Bravecto TOPICAL SOLUTION For Dogs 88-123 lbs (40-56 kg)

Description

Bravecto Topical Solution for dogs in the 88 to 123 lb (40 to 56 kg) range contains 1400 mg fluralaner per tube, the highest single-tube dose in the Bravecto Topical lineup, designed for giant and large-breed dogs requiring full systemic ectoparasite coverage across a 12-week interval. Fluralaner is an isoxazoline-class inhibitor of arthropod GABA-gated and glutamate-gated chloride channels; it is distributed systemically following transdermal absorption rather than acting through surface contact with the coat. Dogs exceeding 123 lbs should receive the appropriate combination of tubes; consult a veterinarian to determine the correct multi-tube combination.

Recommended for

Dogs and puppies weighing 88 to 123 lbs (40 to 56 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 1400 mg are:

• Flea treatment and prevention: Kills adult Ctenocephalides felis (cat flea); the U.S. field study recorded a 99.8% reduction in flea burdens across 12 weeks from a single application, with laboratory studies confirming greater than 99% kill within 24 hours and 100% within 48 hours post-infestation.
• Black-legged tick (Ixodes scapularis) control: Targets adult and nymphal stages with 93.3% or greater effectiveness at 48 hours post-infestation, maintained for the full 12-week dosing interval.
• American dog tick (Dermacentor variabilis) control:3% or greater effectiveness at 48 hours post-infestation, sustained across the complete 12-week period.
• 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; coverage against this species terminates at 8 weeks and does not extend to the full 12-week interval.

Key Benefits

The following points are taken directly from the FDA-approved label for Bravecto Topical Solution 1400 mg:

• Formulated for giant breeds: At 1400 mg fluralaner per tube, this variant delivers the minimum therapeutic dose of 11.4 mg/lb (25 mg/kg) to dogs weighing up to 123 lbs (56 kg), covering giant-breed dogs that fall outside the range of all smaller tube sizes.
• Five ectoparasite species per dose: One tube addresses cat fleas and four tick species, removing the need for separate products to cover individual parasite types across the 88 to 123 lb weight class.
• Systemic rather than surface action: Fluralaner circulates via the bloodstream after transdermal uptake; ectoparasites are exposed to the active compound through feeding, extending protection to body regions not in direct contact with the treated site.
• Flea elimination within 24 to 48 hours: Laboratory studies confirm greater than 99% flea kill at 24 hours and 100% at 48 hours post-infestation, across the full 12-week dosing window.
• Four doses per year: The 12-week protection interval limits annual ectoparasite treatments to 4 applications, a material reduction in handling frequency for large and giant-breed dogs that are difficult to restrain for monthly treatments.
• Water resistance established at day 3: Bathing, swimming, or sustained rain exposure from day 3 onward does not diminish efficacy against fleas or Ixodes ricinus ticks, confirmed by a European laboratory study incorporating repeated shampooing and water immersion.
• Topical format eliminates oral compliance risk: Giant-breed dogs that refuse chewable tablets or partially ingest them receive the complete labeled dose through the spot-on route without reliance on voluntary swallowing.
• Flea allergy dermatitis improvement: Sustained elimination of the flea burden in the U.S. field study produced documented clinical resolution of flea allergy dermatitis signs including erythema, alopecia, papules, scales, crusts, and excoriation.

Caution

Hazards to Humans

Not for human use. Keep out of reach of children; do not allow children to contact the application site for at least 2 hours post-dosing. Avoid direct skin and eye contact during handling; if eye exposure occurs, flush with water and seek medical attention if wearing contact lenses. Wash hands and contacted skin with soap and water immediately after use. The product is highly flammable: keep clear of heat sources and open flame.

Hazards to Domestic Animals

Bravecto Topical Solution 1400 mg is for external application to dogs only; oral ingestion by the treated dog should be prevented throughout the absorption period. This tube is not appropriate for dogs below 88 lbs (40 kg) or younger than 6 months, as the 12-week efficacy window has not been established in puppies under that age. Fluralaner carries an FDA precaution for neurological adverse reactions including tremors, ataxia, and seizures as a member of the isoxazoline class; dogs with any history of seizures or neurological disorders require veterinary clearance before administration, and debilitated, aged, pregnant, or lactating animals should be assessed by a veterinarian prior to each dosing cycle. Individual sensitivity reactions remain possible across any patient population.

Possible Side Effects

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

The reactions below are compiled from a well-controlled U.S. field study (221 fluralaner-treated dogs over 105 days) and post-approval adverse event reports filed with FDA/CVM. While the field study did not specifically isolate the 88 to 123 lb cohort, the adverse reaction profile applies across the labeled weight range:

• Application site reactions: Alopecia at or near the treated site was documented in 4.1% of field study dogs; isolated laboratory cases recorded localized redness, flaking, crusting, and one instance of self-limiting generalized erythema consistent with an allergic response.
• Gastrointestinal signs: Vomiting was reported in 6.3% of treated dogs; diarrhea occurred in 2.7%, notably lower than the 11.0% rate recorded in the active control group during the same study period.
• Neurological signs: Two dogs with no prior seizure history experienced seizures during the field study; post-approval FDA reports include tremors and ataxia. Giant-breed dogs with any pre-existing neurological condition require veterinary assessment before receiving this or any isoxazoline-class compound.
• Systemic signs: Post-approval adverse event data list lethargy (2.7%), decreased appetite (1.4%), and behavioral changes including hyperactivity and vocalization among reported reactions.
• 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. Review the Post-Approval Experience and Animal Safety sections of the full prescribing information before administering to any breeding female, regardless of tube size.