Tuberculin Purified Protein Derivative


Generic Medicine Info
Indications and Dosage
Intradermal
Mantoux test
Adult: Standard doses may differ among individual products or between countries as the units are not equivalent (refer to local specific product guidelines). As preparation containing 5 Tuberculin Units (TU)/0.1 mL: 5 TU (0.1 mL) to be injected slowly on the volar aspect of the forearm. As preparation containing 2 TU/0.1 mL: 2 TU (0.1 mL) for 1 dose, slowly administered into the middle third of the forearm (palm-up). Correct intradermal inj forms a small round wheal (approx 6-10 mm in diameter), which will remain visible for approx 10 minutes. The result will be read after 48-72 hours of administration. Measure the palpable induration only; redness is not considered in interpreting the test. Refer to detailed product guideline for the interpretation of tuberculin reaction.
Child: As preparation containing 5 TU/0.1 mL: ≥6 months Same as adult dose.
Contraindications
Hypersensitivity to tuberculin purified protein derivative (PPD). Previous severe reaction (e.g. anaphylactic shock, vesiculation, necrosis, ulceration) to tuberculin PPD skin test (TST); documented active TB or clear history of TB infection or disease treatment, extensive burns or eczema.
Special Precautions
Patient with bacterial (e.g. typhoid fever, pertussis), fungal (e.g. South American blastomycosis) or viral (e.g. influenza, measles, HIV) infections; chronic renal failure, severe protein depletion, afibrinogenaemia and other conditions that impair immune response; diseases affecting lymphoid organs (e.g. Hodgkin's disease, lymphoma, chronic leukaemia, sarcoidosis), malignancy, altered or attenuated cell-mediated immunity (CMI). Malnourished patients and those under stressful conditions (e.g. surgery, burns, mental illness, graft-versus-host reactions). Pregnancy and lactation.
Adverse Reactions
Significant: Vesiculation, ulceration or necrosis at inj site (particularly in highly sensitive patients); syncope.
General disorders and administration site conditions: Fever, inj site reactions (e.g. pain, pruritus, discomfort, erythema, urticaria, rash (without induration), oedema, haematoma, haemorrhage; scarring [for strongly positive reactions]).
Nervous system disorders: Presyncope, headache.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, stridor.
Skin and subcutaneous tissue disorders: Generalised rash.
Potentially Fatal: Rarely, allergic reactions, including anaphylaxis/anaphylactoid reactions and angioedema.
Intradermal/Parenteral: C
Monitoring Parameters
Monitor for immediate hypersensitivity reactions (approx 15 minutes following inj).
Drug Interactions
Reactivity to the test may be diminished or suppressed by concomitant corticosteroids or immunosuppressive agents, or following recent immunisation with certain live virus vaccines (e.g. measles, mumps, rubella, oral polio, yellow fever, varicella).
Action
Description: Tuberculin purified protein derivative (PPD) is a PPD preparation obtained from the culture of selected strains of Mycobacterium tuberculosis. It is used as a skin test to aid in the diagnosis of TB in individuals suspected of having clinical tuberculosis or in those at high risk for developing active TB disease.
Synonym: tuberculin PPD.
Onset: Delayed hypersensitivity reactions: 5-6 hours.
Duration: Reactions will subside over a few days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
Radiographic & Diagnostic Agents
ATC Classification
V04CF01 - tuberculin ; Belongs to the class of diagnostic agents used to test for tuberculosis.
References
Anon. Tuberculin Tests. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/11/2021.

Anon. Tuberculin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 23/11/2021.

Aplisol Injection (Par Pharmaceutical Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/11/2021.

Buckingham R (ed). Tuberculins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/11/2021.

Joint Formulary Committee. Tuberculin Purified Protein Derivative. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/11/2021.

Sanofi-Aventis New Zealand Limited. Tubersol 5 TU/0.1 mL, Solution for Injection data sheet 02 May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 23/11/2021.

Tuberculin PPD RT 23 AJV (Pharmaniaga LifeScience Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/12/2021.

Tuberculin PPD RT23 SSI (Statens Serum Institute). MIMS Indonesia. http://www.mims.com/indonesia. Accessed 23/11/2021.

Tuberculin Skin Testing. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 23/11/2021.

Tubersol (Sanofi Pasteur Inc.). U.S. FDA. https://www.fda.gov. Accessed 23/11/2021.

Tubersol (Sanofi Pasteur Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/11/2021.

Disclaimer: This information is independently developed by MIMS based on Tuberculin Purified Protein Derivative from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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