Bravecto TOPICAL SOLUTION For Dogs 4.4-9.9 lbs (2-4.5 kg)

Description

Bravecto TOPICAL SOLUTION For Dogs 4.4-9.9 lbs (2-4.5 kg) is formulated as a single 112.5 mg fluralaner tube, delivering 12 weeks of systemic flea and tick protection per application. Fluralaner is an isoxazoline-class compound that inhibits arthropod GABA-gated and glutamate-gated chloride channels, causing uncontrolled neurological activity in parasites through systemic exposure rather than surface contact.

Recommended for

Dogs and puppies weighing 4.4 to 9.9 lbs (2 to 4.5 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 112.5 mg are:

• Flea treatment and prevention: Kills adult Ctenocephalides felis (cat flea); in the U.S. field study, a single dose reduced flea counts by 99.8% across 12 weeks.
• Black-legged tick (Ixodes scapularis) control: Targets adult and nymphal stages; efficacy of 93.3% or greater at 48 hours post-infestation, sustained for 12 weeks.
• American dog tick (Dermacentor variabilis) control:3% or greater effectiveness at 48 hours post-infestation for the full 12-week dosing 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; efficacy is limited to 8 weeks for this species, not the full 12-week interval.

Key Benefits

The following characteristics are drawn directly from the FDA-approved label for Bravecto Topical Solution 112.5 mg:

• Eligible from 4.4 lbs: The 112.5 mg tube covers dogs from the lower boundary of 4.4 lbs (2 kg), meaning small-breed puppies who have reached that threshold at 6 months of age can begin treatment without waiting for a larger weight band.
• Five-species parasite coverage: A single tube addresses fleas and four tick species, including the lone star tick for 8 weeks and all other labeled tick species for 12 weeks.
• Systemic isoxazoline mechanism: Fluralaner is absorbed through the skin and distributed systemically; parasites are exposed to the active compound through feeding, which eliminates the need for a tick or flea to reach a treated surface area.
• Flea kill within 24 to 48 hours: Laboratory studies confirm greater than 99% flea kill within 24 hours and 100% within 48 hours post-infestation.
• 12-week dosing interval: One tube administered every 12 weeks replaces a monthly topical routine for flea and most tick species, reducing the total number of applications per year from 12 to 4.
• Water-resistant after 3 days: Bathing or water immersion occurring 3 or more days after application does not reduce efficacy against fleas or Ixodes ricinus ticks, confirmed in a European laboratory study with repeated shampooing.
• Topical form for dogs that resist oral doses: The spot-on format is applicable to dogs that spit out chewable tablets or cannot tolerate oral administration due to gastrointestinal sensitivity.
• Flea allergy dermatitis resolution: In the U.S. field study, dogs presenting with signs of flea allergy dermatitis showed measurable improvement in erythema, alopecia, papules, scales, crusts, and excoriation following elimination of flea infestation.

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 after administration. Avoid skin and eye contact during handling. If eye contact occurs, flush slowly with water and seek medical attention if wearing contact lenses. Wash hands and any contacted skin thoroughly with soap and water immediately after use. The formulation contains acetone and glycofurol and is highly flammable: keep away from heat, sparks, and open flames.

Hazards to Domestic Animals

Bravecto Topical Solution is for external use on dogs only; avoid oral ingestion by the treated animal. This variant is not indicated for dogs below 4.4 lbs (2 kg) or under 6 months of age, as efficacy over a 12-week duration has not been established in puppies younger than 6 months. Fluralaner belongs to the isoxazoline class, which has been associated with neurological adverse reactions including tremors, ataxia, and seizures; use with caution in dogs with a documented history of seizures or neurological disorders and consult a veterinarian before administering to debilitated, aged, pregnant, or lactating animals. Individual sensitivity reactions are possible in any patient population.

Possible Side Effects

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

The following adverse reactions were identified across a well-controlled U.S. field study (221 dogs treated with fluralaner over 105 days) and post-approval reporting to FDA/CVM:

• Application site reactions: Alopecia at or near the treated site was reported in 4.1% of dogs in the field study; isolated cases of redness, flaking, crusting, and self-limiting generalized erythema were documented in laboratory studies.
• Gastrointestinal signs: Vomiting occurred in 6.3% of dogs in the field study; diarrhea was reported in 2.7%, which was lower than the active control group (11.0%).
• Neurological signs: Seizures were reported in two dogs with no prior seizure history during the field study; tremors and ataxia appear in the post-approval adverse event record. Dogs with pre-existing seizure history require veterinary clearance before use.
• Systemic signs: Lethargy (2.7%), decreased appetite (1.4%), and behavioral changes including hyperactivity and vocalization are listed in post-approval reporting. One dog was observed off-balance for approximately 30 minutes following the first dose.
• 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. Before using this product in breeding female dogs, review the Post-Approval Experience and Animal Safety sections of the full prescribing information.