Spinosad

(spin-oh-sad)
Category: Flea Adulticide
Other Names for this Medication: Comfortis®
Common Dosage Forms: Veterinary: Chewable tablets: 90 mg, 140 mg, 270 mg, 560 mg, 810 mg, & 1620 mg. Human: None as oral products; topical forms are available.

This information sheet does not contain all available information for this medication. It is to help answer commonly asked questions and help you give the medication safely and

effectively to your animal. If you have other questions or need more information about this medication, contact your veterinarian or pharmacist.

Key Information

X Spinosad is an oral tablet given monthly that kills adult fleas on dogs and cats; it begins to kill fleas 30 minutes after dosing. This product does not kill ticks.

X Give medication with food.
X When used as directed on the label, this medication

appears safe.

X Product can be harmful to wildlife, so dispose of unused drugs carefully.

X Keep chewable tablets well out of reach of children and animals.

How is this medication useful?

Spinosad is given by mouth to dogs and cats to prevent and treat flea infestations.

The FDA (U.S. Food & Drug Administration) has approved this drug to prevent and treat flea infestations for 1 month in dogs at least
14 weeks of age that weigh at least 3.3 pounds and in cats that are at least 14 weeks of age and weigh at least 2 pounds. The FDA does allow veterinarians to prescribe and use products containing this drug in different species or for other conditions in certain situations. You and your veterinarian can discuss why this drug is the most appropriate choice.

What should I tell my veterinarian to see if this medication can be safely given?

Many things might affect how well this drug will work in your animal. Be sure to discuss the following with your veterinarian so together you can make the best treatment decisions.
XXOther drugs can interact with this drug, so be sure to tell your

veterinarian and pharmacist what medications (including vitamins, supplements, or herbal therapies) you give your animal, including the amount and time you give each.

XXTell your veterinarian about any conditions or diseases your animal may have now or has had in the past.

XXIf your animal has been treated for the same disease or condition in the past, tell your veterinarian about the treatment and how well it did or didn’t work.

XXIf your animal is pregnant or nursing, talk to your veterinarian about the risks of using this drug.

XXTell your veterinarian and pharmacist about any medication side effects (including allergic reactions, lack of appetite, diarrhea, itching, hair loss) your animal has developed in the past.

When should this medication not be used or be used very carefully?

No drug is 100% safe in all patients, but your veterinarian will discuss with you any specific concerns about using this drug in your animal.

This drug SHOULD NOT be used in patients:

XXThat are allergic to it.

This drug should be used WITH CAUTION in:

XXAnimals with a seizure disorder (eg, epilepsy).

XXCats: Less than 14 weeks of age or that weigh less than 2 pounds; safe use in these animals has not been determined.

XXDogs: Less than 14 weeks of age or that weigh less than 3.3 pounds; safe use in these animals has not been determined.

XXAnimals receiving higher doses of a drug called ivermectin.
If your animal has any of these conditions, talk to your veterinarian

about the potential risks versus benefits.

What are the side effects of this medication?

Spinosad is normally tolerated well and side effects are rare.

Common but not serious side effects include:

XXVomiting, diarrhea.XXExcessive salivation (drooling).XXItching.
XXTrembling.
XXLack of energy.
XXReduced appetite.

You don’t have to be overly concerned if you see any of these signs unless they are severe, worsen, or continue to be a problem. Con- tact your veterinarian if this happens.

Side effects that may be serious or indicate a serious problem:

XXStumbling, incoordination, weakness.
XXSeizures (convulsions).
If you see any of these signs, contact your veterinarian immediately.

If my pet gets too much of this medication (an overdose), what should I do?

If you witness or suspect an overdose, contact your veterinarian or an animal poison control center for further advice. Animal poison control centers that are open 24 hours a day include Pet Poison HELPLINE (855-764-7661) and ASPCA Animal Poison Control Cen- ter (888-426-4435); a consultation fee is charged for these services.

©2017 PharmaVet, Inc. ALL RIGHTS RESERVED. Plumb’s® Veterinary Medication Guides have not been reviewed by FDA Center for Veterinary Medicine.

How should this medication be given?

For this medication to work, give it exactly as your veterinarian has prescribed. It’s a good idea to always check the prescription label to be sure you are giving the drug correctly.

XXSpinosad is given monthly when used for flea control.

XXDogs usually willingly eat the chewable tablets when offered them just before feeding, and cats willingly take before or after feeding. Alternatively, tablets can be mixed in food or given like other tablet medications.

XXIf vomiting occurs within an hour of administration, re-dose with another full dose.

XXCompounded liquid forms of this medication must be measured carefully. Your veterinarian or pharmacist can help by providing special measuring spoons or syringes.

XXIf you have difficulty getting your animal to take the medicine, contact your veterinarian or pharmacist for tips to help with dosing and reducing the stress of medication time.

XXThis medication can be given for various lengths of time. Be sure you understand how long your veterinarian wants you
to continue giving this medication. Prescription refills may be necessary before the therapy will be complete. Before stopping this medication, talk to your veterinarian, as there may be important reasons to continue its use.

What should I do if I miss giving a dose of this medication?

If you miss a dose, give it when you remember, and then wait the amount of time between doses recommended by your veterinarian before giving another dose. Do not double-up or give extra doses.

How should I store this medication?

XXStore this medication in the original prescription container or an approved dosage reminder container (ie, pill minder) at room temperature and protected from light.

XXIf your veterinarian or pharmacist has made (compounded) a special formulation for your animal, follow the storage recommendations and expiration date for the product.

XXKeep away from children and other animals.

Can handling this medication be hazardous to me, my family, or other pets?

There are no specific precautions required when handling this med- ication unless you are allergic to it. Wash your hands after handling any medication.

How should I dispose of this medication if I don’t use it all?

XXDo not flush this medication down the toilet or wash it down the sink. If a community drug “take-back” program is available, use this option. If there is no take-back program, mix the drug with coffee grounds or cat litter (to make it undesirable to children and animals and unrecognizable to people who might go through your trash), place the mixture in a sealable plastic bag to keep it from leaking out, and throw the bag out with the regular trash.

XXDo not save left over medication for future use or give it to others to use.

What other information is important for this medication?

XXTreatment with spinosad may begin at any time of the year but should preferably start 1 month before fleas become active
and continue monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment should continue year round without stopping.

XXTo reduce the chance of flea reinfestation, all animals in the household must be treated with an approved flea protection product.

XXUse of this drug may not be allowed in certain animal competitions. Check rules and regulations before entering your animal in a competition while this medication is being administered.

If you have any other questions or concerns about this medica- tion, contact your veterinarian or pharmacist.

©2017 PharmaVet, Inc. ALL RIGHTS RESERVED. Plumb’s® Veterinary Medication Guides have not been reviewed by FDA Center for Veterinary Medicine.

Spinosad with Milbemycin

(spin-oh-sad with mil-beh-my-sin)
Category: Heartworm Preventive; Agent to Treat and Control Intestinal Parasites; Kills Adult FleasOther Names for this Medication: Trifexis®
Common Dosage Forms: Veterinary: (Spinosad/Milbemycin) 140 mg/2.3 mg, 270 mg/4.5 mg,

560 mg/9.3 mg, 810 mg/13.5 mg, & 1620 mg/27 mg flavored oral tablets. Human: None.

This information sheet does not contain all available information for this medication. It is to help answer commonly asked questions and help you give the medication safely and

effectively to your animal. If you have other questions or need more information about this medication, contact your veterinarian or pharmacist.

Key Information

X Oral combination product given monthly to kill adult fleas, prevent heartworm infection, and control hookworms, roundworms, and whipworms in dogs. This combination product does not kill ticks.

X Give medication with food.
X When used as directed by the label, spinosad with

milbemycin appears safe.

X This drug combination can be harmful to wildlife, so dispose of unused drugs carefully.

X Keep chewable tablets well out of reach of children and animals.

How is this medication useful?

Spinosad with milbemycin is given for the prevention of heartworm disease, prevention and treatment of flea infestations, and the treatment and control of hookworm, roundworm, and whipworm infections in dogs and puppies 8 weeks of age or older that weigh at least 5 pounds.

The FDA (U.S. Food & Drug Administration) has approved this drug combination for use in dogs. The FDA allows veterinarians to pre- scribe and use products containing this drug in different species or for other conditions in certain situations. You and your veterinarian can discuss why this drug is the most appropriate choice.

What should I tell my veterinarian to see if this medication can be safely given?

Many things might affect how well this drug will work in your animal. Be sure to discuss the following with your veterinarian so together you can make the best treatment decisions.
XXOther drugs can interact with this drug combination, so be

sure to tell your veterinarian and pharmacist what medications (including vitamins, supplements, or herbal therapies) you give your animal, including the amount and time you give each.

XXTell your veterinarian about any conditions or diseases your animal may have now or has had in the past.

XXIf your animal has been treated for the same disease or condition in the past, tell your veterinarian about the treatment and how well it did or didn’t work.

XXIf your animal is pregnant or nursing, talk to your veterinarian about the risks of using this drug.

XXTell your veterinarian and pharmacist about any medication side effects (including allergic reactions, lack of appetite, diarrhea, itching, hair loss) your animal has developed in the past.

When should this medication not be used or be used very carefully?

No drug is 100% safe in all patients, but your veterinarian will discuss with you any specific concerns about using this drug in your animal.

This drug SHOULD NOT be used in patients:
XXThat are allergic to spinosad, milbemycin, or other avermectin

drugs (eg, ivermectin, selamectin).
This drug should be used WITH CAUTION in patients:

XXThat have not been tested for heartworm infection. Shock- like reactions can occur if milbemycin is given to animals with heartworm infection.

XXThat are pregnant, nursing, or used for breeding; safe use in these animals has not been determined.

XXWith a seizure disorder (eg, epilepsy).
XXLess than 8 weeks old and that weigh less than 5 lb (dogs); safe

use in these animals has not been determined.

If your animal has any of these conditions, talk to your veterinarian about the potential risks versus benefits.

What are the side effects of this medication?

In dogs, spinosad with milbemycin is usually tolerated well.

Common but not serious side effects include:

XXVomiting, diarrhea.XXExcessive salivation (drooling).XXItching.
XXTrembling.
XXDepression, lack of energy.XXReduced appetite.
XXSkin reddening.

You don’t have to be overly concerned if you see any of these signs unless they are severe, worsen, or continue to be a problem. Con- tact your veterinarian if this happens.

Side effects that may be serious or indicate a serious problem:

XXStumbling, incoordination, weakness.
XXSeizures (convulsions).
If you see any of these signs, contact your veterinarian immediately.

If my pet gets too much of this medication (an overdose), what should I do?

If you witness or suspect an overdose, contact your veterinarian or an animal poison control center for further advice. Animal poison control centers that are open 24 hours a day include Pet Poison HELPLINE (855-764-7661) and ASPCA Animal Poison Control Cen- ter (888-426-4435); a consultation fee is charged for these services.

©2017 PharmaVet, Inc. ALL RIGHTS RESERVED. Plumb’s® Veterinary Medication Guides have not been reviewed by FDA Center for Veterinary Medicine.

How should this medication be given?

For this medication to work, give it exactly as your veterinarian has prescribed. It’s a good idea to always check the prescription label to be sure you are giving the drug correctly.

XXThe spinosad with milbemycin combination product is given once a month.

XXThe chewable tablets are usually willingly eaten by dogs when offered just before feeding. Alternatively, the tablets can be mixed in food or given like other tablet medications.

XXIf vomiting occurs within an hour of administration, re-dose with another full dose.

XXIf you have difficulty getting your animal to take the medicine, contact your veterinarian or pharmacist for tips to help with dosing and reducing the stress of medication time.

XXThis medication can be given for various lengths of time. Be sure you understand how long your veterinarian wants you to continue giving this medication. Prescription refills may be necessary before the therapy will be complete. If you want to stop giving this medication, talk to your veterinarian, as there may be important reasons to continue giving it.

XXTreatment with fewer than 3 monthly doses after the last exposure to mosquitoes may not provide heartworm prevention.

What should I do if I miss giving a dose of this medication?

XXIf you miss a dose, give it when you remember and then wait the amount of time between doses recommended by your veterinarian before giving another dose. Do not double-up or give extra doses.

XXWhen using this product for heartworm prevention, if more than 8 weeks have passed without giving this medication, start giving the drug as soon as you remember. After that, continuing giving the medication monthly, but make sure to have your animal tested for heartworm infection 6 months later, as your dog may have become infected during the time the medication was not given.

How should I store this medication?

XXStore this medication in the original prescription bottle or an approved dosage reminder container (ie, pill minder) at room temperature and protected from light.

XXIf your veterinarian or pharmacist has made (compounded) a special formulation for your animal, follow the storage recommendations and expiration date for the product.

XXKeep chewable tablets well out of reach of children and animals.

Can handling this medication be hazardous to me, my family, or other pets?

There are no specific precautions required when handling this med- ication unless you are allergic to it. Wash your hands after handling any medication.

How should I dispose of this medication if I don’t use it all?

XXDispose of spinosad with milbemycin carefully, as it can be toxic to wildlife.

XXDo not flush this medication down the toilet or wash it down the sink. If a community drug “take-back” program is available, use this option. If there is no take-back program, mix the drug with coffee grounds or cat litter (to make it undesirable to children and animals and unrecognizable to people who might go through your trash), place the mixture in a sealable plastic bag to keep it from leaking out, and throw the bag out with the regular trash.

XXDo not save left over medication for future use or give it to others to use.

What other information is important for this medication?

XXTreatment with spinosad with milbemycin may begin at any time of the year, preferably starting 1 month before fleas or mosquitos become active and continuing monthly through the end of mosquito or flea season. In areas where fleas or mosquitos are common year-round, monthly treatment should continue the entire year without stopping.

XXTo reduce the chance of flea reinfestation, all animals in the household must be treated with an approved flea protection product.

XXUse of this drug may not be allowed in certain animal competitions. Check rules and regulations before entering your animal in a competition while this medication is being administered.

If you have any other questions or concerns about this medica- tion, contact your veterinarian or pharmacist.

©2017 PharmaVet, Inc. ALL RIGHTS RESERVED. Plumb’s® Veterinary Medication Guides have not been reviewed by FDA Center for Veterinary Medicine.