Credelio Quattro / Credelio Quattro-CA1 Chewable Tablets for Dogs

Description

Credelio Quattro / Credelio Quattro-CA1 is a prescription flavored chewable medication for dogs and puppies 8 weeks of age or older and weighing at least 3.3 pounds. It combines lotilaner, moxidectin, praziquantel, and pyrantel to provide labeled protection against multiple internal and external parasites.

Credelio Quattro is indicated for the prevention of heartworm disease and the treatment and control of labeled roundworm, hookworm, and tapeworm infections. It kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for one month.

Credelio Quattro is also indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks.

Credelio Quattro-CA1 is conditionally approved for the treatment of infestations caused by New World screwworm (NWS) larvae in dogs and puppies 8 weeks of age or older and weighing at least 3.3 pounds.

Uses & Benefits

• Prevents heartworm disease
• Treats and controls labeled roundworm infections
• Treats and controls labeled hookworm infections
• Treats and controls labeled tapeworm infections
• Kills adult fleas
• Treats and prevents flea infestations
• Treats and controls five labeled tick species for one month
• Prevents Lyme disease infections as a direct result of killing black-legged ticks
• Credelio Quattro-CA1 is conditionally approved for treatment of New World screwworm larval infestations
• Combines four active ingredients in one flavored chewable tablet

How It Works

Credelio Quattro / Credelio Quattro-CA1 combines four active ingredients: lotilaner, moxidectin, praziquantel, and pyrantel.

These active ingredients provide complementary antiparasitic activity against the internal and external parasites included in the product's labeled indications.

Lotilaner is an isoxazoline that provides activity against labeled fleas and ticks. Moxidectin provides activity for heartworm prevention and contributes to labeled intestinal parasite control. Praziquantel provides activity against labeled tapeworms, while pyrantel provides activity against labeled roundworms and hookworms.

Indications

Credelio Quattro is indicated for use in dogs and puppies 8 weeks of age or older and weighing 3.3 pounds or greater for the following:

Heartworm Disease

Prevention of heartworm disease caused by Dirofilaria immitis.

Roundworms

Treatment and control of:

• Immature adult and adult Toxocara canis
• Adult Toxascaris leonina

Hookworms

Treatment and control of:

• Fourth stage larvae, immature adult, and adult Ancylostoma caninum
• Adult Uncinaria stenocephala

Tapeworms

Treatment and control of:

• Dipylidium caninum
• Taenia pisiformis
• Echinococcus granulosus

Fleas

Kills adult fleas and is indicated for the treatment and prevention of flea infestations caused by Ctenocephalides felis.

Ticks

Treatment and control of infestations for one month caused by:

• Amblyomma americanum — Lone star tick
• Dermacentor variabilis — American dog tick
• Ixodes scapularis — Black-legged tick
• Rhipicephalus sanguineus — Brown dog tick
• Haemaphysalis longicornis — Longhorned tick

Lyme Disease

Credelio Quattro is indicated for the prevention of Borrelia burgdorferi infections, also known as Lyme disease, as a direct result of killing Ixodes scapularis vector ticks.

New World Screwworm

Credelio Quattro-CA1 is conditionally approved for the treatment of infestations caused by New World screwworm (NWS; Cochliomyia hominivorax) larvae, or myiasis, in dogs and puppies 8 weeks of age or older and weighing 3.3 pounds or greater.

Credelio Quattro-CA1 is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-619.

Ingredients

Active Ingredients:

Lotilaner
Moxidectin
Praziquantel
Pyrantel, as pyrantel pamoate

Credelio Quattro / Credelio Quattro-CA1 is formulated to provide minimum doses of:

• Lotilaner: 9 mg/lb (20 mg/kg)
• Moxidectin: 0.009 mg/lb (0.02 mg/kg)
• Praziquantel: 2.28 mg/lb (5 mg/kg)
• Pyrantel: 2.28 mg/lb (5 mg/kg), as pamoate salt

Inactive Ingredients:

Refer to the manufacturer label for complete inactive ingredient information.

Directions

Administer Credelio Quattro / Credelio Quattro-CA1 orally according to the dog's body weight.

Administer with food or within 30 minutes after feeding.

Care should be taken to ensure that the dog consumes the complete dose and that no portion of the tablet is lost or refused.

If vomiting occurs within one hour after administration, redose with another full dose.

Administer exactly as prescribed by your veterinarian. Follow the prescription label exactly and veterinarian directions. Do not adjust the dose, frequency, or duration of administration unless directed by your veterinarian.

Weight / Dosage

*Pyrantel as pamoate salt.

Heartworm Prevention

Administer Credelio Quattro at monthly intervals. It may be administered year round or started within one month after the dog's first seasonal exposure to mosquitoes and continued until at least one month after the dog's last seasonal exposure.

When replacing another monthly heartworm preventive, administer the first dose of Credelio Quattro within one month of the last dose of the previous medication.

Roundworm, Hookworm & Tapeworm Treatment and Control

Administer according to the prescribed dosing schedule for treatment and control of the labeled intestinal parasites.

Flea Treatment & Prevention

Administer monthly for treatment and prevention of flea infestations. Fleas can reproduce on untreated animals, so other pets in the household should receive an appropriate flea control product when necessary.

Tick Treatment & Control

Administer monthly for treatment and control of the labeled tick infestations for one month.

New World Screwworm Treatment

If New World screwworm larvae are suspected, seek veterinary care immediately.

Treatment of New World screwworm myiasis includes removal of larvae and appropriate wound care. Veterinary management may also include lesion cleaning, removal of damaged tissue when necessary, and appropriate pain management.

Cautions

• Federal law restricts this drug to use by or on the order of a licensed veterinarian.
• For oral use in dogs only.
• For dogs and puppies 8 weeks of age or older and weighing at least 3.3 pounds.
• Administer with food or within 30 minutes after feeding.
• Not for human use.
• Keep out of reach of children.
• Wash hands after handling.
• Store securely to prevent accidental ingestion by children or animals.
• Contact your veterinarian if your dog experiences a severe or concerning reaction.

Possible Side Effects

The most frequently reported adverse reactions in clinical trials were:

• Vomiting
• Diarrhea

Other adverse reactions observed during clinical evaluation have included gastrointestinal, dermatologic, neurologic, and general clinical signs.

Lotilaner, an ingredient in Credelio Quattro / Credelio Quattro-CA1, belongs to the isoxazoline class. Isoxazolines have been associated with neurologic adverse reactions including:

• Tremors
• Incoordination or ataxia
• Seizures

These reactions have been reported even in dogs without a previous history of seizures.

Contact your veterinarian if your dog develops a severe, persistent, or concerning reaction following administration.

Precautions

Lotilaner, an ingredient in Credelio Quattro / Credelio Quattro-CA1, belongs to the isoxazoline class and has been associated with neurologic adverse reactions such as tremors, incoordination, and seizures, including in dogs without a previous history of seizures.

Use with caution in dogs with a history of seizures or neurologic disorders.

Dogs should be tested for existing heartworm infections before Credelio Quattro / Credelio Quattro-CA1 administration because this medication is not effective against adult heartworms.

At the veterinarian's discretion, dogs with an existing heartworm infection should receive appropriate treatment for adult heartworms.

The safe use of Credelio Quattro / Credelio Quattro-CA1 in breeding, pregnant, or lactating dogs has not been evaluated.

Credelio Quattro-CA1 is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-619.

If you suspect that your dog is infested with New World screwworm larvae, seek veterinary care immediately for treatment that includes removal of larvae and appropriate wound care.

Storage

Store at 15°C to 25°C (59°F to 77°F).

Excursions are permitted between 5°C and 40°C (41°F and 104°F).

Keep Credelio Quattro / Credelio Quattro-CA1 securely stored and out of reach of children and animals.

Disposal

Dispose of unused or expired Credelio Quattro / Credelio Quattro-CA1 tablets and packaging according to applicable local requirements. Keep discarded medication securely out of reach of children and animals.