Atopica

Before using cyclosporine, tell your doctor about all of your medical conditions including:

• if you are allergic to cyclosporine, cyclosporine (modified), any other medications, or any of the inactive ingredients in cyclosporine or cyclosporine (modified) capsules or solution. Ask your pharmacist for a list of the inactive ingredients
• tell your doctor if you have or have ever had any of the conditions mentioned in the "Cyclosporine Precautions" section
• tell your doctor if you have low cholesterol, low levels of magnesium in your blood, any condition that makes it difficult for your body to absorb nutrients, or liver disease
• tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye
• if you are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not have vaccinations without talking to your doctor.

Oral:

Cyclosporine and cyclosporine (modified) both come as a capsule and a solution (liquid) to take by mouth. Cyclosporine is usually taken once a day. Cyclosporine (modified) is usually taken twice a day. It is important to take both types of cyclosporine on a regular schedule. Take cyclosporine or cyclosporine (modified) at the same time(s) each day, and allow the same amount of time between doses and meals every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cyclosporine or cyclosporine (modified) exactly as directed. Do not take more or less of the medication or take it more often than prescribed by your doctor.

You may notice an unusual smell when you open a blister card of cyclosporine capsules. This is normal and does not mean that the medication is damaged or unsafe to use.

Cyclosporine (modified) oral solution may gel or become lumpy if it is exposed to temperatures below 68 °F (20 °C). You can use the solution even if it has gelled, or you can turn the solution back to a liquid by allowing it to warm to room temperature (77 °F [25 °C]).

Cyclosporine and cyclosporine (modified) oral solution must be mixed with a liquid before use. Cyclosporine (modified) oral solution may be mixed with orange juice or apple juice but should not be mixed with milk. Cyclosporine oral solution may be mixed with milk, chocolate milk, or orange juice. You should choose one drink from the appropriate list and always mix your medication with that drink.

To take either type of oral solution, follow these steps:

• Fill a glass (not plastic) cup with the drink you have chosen.
• Remove the protective cover from the top of the dosing syringe that came with your medication.
• Place the tip of the syringe into the bottle of solution and pull back on the plunger to fill the syringe with the amount of solution your doctor has prescribed.
• Hold the syringe over the liquid in your glass and press down on the plunger to place the medication in the glass.
• Stir the mixture well.
• Drink all of the liquid in the glass right away.
• Pour a little more of the drink you have chosen into the glass, swirl the glass around to rinse, and drink the liquid.
• Dry the outside of the syringe with a clean towel and replace the protective cover. Do not wash the syringe with water. If you do need to wash the syringe, be sure that it is completely dry before you use it to measure another dose.

Injectable:

• This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
• Cyclosporine injection comes as a solution (liquid) to be injected over 2 to 6 hours into a vein, usually by a health care professional in a hospital or medical facility. It is usually given 4 to 12 hours before transplant surgery and once a day after the surgery until medication can be taken by mouth.
• A health care professional will watch you closely while you are receiving cyclosporine injection so that you can be treated quickly if you have a serious allergic reaction.

Ophthalmic:

• Cyclosporine eye drops are for use only in the eye(s). Do not swallow or apply cyclosporine eye drops to the skin.
• Use cyclosporine eye drops exactly as prescribed. One drop is instilled in each eye twice daily, with doses about 12 hours apart.
• cyclosporine eye drops come in single-use (one dose) vials. The liquid from one vial should be used immediately after opening. Do not save it for later use.
• If you are wearing contact lenses, remove them before instilling cyclosporine eye drops, and wait at least 15 minutes before putting them back in.
• if you are using artificial tears, instill them at least 15 minutes before or after you instill cyclosporine eye drops.

To instill the eye drops, follow these steps:

• Wash your hands thoroughly with soap and water.
• Mix by turning the vial over a few times until the liquid inside looks white and not see-through.
• Open the vial.
• Do not allow the dropper to touch your eye or any other surface.
• Tilt your head back, pull down the lower lid of your eye with your index finger to form a pocket.
• While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
• Close your eye for 2 to 3 minutes and tilt your head down, without blinking or squeezing eyelids.
• Apply gentle pressure on the tear duct with your finger.
• If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
• Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
• Throw away the vial out of the reach of children even if it is not empty.
• Wash your hands to remove any medication.

Atopica (cyclosporine capsules, USP) MODIFIED 

Atopica (cyclosporine capsules, USP) MODIFIED is indicated for the control of atopic

dermatitis in dogs.

Atopica is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs

body weight.

The initial daily dose of Atopica is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily

dose for 30 days. Following this initial daily treatment period, the dose of Atopica

may be tapered by decreasing the frequency of dosing to every other day or two

times a week, until a minimum frequency is reached which will maintain the desired

therapeutic effect. Atopica should be given at least one hour before or two hours

after a meal. 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.

Gastrointestinal problems and gingival hyperplasia may occur at the initial recommended

dose (See Animal Safety).

Atopica should be used with caution with drugs that affect the P-450 enzyme system.

Simultaneous administration of Atopica with drugs that suppress the P-450 enzyme

system, such as ketoconazole, may lead to increased plasma levels of cyclosporine.

The safety and effectiveness of Atopica has not been established in dogs less than 6

months of age or less than 4 lbs body weight. Atopica is not for use in breeding

dogs, pregnant or lactating bitches.

Since the effect of cyclosporine use on dogs with compromised renal function has not

been studied, Atopica should be used with caution in dogs with renal insufficiency.

There have been reports of convulsions in human adult and pediatric patients receiving

cyclosporine, particularly in combination with high dose methylprednisolone (See

Animal Safety).

Killed vaccines are recommended for dogs receiving Atopica because the impact of

cyclosporine on the immune response to modified live vaccines is unknown (See

Animal Safety).

As with any immunomodulation regimen, exacerbation of sub-clinical neoplastic conditions

may occur.

A multisite, placebo controlled, double masked, field study was conducted in the

United States and Canada using 16 investigators. Two hundred sixty five (265) dogs

aged 1-10 years, weighing 4-121 lbs received either Atopica capsules at 5 mg/kg/day

or placebo capsules. After 30 days, placebo dogs were switched to Atopica capsules.

Dogs were treated with Atopica capsules for a total of 4 months. No additional therapy

with antihistamines, corticosteroids or medicated shampoos was permitted.

Evaluations for pruritus and for skin lesions to derive a Canine Atopic Dermatitis Extent

and Severity Index (CADESI) score occurred at enrollment and at monthly intervals. One

hundred ninety-two (192) dogs were included in the statistical analysis of effectiveness.

At the end of the 30 day placebo controlled period, CADESI scores of dogs treated with

Atopica capsules improved by 45% from enrollment, while CADESI scores of dogs

treated with placebo worsened by 9%. Seventy-four (74)% of Atopica treated dogs

showed improvement in their pruritus scores over the first 30 day period, while only

24% of the placebo treated dogs showed an improvement. Owner and Veterinary

Global Assessment in response to treatment also demonstrated statistically significant

(p<0.0001) improvement. After 4 weeks of therapy, Owner and Veterinary Global

Assessments showed approximately twice as much improvement in the Atopica treated

dogs as compared to placebo treated dogs.

Improvements in pruritus accompanied by 50% or 75% improvements in CADESI

scores resulted in dose reductions to every other day or twice weekly respectively. Not

all dogs were able to decrease to twice weekly dosing. Some animals required upward

or downward dosage adjustments during the study. Such adjustments should be

expected during therapy of this disease. Dogs unable to decrease from once daily dosing

after 60 days were considered dose reduction failures for the purposes of the study.

The results of dose assignments, based on the study criteria, for each 4-week dosing

period, are shown in the graph below.

Analysis of blood levels of cyclosporine drawn during the study demonstrated no

correlation between blood cyclosporine levels and CADESI scores or pruritus; therefore

monitoring blood cyclosporine levels is not an appropriate predictor of effectiveness.

Package Label – 10 mg

Atopica (cyclosporine capsules, USP) MODIFIED

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

An immunosuppressant for use in dogs only. For dogs 4 to 9 pounds.

Net contents: 15 capsules, 10 mg cyclosporine each.

Product # 43511

NADA # 141-218, Approved by the FDA.