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 Indications, Dosage, Storage, Stability - Tetanus Toxoid USP
Tetanus Toxoid Indications, Dosage, Storage, Stability - Tetanus Toxoid USP
INDICATIONS
Tetanus Toxoid USP is indicated for booster
injection only for
persons 7 years of age or
older against tetanus. This vaccine
is NOT indicated for primary
immunization.
Primary immunization
schedule for children
under 7 years of age should
consist of five doses of a vaccine
containing tetanus toxoid.
The initial three doses are given as Diphtheria and Tetanus Toxoids
and Pertussis Vaccine Adsorbed (DTP) vaccine,
administered intramuscularly at 2-month intervals beginning at 2
months of age. A fourth dose, either of Diphtheria and Tetanus Toxoids
and Acellular Pertussis (DTaP) or D.P.
is recommended 6 to 12 months after the third dose, usually at 15
to 18 months of age; if given before 15 months. A fifth dose
of DTaP or DTP is given before school entry (kindergarten or elementary
school) at 4 to 6 years of age, unless the fourth dose
was given after the fourth birthday. If the pertussis
component is contraindicated,
Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT)
is recommended. For persons 7 years of age
and older, Tetanus and Diphtheria Toxoids Adsorbed USP For Adult
Use (Td) is preferred to tetanus
toxoid alone.3,4
For the prevention
of neonatal tetanus
in unvaccinated pregnant
women, see PRECAUTIONS -
Pregnancy.1
This vaccine is NOT
to be used for the treatment
of tetanus infection.
Tetanus toxoid is also
available in adsorbed form. Although the rate of seroconversion
is essentially equivalent
with either form, adsorbed toxoids induce more persistent antitoxin
titers.1
As with any vaccine,
vaccination with
Tetanus Toxoid USP may not protect 100% of susceptible
individuals.
If passive immunization
is required, Tetanus Immune Globulin (TIG) (Human) should be used
(see DOSAGE AND ADMINISTRATION
section).
DOSAGE AND ADMINISTRATION
Parenteral drug products
should be inspected visually for extraneous particulate matter
and or discoloration prior
to administration
whenever solution and container
permit. If these conditions exist, the vaccine
should not be administered.
FOR BOOSTER USE ONLY
- NOT RECOMMENDED FOR PRIMARY IMMUNIZATION
SHAKE VIAL WELL before withdrawing each dose.
Inject intramuscularly or subcutaneously in the area
of the vastus lateralis
(lateral mid-thigh) or deltoid. The vaccine
should not be injected
into the gluteal area
or areas where there may be a major nerve
trunk.
After the initial immunization
series is completed (see
INDICATIONS
AND USAGE section), a booster
dose of 0.5 mL of Tetanus
Toxoid should be given intramuscularly every 10 years to maintain
adequate immunity. This 10- year period
is determined from the last dose
administered irrespective of whether it was given earlier in routine
childhood immunization
or as part of wound management.3
Booster Injection After Injury
A thorough attempt must be made to determine whether a patient
has completed primary immunization. Patients with unknown or uncertain
previous immunization histories should be considered to have no
previous tetanus toxoid
injections. Persons who had military service since 1941 can be considered
to have received at least one dose. Although most people in the
military since 1941 may have completed a primary
series of tetanus
toxoid, this cannot be assumed for each individual. Patients who
have not completed a primary
series may require tetanus
toxoid and passive
immunization (TIG
– Human) at the time of wound
cleaning and debridement
(Table 1).1
Available evidence
indicates that complete primary
vaccination with
tetanus toxoid provides
long- lasting protection > 10 years for most recipients.
Consequently, after complete primary
tetanus vaccination,
boosters, even for wound
management, need to be
given only every 10 years when wounds are minor
and uncontaminated. For other wounds, a booster
is appropriate if the patient
has not received tetanus
toxoid within the preceding
five years. Persons who have received at least two doses of tetanus
toxoid develop antitoxin
antibodies.1
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use USP (Td)
is the preferred vaccine
for active tetanus immunization
in wound management of
patients ³ 7 years of age. Because
a large proportion of adults are susceptible
to diphtheria, this vaccine
enhances diphtheria
protection. Thus, by taking advantage of acute
health-care visits, such
as for wound management, some patients can be protected who otherwise
would remain susceptible. For inadequately vaccinated patients of
all ages, completion of primary vaccination at the time
of discharge or at
follow-up visits should
be ensured.1
| TABLE
11,3 Guide to Tetanus Prophylaxis
in Routine Wound Management* |
|
History
of Adsorbed Tetanus
Toxoid
(Doses)
|
Clean,
Minor Wounds
|
All
Other Wounds**
|
|
Td
|
TIG
|
Td
|
TIG
|
| Unknown
or < three |
Yes
|
No
|
Yes
|
Yes
|
| ³Three
|
No†
|
No
|
No§
|
No
|
* Important details are in the text of the insert.
** Such as, but not limited to, wounds contaminated
with dirt, feces, soil, and saliva; puncture
wounds; avulsions; and wounds resulting from missiles, crushing,
burns, and frostbite.
† Yes, if > 10 years since last dose.
§ Yes, if > 5 years since last dose. (More
frequent boosters are not needed and can accentuate side
effects.)
If passive immunization
for tetanus is needed,
TIG (Human) is the product of choice. It provides longer protection
than antitoxin of
animal origin and causes
few adverse reactions. The currently recommended prophylactic dose
of TIG (Human) for wounds of average
severity is 250 units intramuscularly. When tetanus
toxoid and TIG (Human)
are given concurrently, separate syringes and separate sites should
be used. The ACIP recommends
the use of only adsorbed toxoid
in this situation.1
HOW SUPPLIED
Vial, 7.5 mL – Product No. 49281-812 84
STORAGE
Store between 2° – 8°C (35° – 46°F). DO NOT FREEZE.
REFERENCES
1. Recommendations of the Immunization Practices
Advisory Committee (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations
for vaccine use and other preventive
measures. MMWR 40: No.
RR-10, 1991
2. C.C.
Summary of Notifiable Diseases, United States 1992. MMWR
41: No. 55, 1993
3. Active Immunization Procedures. Report of the
Committee on Infectious Diseases. American Academy of Pediatrics,
Elk Grove Village, Illinois. Twenty-third Edition, 1994
4. ACIP. Pertussis Vaccination: Acellular Pertussis
Vaccine for the fourth and fifth doses of the DTP series. Update
of supplementary ACIP statement. MMWR
41: No. RR-15, 1992
5. Wilson GS. The Hazards of Immunization. Provocation
poliomyelitis: 270-274, 1967
6. ACIP. General recommendations on immunization.
MMWR 43: No. RR-1, 1994
7. C.C.
Vaccine Adverse Event Reporting System – United States. MMWR 39:
730-733, 1990
8. C.C.
National Childhood Vaccine Injury Act: requirements for permanent
vaccination records and for reporting of selected events after vaccination.
MMWR 37: 197-200, 1988
9. Food and Drug Administration. New reporting
requirements for vaccine adverse events. FDA Drug Bull 18 (2), 16-18,
1988
10. MacLennan R, et al. Immunization against neonatal
tetanus in New Guinea.
Antitoxin response
of pregnant women to
adjuvant and plain
toxoids. Bull WHO 32: 683-697,
1965
11. Newell KW, et al. The use of toxoid
for the prevention
of tetanus neonatorium. Bull WHO
35: 863-871, 1966
12. Institute of Medicine. Adverse events associated
with childhood vaccines. Evidence Bearing on Causality. National
Academy Press, Washington, DC, 1994
13. Rutledge SL, et al. Neurological complications
of immunizations. J Pediatr 109: 917-924, 1986
14. Schlenska GR. Unusual neurological complications
following tetanus toxoid administration. J Neurol 215: 299-302,
1977
15. Wilson GS. The Hazards of Immunization. Allergic
manifestations: post- vaccinal
neuritis. pp 153-156, 1967
16. Tsairis P, et al. Natural history
of brachial plexus
neuropathy. Arch Neurol 27: 109-117, 1972
17. Blumstein GI, et al. Peripheral neuropathy
following tetanus toxoid
administration. JAMA 198: 1030-1031, 1966
18. Pollard JD, et al. Relapsing neuropathy
due to tetanus toxoid:
report of a case. J Neurol Sci 37: 112-125, 1978
top
