ATOPICA FOR CATS
Feline Allergic DermatitisNovartis ATOPICA for Cats is indicated for the control of feline
allergic dermatitis as manifested by excoriations (including facial and
neck), miliary dermatitis, eosinophilic plaques, and self-induced
alopecia. For cats at least 6 months of age and at least 3 lbs (1.4 kg) in
Dosage and Administration:
The initial dose of ATOPICA for Cats is 3.2 mg/lb/day (7
mg/kg/day) as a single daily dose for a minimum of 4 to 6 weeks or
until resolution of clinical signs. Following this initial daily
treatment period, the dose of ATOPICA for Cats may be tapered by
decreasing the frequency of dosing to every other day or twice weekly to
maintain the desired therapeutic effect. ATOPICA for Cats should be
administered directly on a small amount of food or orally just after
feeding. Whenever possible, ATOPICA for Cats should be administered on a
consistent schedule with regard to meals and time of day. If a dose is
missed, the next dose should be administered (without doubling) as soon
as possible, but dosing should be no more frequent than once daily.
The dispensing system includes an oral dosing syringe
graduated in 1 lb increments. To dose the cat, the syringe should be
filled to the nearest 1 lb corresponding to the cat's body weight (round
down if 0.1 to 0.4 lb, round up if 0.5 to 0.9 lb). Each pound
graduation on the syringe delivers a volume of 0.032 mL providing 3.2
mg/lb. Do not rinse or clean the oral dosing syringe between uses. (See Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats)
Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats
Assembling the Dispensing System
The dispensing system consists of 4 parts:
1. A bottle containing the medicine, with rubber stopper and a screw cap to close the bottle after use.
2. A plastic adapter with dip tube that you will push
into the neck of the bottle. The adapter must always remain in the
bottle after first use.
3. An oral dosing syringe that fits into the top of the
plastic adapter to withdraw the prescribed dose of medicine from the
4. A plastic vial containing the plastic adapter and
oral dosing syringe. Save the plastic vial to store the oral dosing
syringe between each use.
Fitting the Plastic Adapter into the New Bottle of Medicine
- Remove and save the screw cap.
- Remove and dispose of the rubber stopper.
- Hold the open bottle upright on a table and push the
plastic adapter firmly into the neck of the bottle as far as you can,
then close the bottle with the screw cap.
- To provide a child-resistant closure, push down on the child-resistant screw cap as you turn it.
Note: To prepare a dose, carefully follow the instructions for Preparing a Dose of Medicine.
Preparing a Dose of Medicine
1. Push and turn the child-resistant screw cap to open the bottle. Note: Always close the bottle with the child-resistant screw cap after use.
2. Check that the plunger of the oral dosing syringe is pushed all the way down.
3. Keep the bottle upright and insert the oral dosing syringe firmly into the plastic adapter.
4. Slowly pull the plunger up so that the oral dosing syringe fills with the medicine.
5. Expel any large bubbles by pushing
and pulling the plunger a few times. The presence of a few tiny bubbles
is not important for dosing accuracy.
6. Withdraw the dose of medicine prescribed by your
veterinarian. The scale on the oral dosing syringe corresponds to the
cat's body weight.
Note: If the prescribed dose is more
than the maximum volume marked on the oral dosing syringe, you will
need to reload the syringe to withdraw the full dose.
7. Remove the oral dosing syringe by gently twisting it out of the plastic adapter.
You can now place the oral dosing syringe over a small
amount of food or introduce the syringe in the mouth of your cat and
push the medicine out of the syringe. See Information for Cat Owners for complete administration instructions.
Do not rinse or clean the oral dosing syringe between uses. Store the oral dosing syringe in the plastic tube between each use.
ATOPICA for Cats should be stored in the original
container at room temperature between 59 and 77°F. Once opened, use
contents within two months for the 5 mL container and 11 weeks for the
17 mL container.
Close the bottle with the child-resistant screw cap after use.
Keep out of reach of children!
Always close the bottle with the
child-resistant screw cap after use. To provide a child-resistant
closure, push down on the child-resistant screw cap as you turn it.
Do not use in cats with a history of malignant disorders or suspected malignancy.
Do not use in cats infected with feline leukemia virus (FeLV) or feline immunodeficiency virus (FIV).
Do not use in cats with a hypersensitivity to cyclosporine.
ATOPICA for Cats is a systemic immunosuppressant that
may increase the susceptibility to infection and the development of
neoplasia. One of 205 field study cats died of the effusive form of
feline infectious peritonitis. (See Adverse Reactions)
Persistent, progressive weight loss that resulted in
hepatic lipidosis occurred in 2 of 205 cats on treatment with ATOPICA
for Cats in field studies. Monitoring of body weight is recommended.
(See Adverse Reactions)
Not for human use. Keep this and all drugs out of reach of children. For use only in cats.
Special precautions to be taken when administering ATOPICA for Cats:
Do not eat, drink, smoke, or use smokeless tobacco while handling ATOPICA for Cats.
Wash hands after administration.
In case of accidental ingestion, seek medical advice immediately and provide the package insert or the label to the physician.
People with known hypersensitivity to cyclosporine should avoid contact with ATOPICA for Cats.
The safety and effectiveness of ATOPICA for Cats has not
been established in cats less than 6 months of age or less than 3 lbs
(1.4 kg) body weight.
ATOPICA for Cats is not for use in breeding cats, pregnant or lactating queens.
Cats should be tested and found to be negative for FeLV and FIV infections before treatment.
As with any immunosuppressive regimen, exacerbation of
sub-clinical neoplastic and infectious conditions may occur. ATOPICA for
Cats is not for use with other immunosuppressive agents.
Cats that are seronegative for Toxoplasma gondii
may be at risk of developing clinical toxoplasmosis if they become
infected while under treatment, which can be fatal. In a controlled
laboratory study, cats seronegative for T. gondii were administered cyclosporine and subsequently infected with T. gondii, resulting in increased susceptibility to infection and subsequent expression of toxoplasmosis.
Cyclosporine did not increase T. gondii oocyst shedding (see Animal Safety). Potential exposure of seronegative cats to T. gondii should be avoided (e.g. keep indoors, avoid raw meat or scavenging).
In cases of clinical toxoplasmosis or other serious
systemic illness, stop treatment with cyclosporine and initiate
ATOPICA for Cats may cause elevated levels of serum
glucose, creatinine, and urea nitrogen. ATOPICA for Cats should be used
with caution in cases with diabetes mellitus or renal insufficiency.
ATOPICA for Cats should be used with caution with drugs
that affect the P-450 enzyme system. Simultaneous administration of
ATOPICA for Cats with drugs that suppress the P-450 enzyme system, such
as azoles (e.g. ketoconazole), may lead to increased plasma levels of
Treatment with ATOPICA for Cats may result in decreased
immune response to vaccination. Na�ve cats may not develop protective
titers during treatment (see Animal Safety).
The most commonly reported adverse reaction was
vomiting. In most cases, vomiting spontaneously resolved with continued
dosing. Adverse reactions occurred most often with daily dosing compared
to other dosing regimes.Information for Cat Owners:
Owners should be advised to discontinue ATOPICA for Cats
and contact their veterinarian in case of signs of serious illness
and/or persistent, progressive weight loss. Owners should be informed of
the risks of increased susceptibility to infection and the development
of neoplasia, and they should be provided advice on how to avoid
exposure of their cat to Toxoplasma gondii infection.
Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.
ATOPICA for Cats should only be dispensed in the
original container and stored at controlled room temperature between 59
and 77°F (15-25°C). Once opened, use contents within two months for the 5
mL container and 11 weeks for the 17 mL container.
ATOPICA for Cats (cyclosporine oral solution, USP)
MODIFIED is supplied in glass amber bottles of 5 and 17 mL at 100 mg/mL.
A dispensing system is included
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.