INFORMATION FOR HEALTH PROFESSIONALS
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Clear, colourless, sterile eye drops containing Homatropine Hydrobromide PhEur 2% w/v.
Sterile, single-use eye drops.
To be used as a mydriatic and cycloplegic.
Adults and children
One drop applied topically to the eye, as required.
Instil dropwise into the eye according to the recommended dose.
Homatropine hydrobromide has properties similar to those of atropine and is often used in preference to the latter because its action is more rapid in onset and it has a less prolonged mydriatic action..
All mydriatics and cycloplegics are contraindicated in eyes where the filtration angle is narrow, as an acute attack of angle closure glaucoma may be precipitated.
Minims Homatropine Hydrobromide should not be used in patients who are hypersensitive to atropine, patients with myasthenia gravis or patients with tachycardia secondary to cardiac insufficiency or thyrotoxicosis.
Use with caution in patients with fever or in those who may be exposed to elevated environmental temperatures, as there is a risk of heat prostration and hyperthermia.
Minims Homatropine Hydrobromide should not be used during the first three months of life. The safety and efficacy of homatropine in children has not been established. Children with blond hair and blue eyes are more susceptible to the effects of homatropine.
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 the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
None stated.
Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.
None known.
Not applicable.
Homatropine is an anticholinergic agent which, like atropine, blocks the effects of the acetylcholine at post ganglionic parasympathetic receptor sites. Its effect on receptor sites in the smooth muscle of the ciliary body and sphincter pupillae result in paralysis of accommodation and mydriasis.
Since homatropine is a tertiary ammonium compound like atropine, it is likely to be readily absorbed from the conjunctival mucosa and rapidly distributed throughout the body. At physiological pH only 0.32% of homatropine is in the non-ionised form, which limits its corneal penetration. Very little is known about the distribution, metabolism and elimination of homatropine.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the data sheet.
Hydrochloric Acid
Purified Water
None known.
30 months.
Store at 2°-15°C. Do not freeze. Protect from light.
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.
Each Minims unit should be discarded after a single use.
Prescription medicine
Bausch & Lomb (NZ) Ltd
c/o New Zealand Medical & Scientific
2a Fisher Crescent
Mt Wellington
Auckland
NEW ZEALAND
Date of first Authorisation: 19.6.87.
4 October 2006