1. Name Of The Medicinal Product
Pilocarpine Hydrochloride Eye Drops 1% Solution
2. Qualitative And Quantitative Composition
1 ml of solution contains 10 mg pilocarpine hydrochloride
Excipients: benzalkonium chloride 0.1 mg (see section 4.4).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye Drops, Solution
Pilocarpine Hydrochloride Eye Drops is a slightly viscous, almost clear and colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
A directly acting miotic used for the treatment of glaucoma and to counter the effects of cycloplegic and mydriatic eye drops
Chronic Simple Glaucoma:
Patients may be maintained on pilocarpine as long as intraocular pressure is controlled and there is no deterioration in the visual fields.
Acute (Closed-Angle) Glaucoma:
Pilocarpine may be used alone or in conjunction with other agents to decrease intraocular pressure prior to surgical treatment.
4.2 Posology And Method Of Administration
One or two drops up to four times daily or as prescribed. The frequency of instillation and concentration of drops used are determined by the severity of the glaucoma and the response to treatment.
Do not touch dropper tip to any surface as this may contaminate the contents.
If the drop of medication is not retained in the eye upon dosing for any reason, instil another drop.
Use in the elderly
No dosage adjustment is required
Paediatric patients:
At the discretion of the physician. Safety and efficacy of use in children has not been established.
Hepatic/Renal Impairment
No special requirements
4.3 Contraindications
Conditions where pupillary constriction is undesirable, e.g. acute iritis, anterior uveitis and some forms of secondary glaucoma. Hypersensitivity to any component of the pilocarpine or to any of the excipients.
4.4 Special Warnings And Precautions For Use
For topical use only.
Although systemic reactions rarely occur in the treatment of chronic simple glaucoma with the doses used, 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, recent myocardial infarction, marked vagotonia, spastic GI conditions, severe bradycardia, hypotension, hyperthyroidism, epilepsy, bronchial asthma, peptic ulceration, hypertension, urinary tract obstruction and marked vasomotor instability or Parkinson's Disease. As with all miotics rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with pre-existing retinal disease, therefore, fundus examination is advised in all patients prior to the initiation of therapy.
Pilocarpine Hydrochloride Eye Drops contains the preservative benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact lens wear is not recommended. Contact lens wearers must remove their lenses prior to instillation of the drops and wait for 15 minutes after dosing before reinserting the contact lenses.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Although clinically not proven, the miotic effects of pilocarpine may be antagonised by long term topical or systemic corticosteroid therapy, systemic anticholinergics, antihistamines, pethidine, sympathomimetics, or tricyclic antidepressants. Concomitant administration of two different miotic drugs is not recommended because of potential interdrug antagonism, and potential development of unresponsiveness to both drugs.
Caution is advised in patients receiving halogenated inhalational anesthetics.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
4.6 Pregnancy And Lactation
Pregnancy:
There are no adequate clinical data from the use of this product in pregnant woman.
Pilocarpine Hydrochloride Eye Drops should not be used during pregnancy unless clearly necessary.
Lactation:
It is unknown whether Pilocarpine Hydrochloride Eye Drops is excreted in human breast milk. A decision on whether to continue/discontinue breast-feeding should be made taking into account the benefit of breast-feeding to the child and the benefit of Pilocarpine Hydrochloride Eye Drops to the woman.
4.7 Effects On Ability To Drive And Use Machines
Miotics cause difficulty with dark adaptation, therefore, caution is necessary with night driving and when hazardous tasks are undertaken in poor illumination. They may also cause accommodation spasm. Patients should be advised not to drive or use machinery if vision is not clear.
4.8 Undesirable Effects
The following undesirable effects are classified according to the following convention: very common (
Cardiac disorders
Rare: bradycardia
Nervous system disorders
Common: headache
Eye disorders
Very common: eye pruritus,
Common: eye pain, periorbital pain, myopia, photophobia, vision blurred, conjunctival hyperaemia.
Uncommon: retinal detachment
Not known: vitreous haemorrhage, angle closure glaucoma, ciliary muscle spasm, lenticular opacities, eye irritation, lacrimation increased.
Respiratory, thoracic and mediastinal disorders
Rare: bronchospasm
Not known: pulmonary oedema
Gastrointestinal disorders
Common: nausea
Rare: vomiting, diarrhoea, salivary hypersecretion
Skin and subcutaneous tissue disorders
Rare: hyperhidrosis
Vascular disorders
Rare: hypotension
4.9 Overdose
If accidentally ingested, induce emesis or perform gastric lavage. Observe for signs of toxicity (salivation, lacrimation, sweating, nausea, vomiting and diarrhoea). If these occur, therapy with anti-cholinergic agents, such as atropine, may be necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic Group: Antigluacoma Preparations & Miotics
ATC Code: S01E B01
Pilocarpine is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic neuro receptors and smooth muscle such as the iris and secretory glands. Pilocarpine produces miosis through contraction of the iris sphincter, causing increased tension on the scleral spur and opening of the trabecular mesh-work spaces to facilitate outflow of aqueous humour. Outflow resistance is thereby reduced, lowering intraocular pressure.
5.2 Pharmacokinetic Properties
Pilocarpine is able to cross the fat-water-fat corneal barrier thus good ocular penetration is actioned after topical instillation into the eye. In man, after administration of two drops of a 2% solution, concentrations in aqueous humour of 0.2% were found after 20 minutes.
Pilocarpine is hydrolysed by cholinesterase and excreted in the urine in combination with other substances.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Boric acid
Sodium Chloride
Sodium Citrate Dihydrate
Benzalkonium chloride
Hypromellose
Sodium hydroxide and/or Hydrochloric acid
Purified water
6.2 Incompatibilities
None known
6.3 Shelf Life
4 years (unopened), 4 weeks (after first opening).
6.4 Special Precautions For Storage
Do not store above 25°C.
Keep away from direct sunlight.
Do not refrigerate.
Keep container tightly closed.
6.5 Nature And Contents Of Container
10 ml natural low density polyethylene bottle and plug with polystyrene or polypropylene screw cap (DROP-TAINER®).
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
Cusi (UK) Ltd.,
Pentagon Park,
Boundary Way,
Hemel Hempstead,
Herts.,
HP2 7UD.
8. Marketing Authorisation Number(S)
PL 16020/0012
9. Date Of First Authorisation/Renewal Of The Authorisation
04/06/2009
10. Date Of Revision Of The Text
04/06/2009
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