Bravecto TOPICAL SOLUTION For Dogs 9.9-22 lbs (4.5-10 kg)

Description

Bravecto TOPICAL SOLUTION For Dogs 9.9-22 lbs (4.5-10 kg) is formulated as a single 250 mg fluralaner tube, providing 12 weeks of systemic flea and tick protection per application. Fluralaner is an isoxazoline-class compound distributed by Merck Animal Health and approved by the FDA under NADA 141-459; it acts systemically through the arthropod nervous system rather than through surface contact. This variant is designed for small to medium-breed dogs and puppies that have reached the 9.9 lb threshold at 6 months of age.

Recommended for

Dogs and puppies weighing 9.9 to 22 lbs (4.5 to 10 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 250 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 250 mg:

• Covers from 9.9 lbs: Dogs that have crossed the upper boundary of the 4.4 to 9.9 lb variant transition directly to this tube, with no gap in the labeled weight coverage between the two sizes.
• Five tick and flea species: A single tube addresses four tick species plus cat fleas, covering the primary ectoparasites encountered in U.S. environments without requiring a separate product for each.
• Systemic isoxazoline action: Fluralaner is absorbed transdermally and distributed through the bloodstream; parasites are exposed to the active compound when they feed, rather than requiring direct contact with the treated coat surface.
• Greater than 99% flea kill within 24 to 48 hours: Laboratory studies confirm 99% flea elimination within 24 hours and 100% within 48 hours post-infestation, across the full 12-week dosing interval.
• Single tube per 12 weeks: One application per quarter replaces a monthly topical schedule for flea and most tick species, reducing annual applications from 12 to 4.
• Water-resistant after day 3: Bathing or swimming occurring 3 or more days after application does not reduce efficacy against fleas or Ixodes ricinus ticks, based on a European laboratory study with repeated water immersion and shampooing.
• Topical format for oral-resistant dogs: The spot-on formulation bypasses palatability issues and eliminates the risk of incomplete dosing from a dog spitting out or partially chewing a tablet.
• Flea allergy dermatitis resolution: Dogs presenting with erythema, papules, scales, crusts, alopecia, and excoriation secondary to flea infestation showed measurable dermatological improvement in the U.S. field study following elimination of the flea burden.

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 dosing. Avoid skin and eye contact during handling; if eye contact occurs, flush with water and seek medical attention. Wash hands and any contacted skin thoroughly with soap and water immediately after use. The formulation is highly flammable: keep away from heat, sparks, and open flame.

Hazards to Domestic Animals

Bravecto Topical Solution 250 mg is for external use on dogs only; oral ingestion by the treated animal should be avoided. This tube is not indicated for dogs below 9.9 lbs (4.5 kg) or under 6 months of age, as 12-week efficacy has not been established in puppies younger than 6 months. Fluralaner is an isoxazoline-class compound associated with neurological adverse reactions including tremors, ataxia, and seizures; use with caution in dogs with a history of seizures or neurological disorders, and consult a veterinarian before administering to debilitated, aged, pregnant, or lactating animals. Individual sensitivity reactions remain possible across any patient population.

Possible Side Effects

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

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

• Application site reactions: Alopecia at or near the treated site was observed in 4.1% of dogs in the field study; isolated laboratory cases documented localized redness, flaking, crusting, and one instance of self-limiting generalized erythema consistent with a possible allergic reaction.
• Gastrointestinal signs: Vomiting occurred in 6.3% of treated dogs; diarrhea was reported in 2.7%, a rate lower than the active control group (11.0%) in the same study.
• Neurological signs: Seizures were reported in two dogs with no prior seizure history during the field study; post-approval reports to FDA also include tremors and ataxia. Dogs with pre-existing seizure or neurological conditions require veterinary assessment before use.
• Systemic signs: Lethargy (2.7%), decreased appetite (1.4%), and behavioral changes including hyperactivity and vocalization appear 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. Consult the Post-Approval Experience and Animal Safety sections of the full prescribing information before administering to any breeding female.