tachycardia). • follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia). patients who receive a course of treatment with a foreign protein such as north american coral snake antivenin (equine) may become sensitized to it. therefore, use caution when administering a repeat course of treatment with north american coral snake antivenin (equine) for a subsequent envenomation episode.

nding on the response to treatment. • in small children, the dose may be decreased, depending on the response to treatment. 2.2 preparation and administration preparation • pry off the small metal disc in the cap over the diaphragms of the vials of north american coral snake antivenin (equine) and remove cap from diluent vials. • swab the exposed surface of the rubber diaphragms of both vials with an appropriate germicide. • withdraw 10 ml diluent (sterile water for injection, usp) using a sterile syringe and needle, and insert the needle through the stopper of the vacuum-containing vial of north american coral snake antivenin (equine). o the vacuum in the north american coral snake antivenin (equine) vial will pull the diluent out of the syringe into the vial. allow room air to be pulled into the north american coral snake antivenin (equine) vial until all vacuum is released. o point the needle at the center of the lyophilized pellet of north american coral snake antivenin (equine) so that the diluent stream will wet the pellet. • reconstitute by swirling, not by shaking, for 1 minute, at 5-minute intervals until you observe complete dissolution of the lyophilized north american coral snake antivenin (equine). complete reconstitution usually requires at least 30 minutes. administration • parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. • start an intravenous infusion of 250 to 500 ml of sodium chloride injection, usp. • determine whether the patient has hypersensitivity to horse-serum in order to evaluate treatment decisions, and to prepare for treatment of anaphylaxis if it occurs [see warnings and precautions (5.1) ] . • after reconstitution of the lyophilized north american coral snake antivenin (equine) administer the contents of 3 to 5 vials (30 to 50 ml) intravenously by slow injection directly into the intravenous tubing or the reservoir bottle of the intravenous solution. if added to reservoir bottle, mix by gentle swirling – do not shake. • administer the first 1 or 2 ml over a 3- to 5-minute period with careful observation of the patient for evidence of an allergic reaction. if no signs or symptoms of anaphylaxis appear, continue the injection or intravenous infusion. • adjust the infusion rate by the severity of signs and symptoms of envenomation and tolerance of north american coral snake antivenin (equine). administer at the maximum safe rate for intravenous fluids, based on body weight and general condition of the patient. o for adults, if given by intravenous infusion to a previously healthy adult, allow 250 or 500 ml to run in within 30 minutes; o for small children, allow the first 100 ml to run in rapidly but then decrease to a rate not to exceed 4 ml per minute. response to treatment may be rapid and dramatic. • observe the patient carefully and administer additional north american coral snake antivenin (equine) intravenously as required.

mother's clinical need for north american coral snake antivenin (equine) and any potential adverse effects on the breastfed child from north american coral snake antivenin (equine) or from the underlying maternal condition. 8.4 pediatric use controlled clinical studies of safety and effectiveness in pediatric patients have not been conducted. potential cases of coral snake envenomation and subsequent treatment with north american coral snake antivenin (equine) have been reported in pediatric patients; 2 adverse reactions included anaphylaxis (wheezing) requiring treatment with epinephrine, vomiting, and abdominal pain. 8.5 geriatric use specific studies in elderly patients have not been conducted.

umber of vials administered to treated patients was 3.75 (range 1 – 20 vials); the 17 patients who received repeat treatment were administered 8.3 vials, on average. there was no reported usage of foreign antivenom or acetylcholinesterase inhibitors in this case series. the 387 patients were assessed for clinical outcomes, as shown in table 1. outcomes codes range from full recovery with no residual effects ("no effect") to less than full recovery with significant residual effects ("major"). empiric treatment of asymptomatic patients resulted in more 'moderate' and 'major' outcomes compared to withholding treatment until symptoms appeared (p<.001), however, the patients were not randomized and selection biases could have affected this result. table 1 – outcome by treatment strategy treatment strategy empiric (n = 134) withhold (n = 106) symptomatic with av (n = 112) symptomatic without av (n = 35) adr, adverse drug reaction; av, antivenom; avg, average; los, length of stay; icu, intensive care unit. primary outcome endotracheal intubation (%) 3 (2.2) 1 (0.94) 7 (6.25) 0 (0) secondary outcomes days intubated avg. (sd) 5.67 (2.89) 24 (n/a) 8 (6.22) 0 (0) icu admission (%) p < 0.01 between empiric and withhold strategies. 97 (72.39) 49 (46.23) 90 (80.36) 9 (25.71) icu los avg.(sd) 1.5 (1.18) 1.73 (3.28) 2.25 (3.35) 1.3 (0.5) total los avg.(sd) 1.58 (1.56) 1.17 (2.94) 2.47 (3.68) 0.94 (0.85) antivenom adr (%) 26 (19.4) 0 (0) 20 (17.86) 0 (0) outcome code % no effect 4.76 29.29 0 0 minor 71.43 56.57 34.23 63.64 moderate 20.63 13.13 54.05 36.36 major 3.17 1.01 11.71 0 adverse reactions associated with north american coral snake antivenin (equine) administration were documented in 46 (18.25%) cases. the most common adverse reactions were hives, rash and/or welts (12%); itching (9%); shortness of breath (8%); hypotension (2%) and angioedema (1%). antihistamines were administered to 46 patients, corticosteroids to 40, and epinephrine to 10 cases to treat these adverse reactions.