Tropigen Plus0.8%+5%

Tropigen Plus is an ophthalmic combination indicated to induce mydriasis (pupil dilation) for:

• Diagnostic ophthalmic examination - dilated fundus examination, evaluation of the retina, optic nerve, and posterior segment of the eye (established, FDA-approved use).
• Pre-operative mydriasis - dilation of the pupil prior to intraocular surgical procedures such as cataract surgery.
• Short-term pupil dilation where rapid onset and adequate duration of mydriasis are required, combining the anticholinergic action of tropicamide with the alpha-adrenergic action of phenylephrine for a more complete and reliable dilation than either agent alone.

This combination is not intended for treatment of any disease; it is a diagnostic/procedural aid used under professional supervision.

Each mL of ophthalmic solution (or each metered spray, depending on formulation) contains Tropicamide and Phenylephrine Hydrochloride as the active ingredients, formulated as a sterile ophthalmic solution/spray for topical ocular use.

Tropigen Plus is a fixed-dose combination of two mydriatic agents used in ophthalmology. Tropicamide is a short-acting antimuscarinic (anticholinergic) agent that blocks the iris sphincter and ciliary muscle, while phenylephrine hydrochloride is a direct-acting alpha-1 adrenergic agonist that contracts the iris dilator muscle. Combining the two agents produces faster onset and more complete pupil dilation than either drug used alone, making Tropigen Plus a standard tool for diagnostic and pre-operative mydriasis.

Tropigen Plus belongs to the therapeutic class of ophthalmic mydriatic and cycloplegic agents, combining an anticholinergic mydriatic/cycloplegic (tropicamide) with an alpha-adrenergic mydriatic (phenylephrine hydrochloride).

Tropicamide + Phenylephrine Hydrochloride works through two complementary mechanisms:

• Tropicamide is a competitive antagonist at muscarinic acetylcholine receptors in the iris sphincter and ciliary body. By blocking the action of acetylcholine, it relaxes the iris sphincter muscle (producing mydriasis) and paralyzes the ciliary muscle (producing cycloplegia). Onset is rapid (within 15-30 minutes) with recovery generally within a few hours, which is why it is classed as a short-acting mydriatic.
• Phenylephrine hydrochloride is a direct-acting alpha-1 adrenergic receptor agonist that contracts the radial (dilator) muscle of the iris, producing mydriasis without significant cycloplegia.

The combined effect of Tropicamide + Phenylephrine Hydrochloride is faster, deeper, and more sustained pupil dilation suitable for fundus examination and pre-operative preparation.

For topical ophthalmic (eye) use only. Instill into the conjunctival sac; avoid touching the dropper/spray tip to the eye or surrounding tissue to prevent contamination. Apply punctal occlusion (gentle pressure at the inner corner of the eye) for 1-2 minutes after each dose to minimize systemic absorption, particularly important in infants, young children, and patients with cardiovascular disease.

Tropigen Plus has the following clinically significant interactions:

• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: may potentiate the pressor (blood pressure-raising) effect of the phenylephrine component; concurrent use should be approached with caution.
• Other sympathomimetic agents (systemic or ophthalmic): additive cardiovascular effects (increased heart rate, blood pressure) may occur with concurrent use.
• Other anticholinergic drugs (systemic or ophthalmic): additive anticholinergic effects (dry mouth, tachycardia, CNS disturbance) may occur with concurrent use of tropicamide with other antimuscarinic agents.
• Beta-blockers: concurrent use with phenylephrine may result in unopposed alpha-adrenergic effects, potentially causing significant hypertension.

Side effects of Tropigen Plus are generally local and transient but systemic effects can occur, particularly in infants and the elderly.

• Ocular (common): transient blurred vision, photophobia (light sensitivity), stinging or burning on instillation, transient elevation of intraocular pressure, superficial punctate keratitis, mild eye discomfort, and rebound miosis reported the day after use.
• Systemic (less common, more likely with repeated dosing or in susceptible patients): dry mouth, tachycardia, palpitations, elevated blood pressure, headache, dizziness, nausea, vomiting, pallor, and, particularly in children and the elderly, CNS disturbances (restlessness, confusion, behavioral changes).
• Rare: allergic/hypersensitivity reactions (eyelid swelling, conjunctival redness, contact dermatitis).

There are no adequate and well-controlled studies of Tropigen Plus in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under a physician's direction.

It is not known whether tropicamide or phenylephrine is excreted in human milk following ophthalmic administration. Caution should be exercised, and a physician should weigh the clinical need against potential risk, when Tropigen Plus is used in a breastfeeding woman.

Tropigen Plus should be used with the following precautions:

• Cardiovascular disease: use with caution in patients with hypertension, cardiac arrhythmias, or other cardiovascular disease, as the phenylephrine component can raise blood pressure and heart rate, especially with higher concentrations or repeated dosing.
• Elderly patients: increased sensitivity to anticholinergic and adrenergic effects; use the lowest effective dose.
• Infants and young children: higher risk of systemic absorption and associated cardiovascular and CNS effects; use only under direct medical supervision with the minimum number of applications, and use punctal occlusion to reduce systemic absorption.
• Angle-closure risk: assess the anterior chamber angle before use in patients with narrow angles; see Contraindications.
• Visual disturbance: temporary blurred vision and photophobia are expected during the dilation period; patients should be advised not to drive or operate hazardous machinery until vision returns to normal, and to wear sunglasses if light-sensitive.
• Hyperthyroidism: use with caution due to potential sensitivity to sympathomimetic effects of phenylephrine.

Systemic overdose of Tropigen Plus (e.g., from accidental ingestion or excessive/repeated ocular application, especially in infants) may cause a rapid rise in blood pressure, headache, tachycardia or arrhythmias, anxiety, tremor, nausea, and vomiting, as well as anticholinergic effects such as dry mouth, flushing, and CNS disturbance. If overdose or an unexpected systemic reaction is suspected, seek immediate medical attention or contact a poison control center/emergency services; do not attempt home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep the container tightly closed and out of reach of children. Discard any unused solution according to the product's labeled expiry after opening.

Pediatric: Use of Tropigen Plus in infants and young children requires caution because of a higher risk of systemic cardiovascular and CNS effects; use should be limited to the minimum number of doses necessary and administered under direct medical supervision, with punctal occlusion to limit systemic absorption.

Geriatric: No overall differences in effectiveness have been noted with age, but elderly patients may have greater sensitivity to both anticholinergic and adrenergic effects; caution is advised, particularly in those with cardiovascular disease.

Renal/Hepatic impairment: No specific dose adjustment has been established for ophthalmic use; systemic exposure is minimal with correct administration technique, but caution and physician judgment are advised.

Pregnancy and lactation: See Pregnancy and Lactation section.

Ophthalmic mydriatic agents: anticholinergic mydriatic/cycloplegic (tropicamide) combined with alpha-adrenergic mydriatic (phenylephrine hydrochloride).

Tropigen Plus may be used in pediatric patients, including infants, for diagnostic pupil dilation, but with caution because infants and young children are at greater risk of systemic absorption leading to cardiovascular effects (hypertension, tachycardia, arrhythmia) and CNS disturbances. Use in infants under 1 year should be limited to the minimum number of applications necessary and performed only under direct supervision of an ophthalmologist, with punctal occlusion technique to reduce systemic absorption. Safety and efficacy of frequent or repeated dosing in neonates and premature infants have not been well established, and such use should be approached with particular caution.