Country: United States
Language: English
Source: NLM (National Library of Medicine)
SAROLANER (UNII: DM113FTW7F) (SAROLANER - UNII:DM113FTW7F)
Zoetis Inc.
SAROLANER
SAROLANER 5 mg
ORAL
PRESCRIPTION
SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis ), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. There are no known contraindications for the use of SIMPARICA.
SIMPARICA (sarolaner) Chewables are available in six flavored tablet sizes: 5, 10, 20, 40, 80, and 120 mg. Each tablet size is available in color-coded packages of one, three, or six tablets.
New Animal Drug Application
SIMPARICA CHEWABLES- SAROLANER TABLET, CHEWABLE ZOETIS INC. ---------- SIMPARICA Simparica (sarolaner) Chewables FOR ORAL USE IN DOGS ONLY CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION SIMPARICA is a flavored, chewable tablet for administration to dogs over 6 months of age according to their weight. Each tablet is formulated to provide a minimum sarolaner dosage of 0.91 mg/lb (2 mg/kg ) body weight. Sarolaner is a member of the isoxazoline class of parasiticides and the chemical name is 1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)- 3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone. SIMPARICA contains the S-enantiomer of sarolaner. INDICATIONS SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations (_Ctenocephalides felis_), and the treatment and control of tick infestations [_Amblyomma americanum _(lone star tick), _Amblyomma maculatum _(Gulf Coast tick), _Dermacentor variabilis _(American dog tick), _Ixodes scapularis _(black-legged tick), and _Rhipicephalus sanguineus _(brown dog tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA is indicated for the prevention of _Borrelia burgdorferi_ infections as a direct result of killing _lxodes scapularis_ vector ticks. DOSAGE AND ADMINISTRATION SIMPARICA is given orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg). Dosage Schedule: BODY WEIGHT SAROLANER PER TABLET (MG) NUMBER OF TABLETS ADMINISTERED 2.8 to 5.5 lbs 5 One ® ® 5.6 to 11.0 lbs 10 One 11.1 to 22.0 lbs 20 One 22.1 to 44.0 lbs 40 One 44.1 to 88.0 lbs 80 One 88.1 to 132.0 lbs 120 One >132.1 lbs Administer the appropriate combination of tablets SIMPARICA can be offered by hand, in the food, or administered like other tablet medications. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensu Read the complete document