Ethiqa XR: Product Information

ETHIQA XR- buprenorphine hydrochloride injection, suspension, extended release
Fidelis Animal Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ethiqa XR® SCHEDULE(buprenorphine extended-release injectable suspension) 1.3 mg/mL

Opioid Analgesic

For subcutaneous use in mice, rats, and ferrets.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

LEGAL STATUS–In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED–MIF 900-014. Extra-label use is prohibited.

This product is not to be used in animals intended for use as food for humans or food-producing animals.

HUMAN SAFETY WARNING

Abuse Potential ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.

Accidental Exposure Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.

Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

See HUMAN SAFETY WARNINGS for detailed information.

DESCRIPTION

Ethiqa XR is an injectable suspension of extended-release buprenorphine. Buprenorphine hydrochloride, an opioid analgesic, is the active ingredient in Ethiqa XR. Lipid-bound buprenorphine hydrochloride is suspended in medium chain fatty acid triglyceride (MCT) oil. Lipids encapsulate the buprenorphine limiting diffusion which provides for larger doses and prolonged action.1,2 Ethiqa XR has a slightly yellow to white opaque appearance. Each mL contains approximately 1.3 mg buprenorphine hydrochloride. The sterile product contains cholesterol, benzyl alcohol, glyceryl tristearate, and buprenorphine hydrochloride suspended in MCT oil. Buprenorphine belongs to the opioid class of drugs and is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine.

Buprenorphine

Formula C29 H41 NO4

STRUCTURE
(click image for full-size original)

INDICATIONS

Ethiqa XR is indicated for the control of post-procedural pain in mice, rats, and ferrets.

DOSAGE AND ADMINISTRATION

Wear protective clothing when administering Ethiqa XR. Do not dispense Ethiqa XR for administration at home by the pet owner (see HUMAN SAFETY WARNINGS).

It is important to carefully assess pain in each individual animal or experimental group and adjust the timing of Ethiqa XR administration accordingly. For mice, therapeutic blood levels are achieved within 30 minutes of administration7 , for rats within 6 hours4 , and for ferrets within 30 minutes.6

Dosing The dosage of Ethiqa XR is a single subcutaneous injection. At the recommended doses, therapeutic blood levels are maintained for 72 hours after the initial dose. If needed, a single repeat dose may be administered 72 hours after the initial dose.

TABLE: DOSING FOR ETHIQA XR

Species Dose mg/Kg Body Weight
Mouse 3.25 mg/Kg
Rat 0.65 mg/Kg
Ferret 0.6 mg/Kg

For example, the dose for a 20-gram mouse would be a single subcutaneous injection of 0.05 mL (3.25 mg/Kg body weight).

Administration
Shake the vial briefly before each use to ensure uniform suspension. If stored refrigerated, bring to room temperature before use.

Use aseptic techniques to withdraw the dose into a disposable 0.5- or 1-mL syringe. A 20-to-23-gauge needle should be used for injections due to the viscosity of the drug suspension.

Administer Ethiqa XR using minimally stressful restraint techniques, or in sedated animals.

Inject the entire dose into the dorsal subcutaneous space.

An oily sheen may be observed in the dorsal fur after injection. This is due to leakage of Ethiqa XR, which is an oil-based drug suspension, from the injection site. The oily sheen may last for 4 to 5 days post-injection. Leakage from the injection site can be minimized by slowly injecting Ethiqa XR into the subcutaneous space.

The animal can be returned to its cage immediately after receiving Ethiqa XR. (See CONTRADICTIONS , PRECAUTIONS , and ADVERSE REACTIONS for additional information on bedding).

Do not return any unused drug suspension from the syringe back into the vial.

CONTRAINDICATIONS

Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection.

Do not use in animals with pre-existing respiratory compromise.

Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Signs of nausea, including pica, have been observed in rats for up to 3 days post-treatment with Ethiqa XR. Pica involving wood chip type bedding can be lethal (see ADVERSE REACTIONS).

HUMAN SAFETY WARNINGS


Not for use in humans. Keep this and all medications out of reach of children and pets.

Human User Safety While Handling Ethiqa XR in the Hospital:
Ethiqa XR should only be handled and administered by a veterinarian, veterinary technician, or laboratory staff trained in the handling of potent opioids.

To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during injection of Ethiqa XR.

Wear protective clothing when administering Ethiqa XR.

Mucous Membrane or Eye Contact During Application:
Direct contact of Ethiqa XR with the eyes, oral, or other mucous membranes could result in absorption of buprenorphine and the potential for adverse reactions. If accidental eye, oral, or other mucous membrane contact is made during application, flush the area with water and contact a physician immediately. If wearing contact lenses, flush the eye first and then remove the contact lens.

Skin Contact During Application:
If human skin is accidentally exposed to Ethiqa XR, wash the exposed area immediately with soap and water and contact a physician. Accidental exposure could result in absorption of buprenorphine and the potential for adverse reactions.

Drug Abuse, Addiction, and Diversion of Opioids:
Controlled Substance:
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids.

Abuse:
Ethiqa XR contains buprenorphine, an opioid substance, that can be abused and is subject to misuse, abuse, and addiction, which may lead to overdose and death. This risk is increased with concurrent use of alcohol and other central nervous system depressants, including other opioids and benzodiazepines.

Ethiqa XR should be handled appropriately to minimize the risk of diversion, including restriction of access, the use of accounting procedures, and proper disposal methods, as appropriate to the clinical setting and as required by law.

Prescription drug abuse is the intentional, non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse.

Storage and Disposal:
Ethiqa XR is a Schedule III opioid. Store in a locked cabinet according to federal and state controlled substance requirements/guidelines. Discard any broached vials after 90 days. Any unused or expired vials must be destroyed by a reverse distributor; for further information, contact your local DEA field office or call Fidelis Animal Health at 1-833-384-4729.

Information for Physician:
Ethiqa XR contains a mu opioid partial agonist (1.3 mg buprenorphine/mL). In the case of an emergency, provide the physician with this package insert. Naloxone may not be effective in reversing respiratory depression produced by buprenorphine. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride has also been used as a respiratory stimulant.

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