A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tetanus Toxoid Warnings, Precautions, Pregnancy, Nursing, Abuse - Tetanus Toxoid USP
Tetanus Toxoid Warnings, Precautions, Pregnancy, Nursing, Abuse - Tetanus Toxoid USP
WARNINGS
Intramuscular injections should be given with great care in patients
suffering from thrombocytopenia
or other coagulation disorders. In
this situation, subcutaneous
administration
of Tetanus Toxoid may be advisable.
PRECAUTIONS
General
Care is to be taken by the health-care provider
for the safe and effective use of Tetanus Toxoid USP.
Epinephrine Injection (1:1000) must be immediately available should
an acute anaphylactic
reaction occur due
to any component of
the vaccine.
There is an increased incidence
of local and systemic
reactions to booster doses of tetanus
toxoid when given to
previously immunized persons. (Refer to DOSAGE
AND ADMINISTRATION section for timing of booster
injections.) Prior to an injection
of any vaccine, all known precautions should be taken to prevent
adverse reactions. This should include a review of the patient's
history with respect
to possible sensitivity and any previous adverse reactions (see
CONTRAINDICATIONS section)
to the vaccine or similar
vaccines and a current
knowledge of the literature concerning the use of the vaccine
under consideration.
Prior to administration
of Tetanus Toxoid USP, health-care personnel should inform the parent,
guardian, or adult patient
of the benefits and risks of immunization,
and also inquire about the recent health
status of the patient
to be injected.
Special care should be taken to ensure that the injection
does not enter a blood
vessel.
Immunosuppressive therapies including radiation, corticosteroids,
antimetabolites, alkylating agents, and cytotoxic
drugs may reduce the
immune response
to vaccines. Therefore, routine vaccination
should be deferred, if possible, while patients are receiving such
therapy.1 If Tetanus Toxoid USP
has been administered to persons receiving immunosuppressive therapy,
or having an immunodeficiency
disorder, an adequate antibody
response may not be obtained.3 When
possible, immunosuppressive treatment should be interrupted when
immunization is
required due to a tetanus- prone
wound.
Administration of Tetanus Toxoid USP is not contraindicated in
individuals with HIV infection.6
It is advisable to use DT (For Pediatric Use – 6 years of age
and younger) or Td (For Adult Use – 7 years of age
and older) in wound prophylaxis
instead of tetanus toxoid
alone in order to maintain
adequate levels of diphtheria immunity.3
A separate, sterile
syringe and needle
or a sterile disposable
unit must be used for each patient
to prevent transmission
of hepatitis or other
infectious agents from person
to person. Needles should not be recapped and should be properly
disposed.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No studies have been performed to evaluate carcinogenicity, mutagenic
potential, or impact on fertility.
Pregnancy
Reproductive Studies – Pregnancy Category C
Adequate immunization
by routine boosters in non- pregnant
women of child- bearing age
can obviate the need to
vaccinate women during
pregnancy (see DOSAGE AND ADMINISTRATION
section).
Animal reproduction
studies have not been conducted with Tetanus Toxoid USP. It is also
not known whether Tetanus Toxoid USP can cause
fetal harm when administered
to a pregnant woman
or can affect reproduction
capacity. Tetanus Toxoid USP should be given to a pregnant
woman only if clearly
needed.
Physicians generally avoid prescribing unnecessary drugs and biologics
for pregnant women.
However, the ACIP recommends
the following: a previously unvaccinated pregnant woman
whose child might be born
under unhygienic circumstances (without sterile
technique) should receive two doses of Td 4 to 8 weeks apart before
delivery, preferably during the last two trimesters. Pregnant women
in similar circumstances who have not had a complete vaccination
series should complete the three- dose
series. Those vaccinated more than 10 years previously should have
a booster dose. No
evidence exists to
indicate that tetanus
and diphtheria toxoids
administered during pregnancy
are teratogenic.1
It has been reported that Tetanus Toxoid administered to pregnant
women prevents neonatal
tetanus in newborns.10,11
However, the data reported on the safety of Tetanus Toxoid when
so used is inconclusive because the incidence
of neonatal deaths
in New Guinea was significantly higher than in the United States.
A prospective study in the United States has not been done to confirm
these reports.10
Pediatric Use
SAFETY AND EFFECTIVENESS OF TETANUS TOXOID USP IN INFANTS BELOW
THE AGE OF SIX WEEKS HAS NOT BEEN
ESTABLISHED. HOWEVER, THIS VACCINE IS NOT INDICATED FOR CHILDREN
UNDER 7 YEARS OF AGE
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