(Tuberculin Purified Protein Derivative,
Diluted [Stabilized Solution])
Therapeutic Class: Diagnostic Agent
This product is manufactured and
distributed by JHP Pharmaceuticals, LLC
Purified Protein Derivative, Diluted
- Bar Coded
- The 0.1 mL
test dose of Aplisol® is
clinically bioequivalent in
potency to the standard PPD-S (5
TU dose per 0.1 mL) of the US
Public Health Service, National
Centers for Disease Control.
- The result is
read by a healthcare
professional, 48 to 72 hours
after injection and induration
only is considered in
interpreting the test.
Aplisol® (tuberculin PPD, diluted)
is a sterile aqueous solution of a
purified protein fraction for
intradermal administration as an aid
in the diagnosis of tuberculosis.
The solution is stabilized with
polysorbate (Tween) 80, buffered
with potassium and sodium phosphates
and contains approximately 0.25%
phenol as a preservative. This
product is ready for immediate use
without further dilution.
Indications and Usage
Tuberculin PPD is indicated as an
aid in the detection of infection
with Mycobacterium tuberculosis. The
standard tuberculin test employs the
intradermal (Mantoux) test using a 5
TU dose of tuberculin PPD.
The 0.1 mL test dose of Aplisol®
(tuberculin PPD, diluted) is
equivalent to the 5 TU dose which
has been clinically utilized and
standardized with PPD-S. Tuberculin
skin testing is not contraindicated
for persons who have been vaccinated
with BCG and the skin-test results
of such persons are used to support
or exclude the diagnosis of M.
HIV infection is a strong risk
factor for the development of TB
disease in persons having TB
infection. All HIV-infected persons
should receive a PPD-tuberculin skin
Aplisol® is contraindicated in
patients with known hypersensitivity
or allergy to Aplisol® or any of its
components. Aplisol® should not be
administered to persons who have
previously experienced a severe
reaction (e.g., vesiculation,
ulceration, or necrosis) because of
the severity of reactions that may
occur at the test site.
Aplisol® should not be administered to persons
who previously experienced a severe reaction
(e.g., vesiculation, ulceration, or necrosis)
because of the severity of reactions that may
occur at the test site (see CONTRAINDICATIONS of
Not all infected persons will have a delayed hypersensitivity reaction
to a tuberculin test. A number of factors have
been reported to cause a decreased ability to
respond to the tuberculin test, such as the
presence of infections, viral infections
(measles, mumps, chickenpox, HIV), live virus
vaccinations (measles, mumps, rubella and other
live vaccines), bacterial infections (typhoid
fever, brucellosis, typhus, leprosy, pertussis,
overwhelming tuberculosis, tuberculous
pleurisy), fungal infections (South American
blastomycosis), drugs (corticosteroids and other
immunosuppressive agents), metabolic
derangements (chronic renal failure), low
protein states (severe protein depletion,
afibrinogenemia), age (newborns, elderly
patients with waned sensitivity), stress
(surgery, burns, mental illness,
graft-versus-host reactions), diseases affecting
lymphoid organs (Hodgkin’s disease, lymphoma,
chronic leukemia, sarcoidosis), and malignancy.
Any condition that impairs or attenuates
cell-mediated immunity potentially can cause a
false negative reaction, including aging.
Tuberculin skin test results are less reliable
in HIV-infected individuals as CD4 counts
decline (see CLINICAL PHARMACOLOGY of
Avoid injecting tuberculin subcutaneously.
If this occurs, no local reaction develops, but
a general febrile reaction and/or acute
inflammation around old tuberculous lesions may
occur in highly sensitive individuals.
In highly sensitive individuals, strongly positive
reactions including vesiculation, ulceration or necrosis
may occur at the test site. Cold packs or topical
steroid preparations may be employed for symptomatic
relief of the associated pain, pruritus and discomfort.
Strongly positive test reactions may result in scarring
at the test site.
Immediate erythematous or other reactions may occur at
the injection site.
Local hypersensitivity reactions may occur at the
injection site including erythema, pruritus, edema,
urticaria and rash.
Systemic allergic reactions including
anaphylaxis/anaphylactoid reactions have been reported
to occur in association with the use of Aplisol®. The
reactions, including anaphylaxis, generally occurred
within 24 hours of exposure and manifestations included
rash, urticaria, edema/angioedema and pruritus.
For references see full prescribing information.
Please see the full prescribing information
link above for additional information.
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