Regulatory product record
VERAFLOX
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- VERAFLOX
- DIN
- 02437414
- DPD drug code
- 92176
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET
- Ingredients
- PRADOFLOXACIN (120 MG)
- Species (DPD record)
- DOGS
- Company
- ELANCO CANADA LIMITED (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 92176
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, Staphylococcus pseudintermedius. VERAFLOX is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains ofand
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Cattle: Mannheimia haemolytica Pasteurella multocida Histophilus somni Mycoplasma bovis Pradalex is indicated for the treatment of BRD associated with,,andin cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age). Not for use in cattle intended for breeding 1 year of age and older (replacement beef and dairy heifers 1 year of age and older, beef and dairy bulls 1 year of age and older, and beef and dairy cows), beef calves less than 2 months of age, dairy calves, and veal calves. Swine: Bordetella bronchiseptica Glaesserella (Haemophilus) parasuis Pasteurella multocida Streptococcus suis Mycoplasma hyopneumoniae Pradalex is indicated for the treatment of SRD associated with,,,, andin weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter). Not for use in swine intended for breeding (boars intended for breeding, replacement gilts, and sows intended for breeding) and in nursing piglets.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens2
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Dose calculation
Species: Species not recorded. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects179
Table 1 In a multi-site field study, 282 cats (ages 0.3 to 19 years) were evaluated for safety when given either VERAFLOX at a dose of 7.5 mg/kg (3.4 mg/lb) or placebo (vehicle without active ingredient) at a dose of 0.14 mL/lb (0.3 mL/kg). Each group was treated once daily for 7 consecutive days. Adverse reactions are summarized in. The Safety Data Sheet (SDS) provides additional occupational safety information. Table 1: Number of Adverse Reactions Among Cats Treated with Pradofloxacin (N=190) or Vehicle (N=92)* * Some cats may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. Adverse Reactions Pradofloxacin Vehicle Diarrhea / loose stools 7 2 Leukocytosis with neutrophilia 4 6 Elevated CPK levels 4 4 Sneezing 4 1 Hematuria 2 2 Hypersalivation 2 1 Pruritus 2 0 Inappetence 1 3 Lethargy 1 2 Cardiac murmur 1 1 Reclusive behavior 1 1 Vomiting 1 1 Bacteriuria 1 0 Lymphadenopathy 1 0 Polydipsia 1 0 Upper respiratory infection 1 0
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Mild to moderate inflammatory changes of the injection site may be seen in cattle and swine treated with Pradalex.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Behavioural disorder NOS3 reports
- Adipsia2 reports
- Corneal ulcer2 reports
- Death by euthanasia2 reports
- Hypersalivation2 reports
- Lack of efficacy - NOS2 reports
- Lethargy (see also Central nervous system depression in 'Neurological')2 reports
- Vomiting2 reports
- Abnormal ultrasound finding1 reports
- Alopecia NOS1 reports
- Anisocoria1 reports
- Anorexia1 reports
Cat
- Behavioural disorder NOS64 reports
- Vomiting61 reports
- Hypersalivation51 reports
- Diarrhoea50 reports
- Anorexia47 reports
- Lethargy (see also Central nervous system depression in 'Neurological')46 reports
- Death by euthanasia45 reports
- Death42 reports
- Weight loss37 reports
- Other abnormal test result NOS33 reports
- Blindness31 reports
- Lethargy (see also Central nervous system depression in Neurological)27 reports
Contraindications1
DO NOT USE IN DOGS. Pradofloxacin has been shown to cause bone marrow suppression in dogs. Dogs may be particularly sensitive to this effect, potentially resulting in severe thrombocytopenia and neutropenia. Quinolone-class drugs have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Pradofloxacin is contraindicated in cats with a known hypersensitivity to quinolones.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions3
Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens. The use of fluoroquinolones in cats has been associated with the development of retinopathy and/or blindness. Such products should be used with caution in cats. Quinolones have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. The safety of pradofloxacin in immune-compromised cats (i.e., cats infected with feline leukemia virus and/or feline immunodeficiency virus) has not been evaluated. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation that may lead to convulsive seizures. The safety of pradofloxacin in cats younger than 12 weeks of age has not been evaluated. The safety of pradofloxacin in cats that are used for breeding or that are pregnant and/or lactating has not been evaluated. DRUG INTERACTIONS: Compounds (e.g., sucralfate, antacids and multivitamins) containing divalent and trivalent cations (e.g., iron, aluminum, calcium, magnesium, and zinc) may substantially interfere with the absorption of quinolones resulting in a decrease in product bioavailability. Therefore, the concomitant oral administration of quinolones with foods, supplements, or other preparations containing these compounds should be avoided. The dosage of theophylline should be reduced when used concurrently with quinolones. Cimetidine has been shown to interfere with the metabolism of quinolones and should be used with care when used concurrently. Concurrent use of quinolones with oral cyclosporine should be avoided. Concurrent administration of quinolones may increase the action of oral anticoagulants.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. To ensure responsible antimicrobial drug use, use of pradofloxacin should be limited to treatment of bovine respiratory disease (BRD) in cattle and treatment of swine respiratory disease (SRD) in swine only after consideration of other non-fluoroquinolone therapeutic options.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
USER SAFETY WARNINGS Not for use in humans. Keep out of reach of children. Avoid contact with eyes and skin. In case of ocular contact, immediately remove contact lenses and flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water for at least 20 seconds. Consult a physician if irritation persists following ocular or dermal exposures, or in case of accidental ingestion. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. Do not eat, drink or smoke while handling this product. To obtain a copy of the Safety Data Sheet, contact Elanco at 1-800-428-4441. ANIMAL SAFETY WARNINGS Not for use in animals intended for breeding because the effects of Pradalex on bovine and swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in pre-ruminating calves or nursing piglets because safety and effectiveness has not been demonstrated. Swelling and inflammation may be seen at the injection site after administration. These local tissue reactions may persist beyond the slaughter withdrawal period and may result in trim loss of edible tissue at slaughter. Target Animal Safety Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation that may lead to convulsive seizures. Quinolones have been shown to produce erosions of cartilage of weightbearing joints and other signs of arthropathy in immature animals of various species. Seesection for additional information.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
Mechanism of Action Pradofloxacin is a synthetic fluoroquinolone antibacterial drug. Pradofloxacin acts via inhibition of DNA gyrase and topoisomerase IV enzymes in bacteria to inhibit DNA and RNA synthesis. It is bactericidal with a broad spectrum of activity. As a class, fluoroquinolones are considered concentration dependent antimicrobials. Pradofloxacin induces long post-antibiotic effects (PAE) and extended post-antibiotic sub-MIC effects (PA SME), both in aerobic and anaerobic bacteria. Pharmacokinetics Cattle: Table 4 The pharmacokinetic parameters of pradofloxacin inwere determined from two studies following subcutaneous administration of pradofloxacin in 4- to-5-month-old weaned calves weighing 158 to 319 kg. max Pradofloxacin exposure (Cand AUC) was dose proportional over a 10 to 50 mg/kg dose range with no accumulation when administered once every 4 days over 8 days. Pradofloxacin was excreted in both the urine and the feces, largely unchanged, with the majority of the administered dose being excreted in the first 24 hours post-dosing. Swine: Table 4 max The pharmacokinetic parameters of pradofloxacin inwere determined following intramuscular administration of pradofloxacin in 18-day-old weaned pigs weighing 5.5 to 7.9 kg. Pradofloxacin exposure (Cand AUC) was dose proportional over a 7.5 to 37.5 mg/kg dose range with no accumulation when administered once every 2 days over 4 days. Pradofloxacin was excreted in both the urine and the feces, largely unchanged, with approximately one-third of the administered dose being excreted in the first 24 hours post-dosing. Table 4. Arithmetic mean (± standard deviation) plasma pradofloxacin pharmacokinetic parameters following the first of three administrations of Pradalex (pradofloxacin injection). a b max max last ½ Reported as: Median (range)N=11 due to inability to calculate half-life in 1 animalC= maximum concentrationT= time to maximum concentrationAUC= area under the curve from the time of dosing to the time of the last measurable concentrationt= half-life PharmacokineticParameter Weaned calves (N=12)10 mg/kg BW SC Weaned pigs (N = 8)7.5 mg/kg BW IM max C(μg/mL) 1.9 ± 0.4 2.5 ± 1.9 max a T(hours) 1 (1 to 2) 0.75 (0.5 to 2) last AUC(hr*μg/mL) 10.5 ± 1.2 26.2 ± 3.7 1/2 t(hours) b 2.8 ± 0.4 8.5 ± 2.6
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references17
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Pharmacokinetics and pharmacodynamics of oral pradofloxacin administration in dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Microbiota of the conjunctival sac of 120 healthy cats.
Study summary not available in the imported record. Open the original citation to review the study.
- A Review of Fluoroquinolones with a Focus on Veterinary-Approved Agents.
Study summary not available in the imported record. Open the original citation to review the study.
- Bactericidal Activity of Pradofloxacin and Other Antimicrobials Against Swine Respiratory Bacterial Pathogens.
Study summary not available in the imported record. Open the original citation to review the study.
- Pradofloxacin pharmacokinetics after oral and intravenous administration in dogs reveal plasma concentrations sufficient to treat infections caused by susceptible bacteria.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.