Aplisol, Mantoux (tuberculin purified protein derivative) dosing, indications, interactions, adverse effects, and more

Sections

Sections tuberculin purified protein derivative
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatricGeriatric

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

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.

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

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Aplisol intradermal -	5 tub. unit /0.1 mL vial
Aplisol intradermal -	5 tub. unit /0.1 mL vial
Tubersol intradermal -	5 tub. unit /0.1 mL vial
Tubersol intradermal -	5 tub. unit /0.1 mL vial

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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