Midoria Injection(Tropicamide 0.02%, Phenylephrine HCl 0.31% & Lidocaine HCl 1%)
Therapeutic Group: Ophthalmic
Presentation
Midoria™ Injection: Each ampoule contains 0.6 ml sterile solution of Tropicamide BP 0.2 mg/ml, Phenylephrine Hydrochloride BP 3.1 mg/ml and Lidocaine Hydrochloride USP 10 mg/ml.
Description
Midoria™ is a sterile preparation of Tropicamide, Phenylephrine Hydrochloride and Lidocaine hydrochloride. It is a clear and slightly brownish-yellow solution for intracameral injection used during cataract surgery of eye.
Indications
Midoria™ is indicated for cataract surgery to obtain mydriasis (dilation of pupil) and intraocular anaesthesia during the surgical procedure.
Dosage & Administration
Used only in elderly and adults undergoing cataract surgery.
The injection has to be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataract surgery. The recommended dose is 0.2 ml of solution, in only one injection.
The following procedure should be followed:
1. Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye.
2. At the beginning of surgery, 0.2 ml of Midoria™ is slowly injected in only one injection via intracameral route, through the side port or principal port.
Side Effects
Most serious well known complications occurring during or after cataract surgery:
Uncommon: may affect up to 1 in 100 people
• Injury to the lens (posterior capsule rupture)
• Swelling of the retina (cystoid macular edema).
Please seek urgent medical advice in this case.
Other side effects:
Uncommon: may affect up to 1 in 100 people
• Nervous system disorder: Headache
• Eye Disorder: Swelling of the cornea (keratitis), increased pressure in the eye, redness of the eye (ocular
hyperaemia)
• Vascular disorder: High blood pressure (hypertension)
Precautions
Do not use if the blister is damaged or broken. Open under aseptic conditions only. The product should be used immediately after opening of the ampoule and not be reused for the other eye or any other patient.
Midoria™ is not recommended:
• In combined cataract surgery with a certain type of eye surgery (vitrectomy)
• If the ocular anterior chamber is shallow
• If the patient has a history of acute narrow angle glaucoma
The doctor should consider the patient’s medical condition if he is suffering from hypertension, atherosclerosis or any kind of heart disease, hyperthyroidism, prostate gland disorders, epilepsy, any liver disease or kidney problem, breathing problem or myasthenia gravis.
Use in Pregnancy & Lactation
This medicine should not be used during pregnancy and lactation.
Drug Interaction
No data found.
Storage
• Do not store above 30⁰ C
• Does not require refrigeration
• Keep away from light and out of the reach of children
• For single eye use only. This medicine should be used immediately after first opening of the ampoule.
• After use, discard the remaining solution appropriately. Do not keep it for subsequent use.
Commercial Pack
Midoria™ Injection: Each box contains one ampoule of 0.6 ml injectable sterile solution for intraocular use.