Optimmune Ophthalmic Ointment
Ointment For Dogs is indicated for management of chronic dry eye or keratoconjunctivitis sicca (KCS)
and chronic superficial keratitis (CSK). Optimmune is easy to administer and helps to quickly relieve eye irritation due to dry eyes. Optimmune Ointment contains cyclosporine which increases tear production. It is not a cure for dry eye, but rather an effective treatment.
Dosage and Administration: Remove
debris with suitable nonirritating solutions. Apply a 1/4 inch strip of ointment
to the affected eye(s) 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.
For best results in treating KCS, cyclosporine
ophthalmic ointment should be administered early in the course of the disease
before irreversible damage to the lacrimal tissue, or dense corneal scarring or
Dogs afflicted with KCS or CSK will most likely require
lifelong consistent therapy (see EFFICACY
section). 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.1
In cases refractory to cyclosporine, the diagnosis
should be re-evaluated and a different course of therapy considered. Periodic
reassessment of the need for OPTIMMUNE
Ophthalmic Ointment therapy is recommended.
Active Ingredient: Each gram of OPTIMMUNE
Ophthalmic Ointment contains 2 mg of cyclosporine.
MODE OF ACTION: When applied
ophthalmically, cyclosporine is believed to act as a local immunomodulator of
diseases suspected to be immune-mediated such as keratoconjunctivitis sicca
(KCS) and chronic superficial keratitis (CSK). In the management of KCS, the
mechanism by which cyclosporine causes an increase in lacrimation is poorly
understood. Clinical improvement in cases of KCS is not necessarily dependent on
an increase in aqueous tear production (as measured by the Schirmer Tear Test
PRECAUTIONS: The clinical effects of
OPTIMMUNE Ophthalmic Ointment have not been
determined in dogs with 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 which may lead to KCS can be either
transient (eg, facial nerve 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 (eg, 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 are of OPTIMMUNE Ophthalmic
Ointment are of sufficient magnitude such that a previously initiated therapy
can be safely withdrawn. Abrupt cessation of a therapeutic agent immediately
upon initiation of OPTIMMUNE Ophthalmic Ointment
therapy can result in rapid clinical relapse which may be erroneously
interpreted as an adverse reaction to the OPTIMMUNE
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.SAFETY: A target animal safety study
and clinical field studies with OPTIMMUNE
Ophthalmic Ointment showed a wide safety margin in adult dogs. In the 6-month
target animal safety study, dogs were subjected twice daily to up to 10 times
the approved concentration of OPTIMMUNE
Ophthalmic Ointment. No apparent toxicity or adverse reactions were observed.
Dogs in this study were vaccinated with commercially available vaccines. No
effect on antibody titer response was noted. Epiphora was noted in all groups,
including the placebo group, and was not associated with any inflammatory
change, nor was there any correlation to gross and histopathological changes.
ADVERSE REACTIONS: In the KCS
clinical field trial, there were 20 adverse reactions reported out of 132 cases
enrolled. This corresponds to an adverse reaction rate of 12.9% (13 of 101
cases) for OPTIMMUNE Ophthalmic Ointment treated
dogs and 22.6% (7 of 31) for placebo treated dogs. The reactions described were
primarily ocular and periocular inflammatory reactions. These were likely a
function of therapy being unable to fully control the keratoconjunctivitis,
rather than a true adverse reaction. Similarly, in the CSK trial, of 36 cases
evaluated for safety, adverse reactions were noted in 2 animals (5.6%). One
involved transient hyperemia, epiphora, and mild discomfort of the eye. The
other involved periocular/palpebral inflammation and mild alopecia.
On rare occasion, instillation of OPTIMMUNE Ophthalmic Ointment may be associated with local irritation as manifested by
periocular redness, lid spasm, and excessive rubbing. As the eyes of dogs with
KCS often demonstrate considerable inflammation, it will be difficult to
determine whether this local irritation constitutes a hypersensitivity to
OPTIMMUNE Ophthalmic Ointment. If this ocular
irritation persists beyond 7 days, hypersensitivity to a component of OPTIMMUNE
Ophthalmic Ointment should be suspected and therapeutic options reassessed.Storage: Store between 2°
and 30°C (36° and 86°F).
US Federal law restricts
this drug to use by or on the order of a licensed veterinarian
Keep out of reach of children
How Supplied: Optimmune 3.5g sterile ointment tube (NDC 0061-1088-01)
Intervet Schering-Pough Animal Health
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.