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Mydriatic combination Pregnancy: §4.6, verbatim — Pregnancy: 'There are no adequate data from the use of phenylephrine and tropicamide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonic/foetal development, parturition and postnatal development. Although animal studies have revealed no evidence of harm to the foetus, lidocaine crosses the placenta and should not be administered during pregnancy. Even though a negligible systemic uptake is expected, a low systemic exposure cannot be excluded. Therefore, Mydrane should not be used during pregnancy.' Breastfeeding: 'No data are available concerning the secretion of phenylephrine or tropicamide into breast milk. However, phenylephrine is poorly absorbed orally, implying that absorption by the infant would be negligible. On the other hand, infants may be very sensitive to anticholinergics, and despite the expected negligible systemic exposure, tropicamide is therefore not recommended during breast feeding. Small amounts of lidocaine are secreted into breast milk and there is a possibility of an allergic reaction in the infant. Therefore, Mydrane should not be used during breast feeding.' Fertility: 'There is no information on whether Mydrane may affect fertility in human males or females.'

Phenylephrine with tropicamide

Brand names: Mydrane

Phenylephrine with tropicamide is a combination mydriatic eye drop used to dilate the pupil for fundus examination and before intraocular procedures such as cataract surgery, combining a sympathomimetic dilator with a short-acting cycloplegic.

Adult dose

Dose: 0.2 ml of Mydrane — tropicamide 0.2 mg/ml with phenylephrine hydrochloride 3.1 mg/ml and lidocaine hydrochloride monohydrate 10 mg/ml — given as one injection at the start of the surgical procedure; one ampoule for single eye use
Route: Intracameral, administered by an ophthalmic surgeon. §4.2, verbatim: 'At the beginning of surgery, 0.2 ml of Mydrane is slowly injected in only one injection by an ophthalmic surgeon, via intracameral route, through the side port or principal port.' Also §4.2: 'Intracameral use. One ampoule for single eye use. Mydrane must be administered by an ophthalmic surgeon.'
Frequency: Single injection per eye, at the start of the cataract surgical procedure. §4.2: 'Slowly inject, by intracameral route, 0.2 ml of Mydrane in one injection, at the start of the surgical procedure.' Elderly: 'No dose adjustment is necessary.'
Max: 0.2 ml per eye. §4.4, verbatim: 'The recommended dose is 0.2 ml of Mydrane; no additional dose should be injected as no significant add-on effect has been demonstrated, and as increased endothelial cell loss was observed (see also section 4.9).'
SCOPE — the fetched SPC doses exactly this page's primary indication and route (intracameral mydriasis for cataract surgery), and nothing is withheld. COMPONENT QUANTIFICATION — the three strengths come from the SPC product title, 'Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection', read in the order §4.3 names the active substances: 'Hypersensitivity to the active substances (tropicamide, phenylephrine hydrochloride and lidocaine hydrochloride monohydrate)'. Note that this is a TRIPLE combination — it carries a third active, lidocaine, that the page name does not mention. PRE-CONDITION FOR USE, verbatim §4.2: 'Mydrane should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy.' PREPARATION STEP, verbatim §4.2: 'Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye.' NOT RECOMMENDED (§4.4): cataract surgery combined with vitrectomy, 'due to the vasoconstricting effects of phenylephrine'; and 'in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma' — in whom, together with insufficient pupil dilation, use 'can increase the risk of both iridocele and floppy iris syndrome'. NO CLINICAL EXPERIENCE (§4.4) in: insulin-dependent or uncontrolled diabetic patients; corneal disease, especially coexisting endothelial cell impairment; history of uveitis; pupillary abnormalities or ocular traumatism; very dark irides; cataract surgery combined with corneal transplantation; patients at risk of floppy iris syndrome ('Such patients should benefit of a step-by-step pupil dilation strategy starting with the administration of mydriatic eye drops'). Contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free.

Dose adjustments

Renal

No dose adjustment is necessary. §4.2, verbatim: 'Patients with renal impairment: Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary (see section 4.4).' §4.4 adds a caution rather than a dose change, for the lidocaine component: lidocaine 'should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute.'

Hepatic

No dose adjustment is necessary. §4.2, verbatim: 'Patients with hepatic impairment: Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances (tropicamide, phenylephrine hydrochloride and lidocaine hydrochloride monohydrate) or to any of the excipients listed in section 6.1 (§4.3)
  • Known hypersensitivity to anaesthetics of the amide type (§4.3)
  • Known hypersensitivity to atropine derivatives (§4.3)
  • Not a §4.3 contraindication but a §4.4 restriction worth reading alongside it: Mydrane 'is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma', and is not recommended for cataract surgery combined with vitrectomy

Side effects

  • Uncommon (≥1/1,000 to <1/100) — Headache (nervous system disorders)
  • Uncommon — Keratitis (eye disorders)
  • Uncommon — Cystoid macular oedema (eye disorders)
  • Uncommon — Intraocular pressure increased (eye disorders)
  • Uncommon — Posterior capsule rupture (eye disorders)
  • Uncommon — Ocular hyperaemia (eye disorders)
  • Uncommon — Hypertension (vascular disorders)
  • §4.8 context: 'Most were ocular and of mild to moderate intensity' and 'Posterior capsule rupture and cystoid macular oedema are well known complications occurring during or after cataract surgery. They may occur uncommonly (less than 1 case per 100 patients).'
  • §4.4 flags a risk not quantified in §4.8: 'Corneal endothelial toxicity has not been reported at the recommended dose of Mydrane; nevertheless, due to limited data, this risk cannot be excluded.'

Monitoring

  • Pre-operative confirmation of pupil dilation — §4.2 restricts use to 'patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy'
  • Intraocular pressure — 'Intraocular pressure increased' is an uncommon adverse reaction in §4.8
  • Corneal endothelium — §4.4: corneal endothelial toxicity 'has not been reported at the recommended dose' but 'due to limited data, this risk cannot be excluded'; §4.4 also records increased endothelial cell loss when more than 0.2 ml was injected
  • Blood pressure — hypertension is an uncommon adverse reaction (§4.8), and §4.4 notes phenylephrine 'has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders'
  • No laboratory monitoring is specified anywhere in the fetched sections

Clinical monograph

How it works

Phenylephrine is an alpha-adrenergic agonist that stimulates the iris dilator muscle, while tropicamide is an antimuscarinic that paralyses the sphincter pupillae and ciliary muscle, so together they produce rapid, effective mydriasis and some cycloplegia.

Prescribing in practice

  • The combination can precipitate acute angle-closure glaucoma in eyes with shallow anterior chambers, and phenylephrine can cause systemic cardiovascular effects, so use with caution in cardiovascular disease and in susceptible eyes.
  • Higher-strength phenylephrine carries greater systemic absorption risk and is generally avoided in infants, the elderly and those with significant hypertension or heart disease.
  • Warn patients that vision, particularly near focusing, will be blurred and that they should not drive until it recovers.

Monitoring

No laboratory monitoring is needed, but observe susceptible patients for systemic cardiovascular effects and for symptoms of acute angle closure after dilation.

Counselling the patient

  • Your vision will be blurred and your eyes light-sensitive for some hours, so arrange not to drive and bring sunglasses.
  • Seek urgent help if you develop a painful red eye with haloes around lights or nausea after dilation.
  • Punctal occlusion (pressing the inner corner of the eye) can reduce systemic absorption if advised.

Evidence & guidelines

Combined phenylephrine and tropicamide is standard practice for diagnostic and pre-operative mydriasis, with class cautions on angle closure and systemic sympathomimetic effects set out in the SPC.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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