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(selamectin) ® Topical Parasiticide For Dogs and Cats BRIEF SUMMARY: See package insert for full Prescribing Information. CAUTION: US Federal law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: Revolution is recommended for use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications: Dogs: Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Cteno cephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. Revolution also is indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) and for the control of tick infestations due to Derma centor variabilis. Cats: Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the preven tion and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Diro filaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. Revolution is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats. WARNINGS: Not for human use. Keep out of the reach of children. In humans, Revolution may be irritating to skin and eyes. Reactions such as hives, itching and skin redness have been reported in humans in rare instances. Individuals with known hypersensitivity to Revolution should use the product with caution or consult a health care professional. Revolution contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). Wash hands after use and wash off any product in contact with the skin immediately with soap and water. If contact with eyes occurs, then flush eyes copiously with water. In case of ingestion by a human, contact a physician immediately. The material safety data sheet (MSDS) provides more detailed occupational safety information. For a copy of the MSDS or to report adverse reactions attributable to exposure to this product, call 1-888-963-8471. Flammable - Keep away from heat, sparks, open flames or other sources of ignition. Do not use in sick, debilitated or underweight animals (see SAFETY). PRECAUTIONS: Prior to administration of Revolution, dogs should be tested for existing heart- worm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. Revolution is not effective against adult D. immitis and, while the number of circulating microfilariae may decrease following treatment, Revolution is not effective for microfilariae clearance. Hypersensitivity reactions have not been observed in dogs with patent heart- worm infections administered three times the recommended dose of Revolution. Higher doses were not tested. ADVERSE REACTIONS: Pre-approval clinical trials: Following treatment with Revolution, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed rarely (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors. Post-approval experience: In addition to the aforementioned clinical signs that were reported in pre- approval clinical trials, there have been reports of pruritus, urticaria, erythema, ataxia, fever, and rare reports of death. There have also been rare reports of seizures in dogs (see WARNINGS). SAFETY: Revolution has been tested safe in over 100 different pure and mixed breeds of healthy dogs and over 15 different pure and mixed breeds of healthy cats, including pregnant and lactating females, breeding males and females, puppies six weeks of age and older, kittens eight weeks of age and older, and avermectin- sensitive collies. A kitten, estimated to be 5–6 weeks old (0.3 kg), died 8 1 ⁄ 2 hours after receiving a single treatment of Revolution at the recommended dosage. The kitten displayed clinical signs which included muscle spasms, salivation and neurological signs. The kitten was a stray with an unknown history and was malnourished and underweight (see WARNINGS ). DOGS: In safety studies, Revolution was administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies, and no adverse reactions were observed. The safety of Revolution administered orally also was tested in case of accidental oral ingestion. Oral administration of Revolution at the recommended topical dose in 5- to 8-month-old beagles did not cause any adverse reactions. In a pre-clinical study selamectin was dosed orally to ivermectin-sensitive collies. Oral administration of 2.5, 10, and 15 mg/kg in this dose escalating study did not cause any adverse reactions; however, eight hours after receiving 5 mg/kg orally, one avermectin-sensitive collie became ataxic for several hours, but did not show any other adverse reactions after receiving subsequent doses of 10 and 15 mg/kg orally. In a topical safety study conducted with avermectin-sensitive collies at 1, 3 and 5 times the recommended dose of Revolution, salivation was observed in all treatment groups, including the vehicle control. Revolution also was administered at 3 times the recommended dose to heartworm infected dogs, and no adverse effects were observed. CATS: In safety studies, Revolution was applied at 1, 3, 5, and 10 times the recommended dose to six-week-old kittens. No adverse reactions were observed. The safety of Revolution administered orally also was tested in case of accidental oral ingestion. Oral administration of the recommended topical dose of Revolution to cats caused salivation and intermittent vomiting. Revolution also was applied at 4 times the recommended dose to patent heartworm infected cats, and no adverse reactions were observed. In well-controlled clinical studies, Revolution was used safely in animals receiv- ing other frequently used veterinary products such as vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos and dips. STORAGE CONDITIONS: Store below 30°C (86°F). HOW SUPPLIED: Available in eight separate dose strengths for dogs and cats of different weights (see DOSAGE). Revolution for puppies and kittens is available in cartons containing 3 single dose tubes. Revolution for cats and dogs is available in cartons containing 3 or 6 single dose tubes. NADA 141-152, Approved by FDA Distributed by: Zoetis Inc. Kalamazoo, MI 49007 www.revolutionpet.com 10309505A&P; Caution Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Indications SENTINEL ® SPECTRUM ® (milbemycin oxime/lufenuron/praziquantel) is indicated for the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older. Dosage and Administration SENTINEL SPECTRUM should be administered orally, once every month, at the minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime, 4.55 mg/lb (10 mg/kg) lufenuron, and 2.28 mg/lb (5 mg/kg) praziquantel. For heartworm prevention, give once monthly for at least 6 months after exposure to mosquitoes. Dosage Schedule Body Weight Milbemycin Oxime per chewable Lufenuron per chewable Praziquantel per chewable Number of chewables 2 to 8 lbs. 2.3 mg 46 mg 22.8 mg One 8.1 to 25 lbs. 5.75 mg 115 mg 57 mg One 25.1 to 50 lbs. 11.5 mg 230 mg 114 mg One 50.1 to 100 lbs. 23.0 mg 460 mg 228 mg One Over 100 lbs. Administer the appropriate combination of chewables To ensure adequate absorption, always administer SENTINEL SPECTRUM to dogs immediately after or in conjunction with a normal meal. SENTINEL SPECTRUM may be offered to the dog by hand or added to a small amount of dog food. The chewables should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewables may be broken into pieces and fed to dogs that normally swallow treats whole. Care should be taken that the dog consumes the complete dose, and treated animals should be observed a few minutes after administration to ensure that no part of the dose is lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. Contraindications There are no known contraindications to the use of SENTINEL SPECTRUM. Warnings Not for use in humans. Keep this and all drugs out of the reach of children. Precautions Treatment with fewer than 6 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. Prior to administration of SENTINEL SPECTRUM, dogs should be tested for existing heartworm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. SENTINEL SPECTRUM is not effective against adult D. immitis. Mild, transient hypersensitivity reactions, such as labored breathing, vomiting, hypersalivation, and lethargy, have been noted in some dogs treated with milbemycin oxime carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae. Do not use in puppies less than six weeks of age. Do not use in dogs or puppies less than two pounds of body weight. The safety of SENTINEL SPECTRUM has not been evaluated in dogs used for breeding or in lactating females. Studies have been performed with milbemycin oxime and lufenuron alone. Adverse Reactions The following adverse reactions have been reported in dogs after administration of milbemycin oxime, lufenuron, or praziquantel: vomiting, depression/lethargy, pruritus, urticaria, diarrhea, anorexia, skin congestion, ataxia, convulsions, salivation, and weakness. To report suspected adverse drug events, contact Virbac at 1-800-338-3659 or the FDA at 1-888-FDA-VETS. Information for Owner or Person Treating Animal Echinococcus multilocularis and Echinococcus granulosus are tapeworms found in wild canids and domestic dogs. E. multilocularis and E. granulosus can infect humans and cause serious disease (alveolar hydatid disease and hydatid disease, respectively). Owners of dogs living in areas where E. multilocularis or E. granulosus are endemic should be instructed on how to minimize their risk of exposure to these parasites, as well as their dog's risk of exposure. Although SENTINEL SPECTRUM was 100% effective in laboratory studies in dogs against E. multilocularis and E. granulosus, no studies have been conducted to show that the use of this product will decrease the incidence of alveolar hydatid disease or hydatid disease in humans. Because the prepatent period for E. multilocularis may be as short as 26 days, dogs treated at the labeled monthly intervals may become reinfected and shed eggs between treatments. Manufactured for: Virbac AH, Inc. P.O. Box 162059, Ft. Worth, TX 76161 NADA #141-333, Approved by FDA © 2015 Virbac Corporation. All Rights Reserved. SENTINEL and SPECTRUM are registered trademarks of Virbac Corporation. 02/15 Veraflox (pradofloxacin) Oral Suspension for Cats 25 mg/mL For the treatment of skin infections (wounds and abscesses) in cats. Do not use in dogs. BRIEF SUMMARY: Before using Veraflox Oral Suspension for Cats, please consult the product insert, a summary of which follows: CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. PRODUCT DESCRIPTION: Pradofloxacin is a fluoroquinolone antibiotic and belongs to the class of quinolone carboxylic acid derivatives. Each mL of Veraflox Oral Suspension provides 25 mg of pradofloxacin. INDICATIONS: Veraflox is indicated for the treatment of skin infections (wound and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius. CONTRAINDICATIONS: DO NOT USE IN DOGS. Pradofloxacin has been shown to cause bone marrow suppression in dogs. Dogs may be particularly sensitive to this effect, potentially resulting in severe thrombocytopenia and neutropenia. Quinolone-class drugs have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Pradofloxacin is contraindicated in cats with a known hypersensitivity to quinolones. HUMAN WARNINGS: Not for human use. Keep out of reach of children. Individuals with a history of quinolone hypersensitivity should avoid this product. Avoid contact with eyes and skin. In case of ocular contact, immediately flush eyes with copious amounts of water. In case of dermal contact, wash skin with soap and water for at least 20 seconds. Consult a physician if irritation persists following ocular or dermal exposure or in case of accidental ingestion. In humans, there is a risk of photosensitization within a few hours after exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. Do not eat, drink or smoke while handling this product. For customer service or to obtain product information, including a Material Safety Data Sheet, call 1-800- 633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874. ANIMAL WARNINGS: For use in cats only. The administration of pradofloxacin for longer than 7 days induced reversible leukocyte, neutrophil, and lymphocyte decreases in healthy, 12-week-old kittens. PRECAUTIONS: The use of fluoroquinolones in cats has been associated with the development of retinopathy and/or blindness. Such products should be used with caution in cats. Q uinolones have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. T he safety of pradofloxacin in cats younger than 12 weeks of age has not been evaluated. The safety of pradofloxacin in immune-compromised cats (i.e., cats infected with feline leukemia virus and/or feline immune- deficiency virus) has not been evaluated. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation that may lead to convulsive seizures. The safety of pradofloxacin in cats that are used for breeding or that are pregnant and/or lactating has not been evaluated. ADVERSE REACTIONS: In a multi-site field study, the most common adverse reactions seen in cats treated with Veraflox were diarrhea/loose stools, leukocytosis with neutrophilia, elevated CPK levels, and sneezing. ANIMAL SAFETY: In a target animal safety study in 32, 12-week-old kittens dosed at 0, 1, 3, and 5 times the recommended dose for 21 consecutive days. One 3X cat and three 5X cats had absolute neutrophil counts below the reference range. The most frequent abnormal clinical finding was soft feces. While this was seen in both treatment and control groups, it was observed more frequently in the 3X and 5X kittens. U.S Patent No. 6,323,213 May, 2012 84364593/84364607, R.0 NADA141-344, Approved by FDA Made in Germany Bayer, the Bayer Cross and Veraflox are registered trademarks of Bayer. 17928 Bayer HealthCare LLC BAY022614 Animal Health Division Shawnee Mission, Kansas 66201, U.S.A.