Etorphine

Indications

CAPTIVON 98 is indicated for immobilisation and anaesthesia of zoo animals, captive wildlife, and free-ranging wildlife species not intended for use as food.

Dosage and Administration

image description VETERINARY INFORMATION SHEET CII CAPTIVON 98 (etorphine hydrochloride) Injectable Solution 9.8 mg/ml VETERINARY INFORMATION SHEET PLEASE READ THIS ENTIRE VETERINARY INFORMATION SHEET AND THE ENTIRE CAPTIVON 98 PACKAGE INSERT PRIOR TO EACH USE. CAUTION : Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product without adequate amounts of reversal agent available. WARNINGS: SERIOUS OR LIFE-THREATENING RISKS TO HUMANS FROM ACCIDENTAL EXPOSURE TO CAPTIVON 98 CAPTIVON 98 is a high concentration (9.8 mg/mL) opioid agonist and Schedule II controlled substance. CAPTIVON 98 should be handled with extreme caution to avoid accidental exposure. Accidental Human Exposure: Accidental exposure of even one dose of CAPTIVON 98, especially in children, can result in a fatal overdose of etorphine. Strict adherence to the recommended handling and disposal instructions is of utmost importance to prevent accidental exposure. If accidental self-injection or ingestion occurs, seek immediate medical treatment, and provide physician with the vial or package insert/Veterinary Information Sheet. The reversal agent for human exposure to CAPTIVON 98 is an opioid antagonist such as naloxone or naltrexone. Symptoms of toxicity include dizziness, nausea, and constriction of pupils (pinpoint) followed by respiratory depression, lowered blood pressure, cyanosis, and in extreme cases, loss of consciousness and cardiac arrest. If necessary, provide airway support, and apply CPR until medical help arrives. If accidental skin exposure occurs, wash area with copious amounts of water and contact a physician. If accidental eye exposure occurs, flush with copious amounts of water for 15 minutes and contact a physician. Life-Threatening Respiratory Depression in Humans: Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of CAPTIVON 98. Monitor for respiratory depression if human exposure to CAPTIVON 98 occurs. Misuse or abuse of CAPTIVON 98 by swallowing, snorting, or injecting poses a significant risk of overdose and death. Abuse Potential in Humans: CAPTIVON 98 contains etorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of CAPTIVON 98 may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of CAPTIVON 98. 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). Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants in Humans: 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. HUMAN SAFETY WARNINGS: Not for use in humans. Keep this and all medications out of reach of children. Accidental exposure to CAPTIVON 98, especially in children, can result in a fatal overdose. Human User Safety while handling CAPTIVON 98: Because of the potential for adverse reactions associated with accidental exposure, CAPTIVON 98 should only be administered by veterinarians in zoo and wildlife practice, or individuals under such veterinary supervision, trained in the handling of potent opioids . It is advisable to ONLY handle CAPTIVON 98 when accompanied by another person. Wear gloves. Do not spray, squirt, or spill the drug when filling the syringes. Wash at once with large volumes of water if CAPTIVON 98 comes in contact with eyes, skin, or mucous membranes. At least two people in the field team should be able to recognize signs of toxicity if accidental exposure occurs. They should be familiar with emergency cardiopulmonary resuscitation procedures plus have FIRST AID KITS containing resuscitation aids available. Information for Physicians CAPTIVON 98 is a high concentration opioid agonist. Accidental human exposure may produce severe central nervous system depression resulting in respiratory depression or failure followed by coma and death. Treatment should start immediately by administering an appropriate opiate antagonist, providing airway support, and cardiopulmonary resuscitation techniques. ( See reverse side for animal use information). (See reverse side for Human Safety Warnings.)

Contraindications

Do not use CAPTIVON 98 in domestic animals and wild felids. Do not use carcasses of animals treated with etorphine for human consumption. CAPTIVON 98 residue studies have not been conducted in wildlife animals and consequently, human and predator consumption of carcasses from animals treated with CAPTIVON 98 is not advisable. DOSAGE AND DIRECTIONS FOR USE IN ANIMALS CAPTIVON 98 (etorphine hydrochloride) dosing is dependent on species, body mass and the condition of the wildlife animal being treated, and doses should be adjusted accordingly. Administration by intravenous or intramuscular injection is recommended. Refer to the table for CAPTIVON 98 dosing. ANALGESIC ANTAGONIST FOR ANIMALS The effects of CAPTIVON 98 may be reversed by administering naltrexone hydrochloride 50 mg/mL at a ratio of 20 mg of naltrexone hydrochloride for every 1 mg of CAPTIVON 98 used. SIDE EFFECTS AND SPECIAL PRECAUTIONS FOR USE IN ANIMALS The most serious adverse effect following CAPTIVON 98 administration is respiratory depression, usually observed within the first five minutes after administration. In cases of severe respiratory depression, CAPTIVON 98 should be reversed as soon as possible, and animals should not remain immobilised for longer than necessary to avoid complications. The use of CAPTIVON 98 in elderly, diseased, emaciated and highly stressed animals carries a greater degree of risk and precautionary measures should be taken, including maintenance of airways and prevention of hyperthermia. Equids and rhino: • CAPTIVON 98 may result in a dramatic rise in blood pressure, tachycardia, hyperpyrexia and pronounced muscle tremors. • Administration in rhino may lead to hypoventilation, hypoxaemia and metabolic acidosis. Ungulates • Significant hypertension due to an increase in total peripheral resistance, and moderate to severe bradycardia has been reported in ungulate species. • Excitement, increased muscle tone and resulting hyperthermia is particularly common in ungulates. • Passive regurgitation of rumen contents is common, and ruminants should be kept in sternal recumbency with heads lifted and tilted downwards to prevent aspiration pneumonia. • Under-dosing may cause hyper-excitability, hyperventilation and severe alkalosis. The safety of CAPTIVON 98 in pregnant and lactating wildlife animals has not been established. There is a risk of respiratory depression in the newborn if CAPTIVON 98 is given to a parturient animal. Rodent studies have shown that etorphine readily crosses the placental barrier. Etorphine administered in pregnant rats results in respiratory depression in the mother and depressed oxygen uptake in the newborn rats that is directly proportional to the maternal dose. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT FOR ANIMALS CAPTIVON 98 toxicity in wildlife animals results in respiratory depression and cardiac suppression. Rhinos are particularly sensitive to CAPTIVON 98. An overdose can be treated with naltrexone hydrochloride and with analeptics such as doxapram hydrochloride. Oxygen supplementation is recommended in cases of severe respiratory depression. Butorphanol tartrate may be used to partially reverse respiratory depression and to lighten the plane of anaesthesia of large species such as rhino. In the latter case, the animals may be walked under sedation onto vehicles for transport. HUMAN SAFETY WARNINGS Accidental exposure to CAPTIVON 98 could have serious effects on humans due to the high concentration of the medicine. • The lethal CAPTIVON 98 dose in humans is estimated to be between 30-120 μg. The following precautions should be taken by veterinarians when using CAPTIVON 98: • Do not work with CAPTIVON 98 unaccompanied. • Ensure that the antidote (naloxone), and a needle and syringe for administration of the antidote are readily available. • An assistant capable of administering the antidote to humans should always be present and should be fully briefed on the procedure to follow in the event of accidental exposure to CAPTIVON 98. • Wear gloves when handling CAPTIVON 98. • Eye protection should be utilised if there is a risk of CAPTIVON 98 splashing into the eyes. • Ensure water or an appropriate irrigation solution is available to treat accidental exposure of the skin or eyes. • CAPTIVON 98 should not be used in blowpipes or similar devices where the medicine solution is pressurised. • Accidental jabbing with a needle containing CAPTIVON 98 could have serious effects. Once the required dose of CAPTIVON 98 has been withdrawn from the vial, the needle should be immediately discarded into a closed container or sharps bin. SYMPTOMS OF TOXICITY IN HUMANS • Symptoms of toxicity in humans include dizziness, nausea, pinpoint pupils, respiratory depression, hypotension, loss of consciousness and cardiac arrest. • In the event of accidental topical exposure of the skin or eyes, wash the affected area immediately with copious amounts of water to prevent absorption. Monitor for symptoms of toxicity. • Should accidental injection occur, seek medical attention immediately. BEFORE CALLING FOR MEDICAL ASSISTANCE, INJECT THE ANTIDOTE. ADMINISTRATION OF THE ANTIDOTE FOR HUMANS • Inject 0.8-1.2 mg naloxone preferably IV or alternatively IM and repeat at 2–3 minute intervals until symptoms are reversed. Monitor airway and ventilation and initiate CPR as necessary until medical help arrives. IDENTIFICATION A clear, colourless solution for injection. PRESENTATION CAPTIVON 98 is supplied in an amber 10 mL glass vial filled to 5 mL. STORAGE INSTRUCTIONS Store at or below 25 °C. Protect from light. Once the rubber stopper has been pierced, the contents of the vial should be used within two weeks. KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS. REGISTRATION NUMBER 93/1.3.1/10 NAME AND BUSINESS ADDRESS OF HOLDER OF CERTIFICATE OF REGISTRATION Wildlife Pharmaceuticals (Pty) Ltd 38 Wilken Street Rocky Drift White River 1240 South Africa

Storage

CAPTIVON 98 is a Schedule II opioid. Store in a locked cabinet at or below 77 °F (25 °C) according to federal and state-controlled substance requirements/guidelines. Once the vial has been pierced, the contents must be used within two weeks. Protect from light and prolonged exposure to excessive heat. Any unused or expired vials must be destroyed by a reverse distributor. For further information, contact your local DEA field office or email Wildlife Pharmaceuticals (Pty) Ltd: pharmacist@wildpharm.co.za. CAPTIVON 98 (etorphine hydrochloride) is not FDA approved. Due to a shortage of etorphine hydrochloride in the US, FDA is allowing temporary use of this South African product in the US. CAPTIVON 98 is authorized for marketing in South Africa for the immobilization and anesthesia of zoo animals, captive wildlife, and free-ranging wildlife species not intended for use as food. NDC NO. 86204-098-05 Wildlife Pharmaceuticals (Pty) Ltd 38 Wilken Street Rocky Drift White River 1240, South Africa +27 13 751 2328 Distributed by: Clovis-Davis Pharmaceuticals, LLC 1520 South Lapeer Rd, Suite 120 Lake Orion, Michigan 48360 833-878-0060 VIAL LABEL CAPTIVON 98 ETORPHINE HCl 9.8 mg/mL INJECTABLE SOLUTION CII IMMOBILIZATION AGENT FOR IV / IM USE WARNING: Due to serious human safety and abuse concerns, read the entire Veterinary Information Sheet and Package Insert before using this drug, including the complete Boxed Warning. NET CONTENTS: 5 mL NDC: 86204-098-05 Store at or below 25 ºC (77 ºF). Protect from light. KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS. CAPTIVON 98 (ETORPHINE HCl) is not FDA approved. Due to a shortage in the USA, the FDA is allowing temporary use of this South African authorized product. CAUTION : Federal law restricts this drug to use by or on the order of a licenced veterinarian. Manufactured by: Wildlife Pharmaceuticals (Pty) Ltd Distributed by: Clovis-Davis Pharmaceuticals, LLC 1520 South Lapeer Rd, Suite 120 Lake Orion, Michigan 48360 833-878-006 image description CARTON VETERINARY MEDICINE CAPTIVON 98 ETORPHINE HCl 9.8 mg/mL INJECTABLE SOLUTION CII WARNING: Due to serious human safety and abuse concerns, read the entire Veterinary Information Sheet and Package Insert before using this drug, including the complete Boxed Warning. Batch: Exp.: CAPTIVON 98 (ETORPHINE HCl ) is not FDA approved. Due to a shortage in the US, the FDA is allowing temporary use of this South African-authorized product. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. NDC NO. 86204-098-05 Net contents: 5 mL Immobilization agent for IV / IM injection in zoo & wildlife species. Store at or below 25 °C (77 °F). Protect from light. KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS. Once the vial is pierced, contents must be used within two weeks. Date first opened: ........................ Because of the potential for adverse reactions associated with accidental exposure, CAPTIVON 98 should only be administered by veterinarians in zoo and wildlife practice, or individuals under such veterinary supervision, trained in handling of potent opioids. Do not use this product without adequate amounts of reversal agent available. Manufactured by: WILDLIFE PHARMACEUTICALS (Pty)Ltd 38 Wilken Street Rocky Drift White River 1240, South Africa Distributed by: Clovis-Davis Pharmaceuticals, LLC 1520 South Lapeer Rd, Suite 120 Lake Orion, Michigan 48360 833-878-0060 image description

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming etorphine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.