Milbemax Flavor-Coated Tablets for Cats (16 mg/40 mg) (Canada)

(milbemycin oxime and praziquantel)

FLAVOR-COATED TABLETS for Small Cats and Kittens

FLAVOR-COATED TABLETS for Cats

DIN 02291940 (4 mg), 02291959 (16 mg)

Introduction

Elanco Canada Limited encourages you to take the time to read the package insert which describes the use of MILBEMAX (milbemycin oxime and praziquantel) as a convenient monthly heartworm preventive and intestinal worm control product.

MILBEMAX is only available through veterinarians.

Description

The active ingredients in MILBEMAX are:

1) Milbemycin oxime, which consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A₄ (C₃₂H₄₅NO₇, MW 555.71) and 20% A₃ (C₃₁H₄₃NO₇).

2) Praziquantel, an acylated pyrazino-isoquinoline derivative (C₁₉H₂₄N₂O₂).

Milbemax Flavor-Coated Tablets for Cats (16 mg/40 mg) Indications

MILBEMAX is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of parasitic infections due to the adult stage of hookworms (Ancylostoma tubaeforme), roundworms (Toxocara cati) and tapeworms (Dipylidium caninum, Taenia taeniaeformis, and Echinococcus multilocularis) in cats six weeks of age or greater and/or weighing greater than 0.5 kg body weight.

Dosage

MILBEMAX is available in two strengths for convenient dosing of cats and kittens of various weights. MILBEMAX Flavor-Coated Tablets for Small Cats and Kittens contains 4 mg milbemycin oxime and 10 mg praziquantel per tablet, and MILBEMAX Flavor-Coated Tablets for Cats contains 16 mg milbemycin oxime and 40 mg praziquantel per tablet.

The minimum recommended dose is 2 mg/kg of milbemycin oxime, and 5 mg/kg of praziquantel. Cats weighing over 8 kg should receive the appropriate combination of tablets.

MILBEMAX should not be administered to kittens less than 6 weeks of age and/or weighing less than 0.5 kg body weight. Cats weighing over 8 kg should receive the appropriate number of tablets. Ensure animals get the appropriate tablet size and amount for their weight.

For heartworm prevention, administer MILBEMAX once per month on the same day.

For heartworm prevention, the initial dose must be given within one month after the first indication of mosquito activity and regular dosing should continue until at least one month after the end of the mosquito season. If the interval between doses exceeds 30 days, the efficacy of MILBEMAX may be reduced. If regular monthly treatment is delayed, it is essential to immediately recommence treatment at the recommended dosage rate. If treatment has been delayed beyond two months, the advice of a veterinarian should be sought.

For hookworm, roundworm, and tapeworm infections, control will be obtained in conjunction with heartworm prevention, or by separate administration of MILBEMAX. Kittens should be treated at 6, 8, 10 and 12 weeks of age, then monthly up to 6 months. In non-heartworm endemic areas, adult cats should be treated 4 times per year, or as directed by the veterinarian.

Administration

The tablet(s) should be placed into the cat’s mouth on the back of the tongue, or can be hidden in food. The cat should be watched closely for several minutes following administration of the tablet to ensure that the entire dose has been swallowed. If it is suspected that any of the dose has been lost, dosing should be repeated.

Contraindications

Do not use in kittens less than 6 weeks of age and/or weighing less than 0.5 kg body weight.

Milbemycin Oxime

Milbemycin oxime has been tested safely in over 8 different breeds of cats and kittens, two weeks of age or greater. In clinical field studies, 310 cats completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, anesthetics, antibiotics, steroids, flea collars, shampoos and dips.

Safety studies were conducted in young cats and kittens beginning at two weeks of age. Doses of 1X, 3X and 5X demonstrated no drug-related effects. Tolerability studies at exaggerated doses of 10X also demonstrated no drug-related adverse effects in kittens and young adult cats.

Heartworm Disease In Cats

Much of the damage due to heartworm disease in cats occurs before there are any outward signs of the disease, and these signs may be quite variable. Prevention of the disease is important.

The disease is caused by Dirofilaria immitis which lives in the right side of the heart and adjacent blood vessels. A cat not on preventive medication can be infected with several worms. The adult worms cause disease by damaging blood vessels in the lungs which obstructs normal blood flow. This can result in an increased workload on the heart which can cause heart failure. The adult worms can also migrate into other tissues of the central nervous system such as the brain.

The disease is spread from animal to animal by any one of over 70 species of mosquitoes. Female adult heartworms discharge larval forms (microfilariae) into the bloodstream of a cat. The mosquito becomes infected by sucking up these microfilariae as it takes a blood meal from an infected cat; during the next two to three weeks these microfilariae grow and molt twice inside the mosquito to reach the infective larval stage which enters another cat as the mosquito feeds again. In the cat, it takes about seven to eight months for these larvae to grow, move to the heart, mate and start the cycle again.

Milbemax Flavor-Coated Tablets for Cats (16 mg/40 mg) Cautions

This product has not been tested in breeding cats, in pregnant queens or in heartworm positive cats. No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function.

Testing: Despite the fact that the sensitivity of the heartworm antigen tests is relatively low in cats, it is still considered good medical practice to test before administering chemoprophylaxis for the first time, if at least 8 months have passed since there was an opportunity for infection. The cat should be examined by a veterinarian prior to starting heartworm prevention medication.

Warnings

Keep out of reach of children. If accidentally swallowed, call a physician.

Adverse Reactions

Although all adverse events are not reported, the following information is based on voluntary post-approval drug experience reporting. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.

The post-marketing adverse event reports for MILBEMAX have shown that lethargy, ataxia, muscle tremor, emesis, anorexia and diarrhea are all very rarely reported.¹ In very rare cases, death has been reported as an outcome of these events.

Signs reported following overdose include lethargy, ataxia, muscle tremor, emesis and hypersalivation and death.

¹Reported in less than 1 in 10,000 animals.

Safety Studies

Praziquantel/Milbemycin oxime:

Target animal safety studies in adult cats have demonstrated that MILBEMAX is well tolerated at up to 5X the recommended dose rate as a single dose. At 6.5X the minimum recommended dose rate (13 mg/kg milbemycin oxime, 33 mg praziquantel), one of eight cats showed reversible tremors. This reaction was mild and transient.

MILBEMAX was well tolerated in 6 week old kittens when given at the recommended dose once weekly for seven treatments (twice the recommended frequency).

Presentation

MILBEMAX is available in the following two strengths:

MILBEMAX Flavor-Coated Tablets for Small Cats and Kittens -

(4 mg milbemycin oxime and 10 mg praziquantel)

Appearance: beige to brown, oblong, double scored flavor-coated tablets

MILBEMAX Flavor-Coated Tablets for Cats -

(16 mg milbemycin oxime and 40 mg praziquantel)

Appearance: reddish-brown, oblong, double scored flavor-coated tablets

Storage Conditions

MILBEMAX should be stored at room temperature, between 15-25 °C.

Date: December 2021

Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

Milbemax, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

©2022 Elanco or its affiliates.

16Dec2021

CPN: 1231096.7