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, the active ingredient in Mydriasert, is a mydriatic agent presented as a sterile ophthalmic solution for ocular use. It, together with Tropicamide, produces rapid pupil dilation to facilitate diagnostic eye examinations in adults and children, and is used by ophthalmologists for routine fundus evaluation and pre‑operative assessment.

GNH India supplies Mydriasert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality and regulatory compliance across markets.

Manufacturer / TM Owner

Laboratoires Thea

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Indications & Clinical Uses

Mydriasert, a combination mydriatic ophthalmic solution, is used to induce pupil dilation for diagnostic eye examinations.

  • Diagnostic eye examinations: provides sufficient mydriasis for fundus photography, retinal imaging, and slit‑lamp evaluation.
  • Pre‑operative ocular assessment: facilitates intra‑ocular pressure measurement and surgical planning.
  • Glaucoma screening: allows thorough visualization of the optic nerve head.

How It Works

  • Phenylephrine hydrochloride acts as an alpha‑1 adrenergic receptor agonist, contracting the radial iris muscles, while tropicamide blocks muscarinic receptors in the sphincter pupillae, paralyzing it. The combined effect rapidly relaxes the iris sphincter and contracts the dilator muscle, producing sustained pupil dilation for ocular examination.

Side Effects

Mydriasert may cause ocular and systemic adverse reactions, most of which are mild and transient.

Common Side Effects

  • Transient ocular burning or stinging: mild discomfort upon instillation.
  • Conjunctival hyperemia: redness of the eye.
  • Temporary blurred vision: due to enlarged pupil.
  • Increased intra‑ocular pressure: especially in susceptible patients.

Serious or Rare Side Effects

  • Acute angle‑closure glaucoma: sudden severe eye pain and vision loss.
  • Systemic hypertension: elevated blood pressure after absorption.
  • Allergic reaction: swelling, itching, or rash around the eye.

Precautions & Warnings

Before using Mydriasert, consider the following precautions to minimize risk.

  • Assess intra‑ocular pressure: avoid use in patients with uncontrolled glaucoma.
  • Screen for cardiovascular disease: phenylephrine may raise systemic blood pressure.
  • Avoid in patients with hypersensitivity: discontinue if allergic signs appear.
  • Use with caution in children: pediatric response may differ.
  • Limit repeated dosing: excessive dilation can increase pressure.
  • Store at room temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Mydriasert can interact with other medications; be aware of the following.

Major Interactions (Avoid)

  • Systemic sympathomimetics (e.g., pseudoephedrine): may cause additive hypertension.
  • Monoamine oxidase inhibitors: increased risk of hypertensive crisis.
  • Topical beta‑blockers: may reduce mydriatic effect.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs (e.g., atropine): may enhance pupil dilation.
  • Oral antihypertensives: monitor blood pressure if systemic absorption occurs.

Frequently Asked Questions

Mydriasert is an ophthalmic solution that combines phenylephrine and tropicamide to produce rapid and sustained pupil dilation. It is primarily used to facilitate diagnostic eye examinations, such as fundus photography, retinal imaging, and slit‑lamp evaluation, by providing clear access to the interior structures of the eye.

Phenylephrine acts as an alpha‑1 adrenergic receptor agonist. By stimulating these receptors on the radial muscles of the iris, it causes contraction of the dilator muscle, leading to pupil enlargement. This effect works together with tropicamide’s antimuscarinic action to achieve full mydriasis.

The specific dosing regimen for Mydriasert is determined by the prescribing ophthalmologist based on the patient’s age, clinical need, and response. Typically, a single drop is instilled in each eye, but the exact amount and frequency should follow the prescriber’s instructions.

Safety data for Mydriasert during pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant. Healthcare providers should evaluate the individual situation and discuss alternatives when appropriate.

To order 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, confirming trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.

Mydriasert combines an alpha‑agonist (phenylephrine) with an antimuscarinic (tropicamide), offering both rapid onset and prolonged dilation. Single‑agent preparations may provide only one mechanism, potentially requiring higher concentrations or repeated dosing to achieve comparable mydriasis.

Mydriasert should be stored at room temperature, below 25 °C, in its original packaging. Protect the solution from light and moisture, and keep the container tightly closed when not in use to maintain sterility and potency.

Mydriasert is applied topically to the eye. The usual method is to instill one drop into the conjunctival sac of each eye, as directed by the ophthalmologist. The patient should avoid touching the dropper tip to any surface to preserve sterility.

The most serious risks include acute angle‑closure glaucoma, which can cause sudden severe eye pain and vision loss, and systemic hypertension due to phenylephrine absorption. An allergic reaction presenting as swelling, itching, or rash around the eye also requires immediate medical attention.

Mydriasert should be avoided in patients with known narrow‑angle or uncontrolled glaucoma, severe cardiovascular disease, uncontrolled hypertension, or a documented hypersensitivity to phenylephrine, tropicamide, or any excipients in the formulation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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