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 ophthalmic solution for ocular use. They produce pupil dilation to facilitate diagnostic eye examinations.

GNH India supplies Mydriasert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to EU GMP standards and providing reliable cold‑chain logistics where required. It meets the specifications set by the European Medicines Agency for ophthalmic preparations.

Manufacturer / TM Owner

Laboratoires Thea

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Indications & Clinical Uses

Mydriasert, a combination mydriatic agent, is used to achieve pupil dilation during ophthalmic examinations.

  • Diagnostic eye examinations: provides rapid and sustained pupil dilation to allow detailed fundus and retinal imaging.
  • Pre‑operative ocular procedures: facilitates adequate pupil opening for cataract extraction, laser iridotomy and other intra‑ocular surgeries.
  • Glaucoma assessment: enables accurate measurement of intra‑ocular pressure and optic nerve evaluation after dilation.
  • Retinal disease monitoring: dilates the pupil to improve visualization of macular lesions, diabetic retinopathy and vascular abnormalities.
  • Uveitis evaluation: allows thorough inspection of the anterior and posterior segments in inflammatory eye conditions.

How It Works

  • Phenylephrine hydrochloride acts as a selective α1‑adrenergic receptor agonist, contracting the radial iris dilator muscle, while tropicamide blocks muscarinic receptors on the sphincter pupillae, causing relaxation. The concurrent stimulation of dilation and inhibition of constriction produces rapid, synergistic mydriasis suitable for ophthalmic assessment. The effect appears within minutes and can last up to several hours, providing a stable window for detailed ocular imaging.

Side Effects

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

Common Side Effects

  • Transient ocular redness
  • Mild eye discomfort or stinging
  • Temporary blurred vision

Serious or Rare Side Effects

  • Acute angle‑closure glaucoma
  • Severe allergic reaction (anaphylaxis)
  • Persistent mydriasis

Precautions & Warnings

When using Mydriasert, clinicians should observe several precautions to minimize risk and ensure optimal efficacy.

  • Assess ocular history: verify absence of narrow-angle glaucoma before administration.
  • Monitor intra‑ocular pressure: check pressure before and after dilation in at‑risk patients.
  • Avoid use in patients with known hypersensitivity to phenylephrine, tropicamide or any excipients.
  • Limit exposure: use the minimal effective volume and avoid repeated dosing within 24 hours.
  • Store at room temperature: keep the solution below 25 °C in the original container, protected from light and moisture.

Avoid Interactions

Mydriasert can interact with other ophthalmic or systemic agents; awareness of these interactions helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Systemic α‑adrenergic agonists (e.g., pseudoephedrine) may exacerbate hypertension.
  • Anticholinergic drugs (e.g., atropine) can cause excessive mydriasis and cycloplegia.
  • Monoamine oxidase inhibitors: increased risk of hypertensive crisis when combined with phenylephrine.

Moderate Interactions (Monitor Closely)

  • Topical beta‑blockers: may mask phenylephrine‑induced tachycardia.
  • Carbonic anhydrase inhibitors: monitor intra‑ocular pressure changes.
  • Other mydriatic agents: avoid concurrent use to prevent over‑dilation.

Frequently Asked Questions

Mydriasert is a prescription ophthalmic solution containing phenylephrine hydrochloride and tropicamide. It is employed to produce rapid and sustained dilation of the pupil (mydriasis) to facilitate diagnostic eye examinations, pre‑operative ocular procedures, retinal imaging and other assessments that require an unobstructed view of intra‑ocular structures.

Phenylephrine hydrochloride is a selective α1‑adrenergic receptor agonist. When applied to the eye it stimulates the radial dilator muscle of the iris, causing contraction and pulling the pupil open. This adrenergic activation produces a prompt increase in pupil size, which is enhanced when combined with an anticholinergic agent such as tropicamide.

The exact dose of Mydriasert is determined by the prescribing ophthalmologist based on the patient’s age, ocular condition and the required degree of dilation. Typically a single drop (or the volume specified in the product labeling) is instilled in the conjunctival sac, and the prescriber may repeat the dose if additional dilation is needed. No universal dosing schedule is provided here.

Safety data for phenylephrine hydrochloride and tropicamide in pregnant or lactating women are limited. The product should only be used during pregnancy or breastfeeding if the potential benefit justifies any possible risk to the fetus or infant, and this decision must be made by the treating physician. Patients should discuss their individual situation with their healthcare provider.

To place an order, visit the product page on gnhindia.com, enter the required quantity of Mydriasert, and submit the enquiry form. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides a quotation that includes pricing, availability, shipping terms and any necessary import documentation.

Compared with single‑agent preparations such as phenylephrine alone or tropicamide alone, Mydriasert combines an α‑adrenergic agonist and an anticholinergic, delivering faster onset and longer‑lasting dilation. This synergistic effect often reduces the need for multiple drops and can improve patient comfort. However, the choice of agent depends on the clinical setting, desired duration of dilation and individual patient tolerance.

Mydriasert should be stored at room temperature, preferably below 25 °C, in its original container. The solution must be kept away from direct sunlight, excessive heat and moisture. Do not freeze the product. Once opened, follow any label‑specified beyond‑use date and discard any remaining solution that appears discolored or contaminated.

Mydriasert is applied topically to the eye. The prescriber directs the patient or healthcare professional to place the recommended number of drops into the conjunctival sac of the target eye(s). The eye should be gently closed for a few seconds to allow absorption, and the patient should avoid rubbing the eye. No systemic administration is involved.

The most serious adverse events include acute angle‑closure glaucoma, severe allergic reactions such as anaphylaxis, and persistent mydriasis that may impair vision. Systemic effects such as marked hypertension or cardiac arrhythmias can also occur, particularly in patients with cardiovascular disease or when combined with other sympathomimetic drugs. Prompt medical attention is required if any of these symptoms develop.

Mydriasert is contraindicated in individuals with known hypersensitivity to phenylephrine, tropicamide or any excipients in the formulation. It should also be avoided in patients with narrow‑angle or acute angle‑closure glaucoma, severe cardiovascular disease, uncontrolled hypertension, or those taking monoamine oxidase inhibitors. Use in children should be under strict medical supervision, and the drug should not be used without a prescription from a qualified ophthalmologist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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