IVERHART PLUS<sup>®</sup> (ivermectin/pyrantel) Flavored Chewables


               
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                  <paragraph>IVERHART PLUS® (ivermectin/pyrantel) Flavored Chewables</paragraph>
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                  <paragraph>CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">INDICATIONS:</content> For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (<content styleCode="italics">Dirofilaria immitis</content>) for a month (30 days) after infection and for the treatment and control of roundworms (<content styleCode="italics">Toxocara canis, Toxascaris leonina</content>) and hookworms (<content styleCode="italics">Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense</content>).</paragraph>
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                  <paragraph>
                     <content styleCode="bold">DOSAGE:</content> IVERHART PLUS<sup>®</sup> (ivermectin/pyrantel) Flavored Chewables should be administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) of body weight. The recommended dosing schedule for prevention of canine heartworm disease and for the treatment and control of roundworms and hookworms is as follows:</paragraph>
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                     <caption/>
                     <tbody>
                        <tr>
                           <td align="center">
                              <content styleCode="bold"> Dog Weight</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Flavored Chewable Per Month</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Ivermectin Content</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Pyrantel Content</content>
                           </td>
                           <td align="center">
                              <content styleCode="bold"> Color Coding on Carton</content>
                           </td>
                        </tr>
                        <tr>
                           <td align="center">0-25 lbs</td>
                           <td align="center"> 1</td>
                           <td align="center"> 68 mcg</td>
                           <td align="center"> 57 mg</td>
                           <td align="center"> Blue</td>
                        </tr>
                        <tr>
                           <td align="center"> 26-50 lbs</td>
                           <td align="center"> 1</td>
                           <td align="center"> 136 mcg</td>
                           <td align="center"> 114 mg</td>
                           <td align="center"> Green</td>
                        </tr>
                        <tr>
                           <td align="center"> 51-100 lbs</td>
                           <td align="center"> 1</td>
                           <td align="center"> 272 mcg</td>
                           <td align="center"> 227 mg</td>
                           <td align="center"> Brown</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content>IVERHART PLUS Flavored Chewables are recommended for dogs 6 weeks of age and older. For dogs over 100 lbs use the appropriate combination of these flavored chewables.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">ADMINISTRATION:</content> Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light.</paragraph>
                  <paragraph>Because most dogs find IVERHART PLUS Flavored Chewables palatable, the product can be ordered to the dog by hand. To avoid the risk of choking or intestinal obstruction, the chewable should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing (see <content styleCode="bold">PRECAUTIONS</content> and <content styleCode="bold">POST-APPROVAL EXPERIENCE</content>). Chewables may be broken into pieces and fed to dogs that normally swallow treats whole. Alternatively, it may be added intact to a small amount of dog food to encourage chewing, but care should be taken to ensure that the dog consumes the complete dose at one time.</paragraph>
                  <paragraph>Treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.</paragraph>
                  <paragraph>IVERHART PLUS Flavored Chewables should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the dogs first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dogs last exposure to mosquitoes.<br/>When replacing another heartworm preventive product in a heartworm disease preventive program, the first dose of IVERHART PLUS Flavored Chewables must be given within a month (30 days) of the last dose of the former medication.</paragraph>
                  <paragraph>If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. Therefore, for optimal performance, the flavored chewable must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with IVERHART PLUS Flavored Chewables and resumption of the recommended dosing regimen will minimize the opportunity for the development of adult heartworms.</paragraph>
                  <paragraph>Monthly treatment with IVERHART PLUS Flavored Chewables also provides effective treatment and control of roundworms (<content styleCode="italics">T. canis, T. leonina</content>) and hookworms (<content styleCode="italics">A. caninum, U. stenocephala, A. braziliense</content>). Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">EFFICACY:</content> IVERHART PLUS (ivermectin/pyrantel) Flavored Chewables, given orally using the recommended dose and regimen, are effective against the tissue larval stage of <content styleCode="italics">D. immitis</content> for a month (30 days) after infection and, as a result, prevent the development of the adult stage. IVERHART PLUS Flavored Chewables are also effective against canine roundworms (<content styleCode="italics">T. canis, T. leonina</content>) and hookworms (<content styleCode="italics">A. caninum, U. stenocephala, A. braziliense</content>).</paragraph>
                  <paragraph>
                     <content styleCode="bold">ACCEPTABILITY:</content> In a trial in client-owned dogs, IVERHART PLUS Flavored Chewables were shown to be a palatable oral dosage form consumed at first offering by the majority of dogs.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">PRECAUTIONS:</content> All dogs should be tested for existing heartworm infection before starting treatment with IVERHART PLUS Flavored Chewables, which are not effective against adult <content styleCode="italics">D. immitis</content>. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with IVERHART PLUS Flavored Chewables.</paragraph>
                  <paragraph>While some microfilariae may be killed by the ivermectin in IVERHART PLUS Flavored Chewables at the recommended dose level, IVERHART PLUS Flavored Chewables are not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating microfilariae.</paragraph>
                  <paragraph>Choking or intestinal obstruction has been reported after dosing with ivermectin/pyrantel. For dogs that normally swallow treats whole, chewables may be broken into pieces (see <content styleCode="bold">POST-APPROVAL EXPERIENCE</content>).</paragraph>
                  <paragraph>
                     <content styleCode="bold">Keep this and all drugs out of the reach of children.</content> In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans.</paragraph>
                  <paragraph>Keep IVERHART PLUS Flavored Chewables in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">ADVERSE REACTIONS:</content> In clinical trials with ivermectin/pyrantel, vomiting or diarrhea within 24 hours of dosing was observed (1.1% of administered doses).</paragraph>
                  <paragraph>
                     <content styleCode="bold">POST-APPROVAL EXPERIENCE (2022):</content> The following adverse events are based on post-approval adverse drug experience reporting for ivermectin/pyrantel. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.</paragraph>
                  <paragraph>The following adverse events reported in dogs are listed in decreasing order of reporting frequency:<br/>Vomiting, diarrhea, lethargy, anorexia, seizures, ataxia, muscle tremors, hypersalivation, pruritus. In some cases, choking or intestinal obstruction has been reported after administration of<br/>ivermectin/pyrantel.</paragraph>
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                     <content styleCode="bold">CONTACT INFORMATION:</content> To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae.</paragraph>
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                     <content styleCode="bold">SAFETY:</content> Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level of 6 mcg/kg) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. lvermectin demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials and bioequivalency studies, support the safety of ivermectin products in dogs, including Collies, when used as recommended.</paragraph>
                  <paragraph>lvermectin/pyrantel has shown a wide margin of safety at the recommended dose level in dogs, including pregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. In clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines and steroid preparations have been administered with ivermectin/pyrantel in a heartworm disease preventive program.</paragraph>
                  <paragraph>In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy against intestinal nematodes, possibly due to a change in intestinal transit time.</paragraph>
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                     <content styleCode="bold">HOW SUPPLIED:</content> IVERHART PLUS Flavored Chewables are available in three dosage strengths (See <content styleCode="bold">DOSAGE</content> section) for dogs of different weights. Each strength comes in a box of 6 tablets, packed 10 boxes per display box.</paragraph>
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                     <content styleCode="bold">STORAGE INFORMATION:</content> Store at 68°F - 77°F (20° - 25°C), excursions permitted between 59°F - 86°F (15° - 30°C). Protect product from light.</paragraph>
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                  <paragraph>Approved by FDA under ANADA # 200-302</paragraph>
                  <paragraph>Manufactured by: Virbac AH, Inc.<br/>Fort Worth, TX 76161, USA<br/>301732-08<br/>03/2025</paragraph>
                  <paragraph>© 2025 Virbac Corporation. All rights reserved.<br/>IVERHART PLUS is a registered trademark of the<br/>Virbac Group of Companies.</paragraph>
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