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 and Tropicamide, the active ingredients in Mydriasert, are mydriatic agents presented as an ocular solution for ocular use. The formulation is indicated for diagnostic and surgical procedures where controlled mydriasis is essential, and it is approved for use in the European Union. They produce rapid pupil dilation and temporary paralysis of the ciliary muscle, facilitating detailed retinal examination and intra‑ocular surgical access in adult patients.

GNH India supplies Mydriasert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics, and research institutions worldwide, ensuring reliable quality and regulatory compliance for global ophthalmic care.

Manufacturer / TM Owner

Laboratoires Thea

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Indications & Clinical Uses

  • Mydriasert, a combination mydriatic ophthalmic solution, is used in ophthalmology to achieve pupil dilation.
  • Diagnostic eye examinations: provides rapid pupil dilation for thorough retinal evaluation.
  • Intra‑ocular surgery: facilitates adequate pupil size for surgical access.
  • Cycloplegic testing: temporarily paralyzes accommodation for accurate refraction assessment.

How It Works

  • Phenylephrine hydrochloride acts as an alpha‑1 adrenergic agonist, stimulating receptors on the radial iris dilator muscle to cause contraction and pupil opening. Tropicamide is a muscarinic antagonist that blocks receptors on the sphincter pupillae muscle, preventing constriction. Together they produce rapid mydriasis and cycloplegia by simultaneously activating dilator pathways and inhibiting constrictor pathways in the iris.

Side Effects

Mydriasert may cause ocular and systemic reactions after administration.

Common Side Effects

  • Transient eye burning or stinging sensation.
  • Redness of the conjunctiva.
  • Temporary blurred vision.
  • Mild increase in intra‑ocular pressure.
  • Light sensitivity.
  • Mild headache.

Serious or Rare Side Effects

  • Acute angle‑closure glaucoma.
  • Severe ocular pain or prolonged dilation.
  • Systemic hypertension or tachycardia.
  • Allergic reactions including rash or swelling.
  • Anaphylaxis.
  • Persistent cycloplegia beyond expected duration.

Precautions & Warnings

  • Before using Mydriasert, consider the following precautions.
  • Assess intra‑ocular pressure: avoid in patients with narrow‑angle glaucoma.
  • Monitor cardiovascular status: phenylephrine may raise blood pressure.
  • Avoid in children unless directed: safety data are limited.
  • Check for hypersensitivity: discontinue if allergic reaction occurs.
  • Store at room temperature: keep in the original container, protect from light and moisture.

Avoid Interactions

Mydriasert can interact with other medications; review patient medication lists.

Major Interactions (Avoid)

  • Systemic sympathomimetics: additive hypertensive effect.
  • Monoamine oxidase inhibitors: risk of hypertensive crisis.

Moderate Interactions (Monitor Closely)

  • Topical beta‑blockers: may mask phenylephrine‑induced tachycardia.
  • Anticholinergic drugs: enhanced cycloplegic effect.
  • Other mydriatics: increased risk of prolonged dilation.

Frequently Asked Questions

Mydriasert is a combination ophthalmic solution containing phenylephrine hydrochloride and tropicamide. It is used to induce rapid pupil dilation (mydriasis) and temporary paralysis of the ciliary muscle (cycloplegia) during eye examinations, diagnostic procedures, and intra‑ocular surgeries where a wide pupil is required. The effect facilitates thorough evaluation of the retina and easier surgical access.

Phenylephrine hydrochloride is an alpha‑1 adrenergic agonist. When applied to the eye, it stimulates alpha‑1 receptors on the radial iris dilator muscle, causing contraction of this muscle and pulling the pupil open. This action produces a prompt increase in pupil size, contributing to the overall mydriatic effect when combined with tropicamide.

The dosing regimen for Mydriasert is determined by the prescribing ophthalmologist based on the specific clinical need, patient age, and ocular condition. Typically, one or two drops are instilled in the conjunctival sac of each eye, and the interval between doses is guided by the desired degree of dilation and safety considerations.

Safety data for phenylephrine hydrochloride and tropicamide during pregnancy and lactation are limited. The product is classified as pregnancy category unknown, and use is generally avoided unless the potential benefit justifies the potential risk to the fetus. Breastfeeding mothers should consult their healthcare provider before using Mydriasert.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Mydriasert. GNH India supplies hospitals, pharmacies, and procurement teams worldwide and will request

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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