Bravecto TOPICAL SOLUTION For Dogs 22-44 lbs (10-20 kg)

Description

Bravecto TOPICAL SOLUTION For Dogs 22-44 lbs (10-20 kg) contains 500 mg fluralaner, formulated as a single spot-on dose delivering 12 weeks of systemic flea and tick protection. Fluralaner is an isoxazoline-class inhibitor of arthropod GABA-gated and glutamate-gated chloride channels, manufactured by Merck Animal Health and approved by the FDA under NADA 141-459. This variant covers medium-breed dogs spanning a weight range that includes breeds such as Beagles, Bulldogs, and Border Collies.

Recommended for

Dogs and puppies weighing 22 to 44 lbs (10 to 20 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 500 mg are:

• Flea treatment and prevention: Kills adult Ctenocephalides felis (cat flea); a single dose reduced flea burdens by 99.8% across 12 weeks in the U.S. field study, 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 interval.
• American dog tick (Dermacentor variabilis) control:3% or greater effectiveness at 48 hours post-infestation, sustained across 12 weeks.
• Brown dog tick (Rhipicephalus sanguineus) control:3% or greater effectiveness at 48 hours post-infestation for the full 12-week dosing period.
• Lone star tick (Amblyomma americanum) control: 90% or greater effectiveness at 72 hours post-infestation; protection against this species is limited to 8 weeks, not the full 12-week interval.

Key Benefits

The following points are drawn from the FDA-approved label for Bravecto Topical Solution 500 mg:

• Suited from 22 lbs: Dogs transitioning out of the 9.9 to 22 lb range move directly into this tube at the 22 lb threshold, with no gap in weight band coverage between the two variants.
• Broad ectoparasite coverage: One tube addresses four tick species plus cat fleas, eliminating the need for separate products targeting individual parasite types across the 22 to 44 lb weight class.
• Systemic absorption, not surface contact: Fluralaner is distributed via the bloodstream after transdermal absorption; ectoparasites are exposed to the active compound when they feed, rather than through contact with the treated coat.
• 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, sustained across the full 12-week dosing interval.
• Four applications per year: The 12-week protection window reduces the total number of annual ectoparasite treatments from 12 to 4, compared with monthly topical alternatives.
• Established water resistance after day 3: Bathing or swimming 3 or more days after application does not reduce efficacy against fleas or Ixodes ricinus ticks, confirmed in a European study involving repeated shampooing and water immersion.
• Topical route for dogs that reject oral doses: The spot-on format delivers the full dose regardless of the dog’s willingness to accept or fully chew a tablet, removing the risk of partial dosing from incomplete ingestion.
• Flea allergy dermatitis improvement: Elimination of the flea burden in the U.S. field study produced measurable 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 and do not allow children to contact the application site for at least 2 hours after dosing. Avoid skin and eye contact during handling; flush eyes with water if exposure occurs and seek medical advice if wearing contact lenses. Wash hands and contacted skin with soap and water immediately after use. The product is highly flammable: keep away from heat sources and open flame.

Hazards to Domestic Animals

Bravecto Topical Solution 500 mg is for external application to dogs only; oral ingestion by the treated animal should be prevented. This tube is not appropriate for dogs below 22 lbs (10 kg) or under 6 months of age, as efficacy over the full 12-week period has not been established in puppies younger than 6 months. Fluralaner belongs to the isoxazoline class, which carries an FDA-documented association with neurological adverse reactions including tremors, ataxia, and seizures; use with caution in dogs with any history of seizures or neurological disorders, and seek veterinary guidance before administering to debilitated, aged, pregnant, or lactating animals. Individual sensitivity reactions are possible in any patient.

Possible Side Effects

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

The reactions below are drawn 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:

• Application site reactions: Alopecia at or near the treated area was recorded in 4.1% of dogs in the field study; laboratory studies identified isolated cases of localized redness, flaking, crusting, and one instance of self-limiting generalized erythema.
• Gastrointestinal signs: Vomiting was reported in 6.3% of treated dogs; diarrhea occurred in 2.7%, a rate markedly lower than the active control group (11.0%) in the same study.
• Neurological signs: Two dogs with no prior seizure history experienced seizures during the field study; post-approval reports to FDA include tremors and ataxia. Dogs with pre-existing neurological conditions require veterinary clearance before receiving any isoxazoline-class product.
• Systemic signs: Lethargy (2.7%), decreased appetite (1.4%), and behavioral changes including hyperactivity and vocalization are documented in post-approval adverse event reporting.
• 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 dog.