Mydriocain PT Injection is a solution which is injected into the eye.
it contains three active substances:
-Tropicamide which belongs to a group of medicines blocking the passage of impulses through particular nerves (known
as anticholinergics),
-Phenylephrine Hydrochloride Which belongs to a group of medicines mimicking the effects of impulses conveyed
through particular nerves (known as alpha sympathomimetics).
Lidocaine Hydrochloride which belongs to a class of drugs called amide type local anesthetics.
• Phenylephrine Hydrochloride..........USP........... 0.31% w/v
• Tropicamide..........USP...........0.02% w/v
• Lidocaine Hydrochloride..........USP...........1% w/v
• Lidocaine Hydrochloride..........USP...........1% w/v
Mydriocain PT Injection is used in adults only. It will be administered by ophthalmic surgeon by injection into the eye at the beginning of cataract surgery (cloudiness of the lens), in order to enlarge the pupil of your eye (mydriasis) and to obtain anaesthesia in your eye during the surgical procedure.
Mydriocain PT Injection is a solution for intracameral injection which combines two synthetic mydriatic agents (Tropicamide - anticholinergic, and Phenylephrine Hydrochloride - alpha sympathomimetic) and one local anaesthetic (Lidocaine Hydrochloride).
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 para sympatholytic 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 Hydrochloride 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.
Although Tropicamide as a mono therapy produces both mydriasis and cycloplegia, additional mydriasis occurs if sympathomimetic agents such as phenylephrine are used simultaneously. Such synergistic combinations are commonly prescribed to achieve maximal dilation of the pupil for cataract extraction. As an average, 95% of the dilation measured before the viscoelastic injection was obtained within 30 seconds after a single 200-uL.
Mydriocain PT Injection will be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataracts urgery. The recommended dose is 0.2 ml of solution, in only one injection. No dditional dose should be injected as no additional effect has been shown and as increased loss of endothelial cells (cells of a layer covering the posterior surface of the cornea) has been observed. The same dose is used for both adults and the elderly. The safety and efficacy of Mydriocain PT Injection in children aged 0 to 18 years have not been established.
Intracameral use The following procedure should be followed:
1. Five minutes before performing the pre-operative 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 Mydriocain PT is slowly injected in only one injection by anophthalmic surgeon,
via intracameral route, through the side port or principal port.
- Hypersensitivity to the active substances (Phenylephrine Hydrochloride, Tropicamide and Lidocaine Hydrochloride) or to any of the excipients which is used in formulation of Mydriocain PT Injection.
- Known hypersensitivity to anaesthetics of the amide type.
- Known hypersensitivity to atropine derivatives.
The recommended dose is 0.2 ml of Mydriocain PT Injection; no additional dose should be injected as no significant addon
effect has been demonstrated, and as increased endothelial cell loss was observed. Corneal endothelial toxicity has
not been reported at the recommended dose of, Mydriocain PT Injection; nevertheless, due to limited data, this risk
cannot be excluded.
There is no clinical experience with Mydriocain PT Injection in:
- Insulin-dependent or uncontrolled diabetic patients,
- Patients with corneal disease, especially those with any coexisting endothelial cell impairment,
- Patients with history of uveitis,
- Patients with pupillary abnormalities or presenting an ocular traumatism,
- Patients with very dark irides,
- Cataract surgery when combined with corneal transplantation.
There is no experience in patients at risk of floppy iris syndrome with Mydriocain PT Injection. Such patients should benefit of a step-by-step pupil dilation strategy starting with the administration of mydriatic eye drops. There is no clinical experience during cataract surgery with Mydriocain PT Injection in patients treated with topical mydriatics and for whom pupil constriction (or even miosis) occurs during surgery. Mydriocain PT Injection is not recommended to be used in cataract surgery when combined with vitrectomy, due to the vasoconstricting effects of Phenylephrine.Mydriocain PT Injection is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.
Mydriocain PT Injection was shown to produce undetectable or very low systemic concentrations of active substances,
Since s ystemic effects of Phenylephrine and Lidocaine are dose dependent, it is unlikely that these effects occur with
Mydriocain PT Injection. However, as the risk cannot be excluded, it is reminded that:
- 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.
No interaction studies have been performed with Mydriocain PT Injection.
Since the systemic exposure is expected to be very low, systemic interactions are unlikely.
There are no adequate data from the use of Phenylephrine Hydrochloride 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 Hydrochloride 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, Mydriocain PT Injection should not be used during pregnancy.
No data are available concerning the secretion of Phenylephrine Hydrochloride or Tropicamide into breast milk. However, Phenylephrine Hydrochloride 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 there fore 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, Mydriocain PT Injection should not be used during breast feeding.
There is no information on whether Mydriocain PT Injection may affect fertility in human males or females.
Mydriocain PT Injection has a moderate influence on the ability to drive and use machines, due to its mydriatic effect. Consequently, after cataract surgery with one Mydriocain PT Injection, the patient should be advised not to drive and/or use machines while the visual disturbances persist.
Systemic effects Due to single administration and low expected systemic passage of Mydriocain PT Injection, the risk of systemic effects due to overdose is considered minimal. The symptoms of Phenylephrine Ophthalmic overdose are likely to be effects resulting from systemic absorption, including extreme tiredness, sweating, dizziness, a slow heartbeat, and coma. Because severe toxic reaction to Phenylephrine is of rapid onset and short duration, treatment is primarily supportive. Prompt injection of a rapidly acting alphaadrenergic blocking agent such as Phentolamine (dose 2 to 5 mg in intravenous use) has been recommended. The symptoms of Tropicamide Ophthalmic overdose include headache, fast heartbeat, dry mouth and skin, unusual drowsiness, and flushing. Systemic effects from Tropicamide are not expected. Should an overdose occur causing local effects, e.g. sustained mydriasis, pilocarpine or 0.25% w/v physostigmine should be applied. In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest). Treatment of a patient suffering from systemic toxicity of Lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration).
24 Months.
Store below 30°C, Do not allow to freeze.
Mydriocain PT 1 mL Injection is supplied in 2.25 mL Glass Syringe.
