INTRODUCTION

MYDRAT J contains Atropine which belongs to the group of medicines called Mydriatics and Cycloplegics. It is used to prevent or delay the progression of myopia in young children (aged between 4-14 years). Myopia (or near-sightedness) is a vision problem in which people can see close objects clearly, but objects farther away appears blur. It happens when your eyes do not perceive light rays properly. As a result, it causes difficulty in viewing objects located far away, eye strain, headache or squinting.

Atropine is an anticholinergic medicine. It works by blocking the effects of a chemical messenger called acetylcholine in the eyes. As a result, it relaxes the eye muscles (ciliary muscle), reduces tension in the eye and allows the eyes to focus better. During therapy with MYDRAT J, your doctor would regularly monitor your child’s health to avoid the risk of unwanted side effects.

Before using MYDRAT J, it is advisable to inform your doctor if your child has any eye problems other than myopia. MYDRAT J is not suitable for use in children aged below 4 years. While using MYDRAT J, your child may find it more difficult to read anything or focus near objects. If this happens, consult your doctor to discuss few options on managing them. Using MYDRAT J may temporarily make your child more sensitive to sunlight (photophobia). Using sunglasses while going outdoors may help. However, if the symptom becomes intolerable for your child, consult your doctor for advice. The most common side effects of using MYDRAT J are blurred vision, eye irritation, redness and swelling, headache, or fatigue. Contact your doctor if any of the symptom worsens.

USES OF MYDRAT J

• Prevents or delay the progression of myopia in young children (4-14 years)

HOW MYDRAT J WORKS

MYDRAT J works by blocking the effects of a chemical messenger called acetylcholine in the eyes. As a result, it relaxes the eye muscles (ciliary muscle), reduces tension in the eye and makes the eyes to focus better.

DIRECTIONS FOR USE

Use MYDRAT J as advised by your physician. It is for ophthalmic use only. Instill few drops of the medicine in the affected eye(s). Do not to touch the tip of the container with your fingers. Your doctor will decide the correct dose and duration for your child depending upon their age, body weight and health condition.

SIDE EFFECTS OF MYDRAT J

HOW TO MANAGE SIDE EFFECTS

Headache:  

Make sure that your child does not strain their eyes too much by looking at mobile phones, television, or computers. Apply a pain-relieving balm on their forehead if required. Consult your doctor if their headache worsens.

Sensitivity to light (photophobia):

Do not exposure your children directly to sun light or to other light sources. Protect their eyes from bright light using sunglasses while going outdoors. If the symptom becomes intolerable, consult your doctor for advice.

Blurred vision:

Make sure that your child does not ride cycle or go alone outdoors while experiencing blurred vision. Advise them to close their eyes for some time and relax. Contact your doctor if your child finds it more difficult to read anything or focus near objects.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using MYDRAT J, inform your doctor if your child is taking any of the following medicines such as:

• medicines used to treat glaucoma (Ex. timolol)
• medicines used to treat muscle weakness (Ex. metaxalone, cyclobenzaprine)
• medicines used to treat allergic reactions (Ex. levocetirizine, diphenhydramine, chlorpheniramine)
• medicines used to treat Parkinson's disease (Ex. levodopa, carbidopa)
• medicines used to treat depression (Ex. phenelzine, isocarboxazid, sertraline)
• potassium citrate or potassium supplements (used to treat potassium deficiencies)

Overdosage:

If your child or anyone else accidentally used/ ingested too much of MYDRAT J, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include dry mouth, difficulty in swallowing or talking, fever, dry skin, or difficulty in passing urine.

SYNOPSIS

MORE INFORMATION

• Keep MYDRAT J out of reach of children
• Store at room temperature

FAQs ABOUT MYDRAT J

Can MYDRAT J cure myopia?

Current studies suggest that there is no permanent cure for myopia. However, few agents like atropine can be used to prevent the onset of myopia. MYDRAT J cannot cure myopia however it is shown to effectively reduce the progression of myopia, especially in the children. If you are doubtful, consult your doctor before use.

Can MYDRAT J cause blurred vision?

Yes. MYDRAT J can cause blurred vision after application. Due to this, your child may find it more difficult to read anything or focus near objects. If this happens, consult your doctor to discuss options on how to manage them. Also, it is not advisable to allow children to ride or travel on their own without parent’s or guardian’s assistance.

Will taking a higher dose of MYDRAT J be more effective?

No. Taking higher dose of MYDRAT J may be not effective in preventing myopia. Higher doses of atropine are used as a diagnostic aid. Therefore, consult your doctor before using a higher dose of atropine.

Can I use MYDRAT J without consulting the doctor?

No. Do not use MYDRAT J without consulting your doctor. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Can MYDRAT J be used for glaucoma?

No. MYDRAT J is not indicated to treat glaucoma. In contrast, people having glaucoma must inform their doctor before using MYDRAT J as a precaution, as it might worsen their existing condition.

Can MYDRAT J be used in toddlers?

No. MYDRAT J is not recommended for use in toddlers and in children aged below 4 years. Consult your doctor for advice before using.

Can MYDRAT J cause headaches?

Yes. MYDRAT J can cause headache in some children, although not everybody gets them. If your child experiences headache, make sure that they do not strain their eyes too much by looking at mobile phone, television or computers. You can apply a pain-relieving balm on their forehead to ease the pain. If there is no improvement in the condition, consult your doctor for advice.

Is there is any specific storage conditions present for MYDRAT J?

MYDRAT J must be stored in a cool, dry place. Do not freeze or refrigerate.

REFERENCES

1. Marcela Frazier and Siret D. Jaanus. Cycloplegics. Clinical Ocular Pharmacology by Jimmy D Barlett, Siret D Jaanus. Fifth edition. 2007. Page – 128.

2. Vidhya. C, Kaushik Murali, Sowmya. R. Safety and efficacy of reconstituted atropine 0.01% eye drops for Indian children with myopic progression. Asian Journal of Ophthalmology. April 2020. [Accessed on 30th April 2022] https://www.asianjo.com/index.php/AsianJO/article/view/572

3. Zhao Y, Feng K, Liu RB, et al. Atropine 0.01% eye drops slow myopia progression: a systematic review and Meta-analysis. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC PubMed Central. August 2019. [Accessed on 30th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694061/

4. Aspen Pharmacare. EIKANCE 0.01% EYE DROPS [Revised in April 2022] [Accessed on 30th April 2022] https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-CMI-02407-1&d=20220422172310101