What is eprinomectin + praziquantel?

Eprinomectin + praziquantel (brand name Centragard®) is a topical (spot-on) antiparasitic drug used to treat and control hookworm, roundworm, and tapeworm infections, and to prevent heartworm disease in cats and kittens that are at least 7 weeks of age and weigh at least 0.8 kg (1.8 lbs).

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It may be used off label (extra label) in other species. Many drugs are commonly prescribed for off-label use in veterinary medicine. 'Off label' means the drug is being used in a way that has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) or Health Canada. In these instances, follow your veterinarian's directions and cautions carefully, as they may be significantly different from those on the label.

How do I give my pet eprinomectin + praziquantel?

Eprinomectin + praziquantel comes in topical solution form.

• Topical solutions are applied directly onto the skin. Part the fur at the base of the head and apply the product directly to visible skin as per manufacturer instructions.
• Do not apply to broken skin or wet fur.
• Do not allow your pet to contact the application site for at least 5 hours after applying the medication.
• Do not allow this medication to touch the eyes or mouth.

This medication should take effect within 1 to 2 days; however, effects may not be noted outwardly for several days.

What if I miss giving my pet the medication?

If you miss a dose, give it as soon as you remember, and then continue with the regular dosing schedule. However, if it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not give the pet two doses at once.

Are there any potential side effects from eprinomectin + praziquantel?

Eprinomectin + praziquantel may cause the following side effects:

• scratching or irritation at site of application
• lack of appetite and/or energy
• vomiting
• fur loss

The following reactions are rare, but if they occur, contact your veterinarian immediately:

• an allergic reaction such as irregular breathing, rash, fever, puffiness and swelling around the face
• neurologic toxicity in cats with two copies of the MDR1 mutation:
  • unsteady gait (ataxia)
  • drooling
  • tremors
  • weakness and/or partial paralysis
  • coma
  • seizures
  • death

Drug sensitivities can develop over time with repeated exposure. Your pet may have no reaction after the first few doses but may develop a sensitivity later. It is important to watch for signs of an allergic reaction over the entire course of treatment.

Other side effects may occur. If you notice anything unusual, contact your veterinarian immediately. This moderate-acting medication lasts for several days, although effects can be longer in pets with liver or kidney disease.

Are there any risk factors for this medication?

Eprinomectin + praziquantel should NOT BE USED in cats who:

• are allergic to any component of the medication
• are under 7 weeks of age or under 0.8 kg (1.8 lb)
• are known to have two copies of the MDR1 mutation

Eprinomectin + praziquantel should be USED WITH CAUTION in cats who:

• are pregnant or used for breeding 
• have tested positive for heartworm disease

Are there any drug interactions I should be aware of?

Certain medications should be USED WITH CAUTION when given with eprinomectin + praziquantel, including:

• albendazole
• azole antifungals
• cimetidine
• medications that affect CYP34A (e.g., dexamethasone, phenobarbital, rifampin, fluoxetine)
• medications that affect P-glycoprotein (e.g., amiodarone, cyclosporine, digoxin, spironolactone)
• medications or supplements containing grapefruit juice

Be sure to tell your veterinarian about any medications (including vitamins, supplements, or herbal therapies) that your pet is taking before starting any new treatment.

Is any monitoring needed with this medication?

• Your veterinarian may schedule follow-up visits for monitoring. In this case, follow your veterinarian's directions.
• At home, monitor for any abnormal changes. If these occur, discontinue the medication and contact your veterinarian.

How do I store eprinomectin + praziquantel?

• Store protected from light at or below 30°C (86°F).
• Keep medication out of reach of children and pets.

What should I do in case of emergency?

If you suspect an overdose or an adverse reaction to the medication, call your veterinary office immediately. If they are not available, follow their directions in contacting an emergency facility.

Approved by FDA under NADA # 141-079

Parasiticide

Contains 5 mg eprinomectin/mL

Not for use in calves to be processed for veal.

INTRODUCTION

EPRINEX Pour-On delivers effective internal and external parasite control in one application. Discovered and developed by scientists from Merck Research Laboratories, EPRINEX Pour-On contains eprinomectin, a unique avermectin. Its broad-spectrum efficacy in a weatherproof formulation, margin of safety, zero slaughter withdrawal and zero milk discard, make it a convenient product for parasite control in beef and dairy cattle, including lactating dairy cattle.

MODE OF ACTION

Eprinomectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.

This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

INDICATIONS

EPRINEX (eprinomectin) Pour-On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.

Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, EPRINEX Pour-On is indicated for the effective treatment and control of the following parasites.

Gastrointestinal Roundworms

  Haemonchus placei

(adults and L4)

  Ostertagia ostertagi (including inhibited L4)

(adults and L4)

  Trichostrongylus axei

(adults and L4)

  Trichostrongylus colubriformis

(adults and L4)

  Trichostrongylus longispicularis

(adults only)

  Cooperia oncophora

(adults and L4)

  Cooperia punctata

(adults and L4)

  Cooperia surnabada

(adults and L4)

  Nematodirus helvetianus

(adults and L4)

  Oesophagostomum radiatum

(adults and L4)

  Bunostomum phlebotomum

(adults and L4)

  Strongyloides papillosus

(adults only)

  Trichuris spp.

(adults only)

Lungworms

  Dictyocaulus viviparus

(adults and L4)

Cattle Grubs (all parasitic stages)

  Hypoderma lineatum, Hypoderma bovis

Lice

  Damalinia bovis, Linognathus vituli, Haematopinus

  eurysternus, Solenopotes capillatus

Mange Mites

  Chorioptes bovis, Sarcoptes scabiei

Horn Flies

  Haematobia irritans

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Persistent Activity

EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment.

Use Conditions

Varying weather conditions, including rainfall, do not affect the efficacy of EPRINEX Pour-On.

Management Considerations for Treatment of External Parasites

For best results EPRINEX Pour-On should be applied to all cattle in the herd. Cattle introduced to the herd later should be treated prior to introduction. Consult your veterinarian or an entomologist for the most effective timing of applications for the control of external parasites.

Chorioptic Mange: In clinical studies evaluating the efficacy of EPRINEX Pour-On against chorioptic mange mites, mites were not recovered from skin scrapings taken 8 weeks after treatment; however, chronic skin lesions were still present on some animals.

Horn flies: For optimal control of horn flies, as EPRINEX Pour-On provides 7 days of persistent activity against horn flies, the product should be used as part of an integrated control program utilizing other control methods to provide extended control.

DOSAGE

The product is formulated only for external application to beef and dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. The product should be applied topically along the backline in a narrow strip extending from the withers to the tailhead.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

ADMINISTRATION

Metering Cup with Measure-Squeeze-Pour System

250 mL (8.5 fl oz) Container with 25 mL Metering Cup

1 Liter (33.8 fl oz) Container with 60 mL Metering Cup

This pack contains 1 Metering Cup and 1 dip tube

1.

Insert the dip tube into base of the Metering Cup. Leave the "slotted end" of the dip tube exposed in the bottom of the container.

2.

Unscrew shipping cap from container top.

3.

Screw the Metering Cup onto container top.

4.

Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting.

5.

Squeeze the container gently to fill the Metering Cup to the required dose. Release your grip and any excess will return to the container.

6.

Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty.

7.

Storage: The Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top.

Collapsible Pack (2.5 L/84.5 fl oz, 5 L/169 fl oz, and 10 L/338 fl oz Packs)

Connect the dosing applicator and draw-off tubing to the collapsible pack as follows:

Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem that is included in the pack (10 L contains two caps ' one for inverted use and the other for upright use). Replace the shipping cap with the cap having the draw-off tubing.

Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing.

20 Liter Pack (20 L/676 fl oz Pack)

Connect the dosing applicator and draw-off tubing to the container as follows:

Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap having the draw-off tubing.

Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing.

ANIMAL SAFETY

Tolerance and toxicity studies have demonstrated the margin of safety for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance study, one of 6 cattle treated once at 10 times the recommended dose showed clinical signs of mydriasis. Application of 3 times the recommended dose had no adverse effect on breeding performance of cows or bulls.

Residue Warnings: When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time is required, therefore, meat and milk from cattle treated with EPRINEX (eprinomectin) Pour-On may be used for human consumption at any time following treatment. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.

WARNING:

Keep this and all drugs out of the reach of children.

NOT FOR USE IN HUMANS.

As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The Safety Data Sheet (SDS) contains more detailed occupational safety information.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at www.fda.gov/reportanimalae.

PRECAUTIONS

This product is for topical application only. Do not administer orally or by injection.

Do not apply to areas of the backline covered with mud or manure.

EPRINEX Pour-On is not recommended for use in species other than cattle. Severe adverse reactions have been reported in other species treated with products containing compounds of this class.

Restricted Drug (California) - Use only as directed.

When to Treat Cattle with Grubs

EPRINEX Pour-On is effective against all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to eprinomectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H.bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with EPRINEX Pour-On at the end of the fly season may be re-treated with EPRINEX Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

OTHER WARNINGS

Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.

Treatment with a dewormer used in conjunction with parasite management practices appropriate to the

geographic area and the animal(s) to be treated may slow the development of parasite resistance.

Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).

A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may

indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

Environmental Safety

Studies indicate that when eprinomectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free eprinomectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, eprinomectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

STORAGE CONDITIONS

Store bottle or pack in the carton to protect from light and at temperatures up to 86°F/30°C. Storage at temperatures up to 104°F/40°C is permitted for a short period of time, however, such exposure should be minimized.

For the 250 mL/8.5 fl oz () or 1 L/33.8 fl oz () bottle with a measure-squeeze-pour system, the Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top.

HOW SUPPLIED

EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle is available in a 250 mL/8.5 fl oz () or 1 L/33.8 fl oz () bottle with a measure-squeeze-pour system, or in a 2.5 L/84.5 fl oz (), 5 L/169 fl oz (), or 10 L/338 fl oz () collapsible pack or 20 L/676 fl oz () container intended for use with appropriate automatic dosing equipment.

Marketed by: Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA

®EPRINEX is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.

© Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

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Rev. 09-

Principal Display Panel - 250 mL Bottle Carton

Product

Eprinex®

Pour-On for Beef
and Dairy Cattle
(eprinomectin)

Parasiticide
Contains 5 mg eprinomectin/mL

For Treatment and Control of Internal and External Parasites

Residue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard

Contains 10 Doses (550 lb)

Approved by FDA under NADA # 141-079

250 mL (8.5 fl oz)

Principal Display Panel ' 250 mL Container Label

Product

Eprinex®

Pour-On for Beef
and Dairy Cattle
(eprinomectin)

Parasiticide
Contains 5 mg eprinomectin/mL

For Treatment and Control of Internal and External Parasites

Residue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard

Approved by FDA under NADA # 141-079

250 mL (8.5 fl oz)

Contact us to discuss your requirements of Eprinomectin Api Manufacturers. Our experienced sales team can help you identify the options that best suit your needs.