Zeniquin

Zeniquin (marbofloxacin) tablets are indicated for the treatment ofinfections in dogs and cats associated with bacteria susceptible tomarbofloxacin.

Clinical effectiveness was confirmed in bacterial skin and soft tissueinfections in dogs and cats and urinary tract infections (cystitis) indogs associated with bacteria susceptible to marbofloxacin.
Available in 25mg (100 tablets), 50mg (100 tablets), 100mg (50 tablets) and 200mg (50 tablets)

For dogs and cats.

CONTRAINDICATIONS:
Marbofloxacin and other quinolones have been shown to cause arthropathyin immature animals of most species tested the dog being particularlysensitive to this side effect. Marbofloxacin is contraindicated inimmature dogs during the rapid growth phase (small and medium breeds upto 8 months of age large breeds up to 12 months of age and giant breedsup to 18 months of age). Marbofloxacin is contraindicated in cats under12 months of age. Marbofloxacin is contraindicated in dogs and catsknown to be hypersensitive to quinolones.

PRECAUTIONS:
Quinolones should be used with caution in animals with known orsuspected central nervous system (CNS) disorders. In such animalsquinolones have in rare instances been associated with CNS stimulationwhich may lead to convulsive seizures. Quinolones have been shown toproduce erosions of cartilage of weight-bearing joints and other signsof arthropathy in immature animals of various species. The use offluoroquinolones in cats has been reported to adversely affect theretina. Such products should be used with caution in cats. The safetyof marbofloxacin in animals used for breeding purposes pregnant orlactating has not been demonstrated.

HUMAN WARNING:
For use in animals only. Keep out of reach of children. Avoidcontact with eyes. In case of contact immediately flush eyes withcopious amounts of water for 15 minutes. In case of dermal contact washskin with soap and water. Consult a physician if irritation persistsfollowing ocular or dermal exposure. Individuals with a history ofhypersensitivity to fluoroquinolones should avoid this product. Inhumans there is a risk of user photosensitization within a few hoursafter excessive exposure to quinolones. If excessive accidentalexposure occurs avoid direct sunlight.

TARGET ANIMAL SAFETY:
Dogs: Thetoxicity of marbofloxacin was assessed in 12- to 14-month-old beagledogs administered marbofloxacin at 2.5 7.5 and 12.5 mg/lb/day for 42days. Vomiting reddened skin (usually involving the ears) and reddenedmucous membranes were occasionally observed in all groups includingcontrols but were noted most frequently in the 12.5 mg/lb group.Decreased food consumption and weight loss were significant in the 7.5mg/lb and 12.5 mg/lb groups. No clinical lameness was noted in any ofthe treated animals. Minimal to slight lesions in the articularcartilage were observed in 1/8 placebo-treated animals and in 3/8animals given 12.5 mg marbofloxacin/lb. Macroscopically these lesionswere vesicles raised areas or depressed light-colored areas.Microscopically these lesions were characterized by the presence of oneor more of the following: fissuring erosion chondrocyte proliferationfibrillation or vertical splitting of the articular cartilage. Thesecartilage lesions in treated dogs were similar to those in control dogsand were not typical of those produced by fluoroquinolones. In additionto the above pathologic alterations red areas of articular cartilagewere noted macroscopically in 0/8 placebo-treated dogs and in 2/8 dogsfrom each of the three marbofloxacin-treated groups. These areasusually correlated microscopically with areas of vascularity of thearticular surface but could not be confirmed microscopically in allanimals. They consisted of large blood vessels in mature fibrousconnective tissue with no indication of active vascularization due todrug-induced damage. They were considered most likely to bedevelopmental anomalies or normal variations of the joint surface andwere not considered to be related to drug treatment.
Marbofloxacinwas administered to 12- to 14-month-old beagle dogs at a dosage of 25mg/lb/day for 12 days. Decreased food consumption vomiting dehydrationexcessive salivation tremors reddened skin facial swelling decreasedactivity and weight loss were seen in treated dogs. No clinicallameness was noted. As in the 42 day study grossly visible focal redareas of articular cartilage were seen. These findings were noted in2/6 placebo-treated dogs and in 4/6 marbofloxacintreated dogs. The fociwere areas of fibrocartilage with prominent vascularization orincreased vascularization of subchondral bone. Due to the appearancemicroscopically and macroscopically these red foci were described aslikely to be developmental anomalies or normal variations in articularcartilage.
Marbofloxacin administered to 3- to 4-month-old largebreed purpose-bred mongrel dogs at a dosage of 5 mg/lb/day for 14 daysresulted in marked lameness in all dogs due to articular cartilagelesions. Lameness was accompanied by decreased appetite and activity.
Cats:Marbofloxacin was administered for 42 consecutive days to 24 catsapproximately 8 months old (8 cats per treatment group) at the dosagesof 2.5 7.5 and 12.5 mg/lb/day (5.5 16.5 and 27.5 mg/kg/day). Treatmentwith marbofloxacin did not produce adverse effects on body weights foodconsumption serum chemistry urinalysis or organ weight parameters.Decreased segmented neutrophil counts were observed in some cats in alltreatment groups including the placebo group but mean counts weresignificantly lower in the marbofloxacin-treated groups. In some catsabsolute neutrophil counts were below normal reference values (as lowas 615 neutrophils/µL in a marbofloxacin-treated cat and as low as 882neutrophils/µL in a placebo-treated cat). Other hematologicalobservations were not adversely affected. Clinical signs wereoccasionally noted in cats in the highest dosage group: excessivesalivation in 4/8 cats and redness of ear pinnae in 2/8 cats.Macroscopic changes in the articular cartilage of femurs were seen inone cat receiving 7.5 mg/lb and in 3 cats receiving 12.5 mg/lb.Microscopically these gross lesions were related to a focal ormultifocal chondropathy. Microscopic chondropathy not associated withmacroscopic observations was also present in one cat treated with 2.5mg/lb daily (1X the upper end of the dose range) and one additional cattreated with 7.5 mg/lb daily. There was no evidence of lameness duringthe course of the study. A perivascular to diffuse dermatitis was seenmicroscopically in one mid-dose cat and 4 high-dose cats. Funduscopicexam by a board-certified ophthalmologist and histologic examination ofretina and optic nerve by ocular pathologists revealed no lesions inany of the treatment groups.
Marbofloxacin was also administeredorally to 6 cats approximately 8 months of age for 14 consecutive daysat a dosage of 25 mg/lb/day (55 mg/kg/day). Clinical signs associatedwith drug intolerance were excessive salivation in 5/6 cats and rednessof ear pinnae in all cats after 8 days of treatment. Emesis was notedoccasionally in several cats and diminished activity was noted in onecat. Decreased food intake was noted in some animals primarily maleswhen compared to controls. Perivascular to diffuse dermatitis was seenmicroscopically in the pinnae of all treated animals and in thestandard skin samples of several animals. There was focal or multifocalarticular chondropathy in 2/6 treated animals. One treated cat had aduodenal mucosal erosion and one treated cat had a pyloric ulcer. Therewere no observations of lameness and no adverse effects on hematologyclinical chemistry urinalysis or organ weight parameters. Funduscopicexamination by a board-certified ophthalmologist and histologicexamination of retina and optic nerve by ocular pathologists revealedno lesions.
A study was conducted to investigate the effect ofmarbofloxacin on articular cartilage of skeletally mature cats 12 - 14months of age. Forty cats were randomly assigned to 4 groups of 10 catseach. Groups received placebo or marbofloxacin at dosages of 1.25 3.75or 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 orother tissues. Emesis and soft stools was noted in all treatment groupsincluding placebo and increased in frequency with increasing dose andduration of treatment. Emesis was more apparent in the high-dose males.

ADVERSE REACTIONS:
The following clinical signswere reported during the course of clinical field studies in dogsreceiving marbofloxacin at dosages up to 2.5 mg/lb daily: decreased orloss of appetite (5.4%) decreased activity (4.4%) and vomiting (2.9%).
The following signs were reported in less than 1% of cases in dogs:increased thirst soft stool/diarrhea behavioral changesshivering/shaking/tremors and ataxia. One dog which had a seizure theday before study enrollment experienced a seizure while onmarbofloxacin therapy. The following clinical signs were reportedduring clinical field studies in cats receiving 1.25 mg/lb/day:diarrhea (2.1%) and soft stool (1.4%). Vomiting was reported in lessthan 1% of cases in cats.

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