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
Diptet Side Effects, and Drug Interactions - Diphtheria and Tetanus Toxoids Adsorbed USP
Diptet Side Effects, and Drug Interactions - Diphtheria and Tetanus Toxoids Adsorbed USP
SIDE EFFECTS
Body System as a Whole
Adverse reactions may be local
and include redness, warmth, edema,
induration, with or without tenderness, as well as urticaria,
and rash. Malaise, transient fever, pain,
hypotension, nausea
and arthralgia may
develop in some patients after the injection. Arthus- type
hypersensitivity
reactions, characterized by severe local
reactions (generally starting 2 to 8 hours after an injection) may
occur, particularly in persons who have received multiple
prior boosters. 2
Rarely, an anaphylactic reaction
(i. e., hives, swelling
of the mouth, difficulty breathing, hypotension,
or shock) and death have
been reported after receiving preparations containing diphtheria
and tetanus antigens.
2
The vaccine was well
tolerated clinically. No
local or systemic
reactions were observed in approximately half of the infants and
only mild or moderate reactions were observed in the remainder of
the study group (Table
3). 3
TABLE 3 3
SUMMARY OF CLINICAL REACTIONS
| |
Category
of REACTIONS
|
|
None
|
Mild*
|
Moderate**
|
Severe
|
| Post
Dose 1 |
9/20
(45%)
|
11
(55%)
|
0
|
0
|
| Post
Dose 2 |
11/20
(55%)
|
7
(35%)
|
2/20
(10%)
|
0
|
| Post
Dose 3 |
11/20
(55%)
|
9
(45%)
|
0
|
0
|
* A small local
reaction and
or temperature elevation
to < 39° C (< 102.2° F).
** Temperature elevation
to³
39° C ³
102.2° F) and or a
significant area
of redness, swelling, and induration associated with tenderness.
Deaths due to causes other than SIDS, including deaths from serious
infections, have been reported in temporal
association with
the administration of diphtheria
and tetanus toxoids
containing vaccines. On rare occasion, anaphylaxis has been reported
following administration
of products containing diphtheria and tetanus
toxoids. Upon review, a report
by the Institute of Medicine (IOM) concluded the evidence
established a causal relationship between diphtheria
and tetanus toxoids
and anaphylaxis. 9
Nervous System
The following neurologic illnesses have been reported as temporally
associated with vaccine
containing tetanus toxoid:
neurological complications 14 including
cochlear lesion, 15
brachial plexus neuropathies,
15,16 paralysis of the radial
nerve, 17 paralysis
of the recurrent nerve, 15 accommodation
paresis, Guillain-Barré syndrom (GBS), and EEG
disturbances with encephalopathy. 18
The IOM following review of the reports of neurologic events following
vaccination with
tetanus toxoid, Td or
DT, concluded the evidence
favored acceptance
of a causal relationship between tetanus toxoid
and brachial neuritis
and GBS. 9,19
EPINEPHRINE INJECTION (1:1000) M.S.
BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR
DUE TO ANY COMPONENT OF THE
VACCINE.
Reporting of Adverse Events
The National Vaccine Injury Compensation Program, established by
the National Childhood Vaccine Injury Act of 1986, requires physicians
and other health-care providers who administer vaccines to maintain
permanent vaccination records and to report
occurrences of certain adverse events to the US Department of Health
and Human Services. Reportable events include those listed in the
Act for each vaccine
and events specified in the package insert as contraindications
to further doses of the vaccine. 12,13
Reporting by parents or guardians of all adverse events after vaccine
administration should be encouraged. Adverse events following immunization
with vaccine should
be reported by health-care providers to the US Department of Health
and Human Services (DHHS) Vaccine Adverse Event Reporting System
(VAERS). Reporting forms and information about reporting requirements
or completion of the form
can be obtained from VAERS through a toll-free number 1-800-822-7967.
11,12,13
Health-care providers also should report
these events to the Director of Medical Affairs, Connaught Laboratories,
Inc., Route 611, PO Box 187, Swiftwater, PA
18370, or call 1-800-822-2463.
DRUG INTERACTIONS
If passive immunization
for tetanus is needed,
TIG (Human) is the product of choice for tetanus. 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. 2
Diphtheria Antitoxin (equine) is available for treatment
of the acute phases of diphtheria. When DT and Diphtheria Antitoxin
are used together, they must be given at different sites using separate
needles and syringes.
As with other intramuscular
injections, use with caution in patients on anticoagulant
therapy.
Immunosuppressive therapies may reduce
the response to vaccines
(see PRECAUTIONS – General
section).
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