Zeniquin: Product Information (Page 3 of 3)

Cats

Marbofloxacin was administered for 42 consecutive days to 24 cats approximately 8 months old (8 cats per treatment group) at the dosages of 2.5, 7.5 and 12.5 mg/lb/day (5.5, 16.5 and 27.5 mg/kg/day). Treatment with marbofloxacin did not produce adverse effects on body weights, food consumption, serum chemistry, urinalysis or organ weight parameters. Decreased segmented neutrophil counts were observed in some cats in all treatment groups, including the placebo group, but mean counts were significantly lower in the marbofloxacin-treated groups. In some cats, absolute neutrophil counts were below normal reference values (as low as 615 neutrophils/μL in a marbofloxacin-treated cat and as low as 882 neutrophils/μL in a placebo-treated cat). Other hematological observations were not adversely affected. Clinical signs were occasionally noted in cats in the highest dosage group: excessive salivation in 4/8 cats and redness of ear pinnae in 2/8 cats. Macroscopic changes in the articular cartilage of femurs were seen in one cat receiving 7.5 mg/lb and in 3 cats receiving 12.5 mg/lb. Microscopically, these gross lesions were related to a focal or multifocal chondropathy. Microscopic chondropathy not associated with macroscopic observations was also present in one cat treated with 2.5 mg/lb daily (1X the upper end of the dose range) and one additional cat treated with 7.5 mg/lb daily. There was no evidence of lameness during the course of the study. A perivascular to diffuse dermatitis was seen microscopically in one mid-dose cat and 4 high-dose cats. Funduscopic exam by a board-certified ophthalmologist and histologic examination of retina and optic nerve by ocular pathologists revealed no lesions in any of the treatment groups.

Marbofloxacin was also administered orally to 6 cats approximately 8 months of age for 14 consecutive days at a dosage of 25 mg/lb/day (55 mg/kg/day). Clinical signs associated with drug intolerance were excessive salivation in 5/6 cats and redness of ear pinnae in all cats after 8 days of treatment. Emesis was noted occasionally in several cats and diminished activity was noted in one cat. Decreased food intake was noted in some animals, primarily males, when compared to controls. Perivascular to diffuse dermatitis was seen microscopically in the pinnae of all treated animals and in the standard skin samples of several animals. There was focal or multifocal articular chondropathy in 2/6 treated animals. One treated cat had a duodenal mucosal erosion and one treated cat had a pyloric ulcer. There were no observations of lameness and no adverse effects on hematology, clinical chemistry, urinalysis, or organ weight parameters. Funduscopic examination by a board-certified ophthalmologist and histologic examination of retina and optic nerve by ocular pathologists revealed no lesions.

A study was conducted to investigate the effect of marbofloxacin on articular cartilage of skeletally mature cats 12–14 months of age. Forty cats were randomly assigned to 4 groups of 10 cats each. Groups received placebo or marbofloxacin at dosages of 1.25, 3.75 or 7.5 mg/lb/day (2.75, 8.25 or 16.5 mg/kg/day) for 42 consecutive days. There were no treatment-related pathological changes in the joints or other tissues. Emesis and soft stools was noted in all treatment groups, including placebo, and increased in frequency with increasing dose and duration of treatment. Emesis was more apparent in the high-dose males.

STORAGE CONDITIONS

Store below 30°C (86°F).

HOW SUPPLIED

Zeniquin tablets are available in the following strengths of marbofloxacin and bottle sizes:

25 mg scored tablets supplied in bottles that contain 100 or 250 tablets
50 mg scored tablets supplied in bottles that contain 100 or 250 tablets
100 mg scored tablets supplied in a 50 tablet bottle
200 mg scored tablets supplied in a 50 tablet bottle

REFERENCES

1. Schneider M, et al: Pharmacokinetics of marbofloxacin in dogs after oral and parenteral administration. J Vet Pharmacol Therap 19:56–61, 1996.

To report suspected adverse effects, and/or obtain a copy of the MSDS, call 1-888-963-8471.

Approved by FDA under NADA # 141-151

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40027358
Revised: May 2019

PRINCIPAL DISPLAY PANEL — 25 mg Bottle Label

Zeniquin®
(marbofloxacin)

Tablets

For oral use in dogs and cats only

Antibacterial

Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian.

Federal law prohibits the
extralabel use of this drugin food-producing animals.

25 mg

100 Tablets

Approved by FDA under NADA # 141-151

zoetis

25 mg 100 ct bottle label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Bottle Label

50 mg bottle label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Bottle Label

100 mg bottle label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label

200 mg bottle label
(click image for full-size original)

ZENIQUIN marbofloxacin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8485
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARBOFLOXACIN (MARBOFLOXACIN) MARBOFLOXACIN 25 mg
Product Characteristics
Color BROWN (Beige) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 25;MG;PFIZER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-8485-1 100 TABLET in 1 BOTTLE None
2 NDC:54771-8485-2 250 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141151 06/26/1999
ZENIQUIN marbofloxacin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARBOFLOXACIN (MARBOFLOXACIN) MARBOFLOXACIN 50 mg
Product Characteristics
Color BROWN (Beige) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code 50;MG;PFIZER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-8488-1 100 TABLET in 1 BOTTLE None
2 NDC:54771-8488-2 250 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141151 06/26/1999
ZENIQUIN marbofloxacin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8490
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARBOFLOXACIN (MARBOFLOXACIN) MARBOFLOXACIN 100 mg
Product Characteristics
Color BROWN (Beige) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code 100;MG;PFIZER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-8490-1 50 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141151 06/26/1999
ZENIQUIN marbofloxacin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8494
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MARBOFLOXACIN (MARBOFLOXACIN) MARBOFLOXACIN 200 mg
Product Characteristics
Color BROWN (Beige) Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code 200;MG;PFIZER
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-8494-1 50 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141151 06/26/1999
Labeler — Zoetis Inc. (828851555)

Revised: 10/2019 Zoetis Inc.

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