FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Not for human use. Keep this and all drugs out of the reach of children. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, a component of COMBOGUARD (see ADVERSE REACTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
COMBOGUARD is indicated for the prevention of heartworm disease (Dirofilaria immitis). COMBOGUARD kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
History
There is currently no drug history available for this drug.
Other Information
COMBOGUARD (spinosad and milbemycin oxime) is available in five sizes for oral administration to dogs and puppies according to their weight. Each chewable flavored tablet is formulated to provide a minimum spinosad dose of 13.5 mg/lb (30 mg/kg) and a minimum milbemycin oxime dose of 0.2 mg/lb (0.5 mg/kg). Spinosad is a member of the spinosyns class of insecticides, which are non-antibacterial tetracyclic macrolides. Spinosad contains two major factors, spinosyn A and spinosyn D, derived from the naturally occurring bacterium, Saccharopolyspora spinosa.
Spinosyn A and spinosyn D have the chemical compositions C41H65NO10 and C42H67NO10, respectively. Milbemycin oxime is a macrocyclic lactone anthelmintic, containing two major factors, A3 and A4 of milbemycin oxime. The approximate ratio of A3:A4 is 20:80. Milbemycin A4 5-oxime has the chemical composition of C32H45NO7 and milbemycin A3 5-oxime has the chemical composition of C31H43NO7.
Sources
Comboguard Manufacturers
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Vicar Operating Inc
Comboguard | Vicar Operating Inc
COMBOGUARD is given orally, once a month at the minimum dosage of
13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight. For heartworm prevention, give once monthly for at least 3 months after exposure to mosquitoes (see EFFECTIVENESS).
Dosage Schedule: Body Weight Spinosad
Per Tablet (mg) Milbemycin oxime
Per Tablet (mg) Tablets
Administered 5 to 10 lbs 140 2.3 One 10.1 to 20 lbs 270 4.5 One 20.1 to 40 lbs 560 9.3 One 40.1 to 60 lbs 810 13.5 One 60.1 to 120 lbs 1620 27 One Over 120 lbs Administer the appropriate combination of tabletsAdminister COMBOGUARD with food for maximum effectiveness. To ensure heartworm prevention, owners should observe the dog for one hour after dosing. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed and a monthly interval between doses is exceeded, then immediate administration of COMBOGUARD with food and resumption of monthly dosing will minimize the opportunity for the development of adult heartworm infections and flea reinfestations.
Heartworm Prevention:COMBOGUARD should be administered at monthly intervals beginning within 1 month of the dog's first seasonal exposure and continuing until at least 3 months after the dog's last seasonal exposure to mosquitoes (see EFFECTIVENESS). COMBOGUARD may be administered year round without interruption. When replacing another heartworm preventative product, the first dose of COMBOGUARD should be given within a month of the last dose of the former medication.
Flea Treatment and Prevention:Treatment with COMBOGUARD may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMBOGUARD should continue the entire year without interruption.
To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product.
Intestinal Nematode Treatment and Control:COMBOGUARD also provides treatment and control of roundworms (T. canis, T. leonina), hookworms (A. caninum) and whipworms (T. vulpis). Dogs may be exposed to and can become infected with roundworms, whipworms and hookworms throughout the year, regardless of season or climate. Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites.
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