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Isoniazid
Overview
What is Isoniazid?
Isoniazid is an antibacterial available as 100 mg or 300 mg tablets for oral administration.
Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula:
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.
Inactive Ingredients:
What does Isoniazid look like?
What are the available doses of Isoniazid?
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What should I talk to my health care provider before I take Isoniazid?
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How should I use Isoniazid?
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 HIVseronegative ( > 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.
(See also ):
NOTE
What interacts with Isoniazid?
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What are the warnings of Isoniazid?
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What are the precautions of Isoniazid?
Sorry No Records found
What are the side effects of Isoniazid?
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 percent 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.
What should I look out for while using Isoniazid?
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.
See boxed warning.
What might happen if I take too much Isoniazid?
How should I store and handle Isoniazid?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Isoniazid Tablets, USP are available as:Protect from moisture and light.Dispense with a child-resistant closure in a well-closed, light-resistant container as defined in the USP/NF.Store at controlled room temperature 15° - 30° C (59° - 86°F).Rx onlyIsoniazid Tablets, USP are available as:Protect from moisture and light.Dispense with a child-resistant closure in a well-closed, light-resistant container as defined in the USP/NF.Store at controlled room temperature 15° - 30° C (59° - 86°F).Rx onlyIsoniazid Tablets, USP are available as:Protect from moisture and light.Dispense with a child-resistant closure in a well-closed, light-resistant container as defined in the USP/NF.Store at controlled room temperature 15° - 30° C (59° - 86°F).Rx onlyIsoniazid Tablets, USP are available as:Protect from moisture and light.Dispense with a child-resistant closure in a well-closed, light-resistant container as defined in the USP/NF.Store at controlled room temperature 15° - 30° C (59° - 86°F).Rx onlyIsoniazid Tablets, USP are available as:Protect from moisture and light.Dispense with a child-resistant closure in a well-closed, light-resistant container as defined in the USP/NF.Store at controlled room temperature 15° - 30° C (59° - 86°F).Rx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 organisms.
Isoniazid resistant bacilli develop rapidly when isoniazid monotherapy is administered.
Non-Clinical Toxicology
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.See boxed warning.
Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see ).
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 post-partum period.
10. HIV seropositive patients.
The most frequent reactions are those affecting the nervous system and the liver.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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