Thursday, September 8, 2016

Minims Tropicamide 1% w / v





1. Name Of The Medicinal Product



Minims Tropicamide 1%.


2. Qualitative And Quantitative Composition



Clear, colourless, sterile eye drops containing Tropicamide Ph. Eur. 1% w/v.



3. Pharmaceutical Form



Single-use, sterile eye drops.



4. Clinical Particulars



4.1 Therapeutic Indications



As a topical mydriatic and cycloplegic.



4.2 Posology And Method Of Administration



Adults (including the elderly):



1 drop followed by a second drop after an interval of 5 minutes. A further 1 drop may be instilled after 30 minutes, if required.



Children:



At the discretion of the physician.



4.3 Contraindications



Do not use in patients with a known hypersensitivity to tropicamide.



Tropicamide is contraindicated in narrow angle glaucoma and in eyes where the filtration angle is narrow, as an acute attack of angle closure glaucoma may be precipitated.



4.4 Special Warnings And Precautions For Use



Use with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.



Care should be exercised in small children.



Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is no evidence as to the drug's safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. This product should only be used in pregnancy if considered essential by the physician



4.7 Effects On Ability To Drive And Use Machines



Patient warning: Patients who receive a mydriatic may suffer from photophobia and this may impair their ability to drive under certain circumstances.



4.8 Undesirable Effects



Transient stinging, dry mouth and blurred vision may occur following the use of this product.



4.9 Overdose



Systemic effects from Minims Tropicamide are not expected. Should an overdose occur causing local effects, e.g. sustained mydriasis, pilocarpine or 0.25% w/v physostigmine should be applied.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Tropicamide is a parasympatholytic agent, which acts by blocking the action of the parasympathetic nervous system. As acetylcholine is the neuro-humoral transmitter at the receptor site of the parasympathetic nervous system, tropicamide competes with acetylcholine for uptake at the receptor sites, thereby blocking its action. The results are mydriasis, due to unopposed action of the dilator pupillae, and cycloplegia.



5.2 Pharmacokinetic Properties



No data on the pharmacokinetics of topical tropicamide are available.



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



Sodium hydroxide



Hydrochloric acid



Purified water



6.2 Incompatibilities



None known.



6.3 Shelf Life



15 months.



6.4 Special Precautions For Storage



Store below 25ÂșC. Do not freeze. Protect from light.



6.5 Nature And Contents Of Container



A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.



6.6 Special Precautions For Disposal And Other Handling



Each Minims unit should be discarded after a single use.



7. Marketing Authorisation Holder



Chauvin Pharmaceuticals Ltd



106 London Road



Kingston-upon-Thames



Surrey



KT2 6TN



England



8. Marketing Authorisation Number(S)



PL 0033/0078



Legal category: POM



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of first Authorisation: 10.7.79



10. Date Of Revision Of The Text



September 2006




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