MINIMS PILOCARPINE NITRATE

Adults (including the elderly) Instil dropwise into the eye according to the recommended dosage. To induce miosis, one or two drops should be used. In cases of emergency treatment of acute narrow-angle glaucoma, one drop should be used every five minutes until miosis is achieved.

Paediatric population Based on the infrequency of reports of adverse events in children, and the extensive experience of use of pilocarpine in childhood glaucoma, concentrations of up to 2% may be safely used in children. 1 but no recommendation on a posology can be made.

Treatment should be started with the lowest available dose and concentration in patients under 18 years of age. Depending on clinical response and tolerability, the dose may be increased up to the maximum recommended adult dosage of the 2% pilocarpine eye drop solution.

Directly after administration of any dose, the lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure.

Adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: 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).

System organ class Frequency Undesirable effect Eye disorders Not known Burning, itching, smarting, blurring Of vision, ciliary spasm, Conjunctival vascular congestion, induced myopia, sensitisation of the lids and conjunctiva, reduced visual acuity in poor illumination, lens changes with chronic use, increased papillary block, retinal detachments and vitreous haemorrhages.

Not known lacrimation Not known Browache and headache (especially in younger patients who have just started therapy). Nervous system disorders Not known Sweating, salivation Cardiac disorders Not known bradycardia Vascular disorders Not known hypotension Respiratory, thoracic and mediastinal disorders Not known pulmonary oedema, bronchial spasm Gastrointestinal disorders Not known nausea, vomiting and diarrhoea Reporting of suspected adverse reactions 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. uk/yellowcard

Systemic reactions rarely occur when treating chronic simple glaucoma at normal doses. However, in the treatment of acute closed-angle glaucoma the possibility of systemic reactions must be considered because of the higher doses given.

Caution is particularly advised in patients with acute heart failure, bronchial asthma, peptic ulceration, hypertension, urinary tract obstruction, Parkinson’s disease and corneal abrasions. Retinal detachments have been caused in susceptible individuals and those with pre- existing retinal disease, therefore, fundus examination is advised in all patients prior to the initiation of therapy.

Patients with chronic glaucoma on long-term pilocarpine therapy should have regular monitoring of intraocular pressure and visual fields. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for one minute during and following the instillation of the drops.

(This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. )

g. acute iritis, anterior uveitis and some forms of secondary glaucoma. Patients with soft contact lenses should not use this preparation. 1.