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Comfortis Chewable Flea Tablets

Comfortis Chewable Flea Tablets

Comfortis tablets are given once a month to control fleas on dogs and cats. The drug is lethal to blood sucking insects but has little or no effect on dogs. (Occasionally dogs will vomit after taking a tablet.) It is best to give Comfortis with food. This reduces the chances of vomiting as well as enabling a more persistent flea-killing effect afterwards, so that one tablet will last for the whole month. Comfrotis tablets come in five different sizes to suit dogs of different body weights and two sizes for cats. Comfortis is not recommended for dogs under 14 weeks of age, or less than 3.9kg bodyweight.

See below the list of products for the Dosage information for dogs and cats.

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Description

Comfortis chewable tablets for Dogs and Cats

Presentation

Comfortis chewable tablets are unscored tan to brown, or speckled, round, flat, bevelled-edge tablets, plain on one side, and debossed on the other side with a number as listed below;

140mg:4222

425mg:4229

1040mg:4231

1620mg:4227

Or debossed on the other side with an underlined number as below;

90mg:4221

270mg:4223

665mg:4230

-

Uses

Dogs and Cats: Treatment and prevention of flea infestations (Ctenocephalides felis).

The preventative effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for upto 4 weeks after administration.

Comfortis can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).

Dosage and administration

Comfortis tablets are administered orally at the following recommended doses at monthly intervals;

Dogs: 45-70 mg/kg

Cats: 50-75 mg/kg

Weight of Dog (kg)

Number of tablets and tablet strength (mg spinosad)

Weight of Cat (kg)

1.3 - 2.0

2.1 - 3.0

3.1 - 3.8

3.9 - 6.0

6.1 - 9.4

1 x 90 mg

1 x 140 mg

2 x 90 mg

1 x 270 mg

1 x 425 mg

1 2 - 1.8

1.9 - 2.8

2.9 - 3.6

3.7 - 5.4

5.4 - 8.5

9.5 - 14.7

14.8 - 23.1

23.2 - 36.0

36.1 - 50.7

50.8 - 72

1 x 665 mg

1 x 1040 mg

1 x 1620 mg

1 x 1620 mg + 1 x 665 mg

2 x 1620 mg

For cats over 8.5kg use appropriate combination of tablets listed above.

Comfortis tablets should be administered at the recommended doses with the following advice:

Comfortis tablets should be administered with or immediately after feeding. The duration of efficacy may be reduced if administered on an empty stomach.

If vomiting occurs within an hour of ingestion and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product.

If a dose is missed, administer Comfortis with the next offering of food and resume a monthly dosing schedule.

Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment. Regular monthly treatments with Comfortis breaks the fleas' life cycle. This is achieved by the capability of spinosad to rapidly kill adult fleas and therefore greatly reduce egg production.

All dogs and cats in the household should be treated.

Contra-indications, warnings, etc

Do not use in dogs or cats under 14 weeks of age.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

Special precautions for use in animals

Use with caution in dogs and cats with pre-existing epilepsy. Accurate dosing is not possible in dogs weighing less than 1.3kg and in cats weighing less than 1.2kg. Therefore use in patients under these minimum weights is not recommended.

Use during pregnancy, lactation or lay

In laboratory species (rats and rabbits) spinosad has not produced any evidence of teratogenic, foetotoxic or maternotoxic effects nor any effect on the reproductive capacity in males and females. In pregnant dogs, the safety of spinosad has not been sufficiently established. The safety of spinosad in pregnant cats has not been evaluated. In dogs, spinosad is excreted in milk and colostrum and it is therefore assumed that spinosad is also excreted in the milk and colostrum of cats. As safety in suckling puppies and kittens has not been established, Comfortis tablets should only be used in pregnancy and lactation according to the risk/benefit assessment by the responsible veterinary surgeon.

The safety of Comfortis tablets in male dogs and cats used for breeding has not been determined.

Adverse Reactions (frequency and seriousness)

The most commonly observed adverse event in dogs and cats is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.

Dogs: On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg, the observed incidence of vomiting in field trials was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments repectively. The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band. In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.

Other adverse events in dogs were uncommon or rare, and include lethargy, anorexia, diarrhoea, ataxia and seizures.

Cats: On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg, the observed incidence of vomiting in a global field trial was 6-11% in the first 3 months of treatment. In the majority of cases, vomiting was transient, mild and did require symptomatic treatment.

Other commonly observed adverse reactions were diarrhoea and anorexia. Lethargy, loss of condition, and salivation were uncommon. Seizures were rare adverse reactions.

Overdose

The incidence of vomiting on the day of, or the day after dosing has been observed to increase as a function of dose in both dogs and cats. At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs. At a dose of 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.

At doses of upto 100 mg/kg administered daily for 10 consecutive days, the only observed clinical symptom was vomiting which occurred usually within 2.5 hours of dosing. Mild elevations of ALT (alanine aminotransferase) were observed, although values returned to their baseline by day 24 (14 days after the final dose). Phospholipidosis (vacuolation of lymphoid tissues) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.

There is no antidote available. In the event of an overdose or adverse reaction, the animal may be given symptomatic treatment if deemed necessary.

Interactions

Spinosad has been shown to be a substrate for P-glycoprotein (PgP). Spinosad could therefore interact with other PgP substrates (for example digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.

Post marketing reports, following the concomitant use of Comfortis with 'off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.

Special precautions to be taken by the person administering Comfortis tablets to animals.

Accidental ingestion may cause adverse reactions. In the case of accidental ingestion, seek medical advise immediately and show the package leaflet or the label to the physician.

Keep out of reach and sight of children.

Wash hands after administering Comfortis tablets.

Pharmaceutical precautions

For animal treatment only.

Keep the blister pack in the cardboard carton.

Any unused veterinary medicinal product, or waste material derived from the veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cardboard cartons containing clear PCTFE/PE/PVC blister packs sealed with aluminium foil containing 3 or 6 chewable tablets.

Not all pack sizes may be marketed.

Further information

Comfortis starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours. Insecticidal activity against new infestations persists for up to 4 weeks.

Spinosad comprises spinosyns A and D. The insecticidal activity of spinosad is characterised by nervous excitation, leading to muscle contractions, tremors, prostration, paralysis and rapid death of the flea. These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs). There is no known interaction at the binding site with other nicotinic or GABAergic receptors as spinosad acts through a novel insecticidal mechanism.

In dogs and cats, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration. Maximum plasma concentrations are reached in 2-4 hours in dogs, and 4-12 hours in cats. AUC and Cmax values are higher in fed than fasted dogs and cats and therefore it is recommended to administer Comfortis with food in both species as this maximises the opportunity for fleas to ingest lethal amounts of spinosad. Excretion of spinosad and its metabolites is primarily in the bile and faeces, and to a lesser extent in urine in dogs. In cats, excretion is primarily via the faeces, and also to a lesser extent in the urine.

Marketing Authorisation Holder (if different from distributor)

-

Marketing authorisation number

EU/2/10/115/001 to 019.

Comfortis chewable tablets for Dogs and Cats

Presentation

Comfortis chewable tablets are unscored tan to brown, or speckled, round, flat, bevelled-edge tablets, plain on one side, and debossed on the other side with a number as listed below;

140mg:4222

425mg:4229

1040mg:4231

1620mg:4227

Or debossed on the other side with an underlined number as below;

90mg:4221

270mg:4223

665mg:4230

-

Uses

Dogs and Cats: Treatment and prevention of flea infestations (Ctenocephalides felis).

The preventative effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for upto 4 weeks after administration.

Comfortis can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).

Dosage and administration

Comfortis tablets are administered orally at the following recommended doses at monthly intervals;

Dogs: 45-70 mg/kg

Cats: 50-75 mg/kg

Weight of Dog (kg)

Number of tablets and tablet strength (mg spinosad)

Weight of Cat (kg)

1.3 - 2.0

2.1 - 3.0

3.1 - 3.8

3.9 - 6.0

6.1 - 9.4

1 x 90 mg

1 x 140 mg

2 x 90 mg

1 x 270 mg

1 x 425 mg

1 2 - 1.8

1.9 - 2.8

2.9 - 3.6

3.7 - 5.4

5.4 - 8.5

9.5 - 14.7

14.8 - 23.1

23.2 - 36.0

36.1 - 50.7

50.8 - 72

1 x 665 mg

1 x 1040 mg

1 x 1620 mg

1 x 1620 mg + 1 x 665 mg

2 x 1620 mg

For cats over 8.5kg use appropriate combination of tablets listed above.

Comfortis tablets should be administered at the recommended doses with the following advice:

Comfortis tablets should be administered with or immediately after feeding. The duration of efficacy may be reduced if administered on an empty stomach.

If vomiting occurs within an hour of ingestion and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product.

If a dose is missed, administer Comfortis with the next offering of food and resume a monthly dosing schedule.

Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment. Regular monthly treatments with Comfortis breaks the fleas' life cycle. This is achieved by the capability of spinosad to rapidly kill adult fleas and therefore greatly reduce egg production.

All dogs and cats in the household should be treated.

Contra-indications, warnings, etc

Do not use in dogs or cats under 14 weeks of age.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

Special precautions for use in animals

Use with caution in dogs and cats with pre-existing epilepsy. Accurate dosing is not possible in dogs weighing less than 1.3kg and in cats weighing less than 1.2kg. Therefore use in patients under these minimum weights is not recommended.

Use during pregnancy, lactation or lay

In laboratory species (rats and rabbits) spinosad has not produced any evidence of teratogenic, foetotoxic or maternotoxic effects nor any effect on the reproductive capacity in males and females. In pregnant dogs, the safety of spinosad has not been sufficiently established. The safety of spinosad in pregnant cats has not been evaluated. In dogs, spinosad is excreted in milk and colostrum and it is therefore assumed that spinosad is also excreted in the milk and colostrum of cats. As safety in suckling puppies and kittens has not been established, Comfortis tablets should only be used in pregnancy and lactation according to the risk/benefit assessment by the responsible veterinary surgeon.

The safety of Comfortis tablets in male dogs and cats used for breeding has not been determined.

Adverse Reactions (frequency and seriousness)

The most commonly observed adverse event in dogs and cats is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.

Dogs: On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg, the observed incidence of vomiting in field trials was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments repectively. The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band. In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.

Other adverse events in dogs were uncommon or rare, and include lethargy, anorexia, diarrhoea, ataxia and seizures.

Cats: On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg, the observed incidence of vomiting in a global field trial was 6-11% in the first 3 months of treatment. In the majority of cases, vomiting was transient, mild and did require symptomatic treatment.

Other commonly observed adverse reactions were diarrhoea and anorexia. Lethargy, loss of condition, and salivation were uncommon. Seizures were rare adverse reactions.

Overdose

The incidence of vomiting on the day of, or the day after dosing has been observed to increase as a function of dose in both dogs and cats. At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs. At a dose of 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.

At doses of upto 100 mg/kg administered daily for 10 consecutive days, the only observed clinical symptom was vomiting which occurred usually within 2.5 hours of dosing. Mild elevations of ALT (alanine aminotransferase) were observed, although values returned to their baseline by day 24 (14 days after the final dose). Phospholipidosis (vacuolation of lymphoid tissues) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.

There is no antidote available. In the event of an overdose or adverse reaction, the animal may be given symptomatic treatment if deemed necessary.

Interactions

Spinosad has been shown to be a substrate for P-glycoprotein (PgP). Spinosad could therefore interact with other PgP substrates (for example digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.

Post marketing reports, following the concomitant use of Comfortis with 'off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.

Special precautions to be taken by the person administering Comfortis tablets to animals.

Accidental ingestion may cause adverse reactions. In the case of accidental ingestion, seek medical advise immediately and show the package leaflet or the label to the physician.

Keep out of reach and sight of children.

Wash hands after administering Comfortis tablets.

Pharmaceutical precautions

For animal treatment only.

Keep the blister pack in the cardboard carton.

Any unused veterinary medicinal product, or waste material derived from the veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cardboard cartons containing clear PCTFE/PE/PVC blister packs sealed with aluminium foil containing 3 or 6 chewable tablets.

Not all pack sizes may be marketed.

Further information

Comfortis starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours. Insecticidal activity against new infestations persists for up to 4 weeks.

Spinosad comprises spinosyns A and D. The insecticidal activity of spinosad is characterised by nervous excitation, leading to muscle contractions, tremors, prostration, paralysis and rapid death of the flea. These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs). There is no known interaction at the binding site with other nicotinic or GABAergic receptors as spinosad acts through a novel insecticidal mechanism.

In dogs and cats, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration. Maximum plasma concentrations are reached in 2-4 hours in dogs, and 4-12 hours in cats. AUC and Cmax values are higher in fed than fasted dogs and cats and therefore it is recommended to administer Comfortis with food in both species as this maximises the opportunity for fleas to ingest lethal amounts of spinosad. Excretion of spinosad and its metabolites is primarily in the bile and faeces, and to a lesser extent in urine in dogs. In cats, excretion is primarily via the faeces, and also to a lesser extent in the urine.

Marketing Authorisation Holder (if different from distributor)

-

Marketing authorisation number

EU/2/10/115/001 to 019.

Need help or advice? Contact us:

  • Freephone: 0800 084 2608
  • Mon - Fri: 8:30am - 7:00pm
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  • Email: support@viovet.co.uk

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