nsient and occur on dose administration.
Adverse events are categorized by frequency as follows: very common (1/10), common (1/100, <1/10), uncommon (1/1000, <1/100), rare (1/10,0000, <1/1000) and very rare (<1/10,000). Not known (cannot be estimated from the available data).
Infections and Infestations:
Not known:
Herpetic keratitis
Eye Disorders:
Very common:
Increased iris pigmentation; mild to moderate conjunctival hyperaemia eye irritation (burning grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes (increased length, thickness, pigmentation and number) (vast majority of reports in Japanese population).
Common:
transient punctate epithelial erosions, mostly without symptoms; blepharitis; eye pain.
Uncommon:
Eyelid oedema: dry eye; keratitus; vision blurred; conjunctivitis.
Rare:
Iritis/uveitis (the majority of reports in patients with concomitant predisposing factors); macular oedema; symptomatic corneal oedema and erosions; periorbital oedema; misdirected eyelashes sometimes resulting in eye irritation; extra row of cilia at the aperture of the meibomian glands (distichiasis).
Not known:
iris cyst
Nervous System Disorders:
Not known: Headache, Dizziness.
Cardiac Disorders:
Very rare:
Aggravation of angina in patients with pre-existing disease.
Not known:
Palpitations.
Respiratory, Thoracic and Mediastinal Disorders:
Rare:
Asthma, asthma exacerbation and dyspnoea.
Skin and Subcutaneous Tissue Disorders:
Uncommon:
Skin rash.
Rare: Localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids.
Musculoskeletal and Connective Tissue Disorders:
Not known:
Myalgia; Arthralgia.
General Disorders and Administration Site Conditions:
Very rare: Chest pain.
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 (see section 5.1). Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.
4.9 Overdose
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if Xalatan is overdosed.
If Xalatan is accidentally ingested the following information may be useful: One bottle contains 125 micrograms latanoprost. More than 90% is metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and induced no symptoms, but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In monkeys, latanoprost has been infused intravenously in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Intravenous administration of latanoprost in monkeys has been associated with transient bronchoconstriction. However, in patients with moderate bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of Xalatan.
If overdosage with Xalatan occurs, treatment should be symptomatic.
5. PHAR |
