Optimmune (Canada)

Company: Merck Animal Health

Sterile Cyclosporine A Ophthalmic Ointment

DIN 02142155

Veterinary Use Only.

For Ophthalmic Use in Dogs Only.

Description

Each gram of OPTIMMUNE Ophthalmic Ointment contains 2 mg of cyclosporine A in a petrolatum/corn oil/lanolin base.

Optimmune Indications

OPTIMMUNE Ophthalmic Ointment is indicated for treatment of chronic idiopathic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. For KCS, response to therapy is characterized by a reduction in the severity of the ocular lesions associated with chronic conjunctival and corneal inflammation, with or without an increase in the Schirmer tear test value.

Dosage and Administration

Remove debris with suitable non-irritating solutions. Apply a 0.6 cm strip (1/4 inch) of ointment into the affected eye every 12 hours. The ointment may be placed directly on the cornea or into the conjunctival sac.

It is recommended that dogs exhibiting chronic recurring conjunctivitis be tested for adequate tear production to determine if they are suffering from early stages of chronic KCS.

Duration of therapy depends upon severity of the condition and the response obtained. Clinical experience with KCS suggests that over 90% of dogs will require life long therapy. For best results in treating keratoconjunctivitis sicca, cyclosporine A should be administered early in the course of the disease before irreversible damage to and fibrosis of the lacrimal tissue occurs.

For KCS, improvement in the Schirmer Tear Test is associated with a good prognosis if therapy is maintained.

Most of the dogs affected with KCS or CSK will most likely require life long consistent therapy. For CSK, because environmental factors such as ultraviolet (UV) radiation are implicated in the pathogenesis, clinical signs may subside in the winter months when light intensity is reduced or if the dog is moved to a lower altitude, or indoors, and thus exposed to less UV radiation.

In cases refractory to cyclosporine, the diagnosis should be reevaluated and a different course of therapy considered. Periodic reassessment of the need of OPTIMMUNE Ophthalmic Ointment therapy is recommended.

In order to properly assess response to treatment, it is recommended to test for tear production approximately 3 hours after a dose of OPTIMMUNE Ophthalmic Ointment, which corresponds to the time of peak cyclosporine concentration within the cornea.

Precautions

The clinical effects of OPTIMMUNE Ophthalmic Ointment have not been determined in dogs with keratoconjunctivitis sicca (KCS) due to the following conditions: congenital alacrima, sulfonamide usage, canine distemper virus, metabolic disease, surgical removal of the third eyelid gland, and facial nerve paralysis with loss of the palpebral reflex. Some of the underlying conditions for chronic idiopathic KCS may be either transient (i.e., facial trauma) or correctable with appropriate treatment. Consequently, recovery from clinical signs attributed to KCS may be observed and treatment options may need reconsideration.

When switching to cyclosporine from another therapeutic agent (e.g. frequent application of an artificial tear preparation) for KCS or CSK, it should be kept in mind that clinical efficacy is not necessarily apparent immediately after initiation of OPTIMMUNE Ophthalmic Ointment therapy. Several days to a few weeks may be required before the clinical effects of OPTIMMUNE Ophthalmic Ointment are of sufficient magnitude such that previously initiated therapy can be safely withdrawn. Abrupt cessation of a therapeutic agent immediately after the initiation of OPTIMMUNE Ophthalmic Ointment therapy can result in rapid clinical relapse which may be erroneously interpreted as an adverse reaction to OPTIMMUNE Ophthalmic Ointment.

The safety of OPTIMMUNE Ophthalmic Ointment has not been determined in cases of preexisting viral or fungal ocular infections. It is recommended that in such cases, OPTIMMUNE Ophthalmic Ointment therapy be delayed until the fungal/viral ocular infection has been successfully treated.

The safety of OPTIMMUNE Ophthalmic Ointment in puppies, pregnant bitches, or dogs used for breeding has not been determined.

On rare occasion, instillation of OPTIMMUNE Ophthalmic Ointment may be associated with stinging. As the eyes of dogs with chronic keratoconjunctivitis sicca (KCS) often demonstrate considerable inflammation, it will be difficult to determine whether this stinging constitutes a hypersensitivity to the drug or expected pain associated with the instillation of a foreign substance into a highly diseased eye. If this stinging persists beyond 7 days hypersensitivity to this drug should be suspected and therapeutic options reassessed.

No controlled study was conducted to investigate the interaction between this product and other topical drugs, notably corticosteroids.

TOXICOLOGY: Clinical and Safety Studies with OPTIMMUNE Ophthalmic Ointment have shown a wide safety margin at the recommended dose level in dogs. In a 6 month study in which dogs were subjected to up to 10 times the optimal concentration of OPTIMMUNE Ophthalmic Ointment, no adverse reaction nor alteration in the titer response to vaccination were seen.

Warnings

Not for human use. Keep out of reach of children.

Side Effects

During clinical studies, no significant side effects were reported.

STORAGE CONDITIONS: Store between 2° and 25°C.

How Supplied

OPTIMMUNE Ophthalmic Ointment is available in a 3.5 g tube.

Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866-683-7838

^® Merck Sharp & Dohme Corp. Used under license.

CPN: 1208066.7