Product for Cataract,Product for Conjuctivitis,Product for Eye Allergies,Product for Glaucoma,Product for Seasonal Allergies,Sterile Formulations,Three Piece drops,Three Piece VialsMydrimax ® Eye Drops

Composition:

Each 1 ml contains :

Active ingredient: Phenylephrine hydrochloride – 50.0 mg, Tropicamide – 8.0 mg Excipients: Sodium methabisulfite 2 mg, benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, hypromellose 5.0 mg, sodium hydroxide, qs, hydrochloric acid qs, water for injection to 1 ml.

Pharmacotherapeutic Group:

Eye diseases diagnostic remedy (m-cholinergic antagonist + α- adrenoagonist).

Indications:

It is used as a mydriatic remedy:

  • For diagnostic ophthalmic procedures.
  • Prior to surgical and laser operations.

Dosage and Administration:

For dilation of the pupil for ophthalmic diagnostic and surgical interventions in the conjunctival sac instill 1-2 drops at15-30 minutes before the procedure or surgery.

Contraindications:

Hypersensitivity to any of component,

  • Narrow angle closure glaucoma,
  • The age below 18,
  • Diseases of the cardiovascular system (including coronarosclerosis, angina, arrhythmias, hypertensive crisis)
  • Thyrotoxicosis,
  • Type 1 diabetes,
  • Simultaneous reception (as well as 3 weeks after withdrawal) of inhibitors of monoamine oxidase (MAO)
  • Pregnancy,
  • The period of lactation.

Warning and Precautions:

Due to changes in accommodation and pupil width after using the drug visual acuity is possibly reduces, and the use of the drug is not recommended when driving a vehicle and during the occupation of other potentially hazardous activities that require high concentration and quickness of psychomotor reactions.

Due to a significant reduction in the pupil dilator in 30-45 min after instillation particles of pigment from the pigment layer of the iris can be detected in the anterior chamber moisture. A suspension of moisture in the chamber must be differentiated with manifestations of anterior uveitis or a hit of blood cells in the anterior chamber of the moisture. Preservatives contained in the product may be absorbed by soft contact lenses. The drug can be irritating to the eyes when wearing contact lenses, so any contact lenses should be removed before instillation and put on no earlier than 15 minutes after it.

To reduce the risk of systemic side effects it is recommended to slight press with the finger on the projection area of the lacrimal sac at the inner corner of eye for 1-2 minutes after instillation.

Type 2 diabetes mellitus, older age (risk of ventricular arrhythmias and myocardial infarction in patients with diseases of the cardiovascular system).

Side Effects:

Topical:
Allergic reactions, increased intraocular pressure, transient pain, burning sensation in the eye and photophobia, transient decrease in vision, allergic reactions, release of pigment in the aqueous humor with a temporary increase in intraocular pressure, blocking the anterior chamber angle (while narrowing of the angle), pain in the brow, lacrimation, conjunctival hyperemia, keratitis, rarely – reactive miosis on the day after application (repeat instillation of the drug at this time may give a less pronounced mydriasis than the day before, the effect is often seen in elderly patients).

System:
Pale skin, dry mouth, flushed dry skin, contact dermatitis, headache, bradycardia, tachycardia and arrhythmia, high blood pressure, ventricular occlusion of the coronary arteries, pulmonary embolism, disorders of the central nervous system and muscular rigidity, frequent urge to urinate , difficulty urinating, decreased tone of the gastro-intestinal tract motility, leading to constipation. Sometimes – vomiting and dizziness.

In elderly patients with diseases of the cardiovascular system may be ventricular arrhythmia, myocardial infarction.

Drug Interaction:

  • In the simultaneous appointment with β-blockers may increase the vasoconstrictive action of phenylephrine by inhibition of vasodilation.
  • Due to the risk of hypertensive crisis it is not recommended the simultaneous appointment phenylephrine and guanidine, as well as any other blocker or inhibitor of the reuptake of monoamines.
  • The simultaneous (and within three weeks after the end of withdrawal) use with monoamine oxidase inhibitors increases the risk of systemic adrenergic effects.
  • Vasopressor action of adrenoagonists may also be amplified when combined with tricyclic antidepressants, methyldopa, and m-cholinergic antagonists.
  • Pre-instillation of local anesthetics may increase the systemic absorption of active substances and prolong mydriasis.

Over-Dosage:

Symptoms (in case of accidental oral administration): dryness of the skin and mucous membranes, hyperthermia, tachycardia, mydriasis, agitation, convulsions, coma, respiratory depression.

Treatment: gastric lavage, activated charcoal as an antidote – physostigmine (0.03 mg / kg by slow intravenous injection), benzodiazepines, to eliminate hyperthermia – a cold compress. For relief of systemic phenylephrine action – α-blockers (phentolamine 5-10 mg intravenously, if necessary, repeat injections).

Packaging:

Eye drops. 5 ml in a plastic vial-dropper with screw-on cap or a plastic vial, sealed with dropper-stopper, closed with the plastic screw-on cap with the control of the first opening. Each vial-dropper or a plastic vial, along with instructions for use is placed into unit carton.

Storage Conditions:

  • Store at temperatures below 25 °C in a dark place
  • Do not freeze. Keep out of reach of children.

Shelf Life:

  • 2 years
  • 1 month after opening the bottle
  • Do not use after expiration date printed on the packaging.