PILOCARPINE Eye drops (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pilocarpine Eye Drops 4.0% w/v.
Qualitative and quantitative composition
Excipient(s) with known effect: Pilocarpine Hydrochloride 40 mg/ml also contains Benzalkonium Chloride. For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye Drops.
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 ...
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 ...
Contraindications
Hypersensitivity to any component. Acute iritis Anterior uveitis Some forms of secondary glaucoma Soft contact lenses. Hypersensitivity to the active substances(s) or to any of the excipients listed in ...
Special warnings and precautions for use
Although rare, the possibility of systemic absorption should be considered especially in the treatment of acute closed-angle glaucoma where higher doses are administered. It should be used with caution ...
Interaction with other medicinal products and other forms of interaction
If systemic absorption occurs, pilocarpine may enhance the effects of alcohol and anticholinesterases and diminish the effects of anticholinergics. The effects of pilocarpine may be enhanced by anticholinesterases, ...
Pregnancy and lactation
Pregnancy Safety of pilocarpine for use during pregnancy has not been established. Ophthalmic pilocarpine may be systemically absorbed and mothers using the drug may give birth to infants with signs mimicking ...
Effects on ability to drive and use machines
The miotic effects of pilocarpine cause difficulty in adapting to the dark. Caution is therefore necessary if driving or operating machinery in poorly lit conditions. Pilocarpine impairs accommodation ...
Undesirable effects
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 ...
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, ...
Pharmacodynamic properties
Pharmacotherapeutic group: parasympathomimetics ATC code: S01EB01 Pilocarpine is an alkaloid of natural plant origin, which is a direct-acting cholinergic agonist. It acts primarily at muscarinic receptor ...
Pharmacokinetic properties
Onset of miosis after topical administration of a 1% solution of pilocarpine hydrochloride or nitrate to the conjunctival sac occurs within 10-30 minutes, with maximal effect within 30 minutes. Miosis ...
Preclinical safety data
None available.
List of excipients
Benzalkonium chloride solution BP Purified water BP
Incompatibilities
Soft contact lenses absorb water soluble compounds such as pilocarpine and its salts and the preservative benzalkonium chloride, and should therefore not be worn when administering pilocarpine eye drops. ...
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.
Marketing authorization holder
Martindale Pharmaceuticals Ltd, T/a Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG
Marketing authorization number(s)
PL 00156/0078
Date of first authorization / renewal of the authorization
6 June 1997
Date of revision of the text
04/2016
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