Details About Overdose or Poisoning Generic Salt ::  Botulinum Antitoxin

Botulinum Antitoxin

    

Drug Pharmacology ::

I. Pharmacology. Botulinumantitoxin contains concentrated equine-derived antibodies directedagainst the toxins produced by the various strains of Clostridium botulinum(A, B, and E). The antitoxin is currently available in the bivalent (A,B) and monovalent (E) forms. The monovalent (E) form provides coveragefor botulism from fish sources and is available only through aninvestigational new drug (IND) protocol. If type F is suspected, theCDC advises that there is variable cross-reactivity with type Eantitoxin. An equine-derived heptavalent formulation has been developedfor bioterrorism preparedness. It covers toxin types A, B, C, D, E, F,and G and is available only through an IND protocol. In October 2003, ahuman-derived botulism immune globulin (IgG antibodies), BabyBIG, wasapproved for the treatment of infant botulism caused by toxins A and B.The antibodies bind and inactivate freely circulating botulinum toxinsbut do not remove toxin that is already bound to nerveterminals. Because antitoxin will not reverse established paralysisonce it occurs, it must be administered before paralysis sets in.Treatment within 24 hours of the onset of symptoms may shorten thecourse of intoxication and prevent progression to total paralysis.

Drug Indications ::

Indications. Theequine-derived botulinum antitoxin is used to treat clinical botulism(see Botulism) from food-borne, wound, or intestinal colonization inchildren or adults to prevent the progression of neurologicmanifestations. With the recent approval of the human-derived immuneglobulin, the equine-derived antitoxin is generally not recommended fortreatment of infant botulism.

Drug Contra-Indications ::

III. Contraindications.

   

Equine-derived antibodies.No absolute contraindications. Known hypersensitivity to botulinumantitoxin or horse serum requires extreme caution if this product isgiven.

B. Human-derived immune globulin.BabyBIG should not be given to patients with a prior history of severereaction to human immunoglobulin products. BabyBIG contains traceamounts of immunoglobulin A. Individuals with selective immunoglobulinA deficiency may develop anaphylactic reactions to subsequentadministration of blood products with immunoglobulin A.

Drug Adverse Effects ::

IV. Adverse effects

   

Equine-derived antibodies. Immediate hypersensitivity reactions (anaphylaxis) resulting from the equine source of antibodies.

Human-derived immune globulin. Mildtransient erythematous rashes of face and trunk are reported commonly.Minor reactions such as flu-like symptoms similar to those seen withthe use of other IGIV products were observed. Infusion rate–relatedreactions ranging from mild flushing to severe anaphylaxis may occur.

Use in pregnancy. Thereare no data on teratogenicity. Anaphylactic reaction resulting in shockor hypoxemia in the mother could conceivably affect the fetus adversely.

Drug Lab Interactions ::

Drug or laboratory interactions. Noknown interactions with equine-derived antibodies. Human-derived immuneglobulin preparations contain antibodies that may interfere with theimmune response to live vaccines such as polio, measles, mumps, andrubella.

Drug Dose Management ::

Dosage and method of administration

   

Forsuspected or established clinical botulism, give one 10-mL vial diluted1:10 in 0.9% saline (normal saline) and administer by slow IV infusion.A second vial may be administered in 2 to 4 hours if signs or symptomsworsen but is usually not necessary as the neutralizing antibodies(half-life of 5–8 days) far exceed the levels of circulating toxin. Forheptavalent antitoxin, the IND protocol outlines the necessary stepsfor administration.

Performa skin test prior to administration according to the packageinstructions. If the patient has known sensitivity to horse serum ordemonstrates a positive skin test, provide desensitization as indicatedin the package insert. Even if the skin test is negative, anaphylaxismay occur unpredictably. Pretreat the patient with diphenhydramine (seeDiphenhydramine), 1–2 mg/kg IV, and cimetidine, 300 mg IV (or other H2 blocker, Cimetidine and Other H2 Blockers), and have epinephrine (Epinephrine) ready in case anaphylaxis occurs.

Incases of infant botulism, the recommended dosage for BabyBIG is 1 mL/kg(50mg/kg) as a single intravenous infusion as soon as a clinicaldiagnosis of infant botulism is made. BabyBIG should be administeredintravenously at 0.5 mL/kg/hr (25 mg/kg/h). The rate may be increasedto 1.0 mL/kg/h (50 mg/kg/h) if no untoward reaction occurs 15 minutesafter the initial infusion rate. Do not exceed this rate ofadministration because of the risk for infusion-related anaphylaxis.The half-life of injected BabyBIG is approximately 28 days in infants,and a single intravenous infusion is expected to provide a protectivelevel of neutralizing antibodies for 6 months.

Drug Chemical Formulations ::

Formulations

   

Parenteral. Bivalentbotulinum antitoxin or botulism antitoxin bivalent (equine) (7500 IUtype A, 5500 IU type B) and monovalent botulinum antitoxin (8500 IUtype E); available through the Centers for Disease Control (CDC),telephone (404) 639-3356 (weekdays) or (404) 639-2888 (after hours) orcontact your local health department (for reporting and to facilitateaccess to antitoxin). BabyBIG is supplied in a single-dose, 6-mL vialcontaining 100 mg ± 20 mg lyophilized immunoglobulin forreconstitution. Reconstituted BabyBIG should be used within 2 hours. Toobtain or determine the availability of BabyBIG for suspected infantbotulism, contact the Infant Botulism Treatment and Prevention Program(IBTPP) at (510) 231-7600. More information is available atwww.infantbotulism.org.

Suggested minimum stocking level. Not relevant; available only through federal (CDC) or state (California) government.

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