Dosing & Uses
Dosage Forms & Strengths
Intradermal solution
- 5 Unit/0.1mL
Tuberculosis
Diagnosis: Mantoux test, inject 0.1 mL (5 tuberculin units) intradermally; the result is read 48 to 72 hours after administration
Positive if 10 mm induration
Use 1 TU in sensitized patients, 250 TU if no response to 5 TU
Dosage Forms & Strengths
Intradermal solution
- 5 Unit/0.1mL
Tuberculosis
Diagnosis: Mantoux test, inject 0.1 mL (5 tuberculin units) intradermally; the result is read 48 to 72 hours after administration
Positive if 10 mm induration
Use 1 TU in sensitized patients, 250 TU if no response to 5 TU
Tuberculosis
Diagnosis: Mantoux test, inject 0.1 mL (5 tuberculin units) intradermally; the result is read 48-72 hours after administration
Positive if >10 mm induration
Use 1 TU in sensitized patients, 250 TU if no response to 5 TU
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
Frequency Not Defined
Rash
Itch
Vesiculation
Ulceration
Necrosis
Pain
Warnings
Contraindications
Hypersensitivity
Previous positive tuberculin skin test responsiveness suppressed within 6 weeks of viral infection, inactive TB
Cautions
Contains soluble growth products from tubercle bacillus
Old tuberculin (OT) is culture filtrate of uniform potency
PPD is more refined and is preferred product
Multiple puncture device (Aplitest, SclavoTest-PPD, Tine Test PPD) not as sensitive
A number of factors 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.
Test results are less reliable in HIV-infected individuals as CD4 counts decline
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.
The predictive value of the tuberculin skin test depends on the prevalence of infection with M. tuberculosis and the relative prevalence of cross-reactions with nontuberculous mycobacteria
A separate, sterile, single-use disposable syringe and needle should be used for each individual patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another; special care should be taken to ensure that the product is injected intradermally and not into a blood vessel
Before administration of Aplisol, review the patient’s history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of the agent, and the presence of any contraindication to the test
As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
Failure to store and handle the drug as recommended may result in a loss of potency and inaccurate test results
Reactivity to the test may be depressed or suppressed for as long as 5–6 weeks in individuals following immunization with certain live viral vaccines, viral infections or discontinuation of corticosteroids or immunosuppressive agents
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known if excreted in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antigenic purified protein derivative (PPD) of Mycobacterium tuberculosis; patients become sensitized to certain antigenic components of the M. tuberculosis organism.
Pharmacokinetics
Onset of action: 5-6hr (delayed hypersensitivity reactions)
Peak effect: 48-72 hr
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Tubersol intradermal - | 5 tub. unit /0.1 mL vial | ![]() | |
Tubersol intradermal - | 5 tub. unit /0.1 mL vial | ![]() | |
Aplisol intradermal - | 5 tub. unit /0.1 mL vial | ![]() | |
Aplisol intradermal - | 5 tub. unit /0.1 mL vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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