Product image of Mydriasert (Phenylephrine Hydrochloride, Tropicamide) supplied by GNH India

Mydriasert

Active Ingredient:
Phenylephrine Hydrochloride, Tropicamide
Origin:
EU

Mydriasert (Phenylephrine Hydrochloride, Tropicamide)

Phenylephrine Hydrochloride / Tropicamide, the active ingredients in Mydriasert, are mydriatic agents presented as a topical ophthalmic solution for ocular use. They facilitate rapid pupil dilation for diagnostic eye examinations and ocular surgery.
GNH India supplies Mydriasert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Manufacturer / TM Owner

Laboratoires Thea

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Indications & Clinical Uses

Mydriasert, a combination mydriatic eye drop, is employed to induce pupil dilation in ophthalmic examinations and procedures.

  • Diagnostic eye examinations: provides rapid and sufficient mydriasis for fundus evaluation.
  • Ocular surgery: facilitates adequate pupil dilation during cataract or intra‑ocular procedures.
  • Laser retinal therapy: enables proper exposure of retinal tissue for laser treatment.

How It Works

  • Phenylephrine hydrochloride acts as an alpha‑1 adrenergic agonist, contracting the iris dilator muscle, while tropicamide blocks muscarinic receptors in the iris sphincter muscle. The concurrent stimulation of the dilator and inhibition of the sphincter produce a swift and sustained enlargement of the pupil, improving ocular access for examination or surgery.

Side Effects

Mydriasert may cause ocular and systemic reactions following topical administration.

Common Side Effects

  • Transient blurred vision: temporary loss of visual clarity after instillation.
  • Photophobia: increased sensitivity to light due to pupil dilation.
  • Ocular irritation: mild burning or stinging sensation.
  • Conjunctival redness: mild hyperemia of the eye.
  • Elevated intra‑ocular pressure: short‑term rise in pressure, especially in glaucoma‑susceptible patients.
  • Allergic conjunctivitis: mild allergic response of the conjunctiva.

Serious or Rare Side Effects

  • Acute angle‑closure glaucoma: sudden, severe increase in intra‑ocular pressure.
  • Persistent mydriasis: prolonged pupil dilation beyond the expected duration.
  • Severe allergic reaction: anaphylaxis or angioedema.
  • Systemic hypertension: notable rise in blood pressure after absorption.
  • Cardiac arrhythmia: irregular heart rhythm in susceptible individuals.
  • Severe ocular inflammation: uveitis or keratitis.

Precautions & Warnings

Prior to using Mydriasert, consider the following safety measures.

  • Assess intra‑ocular pressure: measure IOP in patients with glaucoma risk.
  • Evaluate allergy history: avoid if hypersensitivity to phenylephrine, tropicamide, or excipients exists.
  • Use caution in cardiovascular disease: monitor blood pressure in patients with hypertension or coronary conditions.
  • Avoid in pediatric patients: limited safety data; use only under specialist supervision.
  • Consider systemic drug interactions: review concomitant adrenergic or anticholinergic agents.
  • Store at room temperature: keep in the original container, protect from light and moisture.

Avoid Interactions

Mydriasert can interact with other medications; awareness of the interaction level helps guide clinical decisions.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis.
  • Systemic sympathomimetics (e.g., epinephrine): additive cardiovascular effects.
  • Anticholinergic drugs (e.g., atropine): excessive mydriasis and systemic anticholinergic load.
  • Beta‑blockers: may mask tachycardia induced by phenylephrine.
  • Tricyclic antidepressants: increased risk of hypertension.

Moderate Interactions (Monitor Closely)

  • Topical ocular anesthetics: may enhance corneal toxicity.
  • Other mydriatics: cumulative pupil dilation.
  • Systemic antihypertensives: may blunt phenylephrine effect.
  • Antihistamines: increased anticholinergic side effects.
  • Diabetes medications: monitor blood glucose if systemic absorption occurs.

Frequently Asked Questions

Mydriasert is a combination ophthalmic solution containing phenylephrine hydrochloride and tropicamide. It is used to induce rapid pupil dilation (mydriasis) for diagnostic eye examinations, laser retinal procedures, and to facilitate intra‑ocular surgeries such as cataract extraction.

Phenylephrine hydrochloride is an alpha‑1 adrenergic agonist. When applied to the eye, it stimulates alpha‑1 receptors on the iris dilator muscle, causing the muscle to contract and pull the pupil open, contributing to the overall mydriatic effect.

The specific dosing regimen for Mydriasert is determined by the prescribing clinician based on the patient’s age, ocular condition, and procedural requirements. Typically, one or two drops are instilled in the conjunctival sac, but exact instructions must come from a qualified eye‑care professional.

Safety data for Mydriasert in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made by the treating physician in consultation with the patient.

To request Mydriasert, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Mydriasert combines an alpha‑adrenergic agonist (phenylephrine) with an antimuscarinic (tropicamide), offering a faster and more pronounced dilation than single‑agent drops such as phenylephrine alone or tropicamide alone. This dual mechanism can reduce the number of drops needed and shorten the time to achieve adequate mydriasis.

Mydriasert should be stored at room temperature, below 25 °C, in its original container. Protect the product from direct light and moisture to maintain stability and potency throughout its shelf life.

Mydriasert is applied topically to the eye. The prescribed number of drops is placed into the lower conjunctival sac of the target eye(s). The patient should be instructed to avoid touching the dropper tip to the ocular surface and to wash hands before and after administration.

Serious adverse events include acute angle‑closure glaucoma, persistent mydriasis, severe allergic reactions such as anaphylaxis, and systemic hypertension or cardiac arrhythmia. Patients should be monitored for sudden eye pain, visual loss, or systemic symptoms and seek immediate medical attention if they occur.

Mydriasert is contraindicated in individuals with known hypersensitivity to phenylephrine, tropicamide, or any formulation excipients. It should also be avoided in patients with narrow‑angle glaucoma, uncontrolled hypertension, severe cardiovascular disease, or in those where pupil dilation could compromise ocular health without specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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