of container

A bottle and an applicator tip of low density polyethylene (LDPE). A screw cap of polystyrene (MIPS).

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface.

The use of the product by more than one person may spread infection.

Keep the bottle tightly closed when not in use.

There are no special precautions for disposal.

MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

FLUOROMETHOLONE
OPHTHALMIC SUSPENSION USP
0.1% W/V
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorometholone

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

IN THIS LEAFLET:

What Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is and what it is used for
Before you use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma
How to use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma
Possible side effects
How to store Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma
Further information
1. WHAT FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP 0.1% W/V TAJ PHARMA IS AND WHAT IT IS USED FOR

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is an eye drop. It contains a steroid which is used to treat inflammation of the eye.

BEFORE YOU USE FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP 0.1% W/V TAJ PHARMA

Do not use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

if you are allergic (hypersensitive) to fluorometholone, benzalkonium chloride, or any of the other ingredients of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma.
if you have a bacterial, viral, or fungal infection of the eye.

Take special care with Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

You should not use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma for more than one week unless your doctor or eye specialist advises it.

Prolonged use may cause the pressure inside your eye (intraocular pressure) to increase, which could lead to glaucoma, rare damage to the optic nerve, lack of clearness of vision, cataracts, delay in wound healing, or the development of an eye infection. The pressure in your eye will be regularly measured.

If you have or have been previously treated for herpes simplex, use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma only under close supervision of your doctor.

The use of the bottle by more than one person may spread infection.

Contact your doctor if you experience blurred vision or other visual disturbances.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If you are using other eye drops, leave at least 5 minutes before putting in Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma.

Children

The safety and effectiveness in children aged 2 years or less have not been shown.

Pregnancy and breast feeding

Tell your doctor before you start using Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma if you are pregnant or planning to become pregnant or if you are breastfeeding. Your doctor will decide if you should use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma during pregnancy or whilst breastfeeding. Normally it is not recommended for use.

Driving and using machines

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma can cause temporary blurred vision. Should this occur, wait for the blurring to clear before driving or operating machinery or taking part in any activity where this could put yourself or others at risk.

Important information about some of the ingredients of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma contains benzalkonium chloride as a preservative, which is known to discolour soft contact lenses and can cause eye irritation. If you wear soft contact lenses you must remove them before using Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma eye drops and wait at least 15 minutes before putting your lenses back in.

Ask your doctor or pharmacist for advice before taking any medicine.

HOW TO USE FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP 0.1% W/V TAJ PHARMA

Always use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is 1 or 2 drops of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma in each eye that needs treatment 2 to 4 times a day, or more frequently if your doctor advises it. During the first 24 – 48 hours of treatment your doctor may advise you to apply 2 drops at one hour intervals.

Treatment should not be withdrawn too early.

Instructions for use

You must not use the bottle if the seal on the bottle neck is broken before you first use it.

Shake the bottle before use. Wash your hands before opening the bottle.

Use your eye drops in the following way:

Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and gently squeeze it to release 1 or 2 drops into the eye.
4. Let go of the lower lid, and close your eye for 30 seconds.
5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.

If a drop misses your eye, try again.

To keep the eye drops free from contamination and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle tightly straight after use. Wipe off any excess liquid from your cheek with a clean tissue.

If you use more Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma than you should

If you use more drops of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma than you should, it is unlikely to cause you any harm. If you have placed too many drops in your eye(s), wash your eyes with clean water. Put your next dose in at the usual time.

If you drink Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma by accident

If anyone drinks Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma by accident, it is unlikely to cause any harm. The affected person should drink fluids to dilute.

If you forget to use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

If you forget a dose, use Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma as soon as you remember, unless it is almost time for your next dose. Then use your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma

To work properly Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma should be used as advised by your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma can have side effects, although not everybody gets them. The following side effects are known to occur but their frequency can vary, as shown.

If you experience swallowing or breathing difficulties, swelling of your lips, face, throat or tongue contact your doctor or go to the hospital immediately as this could be a sign of a serious allergic reaction. The frequency of an allergic reaction is not known.

Affecting the eye

Frequency – Common (affecting up to 1 in 10 patients):

Increased pressure inside your eye

Frequency not known:

Cataract (a loss of transparency of the lens of the eye with partial or complete loss of vision)

Eye irritation

Eye inflammation

Redness of the eye

Itching of the eye

Eye pain

A feeling that something is in your eye

Difficulty in seeing clearly

Swelling of the eyelid or eye

Eye discharge

Excessive dilatation of the pupil

Excessive tear production

Ulcer(s) on the surface of the eye

Small breaks in the surface of the eye

Visual field defects

Secondary infections (including bacterial, fungal, and viral infections)

Blurred vision

Affecting the body

Frequency not known:

Rash, abnormal sense of taste, allergic reactions (hypersensitivity)

Other side effects reported with eye drops containing phosphates

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP 0.1% W/V TAJ PHARMA

Keep out of the reach and sight of children.

Do not use an unopened bottle of Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma after the expiry date which is stated on the bottle label and on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not freeze.

You must throw away the bottle 28 days after you first opened it, even if there are still some drops left. To help you remember, write down the date you opened it in the space provided on the carton.

Keep the container tightly closed to prevent contamination.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma contains

Each ml contains:
Fluorometholone USP…………………1mg

The other ingredients are polyvinyl alcohol, benzalkonium chloride, edetate disodium, sodium chloride, disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, polysorbate 80, sodium hydroxide (for pH adjustment), and purified water.

What Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma looks like and contents of the pack

Fluorometholone Ophthalmic Suspension USP 0.1% w/v Taj Pharma is a white suspension supplied in a plastic dropper bottle with a screw cap.

The bottle contains 5 ml or 10 ml of suspension.