Genesis (triamcinolone acetonide) Topical Spray for Pets
Why has my veterinarian prescribed Genesis (triamcinolone acetonide) Topical Spray for Pets?
Triamcinolone acetonide is a corticosteroid, a type of medication prescribed to relieve inflamed areas of the body. This medicine may also be used to treat arthritic conditions and to decrease swelling, redness, itching, and allergic conditions. Your veterinarian may prescribe this medicine for other conditions.
How do I give Genesis (triamcinolone acetonide) Topical Spray for Pets?
First, READ THE LABEL CAREFULLY.
Give Triamcinolone Acetonide to your pet as directed by your veterinarian.
Try to give this medication at about the same time each day.
DO NOT give your pet more medicine than directed.
DO NOT give your pet medicine more often than prescribed.
Try not to miss giving any doses.
DO NOT stop giving your pet Triamcinolone Acetonide unless directed by your veterinarian. Plan ahead to ensure you have the refills you need.
If I miss a dose, what do I do?
If you miss a dose, give it to your pet as soon as possible. If it is almost time for the next dose, skip the missed dose, then continue with the regular dosing schedule. Do not give your pet two doses at once. Contact your veterinarian if you miss giving doses two or more days in a row.
How do I store Genesis (triamcinolone acetonide) Topical Spray for Pets?
Keep this medicine out of reach of children.
Store this medicine at room temperature in a dry, cool place. Keep this medicine away from heat and direct sunlight.
Do not store this medicine in damp places, in the bathroom, or near the kitchen sink. This medication can break down when exposed to moisture or heat.
What are the potential side effects of Genesis (triamcinolone acetonide) Topical Spray for Pets?
Other side effects may occur. If you notice anything unusual, contact your veterinarian.
What about possible drug interactions?
Be sure to tell your veterinarian about any other medications or supplements you are giving your pet.
It’s not uncommon for your veterinarian to prescribe two different medications, which may cause a drug interaction to occur. If this happens, your veterinarian may change the dose and/or monitor your pet more closely.
Triamcinolone Acetonide may interact with: triamcinolone acetonide: bacteriostatic antibiotics, amphotericin B, furosemide, thiazide diuretics, salicylates, phenytoin, phenobarbital, rifampin, insulin, cyclosporine, non-steroidal anti-inflammatory agents, estrogens, and mitotane.
Live attenuated-virus vaccines should generally not be given to animals receiving Triamcinolone Acetonide.
Contact your veterinarian if your pet experiences any unusual reactions when different medications are given together.
GENESIS® TOPICAL SPRAY
Virbac
Solution of 0.015% triamcinolone acetonide
NADA 141-210, Approved by FDA
FOR TOPICAL USE IN DOGS ONLY
CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
Genesis Topical Spray contains 0.015% triamcinolone acetonide for dermatologic use. Each mL of Genesis Topical Spray contains 0.15 mg triamcinolone acetonide in an aqueous solution containing propylene glycol, specially denatured alcohol, and DMDM hydantoin.
PHARMACOLOGY
Triamcinolone acetonide is a highly potent synthetic glucocorticoid, which is primarily effective because of its anti-inflammatory activity. Topical corticosteroids can be absorbed from normal intact skin. Studies have demonstrated that topical preparations of triamcinolone have decreased plasma cortisol levels and suppressed the response to ACTH.
INDICATIONS
Genesis Topical Spray is indicated for the control of pruritus associated with allergic dermatitis in dogs.
DOSAGE AND ADMINISTRATION
Apply sufficient pump sprays to uniformly and thoroughly wet the affected areas while avoiding run-off of excess product. Avoid getting the spray in dog's eyes. Genesis Topical Spray should be administered twice daily for seven days, once daily for the next seven days, then every other day for an additional 14 days (28 days total).
To avoid overdosing the product, use the following table to determine the maximum number of pump sprays per treatment application. For mild pruritus or for small treatment surface areas, the number of pumps used should be less than this maximum amount.
Table 1. Maximum allowable dosage
|
Dog weight |
Maximum number of pumps per single application* |
Total maximum volume (mL) per 28 day treatment regimen |
|
|
lb |
kg |
||
|
11 |
5 |
4 |
101 |
|
22 |
10 |
7 |
176 |
|
33 |
15 |
11 |
277 |
|
44 |
20 |
15 |
378 |
|
55 |
25 |
19 |
478 (one 16-oz bottle) |
|
66 |
30 |
22 |
554 |
|
77 |
35 |
26 |
655 |
|
88 |
40 |
30 |
756 |
|
99 |
45 |
33 |
832 |
|
110 |
50 |
37 |
932 (two 16-oz bottles) |
*Using the recommended dosing regimen, there are two applications per day for the first week, one application per day for the second week and one application every other day for the last two weeks of treatment.
WARNINGS
User Safety: Wear gloves when applying the product. Spray in a well ventilated area. If the spray causes irritation to mucous membranes, discontinue use. Keep this and all drugs out of reach of children.
Animal Safety: Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palates in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia, and anasarca.
PRECAUTIONS
The safety of this product for dogs less than eight pounds or for dogs less than one year of age has not been evaluated. The safety of this product in breeding, pregnant or lactating dogs has not been evaluated (see WARNINGS). The safety of long term or repeated use of this product (greater than 28 days) has not been evaluated. Prolonged use or overdosage of any corticosteroid may produce adverse effects. Because absorption of triamcinolone acetonide through topical application on the skin and by licking may occur, dogs receiving triamcinolone acetonide therapy should be observed closely for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression. When the product was applied at approximately 6 times the maximum allowable dose (100mL) once daily to normal skin of two dogs for five days, plasma cortisol levels were decreased after the first treatment and response to ACTH was reduced.
If adverse clinical signs are observed, treatment should be discontinued. Once the signs have disappeared, treatment can be resumed at a lower dose or frequency of application. If hypersensitivity to the product occurs, treatment should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
ADVERSE REACTIONS
In a field study with Genesis Topical Spray, polyuria was reported in 3 of 57 dogs (5.3%) and polyphagia in 1 of 57 dogs (1.8%). Mild (within reference range) decreases in total leukocyte, lymphocyte and eosinophil counts were also reported. The following local reactions were reported in ≤ 3.6% of 110 dogs treated with Genesis Topical Spray or the product vehicle: aversion/discomfort, sneezing and watery eyes.
EFFECTIVENESS
In a 28-day field study to demonstrate the effectiveness of Genesis Topical Spray in controlling pruritus associated with allergic dermatitis in dogs under field conditions, 105 dogs with atopy, unspecified allergic dermatitis, flea allergy, and food allergy were treated with Genesis Topical Spray at the recommended use level or placebo. Results are shown in Table 2.
Table 2. Percent of cases considered treatment successes
|
Treatment |
Percent success1 |
|
Genesis Topical Spray |
35/54 = 64.8%* |
|
Placebo |
12/51 = 23.5% |
1Success = reduction in the level of severity by two or more grades in the investigator's overall evaluation from the pre-treatment to the post-treatment evaluation period.
*Significantly different from placebo at p < 0.05
STORAGE CONDITIONS
Store at room temperature, 15°-30°C (59°-86°F).
HOW SUPPLIED
Genesis Topical Spray is supplied in 8 ounce (237 mL) and 16 ounce (478 mL) bottles with spray applicators.
For technical information or to report adverse reactions, please call (800) 338-3659.
Made in the USA.
Distributed by: Virbac AH, Inc., Fort Worth, TX 76137
U.S. Patent No. 6,300, 326
Genesis is a registered trademark of Virbac AH, Inc.
© 2005 Virbac AH, Inc. All rights reserved.
|
Net Contents: |
Product Code |
|
|
8 fl. oz. (237 mL) |
410508 |
T-3684-03, T-3684-05 Iss. 5-05, Rev. 02/05 (R03) 250201-01, 250203-01 |
|
16 fl. oz. (478 mL) |
410500 |
T-3684-05 Rev. 12/02 (R02) |
NAC No.: 10230871
Genesis® Topical Spray
Triamcinolone acetonide topical spray
Triamcinolone acetonide topical spray is a highly potent anti-inflammatory product effective for the control of itching that goes along with allergic dermatitis conditions (eg. flea allergy dermatitis) in dogs. Using this topical product can eliminate the need for steroid tablets and injections. Triamcinolone acetonide topical spray is available in easy-to-use 8 oz and 16 oz spray bottles.
- A highly potent topical glucocorticoid spray; a steroid
- Registered for use in dogs weighing at least 8 pounds and at least 1 year of age, available by prescription only from your veterinarian
- Used in dogs to control itching and inflammation associated with allergic skin conditions
- May also be used to treat other conditions, as directed by your veterinarian
- Breeding, pregnant or nursing animals
- Safety has not been determined for dogs less than 8 pounds, or for dogs less than 1 year of age
- Animals with serious bacterial, fungal or viral infections
- Animals with infections unless antimicrobial (antibiotics) therapy is also given
- If your animal has had an allergic reaction to Triamcinolone acetonide or other glucocorticoids
Read and follow your veterinarian’s directions exactly.
Apply enough spray to wet the affected area(s) but don’t spray so much that the product runs off.
A typical treatment regime looks like this: Apply Triamcinolone acetonide topical spray twice a day for 1 week, then once a day for another week, and then every other day for 2-4 weeks.
It is important to not overdose the product. Give the exact amount prescribed and only as often as directed. Ideally, give the medication at the same time daily.
If your pet has a dermatologic infection as well, an appropriate antifungal or antibiotic may have been prescribed as well.
Ensure your pet has fresh, clean drinking water at all times.
- When will your pet need to be rechecked
- What tests may need to be performed prior to and during treatment with this drug
- What are the risks and benefits of using this drug
- If your pet has experienced side-effects on other drugs/products
- If your pet has experienced digestive upset now or ever
- If your pet has experienced liver or kidney disease now or ever
- If your pet has experienced any other medical problems or allergies now or ever
- All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medicines can be given together.
- If your pet is pregnant or nursing or if you plan to breed your pet
Store in at room temperature away from heat and direct sunlight.
Avoid contact with the eyes.
Use in a well-ventilated area. Wear gloves during application, and wash your hands afterward.
If the spray causes irritation to mucous membranes, discontinue.
Do not use for more than 28 days.
Keep this and all medication out of reach of children and pets.
- Allergy symptoms to this medication include: facial swelling, hives, difficulty breathing, swelling of the lips, tongue or face. Discontinue treatment and contact your veterinarian immediately..
- May weaken your dog’s immune response and infection-fighting capabilities. Try to avoid sources of infection while undergoing Triamcinolone acetonide therapy.
- The safety of long term or repeated use of this product (greater than 28 days) has not been evaluated. Prolonged use/overdosage of any corticosterioid may produce adverse effects. Absorption of this drug through topical application and by licking may occur. If adverse clinical signs are seen, discontinue treatment. Usually treatment can be resumed at a lower dose or frequency of application once the signs have disappeared.
- Increased blood pressure; sudden weight gain
- Increased urination and hunger, discomfort, sneezing, watery eyes
- If you notice any of the above symptoms or anything else unusual, contact your veterinarian
- Yes, but possible interactions may occur with anti-seizure medications, some diuretics, insulin, NSAIDs or other steroids, or with over-the-counter or prescription products. Let your veterinarian know what products you give your animal.
- If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian.
Notify your veterinarian if your animal's condition does not improve or worsens despite this treatment.
As with all prescribed medicines, Triamcinolone acetonide topical spray should only be used on the pet for which it was prescribed. It should be used for the condition for which it was prescribed.
This is just a summary of information about Triamcinolone acetonide topical spray. If you have any questions or concerns about Triamcinolone acetonide topical spray or for the condition it was prescribed, contact your veterinarian.