Bravecto TOPICAL SOLUTION For Dogs 44-88 lbs (20-40 kg)

Description

Bravecto TOPICAL SOLUTION For Dogs 44-88 lbs (20-40 kg) contains 1000 mg fluralaner per tube, delivering 12 weeks of systemic ectoparasite protection through a single spot-on application. Fluralaner is an isoxazoline-class inhibitor of arthropod GABA-gated and glutamate-gated chloride channels, distributed systemically after transdermal absorption. Manufactured by Merck Animal Health and approved by the FDA under NADA 141-459, this variant covers large-breed dogs including Labrador Retrievers, Golden Retrievers, and German Shepherds.

Recommended for

Dogs and puppies weighing 44 to 88 lbs (20 to 40 kg) aged 6 months and older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations, the labeled indications for Bravecto Topical Solution 1000 mg are:

• Flea treatment and prevention: Kills adult Ctenocephalides felis (cat flea); a single dose reduced flea counts by 99.8% across 12 weeks in the U.S. field study, with laboratory data confirming greater than 99% kill at 24 hours and 100% at 48 hours post-infestation.
• Black-legged tick (Ixodes scapularis) control: Targets adult and nymphal stages; 93.3% or greater effectiveness at 48 hours post-infestation, sustained across the full 12-week dosing period.
• American dog tick (Dermacentor variabilis) control:3% or greater effectiveness at 48 hours post-infestation for the complete 12-week interval.
• Brown dog tick (Rhipicephalus sanguineus) control:3% or greater effectiveness at 48 hours post-infestation for 12 weeks.
• Lone star tick (Amblyomma americanum) control: 90% or greater effectiveness at 72 hours post-infestation; protection against this species is limited to 8 weeks and does not extend to the full 12-week interval.

Key Benefits:

The following characteristics are derived directly from the FDA-approved label for Bravecto Topical Solution 1000 mg:

• Calibrated for 44 lbs and above: Dogs crossing out of the 22 to 44 lb range transition into this tube at 44 lbs (20 kg), with no discontinuity in weight band coverage between the two variants.
• Single tube, five parasite species: One 1000 mg application addresses cat fleas and four tick species, covering the principal ectoparasites encountered across the continental United States in one treatment event.
• Systemic delivery via bloodstream: Fluralaner is absorbed transdermally and circulates systemically; parasites ingest the active compound when feeding rather than encountering it on the coat surface, which extends coverage to areas of the body not directly treated.
• Rapid flea kill onset: Greater than 99% of fleas are eliminated within 24 hours and 100% within 48 hours post-infestation in laboratory studies, across the complete 12-week dosing window.
• Quarterly dosing schedule: The 12-week protection interval reduces the number of annual ectoparasite treatments from 12 monthly applications to 4, lowering cumulative handling requirements for large dogs.
• Water-resistant from day 3: Bathing, swimming, or prolonged rain exposure occurring 3 or more days after application does not reduce efficacy against fleas or Ixodes ricinus ticks, as established in a European laboratory study with repeated water immersion and shampooing.
• Spot-on format bypasses oral refusal: Large-breed dogs that spit out, partially chew, or refuse chewable tablets receive the full labeled dose through the topical route without dependence on voluntary ingestion.
• Flea allergy dermatitis resolution: Sustained flea elimination in the U.S. field study resulted in measurable clinical improvement in dogs with flea allergy dermatitis, including reduction of erythema, papules, scales, crusts, alopecia, and excoriation.

Caution

Hazards to Humans

Not for human use. Keep out of reach of children; do not permit children to contact the application site for at least 2 hours after dosing. Avoid skin and eye contact when handling; if eye contact occurs, flush thoroughly with water and seek immediate medical attention if wearing contact lenses. Wash hands and any contacted skin with soap and water straight after use. The formulation is highly flammable: keep away from heat, sparks, and open flame at all times.

Hazards to Domestic Animals

Bravecto Topical Solution 1000 mg is formulated for external application to dogs only; the treated animal should not ingest the solution. This tube is not appropriate for dogs below 44 lbs (20 kg) or under 6 months of age, as 12-week duration efficacy has not been established in puppies younger than 6 months. As an isoxazoline-class compound, fluralaner carries an FDA precaution for neurological adverse reactions including tremors, ataxia, and seizures; dogs with a history of seizures or neurological disorders require veterinary clearance before use, and debilitated, aged, pregnant, or lactating animals should be assessed by a veterinarian prior to administration. Individual sensitivity reactions remain possible.

Possible Side Effects

Monitor your dog at the application site and for systemic signs over the days following each dose.

The reactions below are drawn from a well-controlled U.S. field study involving 221 fluralaner-treated dogs over 105 days, alongside post-approval adverse event reports submitted to FDA/CVM:

• Application site reactions: Alopecia at or near the treated site was recorded in 4.1% of field study dogs; laboratory studies additionally documented localized redness, flaking, crusting, and an isolated case of self-limiting generalized erythema in treated animals.
• Gastrointestinal signs: Vomiting occurred in 6.3% of treated dogs in the field study; diarrhea was reported in 2.7%, considerably lower than the 11.0% rate observed in the active control group.
• Neurological signs: Two dogs with no prior seizure history experienced seizures during the field study; post-approval FDA reports include tremors and ataxia. Any dog with a pre-existing neurological condition requires veterinary assessment before receiving this or any isoxazoline-class product.
• Systemic signs: Post-approval adverse event reports list lethargy (2.7%), decreased appetite (1.4%), and behavioral changes including hyperactivity and vocalization.
• Reproductive adverse events: Birth defects including limb deformities and cleft palate, stillbirth, and abortion have been reported following use of Bravecto fluralaner Chews in breeding females. Consult the full prescribing information, specifically the Post-Approval Experience and Animal Safety sections, before administering to any breeding female dog.