Dosing & Uses
Safety & efficacy not established
Dosage Forms & Strengths
Lf = limits of flocculation
(diphtheria toxoid/tetanus toxoid/inactivated pertussis toxin (PT)/ filamentous hemagglutinin (FHA)/pertactin/hepatitis B surface antigen (HBsAg)/type 1 poliovirus/type 2 poliovirus/type 3 poliovirus)/0.5 mL.
Injection Suspension
(25 Lf/10 Lf/25 mcg/25 mcg/8 mcg/10 mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units)/0.5 mL.
Immunization
Diphtheria, tetanus, pertussis, hepatitis B, & polio (poliovirus types 1, 2, 3)
<6 weeks: Not recommended
6 weeks-7 years: 0.5 mL IM x 3 doses starting at 6-8 weeks old, then 4 months and last dose at 6 months
Administer no sooner than every 4 weeks
Administration
< 1 years: Anterolateral thigh
>1 years: Deltoid muscle
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Irritability/fussiness (61-65%)
Drowsiness (41-57%)
Fever (28-39%)
Loss of appetite (26-31%)
Swelling (17-29%)
1-10%
Fever (≤1%)
<1%
Anorexia
Apnea
Erythema
Decreased consciousness
Diarrhea
Hypotonia
Encephalitis
Brachial neuritis
Erythema
Peripheral neuropathy
Cough
Lethargy
Limb pain
Liver function test abnormalities
Rash
Restlessness
Warnings
Contraindications
Hypersensitivity to any component (including yeast, neomycin, polymyxin B)
History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)
History of encephalopathy (within 7 days of administration not attributable to other causes), progressive neurologic disorder with pertussis-containing vaccine
Progressive neurologic disorder
Infantile spasms, uncontrolled epilepsy, progressive encephalopathy
Do not administer pertussis vaccine until neurologic status is stabilized
Cautions
Associated with higher rates of fever than separately administered vaccines
Apnea reported in premature infants following IM vaccine administration
Tetanus toxoid carries risk for brachial neuritis, Guillain-Barre syndrome and anaphylaxis
Caution in Guillain-Barre syndrome within 6 wk of prior tetanus toxoid vaccine
Syncope accompanied by transient disturbances, tonic-clonic movements, or weakness reported
Consider postponing administration iin patients with moderate or severe acute illness (with or without fever)
Use caution in patients with a history of bleeding disorders (including thrombocytopenia) and or patients on anticoagulants
Use caution in severely immunocompromised patients
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not indicated for women of childbearing age
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Production of specific antibodies to tetanus, diphtheria, and pertusis (active immunity)
Conveys active immunity via stimulation of production of endogenously produced antibodies
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Patient Handout
Formulary
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