Aplisol

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tuberculin injection in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of tuberculin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Extensive skin burns or eczema (skin disease) or
• Tuberculosis, active or history of—Should not be given to patients with these conditions.

• HIV infection or AIDS or
• Organ transplant, history of or
• Weak immune system—May increase your risk of developing active tuberculosis.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-888-INFO-FDA (1-888-463-6332) or www.fda.gov/medwatch/.

• Seibert, F.B. The isolation and properties of the purified protein derivative of tuberculin: Am Rev Tuberc 1934; 30:713. • Seibert, F.B., and Glenn, J.T. Tuberculin purified protein derivative. Preparation and analyses of a large quantity for standard. Am Rev Tuberc 1941; 44:9-25. • Centers for Disease Control and Prevention (CDC). Essential components of a tuberculosis prevention and control program; and Screening for tuberculosis and tuberculosis infection in high-risk populations: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1995;44(RR-11):1-34. • Centers for Disease Control and Prevention (CDC). Prevention and control of tuberculosis in correctional facilities: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1996;45(RR-8):1-27. • Huebner RE, Shein MF, Bass JB. The Tuberculin Skin Test. Clin Infect Dis 1993;17:968–75. • AHFS Drug Information, 1997, 36:84 pp 1962–1968. • American Thoracic Society: Diagnostic standards and classification of tuberculosis in Adults and Children. Am J Respir Crit Care Med 2000 Apr; 161:1376-95. • Am Rev Respir Dis 1985;886. • Brickman HF et.Al. The Timing of Tuberculin Tests in Relation to Immunization with Live Viral Vaccines. Pediatrics 1975;55:392. • Nakayama K, Monma M, Fukushima T, Ohrui T, Sasaki H. Tuberculin responses and risk of pneumonia in immobile elderly patients. Thorax 2000 Oct;55(10):867-9. • Fukushima T, Nakayama K, Monma M, Sekizawa K, Sasaki H. Depression of T helper-1 and the tuberculin responses in older bed-bound patients. J Am Geriatri Soc 1999 Feb;47(2):259-260. • American Academy of Pediatrics. Tuberculosis. In: Pickering LK, CJ Baker, Long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed. Elk Grove Village, IL: American Academy of Pediatrics 2006: 678-698. • Landi S, Held HR. Stability of a dilute solution of tuberculin purified derivative at extreme temperatures. J Biol Stand 1981; 9:195. • Centers For Disease Control and Prevention (CDC). Diagnosis of TB Infection and TB Disease, March 21,1996, Doc# 2250102. • Sewell, E.M., O'Hare, D., and Kendig, E.L., Jr. The Tuberculin Test. Pediatrics Vol. 54, No. 5, Nov.1974. • Centers for Disease Control and Prevention(CDC). Prevention and control of tuberculosis in facilities providing long-term care to the elderly. Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET): MMWR 1990, 39(RR-10): 7–20. • Centers for Disease Control and Prevention(CDC). The use of preventative therapy for tuberculosis infection in the United States, Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET), MMWR 1990 39(RR-8):9–12. • Centers for Disease Control and Prevention(CDC). Screening for tuberculosis and tuberculosis infection in high risk populations. Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET), MMWR 1990, 39(RR-8): 1-7. • Centers for Disease Control and Prevention (CDC). Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR, 2000. 49(RR-6): 1-51. • Pediatrics: Screening for Tuberculosis in Infants and Children, 1994. 93: 131-134. • Centers for Disease Control and Prevention (CDC). Controlling Tuberculosis in the United States. MMWR 2005. 54 (RR-12).

Rx only.

Manufactured by:
Par Pharmaceutical Companies, Inc.
Spring Valley, NY 10977

I08/14
OS104J-1-90-01

3003008D

NDC 42023-104-01

Rx Only

Tuberculin,
Purified Protein
Derivative, Diluted
Aplisol®

5 TU/0.1 mL

For Intradermal Test in
the Diagnosis of Tuberculosis

Stabilized Solution

Latex Free

1 mL (10 tests)

Summary of Use during Lactation

There is no reason to withhold breastfeeding after tuberculosis skin testing or to avoid skin testing in nursing mothers.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

There is some evidence that breastfed infants can acquire immune responsiveness to tuberculin via breastmilk.[1][2][3] However, other investigators have found no evidence of breastmilk transfer of immunity.[4]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Martinez-Cairo Cueto S, Alasio-Chavez C, Davila Velasquez JR. [In vitro transfer of immunity against PPD with dialyzable extract of leukocytes from human colostrum]. Rev Alerg. 1992;39:126-32. PMID: 1492196

2. Schlesinger JJ, Covelli HD. Evidence for transmission of lymphocyte responses to tuberculin by breast-feeding. Lancet. 1977;2:529-32. PMID: 95733

3. Masters PL. Maternal transmission of skin sensitivity to tuberculin. Lancet. 1982;2:276-7. PMID: 6124704

4. Keller MA, Rodgriguez AL, Alvarez S et al. Transfer of tuberculin immunity from mother to infant. Pediatr Res.1987;22:277-81. PMID: 3658548

Substance Name

Tuberculin

CAS Registry Number

92129-86-7

Drug Class

Antigens

Purified Protein Derivative