Product image of Mydrilate (Cyclopentolate Hydrochloride Bp) supplied by GNH India

Mydrilate

Active Ingredient:
Cyclopentolate Hydrochloride Bp
Origin:
EU

Mydrilate (Cyclopentolate Hydrochloride Bp)

Cyclopentolate hydrochloride, the active ingredient in Mydrilate, is an antimuscarinic (anticholinergic) presented as a 0.5% eye drops for ocular use. It produces pupil dilation and temporary paralysis of accommodation, facilitating diagnostic examination and surgical procedures in patients requiring ophthalmic evaluation.

GNH India supplies Mydrilate as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across EU and global markets. The product is manufactured under strict GMP standards and shipped in temperature‑controlled packaging to preserve stability.

Manufacturer / TM Owner

Esteve Pharmaceuticals Gmbh

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Indications & Clinical Uses

Cyclopentolate hydrochloride is a mydriatic/cycloplegic agent used in ophthalmology to achieve pupil dilation and temporary loss of accommodation.

  • Ophthalmic examination: provides mydriasis to allow thorough retinal and optic nerve evaluation.
  • Uveitis or iritis: induces cycloplegia to relieve ciliary spasm, reduce pain and prevent posterior synechiae.
  • Intraocular surgery: maintains pupil dilation and cycloplegia to facilitate safe intra‑operative access and manipulation.
  • Diagnostic laser procedures: ensures a stable, dilated pupil for laser photocoagulation or iridotomy.
  • Anterior segment imaging: stabilizes accommodation to improve accuracy of biometry and corneal topography.
  • Pediatric eye assessment: provides cycloplegia to facilitate accurate refraction in children.

How It Works

  • Cyclopentolate hydrochloride acts as a competitive antagonist at muscarinic acetylcholine receptors (primarily M1, M2 and M3) located in the iris sphincter muscle and the ciliary body. By blocking parasympathetic stimulation, it prevents constriction of the pupil and inhibits the ciliary muscle’s ability to accommodate, resulting in pharmacologic dilation (mydriasis) and paralysis of accommodation (cycloplegia). The effect appears within minutes after topical application and lasts several hours, providing a predictable window for ocular procedures.

Side Effects

Cyclopentolate eye drops may cause ocular and systemic adverse reactions, most of which are mild and transient.

Common Side Effects

  • Transient blurred vision: temporary loss of sharpness that resolves as the drug wears off.
  • Photophobia: increased sensitivity to light due to pupil dilation.
  • Mild ocular irritation or burning sensation: brief discomfort on instillation.
  • Redness of the conjunctiva: mild injection of the eye.

Serious or Rare Side Effects

  • Acute angle‑closure glaucoma: sudden rise in intra‑ocular pressure in predisposed eyes, requiring emergency treatment.
  • Severe allergic reaction (e.g., anaphylaxis, contact dermatitis): signs include swelling, rash, breathing difficulty.
  • Systemic anticholinergic toxicity (dry mouth, tachycardia, confusion): occurs with excessive absorption, especially in children.

Precautions & Warnings

Before using Cyclopentolate eye drops, consider the following precautions to minimize risks and ensure safe administration.

  • Assess intraocular pressure before use: avoid in patients with narrow‑angle glaucoma or uncontrolled IOP.
  • Screen for hypersensitivity: discontinue immediately if signs of allergic reaction appear.
  • Use with caution in children: systemic absorption is higher, monitor for anticholinergic effects.
  • Avoid concurrent use with other mydriatics or miotics: may lead to unpredictable pupil response.
  • Pregnancy and lactation: safety not established; prescribe only when clearly indicated.
  • Store at ambient temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Cyclopentolate may interact with other ophthalmic or systemic agents; awareness of these interactions helps prevent reduced efficacy or increased adverse effects.

Major Interactions (Avoid)

  • Other anticholinergic agents (e.g., atropine): additive mydriatic effect may cause excessive pupil dilation.
  • Miotic agents (e.g., pilocarpine): antagonistic action reduces cyclopentolate efficacy.

Moderate Interactions (Monitor Closely)

  • Topical beta‑blockers: may alter intraocular pressure dynamics when used together.
  • Systemic antihistamines or antidepressants with anticholinergic properties: increase overall anticholinergic load.
  • Intraocular corticosteroids: combined use can elevate intraocular pressure.

Frequently Asked Questions

Mydrilate contains cyclopentolate hydrochloride, a mydriatic and cycloplegic eye drop. It is used to dilate the pupil and temporarily paralyze accommodation, which helps clinicians perform detailed retinal examinations, treat inflammatory eye conditions such as uveitis, and provide a stable, enlarged pupil during intraocular surgeries.

Cyclopentolate hydrochloride blocks muscarinic acetylcholine receptors in the iris sphincter and ciliary body. By preventing parasympathetic stimulation, it stops the muscles that constrict the pupil and focus the lens, resulting in pharmacologic dilation (mydriasis) and loss of accommodation (cycloplegia).

The specific dosing regimen for Mydrilate is determined by the prescribing eye care professional. Typically, a single drop is instilled into the conjunctival sac of the affected eye, and the frequency or repeat dosing is adjusted based on the clinical need and patient response.

Safety data for cyclopentolate hydrochloride in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should be used only when clearly needed, and the prescriber should weigh potential benefits against possible risks.

To request Mydrilate, 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 temperature‑controlled requirements) and the necessary import documentation.

Mydrilate (cyclopentolate) provides both mydriasis and cycloplegia, whereas agents such as tropicamide mainly produce dilation with minimal cycloplegic effect. Cyclopentolate has a slightly longer duration of action than tropicamide, making it useful when prolonged accommodation paralysis is required, but it may also carry a higher risk of systemic anticholinergic side effects.

Mydrilate eye drops should be stored at ambient temperature, ideally below 25 °C, in the original container. Keep the bottle tightly closed, protect it from direct light and moisture, and discard any solution that appears discolored or has been opened beyond the recommended period after opening.

The recommended administration is to instill one drop of Mydrilate into the conjunctival sac of the target eye(s) using aseptic technique. The patient should be instructed to close the eye gently for a few seconds to allow even distribution and avoid blinking or wiping the eye immediately after application.

Serious adverse events include acute angle‑closure glaucoma, which presents with sudden eye pain, redness and visual loss, and requires emergency care. Severe allergic reactions such as anaphylaxis or contact dermatitis, as well as systemic anticholinergic toxicity (dry mouth, rapid heart rate, confusion), are also critical risks that need prompt medical attention.

Mydrilate should be avoided in patients with known narrow‑angle or acute angle‑closure glaucoma, hypersensitivity to cyclopentolate or any component of the formulation, and in individuals where pupil dilation could compromise visual function (e.g., certain retinal disorders). Caution is also advised for children and the elderly due to higher susceptibility to systemic effects.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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