Isoniazid (Page 4 of 4)

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 Resistant 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 drug-resistant tuberculosis is patient noncompliance 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 anti-tuberculosis 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 if 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 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration 8.

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

For following patient compliance: the Potts-Cozart test 9 , a simple colorimetric 6 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 (B 6 ) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).

HOW SUPPLIED

Isoniazid Tablets USP are available as follows:

300 mg: White to off-white, oval-shaped, scored, flat-faced, beveled-edge tablet, debossed with stylized b on one side and 071 over 300 on the other side. Available in bottles of 30 tablets (NDC 43063-463-30).

Protect from moisture and light.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

References

  1. Murphy, R., et al: Annuals of Internal Medicine; 1990: November 15; volume 113: 799-800.
  2. Burke, R.F., et al: Res Commun Chem Pathol Pharmacol; 1990: July; vol. 69: 115-118.
  3. Fleenor, M.F., et al: Chest (United States) Letter; 1991; June; 99 (6): 1554.
  4. Baciewicz, A.M. and Baciewicz, Jr. F.A.: Arch Int Med 1993: September; volume 153: 1970-1971.
  5. Jonviller, A.P., et al: European Journal of Clinical Pharmacol (Germany), 1991: 40 (2) p198.
  6. American Thoracic Society/Centers for Disease Control: Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children. Amer. J. Respir Crit Care Med. 1994; 149: p1359-1374.
  7. Hoglund P., et al: European Journal of Respir Dis (Denmark) 1987: February; 70 (2) p110-116.
  8. Committee on infectious Diseases American Academy of Pediatrics: 1994, Red Book: Report of the Committee on Infectious Diseases; 23 edition; p487.
  9. Schraufnagel, DE; Testing for Isoniazid; Chest (United States) 1990: August; 98 (2) p314-316.

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Package/Label Display Panel

image
(click image for full-size original)

Isoniazid Tablets USP 300 mg Label Text

Isoniazid

Tablets USP

300 mg

Rx only

ISONIAZID
isoniazid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-463(NDC:0555-0071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISONIAZID (ISONIAZID) ISONIAZID 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code b;071;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-463-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080937 09/01/1972
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-463)

Revised: 11/2021 PD-Rx Pharmaceuticals, Inc.

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