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
Sumycin Warnings, Precautions, Pregnancy, Nursing, Abuse - Tetracycline (periodontal)
Sumycin Warnings, Precautions, Pregnancy, Nursing, Abuse - Tetracycline (periodontal)
WARNINGS
The use of the tetracycline
class during tooth
development (last
half of pregnancy,
infancy and childhood
to age of 8 years) may cause
permanent discoloration of the teeth. Tetracycline drugs should
not be used in this age group
unless other treatment
is not likely to be effective or if alternative therapy is contraindicated.
Tetracyclines as a class
are associated with photosensitivity. Treatment should be discontinued
at the first sign of cutaneous
erythema.
Accumulations of tetracycline
associated with renal
failure can lead to
liver toxicity. These
effects have not been studied in the plasma
concentration range associated with Actisite®.
PRECAUTIONS
General
Actisite fibers must be removed after 10 days. Packing fibers tightly
into a draining abscess
without allowance for drainage
might result in the formation
of a lateral fistula.
Fibers should not be used in an acutely abscessed periodontal
pocket. Their use in chronic
abscesses has not been evaluated.
As with other antibiotic
preparations, Actisite (tetracycline hydrochloride) periodontal
fiber therapy
may result in overgrowth
of nonsusceptible organisms, including fungi. Actisite should be
used with caution in patients with a history
of or predisposition
to oral candidiasis.
The safety and effectiveness
of Actisite fiber have
not been established for the treatment
of periodontitis
in patients with coexistent oral
candidiasis.
Use of antibiotic
preparations may result in the development
of resistant bacteria. Resistance has not been observed during 10
days of Actisite fiber therapy. The effects of prolonged treatment
have not been studied.
Management of patients with periodontal
disease should include
a consideration of potentially contributing medical
disorders.
Information for Patients
When Actisite fiber is
in place, patients should avoid actions that may dislodge the fiber.
Patients should receive the following instructions:
1.Do not chew hard, crusty, or sticky foods. 2.Do not brush or
floss near any treated areas. (Continue to clean other teeth.) 3.Do
not engage in any other hygienic
practices that could potentially dislodge the fibers. 4.Do not probe
at the treated area with
tongue or fingers. 5.Notify
the dentist promptly if the fiber
is dislodged or falls out before the scheduled recall visit, or
if pain or swelling
or other problems occur.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies with Actisite fiber
have not been performed to evaluate carcinogenic potential, mutagenic
potential, or effects on fertility.
Pregnancy Category C
Administration of tetracycline
during pregnancy may
cause permanent discoloration
of teeth of offspring.
Animal studies indicate that tetracyclines can cause
retardation of fetal
skeletal development.
Actisite fiber should
be administered to a pregnant
woman only if clearly
needed. Animal reproduction studies have not been conducted with
Actisite fiber. It is also not known whether Actisite fiber
can cause fetal
harm when administered to a pregnant woman or can affect
reproductive capacity.
Nursing Mothers
Tetracycline appears in breast
milk following oral
administration. It is not known whether tetracycline
is excreted in human milk
following use of Actisite® (tetracycline hydrochloride) periodontal
fiber. Because of the potential
for serious adverse reactions from tetracycline
HCl in nursing infants, Actisite fiber
should be used in a nursing
woman only if clearly
needed.
Pediatrics
The safety and effectiveness
of Actisite fiber in children
have not been established. Oral doses of tetracycline
in children up to 8 years of age
have caused permanent
discoloration of teeth.
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