Ethiqa XR: Product Information

ETHIQA XR- buprenorphine hydrochloride injection, suspension, extended release
Fidelis Pharmaceuticals Llc

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.

Opioid Analgesic SCHEDULE

For subcutaneous use in mice and rats only

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.

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE Abuse Potential Ethiqa XR contains buprenorphine, a high concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration of Ethiqa XR may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological 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 drug or alcohol abuse or addiction) or mental illness (suicidal depression).Because of human safety risks, this drug should be used only with veterinary supervision. Do not dispense Ethiqa XR. Life-Threatening Respiratory Depression The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.

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

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 and rats.

MOUSE DOSAGE AND ADMINISTRATION

Wear protective clothing when administering Ethiqa XR (see Human Safety Warnings).
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.

The dosage of Ethiqa XR is a single subcutaneous injection of 0.05 mL per 20 gram mouse (3.25 mg/kg body weight). Therapeutic drug concentrations are maintained for 72 hours after the initial dose. If needed, a single repeat dose may be administered 72 hours after the initial dose.

Secure the mouse in a scruff-of-the-neck hold. Insert the needle into the dorsal subcutaneous space created by the scruff hold. Inject the entire dose into the dorsal subcutaneous space. An oily sheen may be observed in the dorsal fur of the mouse after injection due to leakage of the 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 mouse can be returned to its cage immediately after receiving Ethiqa XR.

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

Once the vial is broached, Ethiqa XR can be stored at 15° to 25°C (59° – 77°F) or refrigerated for 28 days. DO NOT FREEZE

RAT DOSAGE AND ADMINISTRATION

Wear protective clothing when administering Ethiqa XR (see Human Safety Warnings).

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.

The dosage of Ethiqa XR is a single subcutaneous injection of 0.1 mL per 200 gram rat (0.65 mg/kg body weight). Therapeutic drug concentrations are maintained for 72 hours after the initial dose. If needed, a single repeat dose may be administered 72 hours after the initial dose.

Secure the rat in a passive restraint tube or by holding with a heavy glove with one person to secure the rat and a second person to administer the drug. Insert the needle in the dorsal subcutaneous space. Inject the entire dose into the dorsal subcutaneous space. An oily sheen may be observed in the dorsal fur after injection due to leakage of the 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 rat can be returned to its cage immediately after receiving Ethiqa XR. See CONTRAINDICATIONS and Rat PRECAUTIONS for additional information on bedding.

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

Once the vial is broached, Ethiqa XR can be stored at 15° to 25°C (59° – 77°F) or refrigerated for 28 days. DO NOT FREEZE.

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 on mice or rats with pre-existing respiratory deficiencies.
Do not keep rats on wood chip-type bedding after administration of Ethiqa XR.

HUMAN SAFETY WARNINGS


Not for use in humans. Keep out of the reach of children.

Human User Safety while handling Ethiqa XR:

Two trained staff for administration: 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.

Protective covering: To prevent direct contact of Ethiqa XR with human skin or mucous membranes when handling the suspension, protective clothing is recommended.

Mucous membrane or eye contact during administration: Direct contact of Ethiqa XR with the eyes, oral or other mucous membranes of humans could result in absorption of buprenorphine and the potential for adverse reactions. If accidental eye, oral or other mucous membrane contact is made during administration, flush the area with water and contact a physician.

Skin contact during administration: If human skin is accidentally exposed to Ethiqa XR , wash the exposed area 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 mu opioid partial agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. Ethiqa XR can be abused and is subject to misuse, abuse, addiction, and criminal diversion. 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 laboratory setting and as required by law.

Abuse: Abuse of Ethiqa XR poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances including other opioids and benzodiazepines. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse. Drug abuse is the intentional non-therapeutic use of a prescription drug for its rewarding psychological or physiological effects. Abuse of opioids can occur in the absence of true addiction.

Storage and Discard: Ethiqa XR is a Class III opioid. Store in a locked, substantially constructed cabinet according to DEA and local controlled substance guidelines. Discard broached vials after 28 days. Any unused or expired vials must be destroyed by a DEA registered reverse distributor; for further information, call 1-833-384-4729.

Physician information: Ethiqa XR injectable suspension is a mu-opioid partial agonist (1.3 mg buprenorphine/mL). In the case of an emergency, provide the physician with the package insert. Naloxone may not be effective in reversing respiratory depression producedby 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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