Midoria Injection
Tropicamide + Phenylephrine + Lidocaine inj (eye prep)
0.02% + 0.31%+ 1%
Incepta Pharmaceuticals Ltd.
| Pack size | |
|---|---|
| Unite Price | 200.00 BDT |
Indications
Midoria Injection is used for:
Cataract surgery, to obtain mydriasis and intraocular anaesthesia during the surgical procedure
Adult Dose
Adults:
The recommended dose is 0.2 ml of solution, in only one injection.
Patients with hepatic impairment:
Considering the low dose and the very low systemic exposure, no dose adjustment is necessary.
Child Dose
Renal Dose
Patients with renal impairment:
Considering the low dose and the very low systemic exposure, no dose adjustment is necessary.
Administration
Intracameral use. One ampoule for single eye use.
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 solution is slowly injected in only one injection via intracameral route, through the side port or principal port.
Contra Indications
Hypersensitivity to the active substances (tropicamide, phenylephrine hydrochloride and lidocaine hydrochloride) or to any of the excipients.
- Known hypersensitivity to anaesthetics of the amide type.
- Known hypersensitivity to atropine derivatives.
Precautions
Tropicamide + Phenylephrine + Lidocaine inj is not recommended to be used in cataract surgery when combined with vitrectomy, due to the vasoconstricting effects of phenylephrine.
This is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.
Use of Tropicamide + Phenylephrine + Lidocaine inj in patients with shallow anterior chamber, a history of acute narrow angle glaucoma and/or insufficient pupil dilation can increase the risk of both iridocele and floppy iris syndrome.
- Phenylephrine has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and all subjects presenting with a contraindication to the systemic use of pressor amines;
- Lidocaine should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute.
Pregnancy-Lactation
Pregnancy
There are no adequate data from the use of phenylephrine and tropicamide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonic/foetal development, parturition and postnatal development.
Although animal studies have revealed no evidence of harm to the foetus, lidocaine crosses the placenta and should not be administered during pregnancy.
Even though a negligible systemic uptake is expected, a low systemic exposure cannot be excluded.
Therefore, Mydrane should not be used during pregnancy.
Breastfeeding
No data are available concerning the secretion of phenylephrine or tropicamide into breast milk. However, phenylephrine is poorly absorbed orally, implying that absorption by the infant would be negligible. On the other hand, infants may be very sensitive to anticholinergics, and despite the expected negligible systemic exposure, tropicamide is therefore not recommended during breast feeding.
Small amounts of lidocaine are secreted into breast milk and there is a possibility of an allergic reaction in the infant.
Therefore, Mydrane should not be used during breast feeding.
Fertility
There is no information on whether Mydrane may affect fertility in human males or females.
Interactions
Side Effects
Side effects of Tropicamide + Phenylephrine + Lidocaine inj (eye prep) :
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).
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)
Mode of Action
Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha-adrenergic receptors of the pupillary dilator (the resulting contraction of the pupillary dilator causes pupil dilation). There is almost no cycloplegic effect.
Tropicamide is a parasympatholytic agent, which acts by binding to and blocking the M4 muscarinic receptors of the eye muscles. It prevents the iris sphincter muscle and ciliary body muscle from responding to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle (cyclopegia).
Lidocaine is a local anaesthetic of the amide type. It acts by inhibiting the ionic refluxes required for the initiation and conduction of impulses, thereby stabilising the neuronal membrane.
Note
Midoria 0.02% + 0.31%+ 1% Injection generic name is Tropicamide + Phenylephrine + Lidocaine inj (eye prep). Midoria 0.02% + 0.31%+ 1% Injection is manufactured by Incepta Pharmaceuticals Ltd.Midoria is availble in all over Bangladesh.
Mes BD drug index information on Midoria Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.