Today's Veterinary Practice

SEP-OCT 2018

Today's Veterinary Practice provides comprehensive information to keep every small animal practitioner up to date on companion animal medicine and surgery as well as practice building and management.

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INDICATIONS IMMITICIDE Sterile Power is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. See full package insert for Heartworm Disease Classification CONTRAINDICATIONS IMMITICIDE is contraindicated in dogs with very severe (Class 4) heartworm disease. Patients in this category have Caval Syndrome (D. immitis present in the venae cavae and right atrium). WARNINGS (See boxed Warning). For use in dogs only. Safety for use in breeding animals and lactating or pregnant bitches has not been determined. HUMAN WARNINGS Keep this and all medications out of the reach of children. Avoid human exposure. Wash hands thoroughly aer use or wear gloves. Potentially irritating to eyes. Rinse eyes with copious amounts of water if exposed. Consult a physician in cases of accidental exposure by any route (dermal, oral, or by injection). PRECAUTIONS Dogs with heartworm disease are at risk for post-treatment pulmonary thromboembolism (death of worms which may result in fever, weakness, and coughing). Dogs with severe pulmonary arterial disease have an increased risk and may exhibit more severe signs (dyspnea, hemoptysis, right heart failure and possibly death). Dogs should be restricted from exercise aer treatment. Studies indicate that adverse reactions may occur aer the second injection in the series even if no problems were encountered with the first injection. All patients should be closely monitored during treatment and for up to 24 hours aer the last injection. Special Considerations for Class 3 dogs: Following stabilization, severely ill (Class 3) dogs should be treated according to the alternate dosing regime in an attempt to decrease post-treatment mortality associated with thromboembolism. Post-treatment mortality due to thromboembolism and/or progression of the underlying disease may occur in 10 to 20% of the Class 3 patients treated with IMMITICIDE. Hospitalization post- treatment and strict exercise restriction are recommended. If the alternate dosing regime is used, expect increased injection site reactions on the side receiving the second injection since the skeletal muscles at the first injection site may not have fully recovered (healed). If persistent swelling is present at 1 month, the second injections may be delayed for several weeks up to 1 month. Special Considerations for Older Dogs: In clinical field trials, dogs 8 years or older experienced more post-treatment depression/lethargy, anorexia/inappetence, and vomiting than younger dogs. DOSAGE AND ADMINISTRATION Care must be taken to administer the proper dose deep into epaxial muscles ONLY (see boxed WARNING). Accurately weigh the dog and calculate the volume to be injected based on the dose of 2.5 mg/kg (1.1 mg/lb). is is equivalent to 0.1 mL/kg (0.045 mL/lb). See full product insert for dosing table. Use a 23 gauge 1 inch needle for dogs equal to or less than 10 kg (22 lb) in weight. Use a 22 gauge 1 ┬Ż inch needle for dogs greater than 10 kg (22 lb). Use alternating sides with each administration and avoid injecting at the same lumbar location. Disease Classification: It is vital to classify the severity of heartworm disease to apply the appropriate dosage regime for IMMITICIDE. See full product insert for Heartworm Disease Classification criteria. Class 1 and 2: IMMITICIDE should be given in two intramuscular injections of 2.5mg/kg, 24 hours apart. Four months following treatment, a second treatment series (2.5 mg/kg twice, 24 hours apart) can be elected. Class 3: Alternate Dosing Regime: Dogs with severe (Class 3) heartworm disease should be stabilized prior to treatment and then dosed intramuscularly in the lumbar (L3 - L5) muscles with a single injection of 2.5 mg/kg then approximately 1 month later with 2.5 mg/kg administered twice, 24 hours apart. SAFETY IMMITICIDE has a low margin of safety. A single dose of 7.5 mg/kg (3X the recommended dose) can result in pulmonary inflammation, edema, and death. Symptoms of overdose (2x recommended dose) may include excessive salivation, panting, restlessness, fever, vomiting and diarrhea. ese symptoms were seen in the clinical trials and all signs resolved within 24 hours. Symptoms of up to 3x the recommended dose included tremors, lethargy, unsteadiness, restlessness, panting, shallow and labored breathing, pulmonary inflammation, edema, and vomiting which progressed to respiratory distress, collapse, and death. Daily administration of 2X and 3X the recommended dose for 14 days caused renal damage in healthy dogs. In Case of Overdosage: BAL in Oil Ampules (Dimercaprol Injection, USP) [Akorn, San Clemente, California, at 1-800-223-9851] is reported in the literature to be an antidote for arsenic toxicity and was shown in one study to reduce the signs of toxicity associated with over-dosage of IMMITICIDE. e efficacy of IMMITICIDE may be reduced with co-administration of BAL. ADVERSE REACTIONS (SIDE EFFECTS) In clinical field trials, the most common reactions seen in dogs treated with IMMITICIDE were coughing/gagging, depression/ lethargy, anorexia/inappetence, fever, lung congestion, and vomiting. Hypersalivation and panting occurred more rarely, however, these signs may occur within 30 minutes of injection and may be severe. Significant irritation was also observed at the intramuscular injection sites, accompanied by pain, swelling, tenderness, and reluctance to move. Generally, injection site reactions were mild to moderate in severity and recovery occurred in 1 week to 1 month, however, firm nodules can persist indefinitely. Avoid superficial or subcutaneous injection and leakage. Heartworm disease may cause death in dogs with or without treatment, especially in the Class 3 dogs. Post Approval Experience: ere have also been rare reports of paresis and paralysis in dogs following administration of IMMITICIDE. e information provided here is not comprehensive. e full FDA-approved product insert is available at http://www.merial. us/SiteCollectionDocuments/Immiticide_PI_8.5x11_version.pdf. Consult your veterinarian for further information. For technical assistance, to request a Safety Data Sheet or to report suspected adverse events, call 1-888-637-4251. For additional information about adverse event reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http:// www.fda.gov/AnimalVeterinary. NADA 141-042 Marketed by Merial, Inc. IMMITICIDE┬« STERILE POWDER (MELARSOMINE DIHYDROCHLORIDE) Brief Summary: Before Using IMMITICIDE, please consult the product insert, a summary of which follows. CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian. WARNING IMMITICIDE should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (between L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. (See SAFETY).

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