Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant antituberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication, is inadequate therapy.

Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion a skin test (in millimeter of induration) for each group is given in parenthesis):

1. Persons with human immunodeficiency virus (HIV) infection (³ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection.

Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy.

2. Close contacts of persons with newly diagnosed infectious tuberculosis ³ 5 mm). In addition, tuberculinnegative (< 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (> 5 mm), therapy should be continued.

3. Recent converters, as indicated by a tuberculin skin test (³ 10 mm increase within a 2 -year period for those < 35 years old ³ 15 mm increase for those ³ 35 years of age). All infants and children younger than 4 years of age with a > 10 mm skin test are included in this category.

4. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis ( ³ 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.

5. Intravenous drug users known to be HIV-seroneg-ative ( > 10 mm).

6. Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease clinical situations associated with substantial rapid weigh loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that preven adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.

Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups:

1. Foreign-born persons from high-prevalence countries who never received BCG vaccine.

2. Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially Blacks, Hispanics, and Native Americans.

3. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes, and mental institutions).

Children who are less than 4 years old are candidates for isoniazid preventive the apy if they have > 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who

a) have none of the above risk factors (1-6);

b) belong to none of the high incidence groups; and

c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy.

The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactors over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (16) and on an individual basic situations where there is likelihood of serious consequences to contacts who may become infected.

(See also

INDICATIONS

NOTE: For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the f ollowing publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359 -1374, 1994.

For Treatment of Tuberculosis

Isoniazid is used in conjunction with other anti-tuberculosis agents. Drug susceptibility testing should be performed on the organisms initially isolated fro all patients with newl diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible.

Usual Oral Dosage (depending on the regimen used):

Adults: 5mg/kg up to 300 mg daily in a single dose; or 15 mg/kg up to 900 mg/day, two or three times/week.

Children: 10-15 mg/kg up to 300 mg daily in a single dose; or 20-40 mg/kg up to 900 mg/day, two or three times/week.

Patients with Pulmonary Tuberculosis Without HIV Infection: There are 3 regimen options for the initial treatment of tuberculosis in children and adults:

Option1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2-3 times weekly. Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent.

Option 2: Daily isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice isoniazid and rifampin for 16 weeks.

Option 3: Three times weekly with isoniazid rifampin, pyrazinamide, and ethambutol or streptomycin for 6 months.

All regimen given twice weekly or 3 times weekly should be administered by directly observed therapy (see also Directly Observed Therapy below).

The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact o resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.

Patients with Pulmonary Tuberculosis and HIV lnfection: The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co -infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.

Patients with Extra Pulmonary Tuberculosis: The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis, and tuberculous meningitis in infants and children should receive 12 month therapy.

Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings.

The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott's Disease. Corticosteroids have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.

Pregnant Women with Tuberculosis: The options listed above must be adjusted for the pregnant patient Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).

Treatment of Patients with Multi-Drug Resistan Tuberculosis (MDRTB): Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.

Directly Observed Therapy (DOT): A major cause of drugresistant tuberculosis is patient non -compliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests antituberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.

For Preventative Therapy of Tuberculosis

Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed it Extra pulmonary tuberculosis is suspected.

Adults over 30 Kg: 300 mg per day in a single dose.

Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20-30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration.

Continuous administration of isoniazid for a sufficient period is an essential proof of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis resistant organisms may multiple and the emergence of resistant organisms during the treatment may necessitate a change in the regimen.

For following patient compliance: the Potts-Cozart test, a simple colorimetric method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance.

Concomitant administration of pyridoxine (B6) is recommended in malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).

Isoniazid Tablets, USP are available as

100 mg: White, round. scored, flat-faced tablets.

Debossed with Barr/066 on one side and 100 on the other side. Available in bottles of:

30 NDC 0555-0066-01

100 NDC 0555-0066-02

1000 NDC 0555-0066-05

300 mg: White, round, scored, flat-faced tablets.

Debossed with Barr/071 on one side and 300 on the other side. Available in bottles of:

30 NDC 0555-0071-01

60 NDC 0555-0071-09

100 NDC 0555-0071-02

200 NDC 0555-0071-20

1000 NDC 0555-0071-05

Protect from moisture and light. Dispense with a child-resistant closure in a well-closed, lightresistant container as defined in the USP/NF. Store at controlled room temperature 15º-30º C (59º-86º F).

CAUTION: Federal law prohibits dispensing without prescription

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