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SENTINEL® (milbemycin oxime - lufenuron)

By: Novartis Animal Health

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Milbemycin oxime provided complete protection against heartworm infection in both controlled laboratory and clinical trials. In laboratory studies, a single dose of milbemycin oxime at 0.5 mg/kg was effective in removing roundworm, hookworm and whipworm. In well-controlled clinical trials, milbemycin oxime was also effective in removing roundworms and whipworms and in controlling hookworms.

Efficacy (Lufenuron)

Lufenuron provided 99% control of flea egg development for 32 days following a single dose of lufenuron at 10 mg/kg in studies using experimental flea infestations. In well-controlled clinical trials, when treatment with lufenuron tablets was initiated prior to the flea season, mean flea counts were lower in lufenuron-treated dogs versus placebo-treated dogs. After six monthly treatments, the mean number of fleas on lufenuron-treated dogs was approximately 4 compared to 230 on placebo-treated dogs. When treatment was initiated during the flea season, lufenuron was effective in controlling flea infestations on dogs that completed the study. The mean flea count per lufenuron-treated dog was approximately 74 prior to treatment but had decreased to four after six monthly doses of lufenuron. A topical adulticide was used in the first eight weeks of the study to kill the pre-existing adult fleas.

Safety (Milbemycin Oxime)

Milbemycin oxime has been tested safely in over 75 different breeds of dogs, including collies, pregnant females, breeding males and females, and puppies over two weeks of age. In well-controlled clinical field studies, 786 dogs completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, shampoos and dips. Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-related effects. These effects were directly attributable to the exaggerated experimental dosing regimen.

The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of, or shortly after whelping resulted in no effects on the puppies. Some nursing puppies, at two, four and six weeks of age, given greatly exaggerated oral doses of milbemycin oxime (9.6 mg/kg = 19X) exhibited signs typified by tremors, vocalization and ataxia. These effects were all transient and puppies returned to normal within 24 to 48 hours. No effects were observed in puppies given the recommended dose of milbemycin oxime (0.5 mg/kg). This product has not been tested in dogs less than 2.2 pounds in body weight.

A rising-dose safety study conducted in rough coated collies manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency in one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

Safety (Lufenuron)

Lufenuron has been used and tested safely in over forty breeds of dogs, including pregnant females, breeding males and puppies over six weeks of age. In well-controlled clinical trials, 151 dogs completed treatment with lufenuron. Lufenuron was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics and steroids. In a ten-month study, doses up to 10X the recommended dose rate of 10 mg/kg caused no overt toxicity. A single dose of 200 mg/kg (20X the recommended dose rate) had no marked effect on adult dogs, but caused decreased activity and appetite in eight-week-old puppies. Mean body weights of male and female puppies were higher in treated versus control group at the end of the study. In specifically designed target animal safety studies, lufenuron was tested with concurrent administration of flea adulticides containing carbaryl, permethrin, chlorpyriphos and cythioate. No toxicity resulted from these combinations. Lufenuron did not cause cholinesterase inhibition nor did it enhance cholinesterase inhibition caused by exposure to organophosphates.

Four reproductive safety studies were conducted in breeding dogs with lufenuron: two laboratory and two well-controlled clinical studies. In one of the laboratory studies, where lufenuron was administered to beagle dogs at doses equivalent to 90X (3X daily) the monthly recommended dose of 10 mg/kg, the ratio of gravid females to females mated was 8/8 or 100% in the control group and 6/9 or 67% in the lufenuron-treated group. The mean number of pups per litter was two animals higher in the treated versus control groups and the mean birth weights of pups from treated bitches in this study were lower than control groups. These pups grew at a similar rate to control pups. There was a higher incidence of four clinical signs in the lufenuron-treated versus control group: nasal discharge, pulmonary congestion, diarrhea/dehydration and sluggishness. The incidence of these signs was transient and decreasing by the end of lactation. Results from three additional reproductive safety studies, one laboratory and two clinical field studies evaluating eleven breeds of dogs, did not demonstrate any adverse findings for the reproductive parameters measured including fertility, pup birth weights and pup clinical signs after administration of lufenuron up to 5X the recommended monthly use rate. Data from analysis of milk from lactating animals treated with lufenuron tablets at 2X and 6X the recommended monthly use rate demonstrates that lufenuron concentrates in the milk of these dogs. The average milk: blood concentration ratio was approximately 60 (i.e., 60X higher drug concentrations in the milk compared to drug levels in the blood of treated bitches). Nursing puppies averaged 8-9 times higher blood concentrations of lufenuron compared to their dams.

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