Optimmune Opthalmic Ointment is indicated for the treatment of chronic recurrent conjunctivitis resulting from auto-immune disease of the eye. Optimmune is indicated for the therapeutic treatment of keratoconjunctivitis sicca (KCS, `dry eye') and chronic superficial keratitis (`pannus').

Optimmune may be used to augment topical corticosteroids or as a substitute for corticosteroids when these are contraindicated by corneal ulceration

Company name: Intervet / Schering-Plough Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Telephone: 01908 665050 (Switchboard)

Fax: 01908 685555

Email: support.uk@intervet.com

Website: www.intervet.co.uk

Presentation

Optimmune is a white petrolatum based ointment for ophthalmic use, containing 0.2% w/w cyclosporin Ph. Eur.

Uses

Cyclosporin is an immunosuppressant with lacrimomimetic and anti-inflammatory properties.

In the dog, Optimmune is indicated for the treatment of chronic recurrent conjunctivitis resulting from auto-immune disease of the eye. Optimmune is indicated for the therapeutic treatment of keratoconjunctivitis sicca (KCS, `dry eye') and chronic superficial keratitis (`pannus').

Optimmune may be used to augment topical corticosteroids or as a substitute for corticosteroids when these are contraindicated by corneal ulceration.

Dosage and administration

For topical administration to the conjunctival sac.

Apply a small amount of ointment (approximately 1/4 inch or 1/2 cm) into the affected eye(s) every 12 hours.

Any excessive discharge in the eye should be removed prior to application of the ointment by gently cleansing or flushing the eye with a suitable non-irritating solution.

Duration of treatment

Clinical experience suggests that 90% of dogs affected with KCS will require life-long therapy. However, if therapy is maintained the prognosis is good providing that regular clinical assessment is carried out.

Current experience suggests that, in the treatment of `pannus', the frequency of application of Optimmune may be suspended or reduced during certain periods of the year when levels of ultraviolet light, which exacerbates this condition, are reduced.

Contra-indications, warnings, etc

Do not administer to pregnant bitches. Studies to demonstrate safety in pregnant bitches have not been conducted.

Mild irritation in the first few days of therapy has been seen. If such irritation persists, treatment should be discontinued.

Do not use where viral or fungal infection of the eye is suspected.

It is important that continuous treatment is maintained. Studies have shown that stimulation of tear production ceases within 24 hours of withdrawing treatment.

An increase in tear production is expected within 10 days but it may take up to 6 weeks for the full effect to be achieved.

Wear gloves when applying ointment. Avoid contact with skin. Wash hands after use.

For animal treatment only.

Keep out of the reach of children.

Pharmaceutical precautions

Store below 25°C.

Care should be taken to avoid contamination of the contents during use.

Replace cap between applications.

For external topical use only.

Any contents remaining one month after the date on which the container was first opened should be discarded. Empty tubes should be disposed of in the household refuse. Unused or part used product should be returned to a pharmacist for disposal in accordance with any guidance from an appropriate waste regulation authority.

Legal category

POM-V

Packaging Quantities

3.5 g tubes

Further information

Studies have shown that the cornea acts as a depot for cyclosporin, and that in ophthalmic use there is low systemic bioavailability.

A number of common eye conditions have been recognised to be immune-mediated. The majority of cases of recurrent conjunctivitis have been shown to result from inadequate tear production. A Schirmer Tear Test should be conducted in all cases of chronic conjunctivitis. Chronic superficial keratitis (`pannus') is sometimes associated with plasmacytic infiltration of the nictitans(`plasmoma'). Trials have shown this condition to be responsive to Optimmune therapy.

In treating KCS, most dogs will show a response, as demonstrated by Schirmer Tear Test, within 2 weeks. However, in a number of cases, the initial response may take up to 6 weeks.

Studies have demonstrated that long-term use of Optimmune does not increase susceptibility of the eye to microbial infection.

Marketing authorisation number

Vm 00201/4025.

(taken from www.noahcompendium.co.uk 11/11/09)