Mydran

• Approved Indications:
• To induce mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation) for ophthalmic examinations and procedures.
• To provide local anesthesia of the ocular surface during diagnostic or minor surgical interventions such as tonometry, gonioscopy, cataract surgery, and laser procedures.
• Facilitation of retinal examination and intraocular surgeries by dilating the pupil and numbing the eye.
• Off-label Uses:
• Diagnostic aid for detailed retinal imaging.
• Temporary relief of ocular pain and discomfort during minor anterior segment procedures.

• Adults and Children (above 2 years):
• Instill 1–2 drops into the affected eye(s).
• Dose may be repeated every 5 to 15 minutes up to a maximum of three doses prior to procedure.
• Mydriasis typically occurs within 15–30 minutes; anesthesia develops within 30 to 60 seconds.
• Duration: Mydriasis lasts approximately 4–6 hours; anesthesia lasts about 10–20 minutes.
• Special Populations:
• Use cautiously in elderly and pediatric patients due to increased risk of systemic absorption.
• Avoid use in infants under 2 years unless under specialist supervision.
• Administration Notes:
• Remove contact lenses before administration and wait at least 15 minutes before reinsertion.
• Avoid contact between the dropper tip and the eye or any surface to prevent contamination.

• Tropicamide: Blocks muscarinic acetylcholine receptors in the iris sphincter and ciliary muscles, resulting in relaxation that causes pupil dilation and loss of accommodation.
• Phenylephrine: Acts as a selective α1-adrenergic receptor agonist, stimulating the dilator pupillae muscle to dilate the pupil via sympathetic pathways.
• Lidocaine: Acts as a sodium channel blocker, preventing nerve impulse transmission and producing local anesthesia on the ocular surface.

Together, this combination rapidly dilates the pupil while providing effective ocular surface anesthesia, optimizing conditions for examination or surgical procedures.

• Absorption: Minimal systemic absorption through conjunctiva; systemic effects are rare.
• Distribution: Primarily localized in ocular tissues.
• Metabolism:
• Phenylephrine undergoes hepatic metabolism mainly by monoamine oxidase.
• Lidocaine is metabolized hepatically via CYP enzymes.
• Tropicamide undergoes hepatic metabolism.
• Elimination: Metabolites excreted primarily in urine.
• Onset:
• Tropicamide and phenylephrine effects begin within 15–30 minutes.
• Lidocaine anesthesia occurs within 30–60 seconds.
• Duration:
• Mydriasis lasts 4–6 hours.
• Anesthetic effect lasts 10–20 minutes.

• Pregnancy:
• Limited human data; use only if benefits outweigh risks.
• Lactation:
• Unknown if excreted in human milk; caution is advised during breastfeeding.

• Combination of:
• Anticholinergic (Tropicamide)
• Sympathomimetic (Phenylephrine)
• Local anesthetic (Lidocaine)
• Primary use: Ophthalmic diagnostic agent and local anesthetic.

• Hypersensitivity to any component (tropicamide, phenylephrine, lidocaine) or excipients.
• Narrow-angle glaucoma or predisposition to angle-closure glaucoma.
• Severe cardiovascular disease or uncontrolled hypertension (due to phenylephrine).
• Infants under 2 years unless supervised by a specialist.

• Risk of increased intraocular pressure; avoid use in patients with narrow-angle glaucoma unless closely monitored.
• Phenylephrine can cause systemic cardiovascular effects such as hypertension, tachycardia, and arrhythmias; caution in patients with cardiovascular disease, hypertension, hyperthyroidism, or diabetes.
• Lidocaine may cause local allergic reactions or systemic toxicity if excessively absorbed.
• Avoid contamination of the dropper tip.
• Monitor for systemic signs of toxicity, especially in children and elderly.

• Ocular:
• Blurred vision, photophobia, ocular irritation, dryness, conjunctival hyperemia.
• Systemic (rare):
• Headache, dizziness, palpitations, hypertension, nervousness, nausea.
• Allergic reactions including rash or angioedema.
• Side effects are generally mild and transient.

• Additive hypertensive effects with other sympathomimetics.
• Potential additive anticholinergic effects with other anticholinergic drugs.
• Avoid concurrent use with monoamine oxidase inhibitors (MAOIs) due to hypertensive crisis risk from phenylephrine.
• Use cautiously with other topical anesthetics.

• Continued recommendation for combined mydriatic and anesthetic use in ophthalmic procedures.
• Emphasis on caution in glaucoma and cardiovascular patients.
• No recent major changes in indications or dosing.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep bottle tightly closed when not in use.
• Avoid freezing.
• Keep out of reach of children.