Indications for: DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (for PEDIATRIC USE)
Tetanus and diphtheria immunization in patients 6 weeks through 6 years of age (before 7th birthday) when pertussis vaccine cannot be used.
A clinical study conducted in Baltimore, MD evaluated 3 lots of Diphtheria and Tetanus Toxoids Adsorbed (formulation that contained thimerosal) in infants. Patients received 0.5mL of Diphtheria and Tetanus Toxoids Adsorbed at 2, 4, and 6 months of age. Patients also received concomitant oral poliovirus vaccine (no longer licensed in the US) at 2 and 4 months of age. Levels were evaluated at 8 months of age.
At 8 months of age, protective levels of diphtheria antitoxin (≥0.01 IU/mL) and tetanus antitoxin (≥0.01 IU/mL) were detected in 99% and 100%, respectively, of the Diphtheria and Tetanus Toxoids Adsorbed recipients after 3 doses.
The geometric mean titers (GMT's) for diphtheria and tetanus antitoxin antibodies in recipients were not significantly different, ranging from 0.25 to 0.35 IU/mL for diphtheria antitoxin antibodies, and from 0.75 to 0.80 IU/mL for tetanus antibodies after the third dose.
Among 75 infants who received an investigational acellular pertussis vaccine simultaneously with the Diphtheria and Tetanus Toxoids Adsorbed but at separate sites, the protective antitoxin levels for diphtheria and tetanus developed in 100% of the recipients.
<6wks and ≥7yrs: not recommended. Give IM in anterolateral thigh (for infants <1yr) or deltoid (for older children). 5-dose series: give at 2, 4, 6, 15–18 months, and 4–6 years. May give first dose as early as 6 weeks of age.
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (for PEDIATRIC USE) Contraindications:
History of systemic allergic or neurologic reactions to a previous dose of DT.
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (for PEDIATRIC USE) Warnings/Precautions:
Defer in moderate or severe active respiratory or other febrile infection (may vaccinate if mild or minor illness) or during polio outbreak. Bleeding disorders. Guillain-Barre syndrome (within 6 weeks) of previous tetanus vaccination. Immunosuppressed. Have epinephrine (1:1000) available. Risk of apnea (premature infants).
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (for PEDIATRIC USE) Classification:
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (for PEDIATRIC USE) Interactions:
Concomitant vaccines: insufficient data; see full labeling. Concomitant tetanus immune globulin (human): give at a separate site using a separate needle and syringe. May get suboptimal response with immunosuppressants (eg, chemotherapy, high dose corticosteroids ≥2 weeks, radiation).
Local reactions (eg, erythema, edema), malaise, fever, hypotension, arthralgia, nausea; syncope, rare: neurologic disorders.
Single-dose vials (0.5mL)—10