Label: CREDELIO- lotilaner tablet, chewable

  • NDC Code(s): 58198-5451-1, 58198-5451-2, 58198-5451-3, 58198-5451-4, view more
    58198-5451-6, 58198-5451-7, 58198-5452-1, 58198-5452-2, 58198-5452-3, 58198-5452-4, 58198-5452-5, 58198-5452-6, 58198-5452-7, 58198-5454-1, 58198-5454-2, 58198-5454-3, 58198-5454-4, 58198-5454-6, 58198-5454-7, 58198-5456-1, 58198-5456-2, 58198-5456-3, 58198-5456-4, 58198-5456-5, 58198-5456-6, 58198-5456-7, 58198-5458-1, 58198-5458-2, 58198-5458-3, 58198-5458-4, 58198-5458-5, 58198-5458-6, 58198-5458-7
  • Packager: Elanco US Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 10, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Chewable Tablets

    For oral use in dogs

    Caution:

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Description:

    CREDELIO (lotilaner) is a beef-flavored, chewable tablet for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum lotilaner dosage of 9 mg/lb (20 mg/kg).

    Lotilaner has the chemical composition of 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]- 2-thiophenecarboxamide.

  • Indications:

    CREDELIO 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), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.

  • Dosage and Administration:

    CREDELIO is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg).

  • Dosage Schedule:

    Body Weight

    Lotilaner Per Chewable Tablet (mg)

    Chewable Tablets Administered

    4.4 to 6.0 lbs

    56.25

    One

    6.1 to 12.0 lbs

    112.5

    One

    12.1 to 25.0 lbs

    225

    One

    25.1 to 50.0 lbs

    450

    One

    50.1 to 100.0 lbs

    900

    One

    Over 100.0 lbs

    Administer the appropriate combination of chewable tablets

    CREDELIO must be administered with food (see Clinical Pharmacology).

    Treatment with CREDELIO can begin at any time of the year and can continue year-round without interruption.

  • Contraindications:

    There are no known contraindications for the use of CREDELIO.

  • Warnings:

    Not for human use. Keep this and all drugs out of the reach of children. Keep CREDELIO in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

  • Precautions:

    Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders.

    The safe use of CREDELIO in breeding, pregnant or lactating dogs has not been evaluated.

  • Adverse Reactions:

    In a well-controlled U.S. field study, which included 284 dogs (198 dogs treated with CREDELIO and 86 dogs treated with an oral active control), there were no serious adverse reactions.

    Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence of 1% or greater are presented in the following table.

    Dogs with Adverse Reactions in the Field Study

    *Two geriatric dogs developed mildly elevated BUN (34 to 54 mg/dL; reference range: 6 to 31 mg/dL) during the study. One of these dogs also developed polyuria and a mildly elevated potassium (6.5 mEq/L; reference range: 3.6 to 5.5 mEq/L) and phosphorous (6.4 mg/dL; reference range: 2.5 to 6.0 mg/dL). The other dog also developed a mildly elevated creatinine (1.7 to 2.0 mg/dL; reference range: 0.5 to 1.6 mg/dL) and weight loss.

    Adverse Reaction
    (AR)

    CREDELIO Group:
    Number (and Percent) of
    Dogs with the AR

    (n=198)

    Active Control Group:
    Number (and Percent) of
    Dogs with the AR
    (n=86)

    Weight Loss

    3 (1.5%)

    2 (2.3%)

    Elevated Blood Urea Nitrogen (BUN)

    2 (1.0%)*

    0 (0.0%)

    Polyuria

    2 (1.0%)*

    0 (0.0%)

    Diarrhea

    2 (1.0%)

    2 (2.3%)

    In addition, one dog experienced intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of CREDELIO. The head tremors resolved within 24 hours without treatment. The owner elected to withdraw the dog from the study.

    In an Australian field study, one dog with a history of seizures experienced seizure activity (tremors and glazed eyes) six days after receiving CREDELIO. The dog recovered without treatment and completed the study. In the U.S. field study, two dogs with a history of seizures received CREDELIO and experienced no seizures throughout the study.

    In three well-controlled European field studies and one U.S. laboratory study, seven dogs experienced episodes of vomiting and four dogs experienced episodes of diarrhea between 6 hours and 3 days after receiving CREDELIO.

  • Post-Approval Experience (2023):

    The following adverse events are based on post-approval adverse drug experience reporting for CREDELIO. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

    The following adverse events reported in dogs are listed in decreasing order of reporting frequency:
    Vomiting, diarrhea (with and without blood), lethargy, anorexia, seizure, pruritus, ataxia, urinary-related signs (polyuria, polydipsia, urinary incontinence, and inappropriate urination), and muscle tremor.

  • Contact Information:

    To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US Inc. at 1-888-545-5973.

    For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • Clinical Pharmacology:

    Following oral administration of 43 mg/kg (approximately 1X the maximum labeled dose), peak lotilaner concentrations were achieved between 6 hours and 3 days in dogs 2 months of age and between 1 and 7 days in dogs 10 months of age. Dogs 2 months of age had a shorter elimination half-life (average of 9.6 days) than at 10 months of age (average of 28.4 days). Due to reduced drug bioavailability in the fasted state, CREDELIO must be administered with a meal or within 30 minutes after feeding.

  • Mode of Action:

    Lotilaner is an ectoparasiticide belonging to the isoxazoline group. Lotilaner inhibits insect and acarine gamma-aminobutyric acid (GABA)-gated chloride channels. This inhibition blocks the transfer of chloride ions across cell membranes, which results in uncontrolled neuromuscular activity leading to death of insects and acarines. The selective toxicity of lotilaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.

  • Effectiveness:

    In well-controlled European laboratory studies, CREDELIO began to kill fleas four hours after administration or infestation, with greater than 99% of fleas killed within eight hours after administration or infestation for 35 days. In a well-controlled U.S. laboratory study, CREDELIO demonstrated 100% effectiveness against adult fleas 12 hours after administration or infestation for 35 days.

    In a 90-day well-controlled U.S. field study conducted in households with existing flea infestations of varying severity, the effectiveness of CREDELIO against fleas on Days 30, 60 and 90 compared to baseline was 99.5%,100% and 100%, respectively. Dogs with signs of flea allergy dermatitis showed improvement in erythema, papules, scaling, alopecia, dermatitis/pyodermatitis and pruritus as a direct result of eliminating fleas.

    In a well-controlled laboratory study, CREDELIO killed fleas before they could lay eggs, thus preventing subsequent flea infestations for 30 days after the start of treatment of existing flea infestations.

    In well-controlled laboratory studies, CREDELIO demonstrated > 97% effectiveness against Amblyomma americanum, Dermacentor variabilis, Ixodes scapularis and Rhipicephalus sanguineus ticks 48 hours after administration or infestation for 30 days. In a well-controlled European laboratory study, CREDELIO started killing Ixodes ricinus ticks within four hours after administration.

    Palatability: In the U.S. field study, which included 567 doses administered to 198 dogs, 80.4% of dogs voluntarily consumed CREDELIO when offered by hand or in an empty bowl, an additional 13.6% consumed CREDELIO when offered with food, and 6.0% required placement of the chewable tablet in the back of the dog's mouth.

  • Animal Safety:

    In a margin of safety study, CREDELIO was administered orally to 24 (8 dogs/group) 8-week-old Beagle puppies at doses of 43 mg/kg, 129 mg/kg, and 215 mg/kg (approximately 1, 3, and 5X the maximum labeled dose, respectively) every 28 days for eight consecutive doses. The 8 dogs in the control group (0X) were untreated. There were no clinically-relevant, treatment-related effects on clinical observations, physical and neurological examinations, body weights, food consumption, electrocardiograms, clinical pathology (hematology, clinical chemistries, coagulation profiles and urinalysis), gross pathology, histopathology, or organ weights. Blood concentrations of lotilaner confirmed systemic exposure of all treated dogs, although the exposure was less than dose proportional at 5X.

    In a well-controlled field study, CREDELIO was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics, steroids, NSAIDS, anesthetics, and antihistamines. No adverse reactions were observed from the concomitant use of CREDELIO with other medications.

  • Storage Information:

    Store at 15-25°C (59 -77°F), excursions permitted between 5 to 40°C (41 to 104°F).

  • How Supplied:

    CREDELIO is available in five chewable tablet sizes for use in dogs: 56.25, 112.5, 225, 450, and 900 mg lotilaner.

    Each chewable tablet size is available in color-coded packages of 1, 3 or 6 chewable tablets.

    Approved by FDA under NADA # 141-494

    Manufactured for:
    Elanco US Inc
    Greenfield, IN 46140 USA
    Credelio.com
    Rev. date 02/2024

    Credelio, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
    © 2024 Elanco or its affiliates

    ElancoTM

    PA104186X

  • Principal Display Panel - 3 Tablets 56.25 mg Box Label

    3 Tablets

    Dogs &
    puppies

    4.4-6.0 lbs

    Credelio™
    (lotilaner)

    For the treatment and
    prevention of flea infestations
    and for the treatment and control
    of tick infestations in dogs and
    puppies 8 weeks of age and older

    56.25 mg chewable tablet

    Kills fleas

    Kills ticks

    Monthly dose

    Give with
    food

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

    Approved by FDA under NADA # 141-494

    ElancoTM

    Principal Display Panel - 3 Tablets 56.25 mg Box Label
  • Principal Display Panel - 3 Tablets 112.5 mg Box Label

    3 Tablets

    Dogs &
    puppies

    6.1-12.0 lbs

    Credelio™
    (lotilaner)

    For the treatment and
    prevention of flea infestations
    and for the treatment and control
    of tick infestations in dogs and
    puppies 8 weeks of age and older

    112.5 mg chewable tablet

    Kills fleas

    Kills ticks

    Monthly dose

    Give with
    food

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

    Approved by FDA under NADA # 141-494

    ElancoTM

    Principal Display Panel - 3 Tablets 112.5 mg Box Label
  • Principal Display Panel - 3 Tablets 225 mg Box Label

    3 Tablets

    Dogs &
    puppies

    12.1-25.0 lbs

    Credelio™
    (lotilaner)

    For the treatment and
    prevention of flea infestations
    and for the treatment and control
    of tick infestations in dogs and
    puppies 8 weeks of age and older

    225 mg chewable tablet

    Kills fleas

    Kills ticks

    Monthly dose

    Give with
    food

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

    Approved by FDA under NADA # 141-494

    ElancoTM

    Principal Display Panel - 3 Tablets 225 mg Box Label
  • Principal Display Panel - 3 Tablets 450 mg Box Label

    3 Tablets

    Dogs &
    puppies

    25.1-50.0 lbs

    Credelio™
    (lotilaner)

    For the treatment and
    prevention of flea infestations
    and for the treatment and control
    of tick infestations in dogs and
    puppies 8 weeks of age and older

    450 mg chewable tablet

    Kills fleas

    Kills ticks

    Monthly dose

    Give with
    food

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

    Approved by FDA under NADA # 141-494

    ElancoTM

    Principal Display Panel - 3 Tablets 450 mg Box Label
  • Principal Display Panel - 3 Tablets 900 mg Box Label

    3 Tablets

    Dogs &
    puppies

    50.1-100.0 lbs

    Credelio™
    (lotilaner)

    For the treatment and
    prevention of flea infestations
    and for the treatment and control
    of tick infestations in dogs and
    puppies 8 weeks of age and older

    900 mg chewable tablet

    Kills fleas

    Kills ticks

    Monthly dose

    Give with
    food

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

    Approved by FDA under NADA # 141-494

    ElancoTM

    Principal Display Panel - 3 Tablets 900 mg Box Label
  • INGREDIENTS AND APPEARANCE
    CREDELIO 
    lotilaner tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-5452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lotilaner (UNII: HEH4938D7K) (Lotilaner - UNII:HEH4938D7K) Lotilaner56.25 mg
    Product Characteristics
    ColorWhite (beige with brownish spots) Scoreno score
    ShapeROUND (biconvex beveled edges) Size7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5452-316 in 1 BOX
    1NDC:58198-5452-11 in 1 CARTON
    11 in 1 BLISTER PACK
    2NDC:58198-5452-410 in 1 BOX
    2NDC:58198-5452-22 in 1 CARTON
    23 in 1 BLISTER PACK
    3NDC:58198-5452-57 in 1 BOX
    31 in 1 CARTON
    31 in 1 BLISTER PACK
    4NDC:58198-5452-616 in 1 BOX
    4NDC:58198-5452-71 in 1 CARTON
    43 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14149401/19/2018
    CREDELIO 
    lotilaner tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-5458
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lotilaner (UNII: HEH4938D7K) (Lotilaner - UNII:HEH4938D7K) Lotilaner112.5 mg
    Product Characteristics
    ColorWhite (beige with brownish spots) Scoreno score
    ShapeROUND (biconvex beveled edges) Size9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5458-316 in 1 BOX
    1NDC:58198-5458-11 in 1 CARTON
    11 in 1 BLISTER PACK
    2NDC:58198-5458-410 in 1 BOX
    2NDC:58198-5458-22 in 1 CARTON
    23 in 1 BLISTER PACK
    3NDC:58198-5458-57 in 1 BOX
    31 in 1 CARTON
    31 in 1 BLISTER PACK
    4NDC:58198-5458-616 in 1 BOX
    4NDC:58198-5458-71 in 1 CARTON
    43 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14149401/19/2018
    CREDELIO 
    lotilaner tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-5456
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lotilaner (UNII: HEH4938D7K) (Lotilaner - UNII:HEH4938D7K) Lotilaner225 mg
    Product Characteristics
    ColorWhite (beige with brownish spots) Scoreno score
    ShapeROUND (biconvex beveled edges) Size12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5456-316 in 1 BOX
    1NDC:58198-5456-11 in 1 CARTON
    11 in 1 BLISTER PACK
    2NDC:58198-5456-410 in 1 BOX
    2NDC:58198-5456-22 in 1 CARTON
    23 in 1 BLISTER PACK
    3NDC:58198-5456-57 in 1 BOX
    31 in 1 CARTON
    31 in 1 BLISTER PACK
    4NDC:58198-5456-616 in 1 BOX
    4NDC:58198-5456-71 in 1 CARTON
    43 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14149401/19/2018
    CREDELIO 
    lotilaner tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-5454
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lotilaner (UNII: HEH4938D7K) (Lotilaner - UNII:HEH4938D7K) Lotilaner450 mg
    Product Characteristics
    ColorWhite (beige with brownish spots) Scoreno score
    ShapeROUND (biconvex beveled edges) Size15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5454-316 in 1 BOX
    1NDC:58198-5454-11 in 1 CARTON
    11 in 1 BLISTER PACK
    2NDC:58198-5454-410 in 1 BOX
    2NDC:58198-5454-22 in 1 CARTON
    23 in 1 BLISTER PACK
    3NDC:58198-5454-616 in 1 BOX
    3NDC:58198-5454-71 in 1 CARTON
    33 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14149401/19/2018
    CREDELIO 
    lotilaner tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-5451
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lotilaner (UNII: HEH4938D7K) (Lotilaner - UNII:HEH4938D7K) Lotilaner900 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWhite (beige with brownish spots) Scoreno score
    ShapeROUND (biconvex beveled edges) Size19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5451-316 in 1 BOX
    1NDC:58198-5451-11 in 1 CARTON
    11 in 1 BLISTER PACK
    2NDC:58198-5451-410 in 1 BOX
    2NDC:58198-5451-22 in 1 CARTON
    23 in 1 BLISTER PACK
    3NDC:58198-5451-616 in 1 BOX
    3NDC:58198-5451-71 in 1 CARTON
    33 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14149401/19/2018
    Labeler - Elanco US Inc. (966985624)