INTRODUCTION

PREDACE contains Prednisolone which belongs to the group of medicines called Corticosteroids. It is used as a short-term management of eye inflammation in adults which are not caused by viral, bacterial, and/or fungal agents. It is also used to reduce redness, irritation, burning sensation, and swelling of the eye that occurs due to chemicals, heat, radiation, allergy, and/or foreign objects in the eye.

PREDACE is not recommended for use in patients with tuberculosis of the eye and previous history of herpes simplex infection. Before using PREDACE, inform your doctor if you have eye ulcers or had a disease/management to the eye, glaucoma, history of cataract surgery, bacterial, viral or fungal eye infections. PREDACE should be used with caution in pregnant and breastfeeding woman.

PREDACE is not recommended for use in children (below 12 years of age). The most common side effects of using PREDACE are iridocyclitis (swelling and irritation in the eye pupil), common cold, increase in intra ocular pressure (fluid pressure in the eye), and headache. Consult your doctor if you experience any unusual effects due to use of this medicine.

USES OF PREDACE

• Used as short-term management of eye inflammation in adults (which are not caused by viral, bacterial and/or fungal agents)
• Used to reduce redness, irritation, burning sensation and swelling of the eye (caused due to chemicals, heat, radiation, allergy, and/or foreign objects in the eye)

HOW PREDACE WORKS

PREDACE works by blocking the production of polymorphonuclear leukocytes (immune cells responsible for inflammation and allergic reaction) which results in preventing and manageing the occurrence of inflammatory and allergic reaction of the eyes in affected individuals.

DIRECTIONS FOR USE

Always apply PREDACE as directed by your doctor. It is for ophthalmic use only. Shake the bottle well before each use. Wash your hands and tilt your head backwards and gently pull the lower eyelid down to form a small pocket. Turn the bottle upside down and squeeze gently to release one or two drops in the affected eye. Avoid eye injury and contamination by placing the tip not too close to the eye. Release the lower eyelid after use and close your eye for few seconds.

SIDE EFFECTS OF PREDACE

HOW TO MANAGE SIDE EFFECTS

Headache:

Apply hot or cold-water bag on your head. Try to take rest in a quiet and dark room. Massage on scalp or head with mild pressure. Consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before using PREDACE inform to your doctor, if you are using or taking any of these medicines:

• other steroid eye drops (medicines used to manage allergies and inflammation of eye) such as hydrocortisone, loteprednol, and dexamethasone
• ritonavir, cobicistat (medicines used to manage HIV)

Overdosage:

If you or anyone else accidentally use too much of PREDACE, wash your eyes with clean water and consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep PREDACE out of reach of children
• Store at room temperature

FAQs ABOUT PREDACE

What is PREDACE used for?

PREDACE is used as a short-term management of eye inflammation in adults which are not caused by viral, bacterial, and/or fungal agents. It is also used to reduce redness, irritation, burning sensation and swelling of the eye in affected individuals that occurs due to chemicals, heat, radiation, allergy, and/or foreign objects in the eye.

How to use PREDACE?

Always apply PREDACE as directed by your doctor. It is for ophthalmic use only. Shake the bottle well before each use. Wash your hands and tilt your head backwards and gently pull the lower eyelid down to form a small pocket. Turn the bottle upside down and squeeze gently to release one or two drops in the affected eye. Avoid eye injury and contamination by placing the tip not too close to the eye. Release the lower eyelid after use and close your eye for few seconds.

Can PREDACE be used in pregnant and breastfeeding women?

PREDACE should be used with caution in pregnant and breastfeeding women. Consult your doctor before using PREDACE if you are pregnant or planning to get pregnant or a breastfeeding mother.

Can I drive or operate any machines while using PREDACE?

Do not drive or operate any heavy machines while using PREDACE as it may cause temporary blurred vision. Consult your doctor for advice before using PREDACE.

Can PREDACE be used in children?

PREDACE is not recommended for use in children (aged less 12 years) since it may impair fertility in future. Consult your doctor before using PREDACE.

REFERENCES

1. KD. Tripathi. Corticosteroids. Essentials of medical pharmacology. Eighth edition. 2019. Page – 313.

2. John D. Sheppard, Melissa M. Toyos, John H. Kempen, Paramjit Kaur,and C. Stephen Foster. Difluprednate 0.05% Versus Prednisolone Acetate 1% for Endogenous Anterior Uveitis: A Phase III, Multicenter, Randomized Study. NIH National Library of Medicine. National center for biotechnology information. PMC PubMed Central. May 2014. [Accessed on 11th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4581692/

3. Anu Vaajanen and Heikki Vapaatalo. A Single Drop in the Eye – Effects on the Whole Body? NIH National Library of Medicine. National center for biotechnology information. PMC PubMed Central. October 2017. [Accessed on 11th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5725525/

4. Els Mehuys, Christophe Delaey, Thierry Christiaens, Luc Van Bortel, Inge Van Tongelen, Jean-Paul Remon,and Koen Boussery. Eye drop technique and patient-reported problems in a real-world population of eye drop users. NIH National Library of Medicine. National center for biotechnology information. [Revised in August 2020] [Accessed on 11th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376112/

5. Allergan Pharmaceuticals Ireland. Health Products Regulatory Authority (HPRA). [Revised in April 2022] [Accessed on 11th July 2022] http://www.hpra.ie/img/uploaded/swedocuments/8b97bf2a-158c-4a13-adc2-4118cc02d776.pdf

6. Sandoz Inc. Prednisolone Acetate. Dailymed. [Revised in May 2022] [Accessed on 11th July 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=05d205c7-8f51-46b9-a6c5-4199bc432b26&type=display#:~:text=They%20inhibit%20the%20edema%2C%20fibrin,of%20action%20of%20ocular%20corticosteroids.

USEFUL DIAGNOSTIC TESTS

• Ophthalmoscopy