COMBOGUARD®

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SPINOSAD (UNII: XPA88EAP6V) (SPINOSAD - UNII:XPA88EAP6V), MILBEMYCIN OXIME (UNII: 0502PUN0GT) (MILBEMYCIN OXIME - UNII:0502PUN0GT)

Available from:

Vicar Operating Inc

INN (International Name):

SPINOSAD

Composition:

SPINOSAD 140 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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. There are no known contraindications to the use of COMBOGUARD.

Product summary:

COMBOGUARD is available in five tablet sizes. Each tablet size is available in color-coded packages of 6 tablets. 5-10 lbs (140 mg spinosad and 2.3 mg milbemycin oxime) 10.1-20 lbs (270 mg spinosad and 4.5 mg milbemycin oxime) 20.1-40 lbs (560 mg spinosad and 9.3 mg milbemycin oxime) 40.1-60 lbs (810 mg spinosad and 13.5 mg milbemycin oxime) 60.1-120 lbs (1620 mg spinosad and 27 mg milbemycin oxime) NADA 141-321, Approved by the FDA Distributed by Vicar Operating, Inc. 12401 West Olympic Blvd. Los Angeles, CA 90064 All trademarks are the property of their respective owners. All rights reserved. NDC 50386-4332-7 NDC 50386-4333-7 NDC 50386-4334-7 NDC 50386-4335-7 NDC 50386-4336-7 CA4332Y07AMC1 CA4333Y07AMC1 CA4334Y07AMC1 CA4335Y07AMC1 CA4336Y07AMC1

Authorization status:

New Animal Drug Application

Summary of Product characteristics

COMBOGUARD- SPINOSAD AND MILBEMYCIN OXIME TABLET, CHEWABLE
VICAR OPERATING INC
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COMBOGUARD
(spinosad + milbemycin oxime)
CHEWABLE TABLETS
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.
DES CRIPTION:
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 C
H NO and C
H NO ,
respectively. Milbemycin oxime is a macrocyclic lactone anthelmintic,
containing two major factors, A
and A of milbemycin oxime. The approximate ratio of A :A is 20:80.
Milbemycin A 5-oxime has the
chemical composition of C
H NO and milbemycin A 5-oxime has the chemical composition of
C
H NO .
INDICATIONS :
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.
DOSAGE AND ADMINISTRATION:
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