PILOCARPINE Eye drops Ref.[7850] Active ingredients: Pilocarpine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Martindale Pharmaceuticals Ltd, T/a Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG

Therapeutic indications

Pilocarpine is a direct acting miotic indicated for:

  • chronic simple glaucoma
  • acute (closed angle) glaucoma alone, or in conjunction with other agents to decrease intra-ocular pressure prior to surgical treatment
  • miosis – to counteract the effects of cycloplegic or mydriatic eye drops

Posology and method of administration

Posology

Adults and the elderly

a) In the treatment of open angle glaucoma, the dosage is one or two drops every six hours or as prescribed by the physician.

The strength of the preparation and the frequency of use are determined by the severity of the condition and the response to treatment.

b) When used prior to surgery for acute attacks of closed-angle glaucoma, the dosage is one drop every five minutes until miosis is obtained or as directed by the physician.

c) To overcome weaker mydriatics, the normal dosage is one drop every five minutes until the effect is counteracted or as directed by the physician.

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. Currently available data are described in section 5.1 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.

Method of administration

Eye drops for topical administration into the conjunctival sac.

Overdose

If pilocarpine is accidentally ingested, emesis should be induced or gastric lavage performed. The patient should be monitored for signs of pilocarpine toxicity such as increased salivation and sweating, lacrimation, nausea, vomiting and diarrhoea. If these occur, therapy with an anticholinergic such as atropine may be required.

Shelf life

24 months from manufacture.

28 days from first opening.

Special precautions for storage

Store upright below 25°C in a dry place away from strong light.

Nature and contents of container

Plastic tamper evident eye dropper bottle assembly. Pack size 10ml.

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should disposed of in accordance with local requirements.

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