Chloroquine Phosphate, Embutramide, Lidocaine: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Chloroquine Phosphate, Embutramide, Lidocaine, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Tributame™ Euthanasia Solution (NADA/ANADA 141-245)
Tributame™ Euthanasia Solution NADA 141-245, Original approval, May 20, 2005; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 795; FDA PDF
Indication
Euthanasia in dogs only.
Dose regimen
1 mL per 5 pounds body weight (0.45 mL/kg), Intravenous, single bolus injection over a 10- to 15-second period, Single dose, Do not overdose; do not use in cats. Each mL contains 135 mg embutramide, 45 mg chloroquine phosphate, 1.9 mg lidocaine.
Inject 1 mL of TRIBUTAME Euthanasia Solution for each 5 pounds body weight (0.45 mL/kg). Administer the calculated dose as a single intravenous bolus injection within a 10- to 15- second period. Do not overdose. Do not use in cats.
Target-animal safety
Within the framework of evaluating a euthanasia agent, safety in the dog refers to rapid, painless induction of unconsciousness and clinical and physiologic death.
| Finding | Quote |
|---|---|
| No dedicated target animal safety (margin of safety) study was required; safety for a euthanasia agent was judged from the effectiveness studies' demonstration of unconsciousness and death despite observer-objectionable side effects. | Although this product results in potentially objectionable side effects from the observer's perspective, the field and laboratory effectiveness studies adequately demonstrated unconsciousness and death. Therefore, no additional safety studies were required. |
Effectiveness
Pivotal clinical field trial (Study PSI-0736-00C-002), single treatment group, unmasked, six US sites (five veterinary practices, one humane society/animal control facility); 85 dogs enrolled, 84 dosed, 81 valid cases; 0.45 mL/kg single-bolus IV injection of the pre-final formulation (final formulation adds denatonium benzoate).; n = 81 valid cases; primary endpoint: Timed events from start of injection (collapse, apnea, loss of palpebral reflex, loss of palpable heartbeat, death), quality-of-induction and reaction-to-injection scores, adverse reactions; result: Mean time to collapse 20 s (range 5-58) and to death 53 s (range 12-282); induction excellent in 60 (74.1%), good 16 (19.7%), poor 5 (6.2%); no injection reaction in 69 (85.2%), severe in 8 (9.9%); adverse reactions in 35.8% (29/81) of dogs, most frequently agonal breathing (24.6%).
Table 9: Timed Events Results Timed Event1 Mean (in Seconds) Range (in Seconds) Collapse 20 5-58 Apnea 31 9-78 Loss of Palpebral Reflex 34 10-78 Loss of Palpable Heart Beat 44 8-205 Death 53 12-282 1 All times were measured from the start of the injection until the event. 4. Adverse Reactions: Adverse reactions were recorded for 35.8% (29/81) of the study animals.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Any adverse reaction (field trial, single arm) | 29/81 (35.8%) | Adverse reactions were recorded for 35.8% (29/81) of the study animals. | |
| Agonal breathing | 20 (24.6%) | Table 10: Incidence of Adverse Reactions Adverse Reaction Number of Dogs (%) Agonal breathing 20 (24.6%) Vocalization 8 (9.9%) Muscle twitching1 4 (4.9%) Opisthotonus 1 (1.2%) Excitability 1 (1.2%) | |
| Vocalization | 8 (9.9%) | Table 10: Incidence of Adverse Reactions Adverse Reaction Number of Dogs (%) Agonal breathing 20 (24.6%) Vocalization 8 (9.9%) Muscle twitching1 4 (4.9%) Opisthotonus 1 (1.2%) Excitability 1 (1.2%) | |
| Muscle twitching (includes tremors and fasciculations) | 4 (4.9%) | Table 10: Incidence of Adverse Reactions Adverse Reaction Number of Dogs (%) Agonal breathing 20 (24.6%) Vocalization 8 (9.9%) Muscle twitching1 4 (4.9%) Opisthotonus 1 (1.2%) Excitability 1 (1.2%) | |
| Opisthotonus | 1 (1.2%) | Table 10: Incidence of Adverse Reactions Adverse Reaction Number of Dogs (%) Agonal breathing 20 (24.6%) Vocalization 8 (9.9%) Muscle twitching1 4 (4.9%) Opisthotonus 1 (1.2%) Excitability 1 (1.2%) | |
| Excitability | 1 (1.2%) | Table 10: Incidence of Adverse Reactions Adverse Reaction Number of Dogs (%) Agonal breathing 20 (24.6%) Vocalization 8 (9.9%) Muscle twitching1 4 (4.9%) Opisthotonus 1 (1.2%) Excitability 1 (1.2%) |
Extraction notes: Euthanasia product; no pharmacokinetic data. Adverse-reaction counts in Table 10 are out of the 81 valid field-trial dogs (no control group). Dose selection: dose titration study (104 dogs, 64 healthy/40 sick; 0.15, 0.25, 0.35, 0.45 mL/kg) found 0.35 mL/kg the minimum acceptable dose and selected 0.45 mL/kg because of more opisthotonus and resumption of breathing at 0.35 mL/kg. Dose confirmation/physiology study (32 dogs, ECG/EEG): 0.45 mL/kg single bolus gave apnea, collapse, loss of audible heartbeat and flatline EEG within one minute; ECG electrical activity persisted up to 20 minutes. Denatonium benzoate comparison study (22 dogs) showed no increase in injection pain/discomfort and repeated the high incidence of agonal breathing and vocalization. Two field-trial dogs overdosed showed muscle twitching; acepromazine premedication not recommended based on one case. Studies refer to the product as EMBUTANE (earlier trade name).
Reproduce: foi_structured_search(query="Chloroquine Phosphate, Embutramide, Lidocaine") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).