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H1 antihistamine + mast cell stabiliser Pregnancy: SPC 4.6: Pregnancy - there are no or limited data from the use of ophthalmic olopatadine in pregnant women; animal studies have shown reproductive toxicity following systemic administration; olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding - animal data show excretion of olopatadine in milk following oral administration; a risk to the newborn/infant cannot be excluded and Opatanol should not be used during breast-feeding. Fertility - studies have not been performed to evaluate the effect of topical ocular administration of olopatadine on human fertility.

Olopatadine

Brand names: Opatanol, Patanase

Olopatadine is a topical antihistamine, available as eye drops and a nasal spray, used to relieve the symptoms of allergic conjunctivitis and allergic rhinitis.

Adult dose

Dose: Ocular signs and symptoms of seasonal allergic conjunctivitis (Opatanol 1 mg/ml eye drops, olopatadine as hydrochloride): one drop in the conjunctival sac of the affected eye(s) twice daily (8 hourly)
Route: Ocular (eye drops, conjunctival sac)
Frequency: Twice daily (8 hourly)
SOURCE: UK SPC for ONE product - Opatanol 1 mg/ml eye drops, solution (PLGB001011114, Novartis Pharmaceuticals UK Limited); 1 mL of solution contains 1 mg olopatadine (as hydrochloride). SPC 4.2 verbatim: 'The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary.' The SPC prints no separate maximum dose, so none is given; four months is a treatment duration, not a dose ceiling. SCOPE - OCULAR ROUTE ONLY: 4.1 licenses Opatanol only for 'Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis' and 4.2 says 'For ocular use only'. This page also lists a nasal route (nasal spray, brand Patanase); this SPC does not cover any intranasal olopatadine product, so no nasal dose is given and that product's regimen and indication differ. ELDERLY (4.2): no dosage adjustment necessary. METHOD (4.2): care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip; keep the bottle tightly closed when not in use; with other topical ocular medicines allow an interval of five minutes between successive applications and give eye ointments last. Remove soft contact lenses before instillation and wait at least 15 minutes before re-inserting (benzalkonium chloride 0.1 mg/ml discolours them). SOURCE LIMITS: text came from a PDF; section 4.8 was truncated at the source-fetch limit (after the tabulated reactions, inside the reporting boilerplate).

Paediatric dose

Dose: Aged 3 years and older: same dose as in adults - one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Safety and efficacy in children aged under 3 years have not been established; no data are available
Route: Ocular (eye drops, conjunctival sac)
Frequency: Twice daily (8 hourly)
THIS IS THE LABEL'S OWN STATEMENT, NOT A SCALED ADULT DOSE. SPC 4.2 verbatim: 'Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of Opatanol in children aged under 3 years has not been established. No data are available.' No dose is given for children under 3 years.

Dose adjustments

Renal

Opatanol has not been studied in patients with renal disease; no dosage adjustment is expected to be necessary in renal impairment (4.2, see 5.2).

Hepatic

Opatanol has not been studied in patients with hepatic disease; no dosage adjustment is expected to be necessary in hepatic impairment (4.2, see 5.2).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Side effects

  • Common: headache, dysgeusia, eye pain, eye irritation, dry eye, abnormal sensation in eyes, nasal dryness, fatigue
  • Uncommon: rhinitis, dizziness, hypoaesthesia, corneal erosion, corneal epithelium defect or disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, increased lacrimation, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia, contact dermatitis, skin burning sensation, dry skin
  • Not known: hypersensitivity, swelling of the face, somnolence, corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting, dyspnoea, sinusitis, nausea, vomiting, dermatitis, erythema, asthenia, malaise
  • Very rare: cases of corneal calcification have been reported in association with phosphate-containing eye drops in some patients with significantly damaged corneas
  • Approximately 4.5% of patients can be expected to experience adverse reactions; the most frequent treatment-related adverse reaction was eye pain (0.7%)

Interactions

  • No interaction studies with other medicinal products have been performed
  • In vitro, olopatadine did not inhibit metabolic reactions involving cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4, so metabolic interactions with other active substances are unlikely
  • With other topical ocular medicines allow an interval of five minutes between successive applications; give eye ointments last

Monitoring

  • Although administered topically, olopatadine is absorbed systemically - discontinue if signs of serious reactions or hypersensitivity occur (4.4)
  • Benzalkonium chloride may cause eye irritation and has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy - close monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised (4.4)
  • Remove soft contact lenses before instillation and wait at least 15 minutes before re-inserting them (4.4)

Clinical monograph

How it works

It is a selective histamine H1-receptor antagonist with mast cell stabilising activity, reducing the release and effects of histamine and other mediators of the allergic response.

Prescribing in practice

  • Ophthalmic preparations containing benzalkonium chloride should not be used while soft contact lenses are in place; lenses can be reinserted after a short interval.
  • Transient stinging, blurred vision or an unpleasant taste may occur after application.
  • It treats allergic symptoms and does not address the underlying allergen exposure.

Monitoring

No routine monitoring is required; review if allergic symptoms remain poorly controlled.

Counselling the patient

  • If you wear soft contact lenses, remove them before using the eye drops and wait before reinserting.
  • Brief stinging or blurring after use is common and usually settles quickly.
  • Avoid touching the dropper tip to the eye to prevent contamination.

Evidence & guidelines

Use is supported by its established role in topical treatment of allergic conjunctivitis and rhinitis; see current prescribing references.

Reference: BSACI; 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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