DFROT Eye Drops 5ml

Introduction About DFROT EYE DROPS

DFROT EYE DROPS contains Difluprednate which belongs to the group of medicines
called Corticosteroids. It is used in the management of pain and inflammation
due to eye surgery.

DFROT EYE DROPS is also used to manage endogenous anterior uveitis (an
inflammation of the middle layer of the eye which includes the iris (coloured
part of the eye) and adjacent tissue, known as the ciliary body). Symptoms of
anterior uveitis include red, sore and inflamed eye, blurred vision, light
sensitivity, small, or irregular-shaped pupil.

You should remove the contact lenses before instilling DFROT EYE DROPS and can
put them back after 10 minutes of use. Your doctor may need to adjust the doses
of your medicines or monitor you carefully for side effects.

DFROT EYE DROPS is not recommended for use in patients who have bacterial, viral
or fungal infection of the eye, or any other eye infections. DFROT EYE DROPS
should be used with caution in patients who have glaucoma, diabetes, diseases
causing thinning of cornea, or if you recently had a cataract surgery.

DFROT EYE DROPS should be used with caution in pregnant and breast-feeding
women. The safety and efficacy of DFROT EYE DROPS have not been studied in
children with endogenous anterior uveitis so, consult your child’s doctor for
advice.

The most common side effects of using DFROT EYE DROPS are eye irritation and
pain, headache, increased eye pressure, and blurred vision. Consult your doctor
if any of the symptoms become bothersome.

Uses Of DFROT EYE DROPS

Manage:

• pain and inflammation due to eye surgery
• endogenous anterior uveitis

How DFROT EYE DROPS Works

DFROT EYE DROPS helps in relieving pain and inflammation by inhibiting the
release of prostaglandins and leukotrienes (substances that causes pain and
inflammation).

How to use DFROT EYE DROPS

Use DFROT EYE DROPS as advised by your doctor. It is for ophthalmic use only.
Tilt your head backwards, hold the bottle upside down above the eye and dispense
drops with gentle pressure. Do not let the dropper tip touch your eye surface.

After using DFROT EYE DROPS, press a finger into the corner of your eye, by the
nose. This helps to stop the medicine from getting into other parts of the body.
Wipe any extra liquid from your face with a tissue. If you are using any other
eye medicines, leave at least 5 minutes between each medicine. Wash your hands
to clean any medicine.

Your doctor will decide the right dose and duration of therapy for you according
to your age, body weight and disease condition. Do not stop using DFROT EYE
DROPS unless your doctor advises you to stop.

Side Effects Of DFROT EYE DROPS

Common

• eye irritation and pain
• headache
• increased eye pressure
• blurred vision

Rare

Stop using DFROT EYE DROPS and inform your doctor if you experience any of the
following side effects:

• allergic reactions (hives, swelling of the face, lips, tongue, or throat, difficulty breathing)
• vision changes (sudden vision loss, blurred or tunnel vision, irritation or redness, eye pain or itching, severe headache, sensitivity to light, foreign body sensation in eye)
• symptoms of eye infection (eye swelling, weeping, drainage, crusting)
• swollen trunk and the face area with weight gain
• worsening of infection (eye redness, itching, tearing or discharge, feeling that something is in your eye, seeing floating spots, light sensitivity, red, swollen or crusty eyelids)

Warning & Precautions

!### Pregnancy

Consult your doctorDFROT EYE DROPS should be used during pregnancy only if the potential benefit
justifies the potential risk to the baby. Consult your doctor before using it.

!### Breastfeeding

Use with CautionDFROT EYE DROPS should be used with caution in breastfeeding women as it is not
known if it passes through the breast milk. Consult your doctor before using it.

!### Driving and Using Machines

ContraindicatedDo not drive or operate any machines if you experience blurred vision or any
visual disturbance after using DFROT EYE DROPS.

!### Kidney

Consult your doctorThere is no proper information about the use of DFROT EYE DROPS in kidney
patients. Consult your doctor before using it.

!### Liver

Consult your doctorThere is no proper information about the use of DFROT EYE DROPS in liver
patients. Consult your doctor before using it.

!### Allergy

ContraindicatedDo not use DFROT EYE DROPS if you are allergic to Difluprednate or any of its
other ingredients, or any other steroid medicines.

!### Use In Pediatrics

Consult your doctorDFROT EYE DROPS was found to be safe in children (28 days to 3 years of age)
with inflammation following cataract surgery. The safety and efficacy of DFROT
EYE DROPS have not been studied in children with endogenous anterior uveitis.
Consult your child’s doctor for advice.

!### Use In Geriatrics

Consult your doctorThere is no proper information about the use of DFROT EYE DROPS in elderly
patients. Consult your doctor before using it.

Others

DFROT EYE DROPS is not recommended for use if you:

• have eye diseases caused by viruses (Ex. herpes simplex, vaccinia, varicella) or by bacteria or fungus
• think you have any other infection of the eye

Before using DFROT EYE DROPS, inform your doctor if you:

• have glaucoma (excessive pressure in the eye)
• have or had herpes simplex virus (a virus that causes sores on the face, lips, genitals, and rectum and can also cause eye infections)
• currently have any kind of eye infection
• have diabetes (high blood sugar)
• recently had a cataract surgery
• have diseases causing thinning of cornea

Interactions

A. Drug – Drug Interactions:

Inform your physician if you are taking any of the following medicines before
using DFROT EYE DROPS:

• NSAIDs such as ketorolac (used to manage pain and inflammation)
• medicines used in HIV infection (Ex ritonavir, cobicistat)

Overdosage:

If you or anyone else put too many drops of DFROT EYE DROPS, consult your doctor
immediately or visit the nearby hospital. It can be washed out of the eye with
warm water. However, consult your doctor or nurse if you experience anything
unusual.

Synopsis

Drug	:	Difluprednate
Pharmacological Category	:	Glucocorticoids
Therapeutic Indication	:	Pain and inflammation post eye surgery, Endogenous anterior uveitis
Dosage Forms	:	Eye Drops, Ophthalmic Emulsion

More Information

• Keep DFROT EYE DROPS out of reach of children
• Store at a temperature between 15°C - 25°C

FAQs About DFROT EYE DROPS

Q. What is DFROT EYE DROPS and why is it used?

A. DFROT EYE DROPS contains Difluprednate which belongs to the group of
medicines called Corticosteroids. It is used in the management of pain and
inflammation associated with ocular surgery. DFROT EYE DROPS is also used to
manage endogenous anterior uveitis (an inflammation of the middle layer of the
eye which includes the iris (coloured part of the eye) and adjacent tissue,
known as the ciliary body).

Q. Can DFROT EYE DROPS cause increased eye pressure?

A. Prolonged use of DFROT EYE DROPS can cause increased eye pressure and changes
in vision. It should be used with caution in patients who already have glaucoma
(increased eye pressure). Consult your doctor before using it.

Q. Is DFROT EYE DROPS safe to use in pregnant women?

A. DFROT EYE DROPS should be used during pregnancy only if the potential benefit
justifies the potential risk to the baby. If you are pregnant, think you may be
pregnant or are planning for pregnancy, consult your doctor before using it.

Q. Can DFROT EYE DROPS be used if I wear contact lens?

A. If you wear contact lenses, you should remove them before using DFROT EYE
DROPS and can put them back after 10 minutes of use. Consult your doctor for
further queries.

Q. Does DFROT EYE DROPS has to be kept in refrigerator?

A. Do not refrigerate DFROT EYE DROPS. It should be stored at a temperature
between 15°C - 30°C, protected from light. Refer the package leaflet if you have
further queries regarding DFROT EYE DROPS storage.

Q. Can DFROT EYE DROPS cause infection of the eye?

A. Prolonged use of DFROT EYE DROPS, may suppress the immune system response and
thus increase the chances of secondary eye infections. In acute conditions,
DFROT EYE DROPS may worsen an existing infection. Consult with your doctor
before using this medicine if you have an existing eye infection.

Useful Diagnostic Tests

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