Latanoprost

There have been reports of paradoxical elevations in intraocular pressure (IOP) following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended.

There are limited study data on the use of latanoprost during the peri-operative period of cataract surgery. Latanoprost should be used with caution in these patients.

There is limited experience from patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience. Asthmatic patients should therefore be treated with caution until there is sufficient experience.

In patients with known predisposing risk factors for iritis/uveitis, latanoprost can be used with caution.

Latanoprost should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.

The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, latanoprost should not be used during pregnancy.

Latanoprost and its metabolites may pass into breast milk and should therefore not be used in breast-feeding women or breast feeding should be stopped.

Fertility

Latanoprost has not been found to have any effect on male or female fertility in animal studies.

Latanoprost has minor influence on the ability to drive and use machines. In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.

Summary of the safety profile

The majority of adverse reactions relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation. Other ocular adverse reactions are generally transient and occur on dose administration.

List of adverse reactions

Adverse reactions are categorized by frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Infections and infestations

Rare: Herpetic keratitis*§

Nervous system disorders

Uncommon: Headache*; dizziness*

Eye disorders

Very Common: Iris hyperpigmentation; mild to moderate conjunctival hyperaemia; eye irritation (burning grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes)

Common: Punctate keratitis, mostly without symptoms; blepharitis; eye pain; photophobia; conjunctivitis*

Uncommon: Eyelid oedema; dry eye; keratitis*; vision blurred; macular oedema including cystoid macular oedema*; uveitis*

Rare: Iritis*; corneal oedema*; corneal erosion; periorbital oedema; trichiasis*; distichiasis; iris cyst*§; localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids; pseudopemphigoid of ocular conjunctiva*§

Very Rare: Periorbital and lid changes resulting in deepening of the eyelid sulcus

Cardiac disorders

Uncommon: Angina; palpitations*

Very Rare: Angina unstable

Respiratory, thoracic and mediastinal disorders

Uncommon: Asthma*; dyspnoea*

Rare: Asthma exacerbation

Skin and subcutaneous tissue disorders

Uncommon: Rash

Rare: Pruritus

Musculoskeletal and connective tissue disorders

Uncommon: Myalgia*; arthralgia*

General disorders and administration site conditions

Uncommon: Chest pain*

* ADR identified post-marketing
^§ ADR frequency estimated using "The Rule of 3"

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Description of selected adverse reactions

No information is provided.

Paediatric population

In two short term clinical trials (≤12 weeks), involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified. The short-term safety profiles in the different paediatric subsets were also similar. Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.