Atopica Pet Medication Drug Information



Atopica Pet Medication Drug Information

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Category: animals

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1. Overview

What is Atopica?

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3. Precautions

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4. Misdose

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5. Drug Interactions

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6. Side Effects

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7. Storage

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Atopica Pet Medication Drug Information

Overview of Atopica

Atopica is a drug used to control atopic dermatitis (chronic skin allergies) in dogs. It works by targeting specific immune cells and restraining the allergic response that dogs may otherwise have to pollens, flea bites, dust mites, molds, grasses, and trees for example. In multi-site, double blind clinical studies, Atopica has significantly reduced itching and skin lesions in dogs.

Other symptoms that Atopica for dogs has treated effectively include hair loss, skin infections, dry eye, and a foul odor. Using Atopica is a way to control skin allergies in dogs without the long-term risks of using steroids. Additionally, feline asthma can be treated with Atopica for cats.

Atopica is a soft gelatin capsule, and must be prescribed by a licensed veterinarian. The active ingredient in Atopica is cyclosporine, which is an immune modulating agent, a potent immunosuppressant that suppresses T-helper and T-suppressor cells and inhibits interleukin-2. Chemically, cyclosporine is a cyclic polypeptide consisting of 11 amino acids. It is produced by the metabolic action of the white mold fungus Beauveria nivea. When taken as a drug, cyclosporine is metabolized mainly in the dog’s liver by the cytochrome P-450 enzyme system.

How to Use Atopica

Atopica is administered orally, once per day. Since Atopica is best absorbed with an empty stomach, the capsule(s) should be inserted directly into the dog’s mouth at least 2 hours before or after feeding. Sufficient drinking water should be available to the dog taking Atopica.

The initial daily dose is 5mg per kg of body weight, which is 2.3mg per lb., or at the recommendation of the prescribing veterinarian. Atopica for dogs is available in color-coded packing containing capsule strengths of 10mg, 25mg, 50mg, and Atopica 100mg. Initial dosages by dog weight are listed below:

4 to 6.5 lbs - Atopica 10 mg capsule

6.5 to 9 lbs - 2 x 10 mg capsules

9 to 16 lbs - Atopica 25 mg capsule

16 to 33 lbs - Atopica 50 mg capsule

33 to 64 lbs - Atopica 100 mg capsule

64 to 79 lbs - 100 mg capsule +50 mg capsule

79 to 121 lbs - 2 x 100 mg capsules

If the symptoms of atopic dermatitis have improved without serious side effects after taking the initial dosage each day for 30 days, the treatment frequency can be reduced to every 2nd or 3rd day until the desired level of benefit is maintained. If, however, after 8 weeks of using Atopica, the dog’s symptoms do not improve, treatment should be discontinued. The veterinarian can offer specific guidance.

Administering Atopica for cats may require many adjustments before the cat is able to absorb a dose that is effective to mitigate its symptoms.

Warnings and Precautions

Dogs should be at least 4 pounds in weight and at least 6 months in age before taking Atopica. Pregnant or lactating dogs should not take Atopica. Because the cyclosporine may increase the development of neoplasia, dogs with malignant neoplasia should not take Atopica.

Additionally, because Atopica targets immune cells to relieve the chronic skin allergies, the dog should have no bacterial and fungal infections prior to beginning treatment. The dog’s readiness for treatment should be verified by a complete clinical examination and the veterinarian may also schedule blood tests to help monitor any changes.

Pets on Atopica should not be vaccinated because the cyclosporine in Atopica is an immunosuppressant; it may increase the susceptibility to infection and to the disease being vaccinated against.

Atopica is not for human use.

Handling an Over Dosage or a Missed Dose

Atopica for dogs is not to be administered more than once per day, even if a daily dose has been inadvertently missed. If, however, an overdose is given, emergency veterinary medical treatment should be sought immediately.

Potential Drug Interactions

Known interactions includes those drugs that inhibit or induce the enzymes involved in the metabolism of cyclosporine. For instance, cytochrome P450-mediated interactions may require adjusting the Atopica dosage. In addition, the drug Ketoconazole is known to lead to an increased concentration of cyclosporine in the blood of dogs.

Many drug interactions could potentially decrease the effectiveness of either Atopica or the other medication being taken by your pet. They may also increase the side effects of Atopica. Be sure to tell the veterinarian all of the medications currently being taken by your pet.

Atopica Side Effects or Adverse Reactions

During clinical studies, vomiting and diarrhea were the most common side effects of Atopica. Other gastrointestinal disturbances such as mucoid, anorexia, or soft stool occurred as well. Because these side effects are generally mild and do not last long, the treatment using Atopica for dogs can continue. In many cases, the dog’s body adjusted to the medication diminishing these adverse reactions over time, while in other cases a brief interruption in treatment or adjustment in dosage reduced these side effects of Atopica.

Adverse reactions observed less frequently include: urinary tract infections, gingival enlargement, persistent otitis externa (ear inflammation), lymphadenopathy, papillomas (warts), footpad callusing, and ear flap swelling. Some of theses Atopica side effects also diminished with dosage adjustments.

While your pet is taking Atopica, all changes should be observed and monitored. The veterinarian should be called about any potential problem. A fever above 103°, tiredness, painful urination, coughing, or other cold symptoms could be early indications of dangerous reactions. Cyclosporine inhibits T-lymphocytes and may lead to increased potential of malignancy.

Proper Storage of Atopica

Atopica for dogs should be stored at room temperature and kept away from moisture and heat. Store the capsules at temperatures between 59F and 77F (15C - 25C). Do not freeze them and keep them out of the reach of children. Leave each capsule in its aluminum blister pack until ready to administer.

Atopica has a shelf life of 3 years.



About Atopica (Generic Name: Cyclosporine)

Itching isn’t comfortable for anyone, including your dog. Do what you can for your dog’s health.

Give him Atopica, a non-steroidal option for long term care of your dog’s canine dermatitis. Atopica is the best choice for your dog’s care, reducing itching by 45% and skin lesions by 67%.

Features/Use/Recommendation

Atopica targets the specific immune cells responsible for the dog’s allergic reactions, and avoids the use of steroids and their long-term risks to the entire immune system.

Manufacturer

Novartis

Directions

Atopica is for use on dogs of 4 lbs. and above. It is given in one daily oral dose for a month, and can be adjusted depending on the dog’s response until it often reaches a schedule of no more than every other day. The initial dose is based on the dog’s weight, according to the recommendation of a veterinarian.

Ingredients

Cyclosporine A

Side Effects

Atopica can have gastrointestinal side effects such as a simple upset stomach or loss of appetite, or even vomiting and diarrhea; many dogs adjust to the medicine and these symptoms fade. Papillomas (warts) may also occur initially when a dog is previously infected with the papilloma virus. Other reported side effects include callusing on the footpads, redness and swelling in the ear flaps, and gingival hyperplasia.

Pregnant or nursing female dogs should not use Atopica, nor should those with a history of malignant neoplasia.

Indications/Uses

Atopica is normally used for managing atopic dermatitis in dogs, which is an allergic skin condition caused by an array of allergens including pollens, molds and dust mites. In addition, Atopica is found to be effective in the treatment of Keratoconjunctivitis sicca (“dry eye”) in dogs, perineal fistulas, Immune-mediated Hemolytic Anemia, Discoid lupus erythemathosus. Feline Asthma can also be treated using Atopica.Atopica acts by targeting specific immune cells, which are responsible for the allergies thereby restraining these responses.

Precautions

Atopica should only be used in dogs that weigh at least 4 lbs. This medication is not recommended in pregnant or lactating dogs or those suffering from malignant neoplasia. While on Atopica treatment, dogs should not be vaccinated as there is a risk that an active infection of the disease vaccinated could be induced. Do not use Atopica in young dogs of less than 6 months of age or in small dogs or cats.

Side Effects

The common side effects of Atopica are gastrointestinal irritations along with gingival hyperplasia and papillomas. Other side effects include vomiting, diarrhea, otitis externa, urinary tract infections or anorexia. As cyclosporine inhibits T-lymphocytes, it might lead to increased incidences of clinically apparent malignancy, which calls for regular monitoring.

Dosage Information

Cyclosporine is available in soft gelatin capsules that are orally administered as a daily dose. Atopica is best given on an empty stomach – either 1 hour before a meal or 2 hours after a meal. If a dose is missed, do not give Atopica more than once in a day. If the dog responds positively to the treatment, the vet would reduce the dosage. Tablets are available in various strengths of 10 mg, 25mg, 50mg and 100mg. The normal dosage for dogs is 5mg/kg/day as a single daily dose for one month.



Atopica is an oral soft capsule for the treatment of skin allergies in dogs. Atopica specifically targets the immune cells involved in the allergic reaction and provides the following benefits. Atopica allows you to control your dog's problem without steroids. It is proven effective in the majority of problem dogs. It significantly reduces itching and skin lesions, and is safe to use over long periods without serious side effects. Administer just one dose a day to keep your dog in a control zone of comfort.

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Atopica is a soft capsule used to treat atopic dermatitis (commonly called skin allergies) in dogs. Signs of skin allergies include scratching, licking, gnawing, chewing, skin infections, hair loss, terrible odor, and sleepless nights. Atopica requires a prescription from your veterinarian.

For: Dogs (at least 6 months of age and weighing at least 4 pounds)

Benefits:

• Significantly reduces itching and skin lesions

• Proven effective in most dogs

• Allows you to control your dog’s problem without steroids

• Safe to use over long periods without the serious side effects usually associated with steroids

How it works:

Atopica targets the immune cells involved in the allergic reaction. You usually only administer one dose a day to control symptoms, but many dogs can be effectively controlled with every-other-day or twice-weekly dosing.

Cautions:

There are many possible drug interactions. Be sure to tell your veterinarian what other medications your pet is currently using. Give Atopica at least one hour before food or 2 hours after food.

More Information:

Brand Name

Atopica (Novartis)

Generic Name

Cyclosporine Modified capsule

What is the most important information I should know about Atopica: Notify your veterinarian immediately if your pet develops fever (over 103°), painful urination, tiredness, sneezing, coughing, or runny nose.These symptoms could be early signs of dangerous side effects.

What is Atopica: Atopica (cyclosporine modified) is an immunosuppressant available by prescription. Atopica is FDA approved for use in the treatment of atopic dermatitis in dogs at least 6 months of age and at least 4 pounds. Atopica is available in 15 capsule blister packs in strengths of 10mg for dogs 4 to 9 pounds, 25mg for dogs 9.1 to 16 pounds, 50mg for dogs16.1 to 33 pounds and 100mg for dogs 33.1 to 64 lbs. For dogs 64.1 to 79 pounds give a combination of one 100mg capsule and one 50mg capsule as a single dose. For dogs 79.1 to 121 pounds give two 100mg capsules as a single dose. Atopica is given once a day to start until satisfactory improvement is seen, usually 4 to 8 weeks. The medication can then be given every other day until the clinical signs of atopic dermatitis are satisfactorily controlled, then the medication can be given every 3 or 4 days.

What should I discuss with my veterinarian before giving Atopica: Tell your veterinarian if your pet has liver disease, kidney disease, cancer, high blood pressure, a viral, bacterial or fungal infection, or any other serious or chronic condition. Tell your veterinarian if your pet is pregnant or lactating, and if you plan to breed your pet.

How should this medication be given: Give Atopica exactly as directed by your veterinarian. If you do not understand these directions, ask your veterinarian or pharmacist to explain them to you. Always give Atopica 1 hour before or 2 hours after a meal. Allow plenty of water for the pet to drink. Do not remove a capsule from the blister pack until required for use. When the capsule is removed from the blister pack there is a characteristic, noticeable smell which is normal. Your veterinarian may want your pet to have regularly scheduled blood tests during treatment to monitor effectiveness and side effects. Store Atopica at room temperature away from moisture and heat.

What happens if I miss giving a dose: Give the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and give the next regularly scheduled dose. Do not give a double dose unless otherwise directed by your veterinarian.

What happens if I overdose the pet: Seek emergency veterinary medical treatment.

What should I avoid while giving Atopica to my pet: The safe use in breeding, pregnant or lactating dogs has not been determined. Do not use Atopica in dogs with known allergy to the medication. The drug should not be used in dogs with kidney disease, stomach ulcers, and certain blood disorders. Prolonged use of Atopica can result in bacterial or fungal infection related to a decreased effect of the immune system.

What are the possible side effects of Atopica: If any of the following serious side effects occur, stop giving Atopica and seek emergency veterinary medical attention; an allergic reaction (difficulty breathing, swelling of the lips, tongue or face, and hives). Other less serious side effects may occur. Continue giving Atopica and talk to your veterinarian if your pet develops vomiting, soft stools or diarrhea, muscle cramps, muscle weakness, loss of appetite, and change of hair coat. Other side effects may occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to the animal.

What other drugs will affect Atopica: There are many drug/drug interactions that occur when taking Atopica. Tell your veterinarian what medications your pet is currently using and any new products, including herbal remedies you may start to give. Drug/drug interactions could cause a decrease in effectiveness or an increase in side effects of either Atopica or the other medication being given. Examples of medications that may cause drug/drug interactions are; SMZ-TMP (Bactrim, Septra), gentamicin, etodolac (EtoGesic), piroxicam (Feldene), ketoconazole (Nizoral), cimetidine (Tagamet), ranitidine (Zantac), itraconoazole (Sporanox), methylprednisolone (Medrol), erythromycin, Allopurinol (Zyloprim), metoclopramide (Reglan), prednisOLOne, digoxin (Lanoxin), any type of vaccination.

HOW TO USE:

• Atopica (cyclosporine modified) is a prescription medication available as a soft capsule for use in the treatment of atopic dermatitis in dogs at least 6 months of age and weighing at least 4 pounds.

• Atopica is available in four strengths: 10mg, 25mg, 50mg, and 100mg.

Tip: Do not remove capsule from blister pack until required for use. When the capsule is removed from the blister pack there may be a characteristic, noticeable smell which is normal.

Dosage:

Pet Weight Dosage

Dogs (Over 6 months of age 4-6.5 lbs Give one 10mg capsule once a day for 30 days to start. (Following the initial daily treatment period, your veterinarian may recommend that the dose 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.)

6.6-9 lbs Give two 10mg capsules as a single dose once a day for 30 days to start.

9.1-16 lbs Give one 25mg capsule once a day for 30 days to start.

16.1-33 lbs Give one 50mg capsule once a day for 30 days to start.

33.1-64 lbs Give one 100mg capsule once a day for 30 days to start.

64.1-79 lbs Give one 100mg capsule AND one 50mg capsule as a single dose once a day for 30 days to start.

79.1-121 lbs Give two 100mg capsules as a single dose once a day for 30 days to start.

INGREDIENTS

Atopica Green for Dogs 4-9 lbs:

Active Ingredients Amount

Cyclosporine 10mg

Atopica Yellow for Dogs 9.1-16 lbs:

Active Ingredients Amount

Cyclosporine 25 mg

Atopica Purple for Dogs 16.1-33 lbs

Active Ingredients: Amount

Cyclosporine 50 mg

Atopica Blue for Dogs 33.1-64 lbs

Active Ingredients: Amount

Cyclosporine 100 mg

PRODUCT REVIEWS

Storage: Should be stored at room temperature. Keep away from pets and children.

Breed:: Vet's Review (Michael Dym, VMD)

"Product review"

When this product was first released several years ago, veterinarians got so excited in hearing all of the wonderful results for those frustrating skin allergy cases that deluge our clinics on a daily basis. And while it was often initially cost prohibitive for many clients, as we have learned to use this product more efficiently, and as the price has come down a bit, most of us have seen the outstanding clinical results with this great product. Inhalent/contact allergies(known as atopic skin disease) to molds, grasses, trees, dust mites, dander, ragweed and pollens, have been the most difficult skin cases to treat, with many clients returning to the clinics over and over again with increasingly larger bills, as we usually only temporarily alleviate the symptoms. Over the past several decades, general veterinary practitioners have often had to resort to antihistamines that are effective often up to only 20 percent of the time, or cortisone, which while highly effective in reducing allergy symptoms, often can have severe short and long term side effects. Now that we have atopica we truly have a safer alternative, other than referring clients to expensive dermatologists for skin and/or blood allergy testing, which often takes months of allergy vaccines to evaluate, and which only has a 65 to at most 70 percent improvement rate in these cases. In my hands I have had equal, if not more success to these allergy vaccines using atopica in these allergic pets, thus often saving clients expensive trips to veterinary dermatologists for extensive testing and repeated visits. While initially atopica is dosed daily for the first several weeks to a few months, we are then often able to decrease its use to once to three times weekly in many pets. This significantly cuts down on long term costs in managing this frustrating allergic skin condition. It is important for clients to realize that most of the experience and clinical data that has been generated with the main ingredient in this product called cyclosporine, has not been duplicated yet in cheaper generic alternatives, so it is important in my opinion to stick with the atopica brand name at this time. The only significant draw back I have seen with this product are the occasional nausea/upset stomach and vomiting seen in roughly 20 percent of treated pets. This can sometimes be overcome by actually giving it with a little food, or sometimes I will prescribe an anti nausea medicine such as pepcid or prescription metoclopromide to decrease the nausea before the atopica is given. To help cut down on the costs, we will sometimes get by with lower doses of atopica than listed on its packaging instructions , if we prescribe a drug called ketoconazole, which can increase blood levels of atopica at a lower dose. . Clients can talk to their veterinarians about using this prescription combination for this purpose. The only other major disadvantage I have seen with atopica is that with small dogs, the larger sized pill can sometimes be a problem in administering it to them, but hiding it in small amount of butter or peanut butter can often help it going down easier. Overall though, I highly recommend this product and give it an overall rating of 5, with an effectiveness of a 4, and an ease of use of a 3.

312 of 315 people found this review helpful.

Breed:: American Short Hair

"Medical Apps VERY different for cats"

One of our cats has had atoptic dermatitis for years due to allergies, and was on Prednisolone to alleviate it. Every time we would try to wean him off the meds, the dermatitis would make a comeback. We even reached a point where he had chewed his whole leg to the quick and developed three different bacterial infections. We decided the best course of action was to keep him on 1/2 pred a day ongoing. This worked for quite a while, but then he developed early stages of diabetes. We had an ultrasound done on his pancreas, which was normal, and found that the diabetes was entirely due to the medication. The Vet put him on a combination of pred and atopica, and it seemed to help the dermatitis, but aggravated the diabetes. We found that once on atopica, any other medication would counterindicate, and would actually render the atopica useless. The Vets also say that the absorption rate of atopica is 30 to 40% at best, so that also became a problem. Here are the difficulties we faced when trying to administer this medication to a cat: The pills, even the small ones, were too large to be able to pill the cat successfully, since they were initially designed for dogs. Therefore, we had to cut the pill open and mix it with food. This affected the absorption rate, as it is supposed to be given on an empty stomach. We then tried the modified, specially compounded with sardine oil, to administer by mouth. The modified DOES NOT WORK, it has to be the straight stuff. Cats metabolize medications differently than dogs, so the whole process of packaging and administering was a huge problem. We finally started to cut the pill open a few hours after the cat had eaten, would draw the contents out of the pill with a syringe, and give it directly to him by mouth. We feel that the absorption rate was the most effective, and it was easier to administer. We had to give him two 25 mg tabs a day for about a month, and went down to one when he started to vomit clear liquid in the AM when his stomach was empty. It is starting to clear his leg, much to our relief, as he can no longer be on the Pred due to the diabetes. We still get him checked for diabetes, and consider him to be in recession, and that it will always be a consideration. We would very much like to see the manufacturer package the liquid cyclosporine in sealed syringes, as that would be the most effect manner of administration. It is a good alternative to any medication with steriods, and should be tried first. The down side is the aborption rate due to the composition of the chemical itself. It has to be tried with the understanding that it is experimental, and may not work for all cats. But it's better than insulin!

Breed:: Chihuahua

"Atopica, Very Effective."

My 12-year+ chihuahua always had very sensitive skin and almost hairless. Her skin is very allergic and has been under shampoo and fatty acid treatment since she was born. One doctor prescribed Atopica to us. We were skeptic, because it is an expensive drug, and it was like "last resort". After a couple of weeks, her skin started to improve, clean up, and started growing hair!. Never in her life she had the very nice hair coat she has now!. Her skin is not sensitive anymore, and her behavior improved too. The medication makes her drink water very often, even at night. As of now, we have not seen any side effects. She had her blood lab work done and came out fine.

Breed:: Miniature Pinscher

"Great Product"

I was beginning to wonder what I was going to do as my dog Princess was scratching continuously and her ears and skin was crusting over and sore. I was told about Atopica and after being on it a couple of weeks her skin cleared up and she stopped itching. When it is allergy season she does scratch some but nothing like she did in the past and no sores or crusting. Thank you Atopica!

Breed:: Mini Schnauzer

"Atopica"

Atopica has been great! It has helped tremendously, no ear infections, no scratching of the ears causing hemotomas (sp) that required surgery, and much less licking of the paws. My dog has been on Atopica for approximately 4 years. The only thing is, Thank God I am working, otherwise I would never be able to afford this medicine....and Thank God that I have a small dog: 20 lbs, or again I would never be able to afford it. Even after all these years, I still need to give a daily dose, missing one day does not work for him. Something has to be done about the price; many people cannot afford it and revert to steroids which, as we all know, is a bad thing. I hope they come up with a generic as I will give it a try. Right now there are many things that I cannot afford because of the cost of this medicine... but it works, so I will continue to use it as long as I can do it.

Does Atopica come in 25 mgs?

Yes it does.

Gary, Dir. of Pharmacy Services

0

Is there an alternative medication that doesn't cost so much?

There is a generic Atopica. It is Cyclosporine Modified.

Gary, Dir. of Pharmacy Services

Putting Atopica in the freezer?

Q:

My dogs dermatologist said to put the Atopica in the freezer, and get each dose out as needed. I asked his IM doc too, and he said he also tells patients to do that.

In searching the internet, I occasionally see the same directions--but it's not in the insert.

Have u heard abt putting Atopica in the freezer?

A:

Atopica should be stored between 59 and 77 degrees F (controlled room temperature). Medications should always be stored according to manufacturer recommendations. Storing in a freezer may cause deterioration of this product.

Gary, Dir. of Pharmacy Services

do i need a presctiption from my veterinarian

Yes. Atopica requires a prescription.

ATOPICA (cyclosporine capsules, USP)

MODIFIED is indicated for the control of atopic

dermatitis in dogs.

Caution:

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

Keep this and all drugs out of reach of children.

Description:

ATOPICA (cyclosporine capsules, USP)

MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in ATOPICA, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species Beauveria nivea.

Chemically, cyclosporine A is designated [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-Nmethyl- L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L-〈-amino-butyryl-Nmethylglycyl- N-methyl-L-leucyl-L-valyl-Nmethyl-L-leucyl).

ATOPICA capsules contain cyclosporine formulated together with inactive ingredients.

ATOPICA is available in 10, 25, 50, and 100 mg capsule strengths in color-coded packaging for

oral administration to dogs.

Indications:

ATOPICA is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.

Dosage and Administration:

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.

Dose Administration

Dog weight (lbs) Dog body weight (kg) Dose 5 mg/kg

4 – 6.5 lbs 2 – 2.9 kg 10 mg capsule

6.6 – 9 lbs 3 – 3.9 kg 2 x 10 mg capsules

9.1 – 16 lbs 4 – 7.9 kg 25 mg capsule

16.1 – 33 lbs 8 – 14.9 kg 50 mg capsule

33.1 – 64 lbs 15 – 28.9 kg 100 mg capsule

64.1 – 79 lbs 29 – 35.9 kg 100 mg capsule +50 mg capsule

79.1 – 121 lbs 36 – 55.9 kg 2 x 100 mg capsules

Contraindications:

ATOPICA is contraindicated for use in dogs with a history of neoplasia.

WARNINGS:

ATOPICA (cyclosporine) is a potent systemic immunosuppressant that may increase the

susceptibility to infection and the development of neoplasia.

Human Warnings:

Not for human use. Keep this and all drugs out of reach of children. For use only in dogs.

Precautions:

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.

Effectiveness Field Study:

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 ................
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