INTRODUCTION

BIODYLE TP EYE DROPS is a combination of Phenylephrine and Tropicamide which belongs to the group of medicines called Nasal decongestants and Anticholinergics. It is indicated for mydriasis and cycloplegia in diagnostic procedures.

It is used directly on the eyelids to produce dilation of pupil before diagnostic and therapeutic procedures. Dilated pupils (mydriasis) are a condition when the black centre of the eyes becomes larger than normal. The condition may be caused by dilating eye drops from an eye exam. The eye drops used for dilation cause your pupils to widen, allowing in light and giving your doctor a better view of your eye. Eye dilation helps your doctor in diagnosing common diseases and conditions, possibly at their earliest stages.

Remove your contact lenses before using this medicine. Do not drive vehicles immediately after using BIODYLE TP EYE DROPS as it may cause blurred vision making it difficult to ride vehicles.

BIODYLE TP EYE DROPS is not recommended for patients with high risk for glaucoma (Narrow anterior chamber angle). BIODYLE TP EYE DROPS should be used with caution in patients with inflamed eyes.

Avoid concomitant use of cardiac medicines along with BIODYLE TP EYE DROPS. There is no proper information regarding the use of BIODYLE TP EYE DROPS and should be used with caution in pregnant women.

BIODYLE TP EYE DROPS should be used with caution in breast-feeding women. BIODYLE TP EYE DROPS should be used with caution in children below 1 year of age and in elder patients.

The most common side effects of BIODYLE TP EYE DROPS are stinging, blurred vision, sensitive to light, redness, watery eye, increased intraocular pressure, local irritation and oedema.

USES OF BIODYLE TP EYE DROPS

• It is used directly on the eyelids to produce dilation of pupil before diagnostic and therapeutic procedures

HOW BIODYLE TP EYE DROPS WORKS

BIODYLE TP EYE DROPS works by dilating the pupils in the eye. Phenylephrine produces dilation effects (mydriasis) by narrowing the blood vessels and muscles present in the eye. Tropicamide blocks the stops the narrowing of the smooth muscles of eye causing dilation of pupil (mydriasis). Thus, both react by producing mydriatic effect necessary for diagnostic and therapeutic purposes.

DIRECTIONS FOR USE

Use BIODYLE TP EYE DROPS as directed by your physician. It is for ophthalmic use only. Your doctor will decide the right dose and duration depending upon your age, body weight and disease condition.

SIDE EFFECTS OF BIODYLE TP EYE DROPS

HOW TO MANAGE SIDE EFFECTS

Headache:

Take some rest, in a quiet place avoid using user mobile phones and other electronic devices for a while. Drink enough amount of water, dehydration may lead you to develop a headache. If the symptom does not improve, contact your doctor.

Nausea or Vomiting:

Drink clear or ice-cold drinks. Eat light, bland foods. Avoid fried, greasy or sweet foods. Eat slowly and eat smaller, more frequent meals, drinking gradually larger amounts of clear liquids, avoid solid food until the vomiting episode has passed, take rest. If the symptom does not improve, contact your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before using BIODYLE TP EYE DROPS, inform your doctor if you are taking any of the following medicine:

• medicines used to treat hypertension (Ex. atenolol, propanolol, enalapril, amlodipine)
• medicines used to treat depression and mental illness (Ex. sertraline, citalopram, escitalopram, selegiline, rasagiline, amitriptyline, trimipramine)
• halothane (used as anaesthesia)
• atropine (used to treat low blood pressure)
• medicines used to treat heart diseases (Ex. digoxin, quinidine)

Overdosage:

If you or anyone else accidentally uses more of BIODYLE TP EYE DROPS, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose include flushing dryness of the skin, rash, blurred vision, irregular pulse, fever, abdominal swelling in infants, convulsions, hallucinations, loss co-ordination, headache, anxiety, nausea, vomiting and irregular heartbeat.

SYNOPSIS

MORE INFORMATION

• Keep BIODYLE TP EYE DROPS out of reach of children
• Store at room temperature

FAQs ABOUT BIODYLE TP EYE DROPS

Can I use BIODYLE TP EYE DROPS without doctor’s prescription?

No, BIODYLE TP EYE DROPS should be used only by a registered medical practitioner for eye examination. Consult your doctor for advice.

I am unable to see objects or drive my vehicle after being treated with BIODYLE TP EYE DROPS, will I get back my vision?

It is completely normal to have blurred vision after being administered with BIODYLE TP EYE DROPS. It is because of the dilation of the pupil make us difficult to see objects. It will be resolved once the effect of BIODYLE TP EYE DROPS is over.

How does BIODYLE TP EYE DROPS work?

BIODYLE TP EYE DROPS works by dilating the pupils in the eye. Phenylephrine is an alpha-1 adrenergic receptor which produces dilation effects (mydriasis) by narrowing the blood vessels and muscles present in the eye. Tropicamide is an anticholinergic preparation that blocks the stops the narrowing of the smooth muscles of eye causing dilation of pupil (mydriasis). Thus, both medicines react by producing mydriatic effect necessary for diagnostic and therapeutic purposes.

What should I do if my child accidentally consumed BIODYLE TP EYE DROPS?

If you or anyone else accidentally took more of BIODYLE TP EYE DROPS, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose include flushing dryness of the skin, rash, blurred vision, irregular pulse, fever, abdominal swelling in infants, convulsions, hallucinations, loss co-ordination, headache, anxiety, nausea, vomiting and irregular heartbeat.

Can I use BIODYLE TP EYE DROPS while wearing contact lenses?

No, do not use BIODYLE TP EYE DROPS while wearing contact lenses. You should inform your health care professional about the contact lense and it has to be removed before administering BIODYLE TP EYE DROPS.

Can I use BIODYLE TP EYE DROPS for eye infections?

No, it is not intended to treat infections and used only to produce mydriasis (pupil dilation) for eye examination.

REFERENCES

1. K.D. Tripathi Drugs Acting on Ans Essentials of Pharmacology seventh edition 2013 Page no – 118.

2. Park, Ji-Hyun et al. The comparison of mydriatic effect between two drugs of different mechanism March 2009 NCBI: National Library of Medicine, PubMed articles. [Accessed on 25th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2655751/

3. Cipla med. [Revised in August 2020] [Accessed on 25th May 2022] https://ciplamed.com/content/itrop-plus-eye-drops

4. Optho life sciences Tropicamide 0.8% w/v, Phenylephrine HCl 2.5% w/v. [Accessed on 25th May 2022] https://www.optholifesciences.com/mydriatics

5. Eyekare kilitch Tropicamide IP 1% w/v Phenylephrine Hydrochloride IP 5% w/v. [Accessed on 25th May 2022] https://eyekarekilitch.com/proDetails.asp?id=29&product=TROPIEYE

6. Intas Tropicamide - 0.8% + Phenylephrine Hcl - 5.0%. [Accessed on 25th May 2022] https://www.intaspharma.com/products/