Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK
Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing ≤20 Kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence (see section 4.8).
Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease.
Some (12.7%) patients in clinical trials experienced an ocular allergic type reaction with Alphagan (see section 4.8 for details). If allergic reactions are observed, treatment with Alphagan should be discontinued.
Delayed ocular hypersensitivity reactions have been reported with ALPHAGAN 0.2%, with some reported to be associated with an increase in IOP.
Alphagan should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Alphagan has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
The preservative in Alphagan, benzalkonium chloride, may cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface. Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Patients should avoid contact with soft contact lenses.
Alphagan should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Alphagan is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenagic transmission (e.g. tricyclic antidepressants and miaserin), (see section 4.3).
Although specific drug interactions studies have not been conducted with Alphagan, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
No data on the level of circulating catecholamines after Alphagan administration are available. Caution, however, is advised in patients taking medications which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.
After the application of Alphagan, clinically insignificant decreases in blood pressure were noted in some patients. Caution is advised when using drugs such as antihypertensives and/or cardiac glycosides concomitantly with Alphagan.
Caution is advised when initiating (or changing the dose of) a concomitant systemic agent (irrespective of pharmaceutical form) which may interact with α-adrenergic agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin).
The safety of use during human pregnancy has not been established. In animal studies, brimonidine tartrate did not cause any teratogenic effects. In rabbits, brimonidine tartrate, at plasma levels higher than are achieved during therapy in humans, has been shown to cause increased preimplantation loss and postnatal growth reduction. Alphagan should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus. To reduce the systemic absorption, see section 4.2.
It is not known if brimonidine is excreted in human milk. The compound is excreted in the milk of the lactating rat. Alphagan should not be used by women nursing infants.
Alphagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Alphagan may cause blurred and/or abnormal vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. The patient should wait until these symptoms have cleared before driving or using machinery.
The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment.
Symptoms of ocular allergic reactions occurred in 12.7% of subjects (causing withdrawal in 11.5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: 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); Very rare (<1/10,000), not known (cannot be estimated from the available data).
Uncommon: systemic allergic reactions
Uncommon: depression
Very rare: insomnia
Very common: headache, drowsiness
Common: dizziness, abnormal taste
Very rare: syncope
Very common:
Common:
Very rare: iritis, miosis
Uncommon: palpitations/arrhythmias (including bradycardia and tachycardia)
Very rare: hypertension, hypotension
Common: upper respiratory symptoms
Uncommon: nasal dryness
Rare: dyspnoea
Very common: oral dryness
Common: gastrointestinal symptoms
Very common: fatigue
Common: asthenia
The following adverse reactions have been identified during post-marketing use of ALPHAGAN in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made
Not known:
Eye disorders:
Skin and subcutaneous tissue disorders:
In cases where brimonidine has been used as part of the medical treatment of congenital glaucoma, symptoms of brimonidine overdose such as loss of consciousness, lethargy, somnolence, hypotension, hypotonia, bradycardia, hypothermia, cyanosis, pallor, respiratory depression and apnoea have been reported in neonates and infants receiving brimonidine (see section 4.3).
In a 3-month, phase 3 study in children aged 2-7 years with glaucoma, inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with Alphagan as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%. The incidence of somnolence decreased with increasing age, being least in the 7-year-old age group (25%), but was more affected by weight, occurring more frequently in those children weighing ≤20 kg (63%) compared to those weighing >20 kg (25%) (see section 4.4).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
Not applicable.
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