DESCRIPTION: Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: anhydrous lactose, calcium stearate, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid.

Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C₆H₇N₃O and a molecular weight of 137.14. It has the following structure:

                                                                                                                                                     M.W. 137.14

Isoniazid is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether.
Isoniazid is slowly affected by exposure to air and light. 

CLINICAL PHARMACOLOGY: Within 1 to 2 hours after oral administration, isoniazid produces peak blood levels which decline to 50 percent or less within 6 hours. It diffuses readily into all body fluids (cerebrospinal, pleural, and ascitic fluids), tissues, organs, and excreta (saliva, sputum, and feces). The drug also passes through the placental barrier and into milk in concentrations comparable to those in the plasma. From 50 percent to 70 percent of a dose of isoniazid is excreted in the urine in 24 hours.

Isoniazid is metabolized primarily by acetylation and dehydrazination. The rate of acetylation is genetically determined. Approximately 50 percent of all Blacks and Caucasians are "slow inactivators" and the rest are "rapid inactivators"; the majority of Eskimos and Orientals are “rapid inactivators”.

The rate of acetylation does not significantly alter the effectiveness of isoniazid. However, slow acetylation may lead to higher blood levels of the drug and, thus, to an increase in toxic reactions.

Pyridoxine (vitamin B₆), deficiency is sometimes observed in adults with high doses of isoniazid and is considered probably due to its competition with pyridoxal phosphate for the enzyme apotryptophanase.

Mechanism of Action: Isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. At therapeutic levels isoniazid is bacteriocidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms.

Isoniazid resistant Mycobacterium tuberculosis bacilli develop rapidly when isoniazid monotherapy is administered.

Microbiology: Two standardized in vitro susceptibility methods are available for testing isoniazid against Mycobacterium tuberculosis organisms. The agar proportion method (CDC or NCCLS M24-P) utilizes middlebrook 7H10 medium impregnated with isoniazid at two final concentrations, 0.2 and 1.0 mcg/mL. MIC₉₉ values are calculated by comparing the quantity of organisms growing in the medium containing drug to the control cultures. Mycobacterial growth in the presence of drug > 1% of the control indicates resistance.

The radiometric broth method employs the BACTEC 460 machine to compare the growth index from untreated control cultures to cultures grown in the presence of 0.2 and 1.0 mcg/mL of isoniazid.

Strict adherence to the manufacturer's instructions for sample processing and data interpretation is required for this assay.

Mycobacterium tuberculosis isolates with an MIC₉₉ < 0.2 mcg/mL are considered to be susceptible to isoniazid. Susceptibility test results obtained by the two different methods discussed above cannot be compared unless equivalent drug concentrations are evaluated.

The clinical relevance of in vitro susceptibility for mycobacterium species other than M. tuberculosis using either the BACTEC or the proportion method has not been determined. 

INDICATIONS AND USAGE: 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 for a positive reaction to a skin test (in millimeters of induration) for each group is
given in parenthesis):

1. Persons with human immunodeficiency virus (HIV) infection (> 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 (> 5 mm). In addition, tuberculin-negative (< 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 (> 10 mm increase within a 2-year period for those < 35 years old; > 15 mm increase for those >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 (> 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-seronegative (>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 weight 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 prevent 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 therapy 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 (1 - 6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.

CONTRAINDICATIONS: Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and, acute liver disease of any etiology.

WARNINGS: See the boxed WARNING.

PRECAUTIONS: General: All drugs should be stopped and an evaluation made at the first sign of a hypersensitivity reaction. If isoniazid therapy must be reinstituted, the drug should be given only after symptoms have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent hypersensitivity reaction.

Use of isoniazid should be carefully monitored in the following:

1. Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of+ isoniazid hepatitis.
2. Patients with active chronic liver disease or severe renal dysfunction.  
3. Age >35.
4. Concurrent use of any chronically administered medication.

5. History of previous discontinuation of isoniazid.

6. Existence of peripheral neuropathy or conditions predisposing to

neuropathy.

7. Pregnancy.

8. Injection drug use.

9. Women belonging to minority groups, particularly in the postpartum

period.

10. HIV seropositive patients.

Laboratory Tests: Because there is a higher frequency of isoniazid

associated hepatitis among certain patient groups, including Age

>35, daily users of alcohol, chronic liver disease, injection drug use

and women belonging to minority groups, particularly in the postpartum

period, transaminase measurements should be obtained

prior to starting and monthly during preventative therapy, or more

frequently as needed. If any of the values exceed three to five times

the upper limit of normal, isoniazid should be temporarily discontinued

and consideration given to restarting therapy.

Drug Interactions: Food: Isoniazid should not be administered with

food. Studies have shown that the bioavailability of isoniazid is

reduced significantly when administered with food.

Acetaminophen: a report of severe acetaminophen toxicity was

reported in a patient receiving Isoniazid. It is believed that the toxicity

may have resulted from a previously unrecognized interaction

between isoniazid and acetaminophen and a molecular basis for

this interaction has been proposed. However, current evidence

suggests that isoniazid does induce P-450IIE1, a mixed-function

oxidase enzyme that appears to generate the toxic metabolites, in

the liver. Furthermore it has been proposed that isoniazid resulted

in induction of P-450IIE1 in the patients liver which, in turn,

resulted in a greater proportion of the ingested acetaminophen

being converted to the toxic metabolites. Studies have demonstrated

that pretreatment with isoniazid potentiates acetaminophen

hepatotoxicity in rats1,2.

Carbamazepine: Isoniazid is known to slow the metabolism of carbamazepine

and increase its serum levels. Carbamazepine levels

should be determined prior to concurrent administration with isoniazid,

signs and symptoms of carbamazepine toxicity should

be monitored closely, and appropriate dosage adjustment of the

anticonvulsant should be made3.

Ketoconazole: Potential interaction of Ketoconazole and Isoniazid

may exist. When Ketoconazole is given in combination with isoniazid

and rifampin the AUC of ketoconazole is decreased by as much

as 88% after 5 months of concurrent Isoniazid and Rifampin therapy4.

Phenytoin: Isoniazid may increase serum levels of phenytoin. To

avoid phenytoin intoxication, appropriate adjustment of the anticonvulsant

should be made5,6.

Theophylline: A recent study has shown that concomitant administration

of isoniazid and theophylline may cause elevated plasma

levels of theophylline, and in some instances a slight decrease in

the elimination of isoniazid. Since the therapeutic range of theophylline

is narrow, theophylline serum levels should be monitored

closely, and appropriate dosage adjustments of theophylline should

be made7.

Valproate: A recent case study has shown a possible increase in the

plasma level of valproate when co-administered with isoniazid.

Plasma valproate concentration should be monitored when isoniazid

and valproate are co-administered, and appropriate dosage

adjustments of valproate should be made8.

Carcinogenesis and Mutagenesis: Isoniazid has been shown to

induce pulmonary tumors in a number of strains of mice. Isoniazid

has not been shown to be carcinogenic in humans. (Note: a diagnosis

of mesothelioma in a child with prenatal exposure to isoniazid

and no other apparent risk factors has been reported). Isoniazid has

been found to be weakly mutagenic in strains TA 100 and TA 1535

of Salmonella typhimurium (Ames assay) without metabolic activation.

Pregnancy: Teratogenic effects: Pregnancy Category C: Isoniazid

has been shown to have an embryocidal effect in rats and rabbits

when given orally during pregnancy. Isoniazid was not teratogenic

in reproduction studies in mice, rats and rabbits. There are no adequate

and well-controlled studies in pregnant women. Isoniazid

should be used as a treatment for active tuberculosis during pregnancy

because the benefit justifies the potential risk to the fetus.

The benefit of preventive therapy also should be weighed against a

possible risk to the fetus. Preventive therapy generally should be

started after delivery to prevent putting the fetus at risk of exposure;

the low levels of isoniazid in breast milk do not threaten the

neonate. Since isoniazid is known to cross the placental barrier,

neonates of isoniazid treated mothers should be carefully observed

for any evidence of adverse affects.

Nonteratogenic effects: Since isoniazid is known to cross the placental

barrier, neonates of isoniazid-treated mothers should be

carefully observed for any evidence of adverse effects.

Nursing Mothers: The small concentrations of isoniazid in breast

milk do not produce toxicity in the nursing newborn; therefore,

breast feeding should not be discouraged. However, because levels

of isoniazid are so low in breast milk, they can not be relied upon

for prophylaxis or therapy of nursing infants.

ADVERSE REACTIONS: The most frequent reactions are those

affecting the nervous system and the liver.

Nervous System Reactions - Peripheral neuropathy is the most

common toxic effect. It is dose-related, occurs most often in the

malnourished and in those predisposed to neuritis (e.g., alcoholics

and diabetics), and is usually preceded by paresthesias of the feet

and hands. The incidence is higher in "slow inactivators".

Other neurotoxic effects, which are uncommon with conventional

doses, are convulsions, toxic encephalopathy, optic neuritis and

atrophy, memory impairment, and toxic psychosis.

Hepatic Reactions - See boxed WARNING. Elevated serum

transaminase (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice,

and occasionally severe and sometimes fatal hepatitis. The common

prodromal symptoms of hepatitis are anorexia, nausea, vomiting,

fatigue, malaise, and weakness. Mild hepatic dysfunction, evidenced

by mild and transient elevation of serum transaminase levels

occurs in 10% to 20% of patients taking isoniazid. This abnormality

usually appears in the first 1 to 3 months of treatment but

can occur at any time during therapy. In most instances, enzyme

levels return to normal, and generally, there is no necessity to discontinue

medication during the period of mild serum transaminase

elevation. In occasional instances, progressive liver damage

occurs, with accompanying symptoms. If the SGOT value exceeds

three to five times the upper limit of normal, discontinuation of the

isoniazid should be strongly considered. The frequency of progressive

liver damage increases with age. It is rare in persons under 20,

but occurs in up to 2.3 percent of those over 50 years of age.

Gastrointestinal Reactions - Nausea, vomiting, and epigastric distress.

Hematologic Reactions - Agranulocytosis; hemolytic, sideroblastic,

or aplastic anemia, thrombocytopenia; and eosinophilia.

Hypersensitivity Reactions - Fever, skin eruptions (morbilliform,

maculopapular, purpuric, or exfoliative), lymphadenopathy, and

vasculitis.

Metabolic and Endocrine Reactions - Pyridoxine deficiency, pellagra,

hyperglycemia, metabolic acidosis, and gynecomastia.

‘

Miscellaneous Reactions - Rheumatic syndrome and systemic

lupus erythematosus-like syndrome.

OVERDOSAGE: Signs and Symptoms - Isoniazid overdosage produces

signs and symptoms within 30 minutes to 3 hours after

ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring

of vision, and visual hallucinations (including bright colors and

strange designs) are among the early manifestations. With marked

overdosage, respiratory distress and CNS depression, progressing

rapidly from stupor to profound coma, are to be expected, along

with severe, intractable seizures. Severe metabolic acidosis, acetonuria,

and hyperglycemia are typical laboratory findings.

Treatment - Untreated or inadequately treated cases of gross isoniazid

overdosage, 80 mg/kg - 150 mg/kg, can cause neurotoxicity6

and terminate fatally, but good response has been reported in most

patients brought under adequate treatment within the first few

hours after drug ingestion.

For the Asymptomatic Patient: Absorption of drugs from the GI

tract may be decreased by giving activated charcoal. Gastric emptying

should also be employed in the asymptomatic patient.

Safeguard the patient's airway when employing these procedures.

Patients who acutely ingest > 80 mg/kg should be treated with

intravenous pyridoxine on a gram per gram basis equal to the isoniazid

dose. If an unknown amount of isoniazid is ingested, consider

an initial dose of 5 grams of pyridoxine given over 30 to 60

minutes in adults, or 80 mg/kg of pyridoxine in children.

For the Symptomatic Patient: Ensure adequate ventilation, support

cardiac output, and protect the airway while treating seizures and

attempting to limit absorption. If the dose of isoniazid is known, the

patient should be treated initially with a slow intravenous bolus of

pyridoxine, over 3 to 5 minutes, on a gram per gram basis, equal to

the isoniazid dose. If the quantity of isoniazid ingestion is unknown,

then consider an initial intravenous bolus of pyridoxine of 5 grams

in the adult or 80 mg/kg in the child. If seizures continue, the

dosage of pyridoxine may be repeated. It would be rare that more

than10 grams of pyridoxine would need to be given. The maximum

safe dose for pyridoxine in isoniazid intoxication is not known. If

the patient does not respond to pyridoxine, diazepam may be

administered. Phenytoin should be used cautiously, because isoniazid

interferes with the metabolism of phenytoin.

General: Obtain blood samples for immediate determination of

gases, electrolytes, BUN, glucose, etc.; type and cross-match blood

in preparation for possible hemodialysis.

Rapid control of metabolic acidosis: Patients with this degree of

INH intoxication are likely to have hypoventilation. The administration

of sodium bicarbonate under these circumstances can cause

exacerbation of hypercarbia. Ventilation must be monitored carefully,

by measuring blood carbon dioxide levels, and supported

mechanically, if there is respiratory insufficiency.

Dialysis: Both peritoneal and hemodialysis have been used in the

management of isoniazid overdosage. These procedures are probably

not required if control of seizures and acidosis is achieved with

pyridoxine, diazepam and bicarbonate.

Along with measures based on initial and repeated determination of

blood gases and other laboratory tests as needed, utilize meticulous

respiratory and other intensive care to protect against hypoxia,

hypotension, aspiration, pneumonitis, etc.

DOSAGE AND ADMINISTRATION (See also INDICATIONS): NOTE:

For preventive therapy of tuberculous infection and treatment of

tuberculosis, it is recommended that physicians be familiar with the

following 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 effective anti-tuberculosis agents. Drug susceptibility

testing should be performed on the organisms initially isolated

from all patients with newly 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: 5 mg/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 time/week

Patients with Pulmonary Tuberculosis Without HIV Infection -There

are 3 regimen options for the initial treatment of tuberculosis in

children and adults:

Option 1: 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 isoniazidresistant

Mycobacterium tuberculosisisolates 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 weekly isoniazid and rifampin for 16

weeks.

Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide,

and ethambutol or streptomycin for 6 months.

*All regiments given twice weekly or 3 times weekly should be

administered by directly observed therapy (see also Directly

Observed Therapy).

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 of 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 Infection

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 regimens are effective.

Because of the insufficient data, miliary tuberculosis, bone/joint

tuberculosis, and tuberculous meningitis in infants and children

should receive 12 months 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.

Corticosteriods 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 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 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, 20-30 mg/kg (not to exceed 900 mg) twice

weekly under the direct observation of a health care worker at the

time of administration8.

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 test9, a simple

colorimetric6 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

the malnourished and in those predisposed to neuropathy (e.g.,

alcoholics and diabetics).

HOW SUPPLIED: Isoniazid Tablets USP, 100 mg: White, round

tablets imprinted "West-ward" on one side and "260" on the scored

side.

Bottles of 100 tablets.

Bottles of 1000 tablets.

Unit Dose Boxes of 100 tablets.

Isoniazid Tablets USP, 300 mg: White, round, scored tablets

imprinted "West-ward 261".

Bottles of 30 tablets.

Bottles of 35 tablets.

Bottles of 100 tablets.

Bottles of 1000 tablets.

Unit Dose Boxes of 100 tablets

Store at controlled room temperature 15°-30°C (59°-86°F). Protect

from light and moisture. Dispense in a tight, light-resistant container

as defined in the USP using a child-resistant closure.

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. Jonville, 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;23rd edition;p487

9. Schraufnagel, DE; Testing for Isoniazid; Chest (United

States) 1990,August:98(2)p314-316.

Manufactured by:  
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724  

Revised October 2001

ISONIAZID TABLETS, USP

1260-1001-08

O=C NHNH2

N