Minims Metipranolol 0.1% w / v

1. Name Of The Medicinal Product

Minims Metipranolol 0.1%

2. Qualitative And Quantitative Composition

Clear, colourless, sterile eye drops containing Metipranolol 0.1% w/v.

3. Pharmaceutical Form

Sterile, single-use eye drops.

4. Clinical Particulars

4.1 Therapeutic Indications

Metipranolol is a beta-adrenoceptor blocking agent. Minims Metipranolol is an eyedrop for topical use which may be used for the treatment of raised intraocular pressure. It is particularly suitable for the treatment of patients who are hypersensitive to preservatives, for control of post operative increases of intraocular pressure and as an initial test for responsiveness to beta-blocker therapy.

4.2 Posology And Method Of Administration

Adults (including the Elderly)

One drop instilled into the affected eye twice daily. In the treatment of post operative rises in intraocular pressure the dosage and frequency should be at the discretion of the physician.

Children

Treatment should be at the discretion of the physician.

4.3 Contraindications

Minims Metipranolol should not be used in patients with bronchial asthma, history of bronchial asthma, chronic obstructive airways disease, sinus bradychardia, second or third degree atrio-ventricular block, cardiac failure, cardiogenic shock or hypersensitivity to any of the components of the preparation.

4.4 Special Warnings And Precautions For Use

Ophthalmic solutions should only be used in patients with contact lenses at the discretion of the physician.

The use of Minims Metipranolol in patients with chronic glaucoma should be restricted only to those patients who are allergic to the preservatives commonly used in multidose preparations, or those patients wearing soft contact lenses in whom benzalkonium chloride should be avoided.

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.)

As with other topically applied beta-blockers, systemic absorption may occur giving adverse reactions similar to those of orally admininstered beta-blockers.

Cardiac and respiratory reactions have been reported with topically applied beta-blockers including, rarely, death due to bronchospasm or cardiac failure.

Congestive cardiac failure should be adequately controlled before starting therapy with Minims Metipranolol. If the patient has a history of cardiac disease, pulse rate should be monitored.

Diabetic control should be monitored during Minims Metiprannolol therapy in patients with labile diabetes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Beta-blockers should not be given with verapamil and neither drug should be administered within several days of discontinuing the other. As absorption into the circulation is possible, Minims Metipranolol should be used only with caution in patients already receiving similar drugs by mouth. In particular care should be taken in patients with sinus bradycardia and greater than first degree heart block.

4.6 Pregnancy And Lactation

Although there is no evidence to suggest that metipranolol has teratogenic properties, its use in pregnancy should be avoided unless the potential benefits are considered to outweigh the possible hazards.

As β-blockers can pass into breast milk, consideration should be given to stopping breast feeding if Minims Metipranolol is considered necessary.

4.7 Effects On Ability To Drive And Use Machines

No such effects have been seen nor are anticipated.

4.8 Undesirable Effects

Granulomatous anterior uveitis has been reported in association with the use of the multidose preparation of Metipranolol (Glauline ) in patients with chronic glaucoma.

Transient burning or stinging on instillation, blurred vision and anterior uveitis have been reported.

Bradycardia and hypotension can occasionally occur following the systemic absorption of topically applied β-blockers.

Bronchospasm may occur, predominantly in patients with a history of reversible obstructive airways disease. Dyspnoea and respiratory failure have been reported with topically applied β-blockers.

Headache, ataxia, weakness and lethargy can occur.

Local manifestations of contact sensitivity can occur. Reactions around the eyes can involve skin rashes on the lower lids and cheeks and periorbital oedema.

4.9 Overdose

As Minims Metipranolol is a unit dose application, overdose is unlikely to occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Metipranolol is a beta-adrenoceptor blocking agent used to lower intraocular pressure. It has a non-selective action and hence will block both beta-1 and beta-2 receptor subtypes. There is no evidence to suggest that it possesses any intrinsic sympathomimetic activity. The resulting reduction in intraocular pressure is achieved primarily by a decrease in the production of aqueous humour.

5.2 Pharmacokinetic Properties

Following topical administration of 0.6% metipranolol no desacetyl metipranolol, the principle metabolite, could be detected in the plasma of volunteers at a detection limit of 1ng/ml.

There are sufficient clinical data on the efficacy of topical metipranolol to obviate the need for the measurement of ocular pharmacokinetics.

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

Hydrochloric acid BP

Sodium chloride PhEur

Sodium hydroxide

Purified water PhEur

6.2 Incompatibilities

Verapamil, as described in section 4.5.

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Store below 25°C. 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. Full instructions for use are provided on the enclosed leaflet.

7. Marketing Authorisation Holder

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

8. Marketing Authorisation Number(S)

PL 0033/0121

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first Authorisation: 16.12.87

Renewed on 08.07.1994

10. Date Of Revision Of The Text

January 1999

November 2001

November 2002